Real testimonials put ORENCIA in the spotlight

This is a transcript for the “How to Use the ClickJect™ Autoinjector” video found on the ORENCIA resources page.

Narrator: Indication/Usage and Important Safety Information for ORENCIA (abatacept).

Adult Rheumatoid Arthritis (RA): ORENCIA is a prescription medicine that reduces signs and symptoms in adults with moderate to severe RA, including those who have not been helped enough by other medicines for RA.

ORENCIA may prevent further damage to your bones and joints and may help your ability to perform daily activities.

In adults, ORENCIA may be used alone or with other RA treatments other than Janus kinase (JAK) inhibitors or biologic disease-modifying antirheumatic drugs (bDMARDs) such as tumor necrosis factor (TNF) antagonists.

Adult Psoriatic Arthritis (PsA): ORENCIA is a prescription medicine that reduces signs and symptoms in adults with active psoriatic arthritis (PsA). In adults, ORENCIA may be used alone or with other PsA treatments.

The concomitant use of ORENCIA with other potent immunosuppressants, for example, bDMARDs, JAK inhibitors, is not recommended.

Your Guide to Self-Injection With the ClickJect Autoinjector

Jeannie: Hi, my name is Jeannie, and I'm a nurse.

As a nurse, I've had the experience of helping many people learn how to take their medication.

If you and your healthcare provider have decided that the ClickJect prefilled Autoinjector is right for you, I'd like you to meet my patient, Lisa, who, along with her healthcare provider, chose the ClickJect Autoinjector.

When she first started ORENCIA, I gave her a hands-on demonstration and helped her with her first injection in her healthcare provider's office.

Now, she will show you how to use it and how it can become routine for you, too.

Let's meet Lisa.

Lisa: Hi, I'm Lisa, and I have moderate to severe rheumatoid arthritis.

When my healthcare provider talked to me about biologic medications, we decided that I would take ORENCIA through weekly self-injections with the ClickJect Autoinjector.

It was a good choice for me. I've given myself injections for a while now, so I'm ready to show you how it's done.

To train me, Jeannie, my nurse, took me through the process step by step.

You, however, could have been trained by your healthcare provider or another healthcare professional.

If you're not comfortable doing the injection yourself, a family member or a friend who's also been trained by your healthcare provider's office can do it for you.

You might feel a little nervous about giving yourself an injection—I know I was—but after a few times, it becomes much more routine.

Think about the time of day you'll self-inject. You want to focus on your injection, not juggling other things.

By the way, what I'm describing is an overview of how to inject.

For detailed instructions, read the Instructions for Use included in the Full Prescribing Information located in the same box as your autoinjectors came in. You can also call your healthcare provider's office.

Remember, if you still have questions, you can call 1-800-ORENCIA (1-800-673-6242), and an ORENCIA nurse will be available to walk you through it.

Okay, the first step is to gather supplies for self-injection on a clean, flat surface and get a ClickJect ready for use.

You will need an alcohol swab, a cotton ball or a gauze, and a disposable SHARPS container to dispose of the used ClickJect.

You may also choose to have a small adhesive bandage available should you need it.

Next, carefully remove one autoinjector from the carton kept in the refrigerator. Keep the Autoinjector refrigerated until ready to prepare your injection. Do not freeze. Do not remove the Autoinjector needle cover until you're ready to inject.

Before you do anything else, check the expiration date on the side of the ClickJect.

If the date has passed, do not use it. Dispose of it properly, which I will explain how to do later, and select a new ClickJect Autoinjector.

Call 1-800-ORENCIA (1-800-673-6242) about the expired date on the ClickJect.

Now, check the liquid in the ClickJect by holding it by the grip with the covered needle pointing downward and looking through the viewing window.

The liquid should be clear and colorless to pale yellow.

Narrator: If the liquid is cloudy, discolored, or if you can see particles in it, do not use the ClickJect and call 1-800-ORENCIA to report it.

Lisa: It is normal to see an air bubble in the liquid. There is no reason to remove it.

Inspect the ClickJect for any damage. If the ClickJect is damaged, do not use it and do not remove the needle cover. Call 1-800-ORENCIA.

After checking, let it rest at room temperature for 30 minutes.

Do not remove the needle cover while allowing it to reach room temperature.

Narrator: Do not try to speed up the warming process in any way, such as using the microwave or placing the ClickJect in warm water. Do not leave the ClickJect unsupervised and do not shake it. Replace the box with the remaining autoinjectors in the refrigerator.

Lisa: Wash your hands thoroughly with soap and warm water.

Next, choose and clean the place on your body where you will administer the injection.

The front of the thigh and the abdomen are the recommended injection sites, except for the two-inch area around the navel.

I sometimes use the same thigh for weekly injections since the same area of the body can be used each week as long as the different injection site in that area is chosen.

I always make sure the new site is at least an inch away from the previous injection site in that same area.

Do not inject into areas where the skin is tender, bruised, red, scaly, or hard. Do not inject in any areas with scars or stretch marks.

The outer area of the upper arms may be used only if the injection is being given by a caregiver.

Don't attempt to use the upper-arm area yourself.

Clean the injection site with an alcohol swab and let the skin dry.

The next step is to administer the injection. To remove the needle cover, the orange cap, I hold the grip of the ClickJect in one hand and pull the cover straight off with my other hand.

It is important to pull the needle cover straight off, so you will not damage the ClickJect.

Narrator: Do not put the needle cap back on. You can discard it in your household waste after injection.

Do not use ClickJect if dropped after removing the needle cover.

It's normal to see a drop of fluid leaving the needle.

Continue to hold the grip of the ClickJect in one hand.

Use your other hand to gently pinch the area of the skin that you cleaned and hold it firmly.

Hold the ClickJect, so you can see the viewing window, and make sure to position it at a 90-degree angle to the injection site.

Push the ClickJect down on the skin to unlock the autoinjector.

This unlocks the blue activation button on the top of the ClickJect.

Press the blue activation button while holding the ClickJect firmly against the skin.

You will hear a click as the injection begins.

Hold it in place for 15 seconds, waiting for the blue indicator to stop moving in the viewing window.

Narrator: When the blue indicator stops moving, the injection is complete.

(Image of pinched skin) Push Autoinjector down into the skin. Press blue button and hold for 15 seconds for full delivery. Wait until blue indicator stops moving.

Lisa: Remove the ClickJect from the injection site by lifting it straight up. Once you remove it from your skin, the transparent tip will lock over the needle, then release the pinched area of skin.

If there is any bleeding, press a cotton ball over the ejection site and hold it without rubbing the skin. Apply a small adhesive bandage if needed.

Watch for injection site reactions. If you have any pain, swelling, or discoloration near the injection site, call your healthcare provider.

Dispose of the used ClickJect Autoinjector into an FDA-cleared SHARPS disposal container right after use.

Narrator: Do not replace the cap on the used ClickJect. Instead, you can throw the cap in your household trash.

Do not throw the ClickJect into household trash.

Keep the autoinjectors and the SHARPS disposal container out of reach of children.

If a caregiver is administering the injection, they should handle the ClickJect carefully afterwards as well to avoid accidental needlestick injury and possibly spreading infection.

(On-screen text: You should always receive your initial training at your doctor's office.)

Lisa: I find it helpful to keep a record of the date, time, and site where I administered the injection and any problems that I encountered so that I can discuss them with my healthcare provider if needed.

That's the procedure to use for the ORENCIA ClickJect prefilled Autoinjector.

Remember, if you still have questions, talk to your healthcare provider, or you can call 1-800-ORENCIA, and an ORENCIA nurse will be available to walk you through it.

When you call 1-800-ORENCIA (1-800-673-6242), you can also sign up for the ORENCIA On Call Patient Support Program.

ORENCIA On Call can help with the issues that matter to you, like living with moderate to severe rheumatoid arthritis, questions regarding health insurance coverage for ORENCIA, and how to take your medication.

You can also get a SHARPS container and travel pack for your ClickJect Autoinjectors.

When you sign up for ORENCIA On Call, personal ORENCIA Care Counselors will be available 24/7 to provide answers and support. No matter where you are in your treatment journey, your Care Counselor is just a phone call or click away with the resources you need.

Please know that neither the Care Counselor nor the nurse can provide medical advice.

Your doctor is the best source of information about your health.

(Narrator) Indications/Usage and Important Safety Information for ORENCIA (abatacept).

Indications/Usage.

Adult Rheumatoid Arthritis (RA): ORENCIA is a prescription medicine that reduces signs and symptoms in adults with moderate to severe RA, including those who have not been helped enough by other medicines for RA.

ORENCIA may prevent further damage to your bones and joints and may help your ability to perform daily activities.

In adults, ORENCIA may be used alone or with other RA treatments other than Janus kinase (JAK) inhibitors or biologic disease-modifying antirheumatic drugs (bDMARDs), such as tumor necrosis factor (TNF) antagonists.

Adult Psoriatic Arthritis (PsA): ORENCIA is a prescription medicine that reduces signs and symptoms in adults with active psoriatic arthritis. In adults, ORENCIA may be used alone or with other PsA treatments.

The concomitant use of ORENCIA with other potent immunosuppressants, for example, bDMARDs, JAK inhibitors, is not recommended.

Important Safety Information

Inform your healthcare provider of the following before you receive treatment with ORENCIA (abatacept):

Infections: If you have any kind of infection, even if it is small, such as an open cut or sore, an infection that is in your whole body, such as the flu, an infection that will not go away, or a history of infections that keep coming back. ORENCIA may make your immune system less able to fight infections, so you may be more likely to get infections, or any infection you have may get worse.

Tuberculosis: If you have had tuberculosis (TB), a positive skin test for TB, or if you have recently been in close contact with someone who has had TB. If you get any of the symptoms of TB—a cough that does not go away, weight loss, fever, night sweats—call your healthcare provider right away.

Before you start ORENCIA, your healthcare provider may examine you for TB or perform a skin test.

If you have or have had Viral Hepatitis. Before you use ORENCIA, your healthcare provider may examine you for hepatitis.

If you have a history of Chronic Obstructive Pulmonary (lung) Disease (COPD).

If you are scheduled to have surgery.

Allergies to the ingredients of ORENCIA (abatacept):

The ingredients of intravenous (IV) ORENCIA are: abatacept, maltose, monobasic sodium phosphate, and sodium chloride for administration.

The ingredients of subcutaneous (SC) ORENCIA are: abatacept, sucrose, poloxamer 188, monobasic sodium phosphate monohydrate, dibasic sodium phosphate anhydrous, and water for injection.

Vaccinations: If you have recently received a vaccination or are scheduled for any vaccination. If you are receiving ORENCIA, and for three months after you stopped receiving ORENCIA, you should not take live vaccines.

Diabetes: If you have diabetes and use a blood glucose monitor to check your sugar levels. The infusion of ORENCIA contains maltose, a sugar that can give falsely high blood glucose readings with some monitors on the day you receive your infusion. Your healthcare provider may tell you to use a different way to monitor your blood sugar levels.

ORENCIA for SC injection does not contain maltose. Therefore, you do not need to change the way you monitor your blood sugar if you are taking ORENCIA subcutaneously.

Pregnancy: If you are pregnant, or plan to become pregnant. It is not known if ORENCIA can harm your unborn baby. If you took ORENCIA during pregnancy, talk to your healthcare provider before your baby receives any vaccines.

There is a registry for pregnant women exposed to ORENCIA. The purpose of this registry is to check the health of the pregnant mother and her child.

Women are encouraged to call the registry themselves or ask their healthcare provider to contact the registry for them by calling 1-877-311-8972.

Breastfeeding: It is not known if ORENCIA (abatacept) passes into your breast milk. Talk to your healthcare provide about the best way to feed your baby if you use ORENCIA.

Skin cancer: Some people treated with ORENCIA have developed skin cancer. Tell your healthcare provider if you have a family or personal history of skin cancer, and if you see any growths or changes in the appearance of your skin during or after your treatment with ORENCIA.

If you take any other kinds of medicine, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

If you are taking other biologic medicines, such as Enbrel (etanercept), Humira (adalimumab). Remicade (infliximab), Kineret (anakinra), Rituxan (rituximab), Simponi (golimumab), Cimzia (certolizumab pegol), or Actemra (tocilizumab). You may have a higher chance of getting a serious infection if you take ORENCIA with other biologic medicines.

Possible Side Effects of ORENCIA.

ORENCIA can cause serious side effects, including:

Serious infections. ORENCIA can make you more likely to get infections or make the infection that you have get worse. Some people have died from these infections.

Call your healthcare provider immediately if you feel sick or get any of the following signs of infection: fever; feel very tired; cough; feel flu-like; or warm, red, or painful skin.

Allergic reactions. Allergic reactions can happen to people who use ORENCIA (abatacept).

Call your healthcare provider or get emergency medical help right away if you have any symptoms of an allergic reaction, which may include hives; swollen face, eyelids, lips, or tongue; or trouble breathing.

Hepatitis B infection. If you are a carrier of the hepatitis B virus, a virus that affects the liver, the virus can become active while you use ORENCIA. Your healthcare provider may do a blood test before you start treatment with ORENCIA.

Vaccinations. You should not receive ORENCIA with certain types of vaccines—live vaccines. You can receive non-live vaccines, such as pneumococcal and inactivated influenza (flu) vaccines.

ORENCIA may cause some vaccinations to be less effective. Talk to your healthcare provider about your vaccination plans.

Respiratory problems in people with COPD. You may get certain respiratory problems more often if you receive ORENCIA and have COPD, including: worsened COPD, cough, or trouble breathing.

Cancer (malignancies). Certain kinds of cancer have been reported in people receiving ORENCIA. It is not known if ORENCIA increases your chance of getting certain kinds of cancer.

Common side effects with ORENCIA are headache, upper respiratory tract infection, sore throat, and nausea. These are not all the possible side effects of ORENCIA.

Call your doctor for medical advice about side effects.

You may report side effects to FDA at 1-800-FDA-1088.

Please read the Patient Information in the Full Prescribing Information found on ORENCIA.com

This is a transcript for the “How to Use the Prefilled Syringe For Your Child with pJIA” video found on the ORENCIA resources page.

Narrator: ORENCIA (abatacept) is a prescription biologic medicine used to reduce signs and symptoms of moderate to severe polyarticular Juvenile Idiopathic Arthritis (pJIA) in patients two years of age and older. ORENCIA may be used alone or with methotrexate (MTX).

ORENCIA should not be used with other strong medicines that affect the immune system, such as biologic disease-modifying antirheumatic drugs (bDMARDs) and Janus kinase (JAK) inhibitors.

Please read the Important Safety Information for ORENCIA provided throughout and at the end of this video.

Guide to Injection With the Pre-filled Syringe

If you and your healthcare provider have decided that ORENCIA self-injection with a prefilled syringe is right for your child with polyarticular Juvenile Idiopathic Arthritis (pJIA), we would like you to meet Jennifer and her daughter Sarah.

When Sarah first started ORENCIA, her healthcare provider showed Jennifer how to inject Sarah with a hands-on demonstration in the doctor's office.

Now, they will show you how it's done, and how it can become part of your routine.

Jennifer: Hi, I'm Jennifer, and this is my 10-year-old daughter, Sarah.

Sarah: Hi!

Jennifer: Sarah has Juvenile Idiopathic Arthritis (JIA).

When Sarah's doctor spoke with us about biologic medications, we decided ORENCIA would be right for her and that she would have weekly injections. It was a good choice for Sarah.

(On-screen text: Sarah weighs 71 pounds, which is 32 kilograms. Her doctor prescribed her the 87.5 mg/0.7 mL dose. The patient's doctor will decide what is the best dosage.)

To train us, the nurse in Sarah's doctor's office took us through the process step-by-step.

(On-screen text: You should always receive your initial training at your healthcare provider's office.)

We were a little nervous at first about the injections.

It helps to think about the time of day you'll do this. You want to focus on the injection, not juggling other things.

Sarah: We do it on Saturday mornings.

Jennifer: By the way, what we're describing is an overview of how to inject.

Sarah: For detailed instructions, read the Instructions for Use manual that comes in the same box as your syringes.

Jennifer: Well said.

You can also call your doctor's office. And, if you still have questions, you can call 1-800-ORENCIA, and an ORENCIA nurse will be available to walk you through it.

Narrator: Infections. ORENCIA can make you more likely to get infections or make the infections that you have worse. In some cases, these infections have been fatal.

Symptoms of an infection include: fever; cough; warm, red, or painful skin; feeling very tired; flu-like symptoms.

Call your healthcare provider right away if you feel sick or have any of the symptoms of an infection.

Preparing for Your Injection

Jennifer: Okay, first, we'll go over how to prepare for your injection.

Think about the place in your home where you'd like to administer ORENCIA.

Sarah: We do almost everything in the kitchen.

Jennifer: So that was a natural fit for us. But just pick a place where you have a lot of light, and where you have a clean, flat space to spread out.

Gather all of your supplies and place them on a clean flat surface.

Sarah: We use the kitchen counter.

Jennifer: Alcohol swabs, cotton balls or gauze, your sharps container, adhesive bandages, should you need them, and your ORENCIA syringe.

Trust me, it helps to keep everything all tidy and organized.

Remove your syringe from the refrigerator and let it sit for 30 minutes before you inject.

(On-screen text: Keep them in the original package and out of the light. Do not freeze them.)

Sarah: That gives it a chance to warm up to room temperature.

Jennifer: Right. And don't try to speed up the warming process in any way, like putting it in the microwave, or placing the syringe in warm water.

ORENCIA is provided in a prefilled syringe.

Do not remove the needle cover until you are ready to inject ORENCIA.

Sarah: And don't forget to wash up before you inject.

Jennifer: I know, it sounds like a no-brainer, but really, before every injection, wash your hands thoroughly with soap and warm water. You want to minimize the amount of germs you carry to your injection site.

Before every injection, hold the syringe with the covered needle pointing down, and check the expiration date. If the date has passed, do not use it.

Throw it away, which we'll explain how to do later, and select a new syringe.

Then look at the ORENCIA liquid inside. The liquid should be clear and colorless to pale yellow.

Look closely at the amount of liquid in the syringe.

The placement of the fill line will be different depending on what dose you are prescribed.

So make sure the amount of liquid is at or just above the fill line for your prescribed dose.

Do not inject ORENCIA if the liquid is cloudy, discolored, or has lumps or particles in it.

Or if the syringe does not have the correct amount of liquid.

Call 1-800-ORENCIA to report it.

So remember, never inject without examining your syringe.

Sarah: But it is normal to see an air bubble in the liquid, and you don't need to remove it.

Jennifer: You've got this down.

The next step is to choose and prepare your injection site.

The nurse recommended the front of the thigh.

But she also suggested the belly, except for a two-inch area around the navel.

Now, since I typically administer Sarah's injections, it's okay to use the outer area of the upper arm.

Sarah: But don't try to inject there by yourself.

Jennifer: Every time you inject, change it up.

That means move away from your last injection site by at least one inch.

You can also switch the site altogether.

We did Sarah's thigh last time, so we're going to do her belly this time.

If you have a tender or bruised area, or your skin is red, scaly, or hard, don't inject there. Also avoid any areas with scars or stretch marks.

Write down the date, time, and specific part of your body where you injected.

I think it's also helpful to write down any questions about the injection so you can ask your doctor.

(On-screen text: How to Inject ORENCIA® [abatacept])

Sarah: Okay, I'm ready.

Jennifer: Alright.

First, wipe the area with an alcohol swab in a circular motion to clean the area, and let it dry naturally. Be sure not to touch the area after you've cleaned it.

Narrator: Allergic reactions.

Allergic reactions can happen with ORENCIA. Symptoms of an allergic reaction may include: hives; swollen face, eyelids, lips, or tongue; trouble breathing.

Seek urgent medical attention if you have any of the symptoms of an allergic reaction.

Jennifer: Remember, only remove the needle cover when you're ready to inject.

Sarah: And don't use the needle if it's damaged or bent.

Jennifer: Hold the housing of the syringe with one hand, and pull the needle cover straight off with your other hand.

Do not touch the plunger while you remove the needle cover.

And do not touch the needle or put the needle cover back on the needle once removed as this may damage the needle.

Be sure not to let the needle touch any surfaces.

And don't use the syringe if it's dropped with the needle exposed.

Sarah: You can throw away the needle cover in your household trash.

Jennifer: There may be a small air bubble in the syringe housing, and that's okay, you don't need to remove it.

You may also notice a drop of fluid leaving the needle. This is also normal and will not affect your dose.

You'll notice that the ORENCIA prefilled syringe with BD UltraSafe Passive Needle Guard has a square shape and extended finger grips.

Hold the housing of the syringe in one hand, between your thumb and your index finger, but don't pull back on the plunger of the syringe.

Use your other hand to gently pinch the area of skin that was cleaned.

Hold firmly. Insert the needle with a quick motion into the pinched skin at a 45-degree angle.

To inject all of the medicine, use your thumb to push the plunger until the plunger head is pushed in as far as it will go.

Slowly lift your thumb from the plunger head.

The needle is completely covered by the needle guard as it is removed from the skin.

You may hear a click.

Now, just remove the syringe, and let go of the surrounding skin.

Sarah: That's it.

Jennifer: If there's a little bleeding, grab a cotton ball, or gauze, and press on the area. You can even place a bandage on it.

Do not rub the injection site.

If you notice a little irritation around the site, that happens sometimes, and the discomfort should be mild to moderate. If you have any pain, swelling, or discoloration near the injection site, call your doctor.

Narrator: If you have the hepatitis B virus, talk to your healthcare provider as hepatitis B can become an active infection while you use ORENCIA. Your rheumatologist may do blood tests before treatment with ORENCIA to check if you have hepatitis B.

If you are receiving or are scheduled to receive vaccinations, it is important to know that:

You should not receive live vaccines while taking ORENCIA.

You can receive non-live vaccines, such as pneumococcal and inactivated influenza (flu) vaccines.

ORENCIA may also cause some other vaccinations to be less effective. Talk to your rheumatologist about your vaccination plans.

Jennifer: Now, for the last part.

Sarah: Disposal.

Jennifer: Do not try to put the needle cover back on the needle.

If your injection is administered by a caregiver, this person must also be careful handling the syringe to prevent accidental needle stick injury and possibly spreading infection.

Check with your healthcare provider or pharmacist for instructions about the right way to throw away used syringes.

There may be special local or state laws about how to dispose of used syringes.

Put the used syringe into an FDA-cleared container made specifically for disposing of used syringes, called a Sharps container.

You can also use a heavy duty plastic container with a tight-fitting, puncture-resistant lid, such as an empty detergent bottle.

Sarah: Or a metal container with a plastic lid, like this coffee can.

Jennifer: Make sure that whatever you use is upright and stable during use and is leak resistant.

Sarah: And make sure you label your container "hazardous waste."

Sharps containers can be purchased at your local pharmacy and many retail outlets.

You can also sign up to get free Sharps containers from the makers of ORENCIA.

When the container is full, tape around the cap or lid to make sure the cap or lid does not come off.

You will need to follow your community guidelines for the right way to dispose of your sharps container.

There may be state or local laws about how you should throw away used needles and syringes.

For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at www.fda.gov/safesharpsdisposal

Do not throw away your used sharps container in your household trash unless your community guidelines permit this. Do not recycle your used sharps container.

Sarah: And never, ever reuse a syringe.

Jennifer: Also, keep your syringes and the disposal container out of the reach of children and pets.

Guess what?

Sarah: We're done.

Jennifer: We hope this helped you feel more comfortable with your ORENCIA injections. Remember, if you have any questions, talk to your doctor.

For any questions or concerns about your ORENCIA syringe, call an ORENCIA nurse at 1-800-ORENCIA.

I know this process may seem like a lot to take in, but you're not alone.

Sarah: Don't worry, you'll get the hang of it. We did.

Narrator: And now, for a brief review.

First, get ready for the injection.

Then choose and prepare an injection site.

Inject ORENCIA.

And finally, dispose of your syringe properly.

And remember, if you still have questions, talk to your healthcare provider, or you can call 1-800-ORENCIA, and an ORENCIA nurse will be available to walk you through it.

ORENCIA nurses are available for assistance Monday through Friday, 8 AM to 8 PM, Eastern Standard Time.

At all other times, nurses will usually return your calls within 30 to 60 minutes.

When you call 1-800-ORENCIA, you can also sign up for the ORENCIA On Call patient support program.

ORENCIA On Call can help with the issues that matter to you, like living with polyarticular Juvenile Idiopathic Arthritis, questions regarding health insurance coverage for ORENCIA.

You can also get a Sharps container and travel pack for your prefilled syringe.

When you sign up for ORENCIA On Call, personal ORENCIA care counselors will be available 24/7 to provide answers and support.

No matter where you are in your treatment journey, your care counselor is just a phone call or a click away with the resources you need.

Please know that neither the care counselor nor the nurse can provide medical advice. Your doctor is the best source of information about your health.

Important Facts About ORENCIA (abatacept).

This is a summary of important information that you need to know in order to take ORENCIA safely. Work with the rheumatologist to make the treatment suitable and safe for you or your loved one.

Keep this information, so you can refer to it before and during your treatment.

Look out for the following icons as you read:

talk to your rheumatologist;

call a healthcare provider right away;

helpful information to remember.

What is ORENCIA?

ORENCIA (abatacept) is a prescription biologic medicine used to reduce signs and symptoms of moderate to severe polyarticular Juvenile Idiopathic Arthritis (pJIA) in patients two years of age and older.

ORENCIA may be used alone or with methotrexate (MTX).

ORENCIA should not be used with other strong medicines that affect the immune system, such as biologic disease-modifying antirheumatic drugs (bDMARDs) and Janus kinase (JAK) inhibitors.

ORENCIA is available in two forms. ORENCIA intravenous (IV) infusion is given by your healthcare provider through a vein in your arm. ORENCIA IV is approved for children six years and older. ORENCIA IV has not been studied in children under the age of six. Or ORENCIA subcutaneous (SC) injection is a shot that is given just under your skin. It is available as a prefilled syringe, or a ClickJect Autoinjector. ORENCIA SC prefilled syringe is available for patients two years and older.

PJIA patients may self-inject with ORENCIA or the patient's caregiver may administer ORENCIA if both the healthcare practitioner and the parent/legal guardian determines it is appropriate.

The ability of pediatric patients to self-inject with the autoinjector has not been tested.

Talk to your rheumatologist about the best way to receive ORENCIA.

What should I discuss with my rheumatologist before starting ORENCIA?

Talk to your rheumatologist about all of your medical conditions, including:

You have any kind of infection, as you may have a higher chance of getting serious side effects from an infection while taking ORENCIA.

Infections include: small infections—such as an open cut or sore—to whole body infections (such as the flu). Any infection that will not go away, or a history of infections that keep coming back.

Viral hepatitis, a viral infection that affects the liver. Tell your rheumatologist if you have or have ever had viral hepatitis. Before starting ORENCIA, your rheumatologist may examine you for hepatitis.

Tuberculosis (TB), a type of lung infection. Tell your rheumatologist if you have ever had TB, or a positive skin test for TB, or have recently been in close contact with someone who has ever had TB.

Before starting ORENCIA, your rheumatologist may check you for TB, or do a skin test. Call your rheumatologist if you notice any symptoms of TB, including: a cough that does not go away, weight loss, fever, or night sweats.

You have allergies to the ingredients of ORENCIA.

For a list of ingredients, see: What are the ingredients in ORENCIA? in the Patient Information section of the Full Prescribing Information

You have Chronic Obstructive Pulmonary Disease (COPD), a type of lung disease.

You have diabetes. Your healthcare provider may tell you to use a different way to monitor your blood sugar levels on the day that you receive ORENCIA IV infusion.

ORENCIA IV contains maltose, which can alter the blood sugar readings with certain types of blood glucose monitors.

You have a family or personal history of skin cancer, or see any growths or changes in the appearance of your skin during or after treatment with ORENCIA.

Some people treated with ORENCIA have developed skin cancer.

Tell your rheumatologist about all of your medical treatments, including if: you are scheduled to have surgery.

You recently received, or are scheduled to receive vaccinations.

If you are receiving ORENCIA, and for three months after you stop receiving ORENCIA, you should not take live vaccines.

You are taking: other medications for pJIA; prescription medications or over-the-counter medications; vitamins or herbal supplements.

Let your rheumatologist know if you are a woman who is: pregnant or considering pregnancy. It is not known if ORENCIA can harm an unborn baby.

If ORENCIA is taken during pregnancy, talk to your healthcare provider before your baby receives any vaccines. There is a registry for pregnant women exposed to ORENCIA.

The purpose of this registry is to check the health of the pregnant mother and her child. Women are encouraged to call the registry themselves or ask their healthcare provider to contact the registry for them by calling 1-877-311-8972.

Breastfeeding or planning to breastfeed. It is not known if ORENCIA passes into breast milk. Talk to your healthcare provider about the best way to feed your baby if you use ORENCIA.

What should I avoid while I am on ORENCIA?

ORENCIA and other medicines may affect each other, which could cause serious side effects.

You should avoid taking ORENCIA with other biologics for your pJIA that may affect your immune system. Doing so may increase your chances of getting a serious infection.

Tell your rheumatologist if you are taking other biologic medicines to treat pJIA, such as:

Enbrel (etanercept), Humira (adalimumab), Remicade (infliximab), Kineret (anakinra), Rituxan (rituximab), Simponi (golimumab), Cimzia (certolizumab pegol), Actemra (tocilizumab).

Talk to your rheumatologist and your other healthcare providers before you begin to take anything new or if you have any changes to your medication during your treatment with ORENCIA.

It is a good idea to keep an up-to-date list of all your medicines, vitamins, and herbal supplements on hand to show your doctors and pharmacists.

What are the possible side effects of ORENCIA?

This is a list of some of the possible side effects of ORENCIA for your reference. Talk to your rheumatologist about any side effect that may be bothering you.

Your rheumatologist can work with you to manage side effects throughout your treatment.

Serious side effects. Serious side effects are those that may require medical treatment or hospitalization, cause permanent damage, or be life-threatening, or sometimes even fatal. Talk to your healthcare provider about any concerns you may have.

Infections. ORENCIA can make you more likely to get infections, or make the infections that you have worse. In some cases, these infections have been fatal.

Symptoms of an infection include: fever; cough; warm, red, or painful skin; feeling very tired; flu-like symptoms.

Call your healthcare provider right away if you feel sick or have any of the symptoms of an infection.

Allergic reactions. Allergic reactions can happen with ORENCIA. Symptoms of an allergic reaction may include: hives; swollen face, eyelids, lips, or tongue; trouble breathing.

Seek urgent medical attention if you have any of the symptoms of an allergic reaction.

If you have the hepatitis B virus, talk to your healthcare provider as hepatitis B can become an active infection while you use ORENCIA.

Your rheumatologist may do blood tests before treatment with ORENCIA to check if you have hepatitis B.

If you are receiving or are scheduled to receive vaccinations, it is important to know that: you should not receive live vaccines while taking ORENCIA; you can receive non-live vaccines, such as pneumococcal and inactivated influenza (flu) vaccines.

ORENCIA may also cause some other vaccinations to be less effective. Talk to your rheumatologist about your vaccination plans.

If you have Chronic Obstructive Pulmonary Disease (COPD), you may experience breathing problems more often while taking ORENCIA. Call your healthcare provider if you experience any of the following: worsened COPD; cough; trouble breathing.

Certain kinds of cancer (malignancies) have been reported in people using ORENCIA. It is not known if ORENCIA increases your chances of developing certain kinds of cancer.

Most common side effects.

The most common side effects of ORENCIA include: Headache; upper respiratory tract infection; sore throat; nausea. In children and adolescents, other side effects may include: diarrhea; cough; fever; abdominal pain.

These are not all the possible side effects of ORENCIA.

If you have any questions, or want more information about side effects, ask your rheumatologist or healthcare provider.

If you experience any side effects and would like to report them to the FDA, you can call 1-800-FDA-1088.

How will I receive ORENCIA?

ORENCIA is available in two forms, as intravenous (IV) infusions and as subcutaneous (SC) injections.

Work with your rheumatologist to determine the right treatment plan for you or your child.

ORENCIA IV infusion is given by a healthcare provider through a vein in your arm.

You will receive your first three infusions two weeks apart from each other (weeks zero, two, and four). After that, you will receive an infusion every four weeks. Each infusion takes about 30 minutes, though actual time in the clinic will be longer.

ORENCIA SC injection is a shot that is given just under your skin. It is available as a prefilled syringe.

ORENCIA SC prefilled syringe is available for patients two years and older. PJIA patients may self-inject with ORENCIA or the patient's caregiver may administer ORENCIA if both the healthcare practitioner and the parent/legal guardian determines it is appropriate.

The ability of pediatric patients to self-inject with the autoinjector has not been tested.

If your rheumatologist decides that your injections can be given at home, you or your caregiver will receive training on how to prepare and inject ORENCIA.

Do not try to inject ORENCIA until you have been shown the right way by your rheumatologist or healthcare provider.

You will use ORENCIA SC injection once weekly.

For more information about preparing and giving ORENCIA SC injections at home, see Instructions for Use in the Patient Information Section of the Full Prescribing Information on ORENCIA.com.

This is a transcript for the “How to Use the Prefilled Syringe” video found on the ORENCIA resources page.

Narrator: Indication/Usage and Important Safety Information for ORENCIA (abatacept).

Indication/Usage.

Adult Rheumatoid Arthritis (RA): ORENCIA is a prescription medicine that reduces signs and symptoms in adults with moderate to severe RA, including those who have not been helped enough by other medicines for RA.

ORENCIA may prevent further damage to your bones and joints and may help your ability to perform daily activities.

In adults, ORENCIA may be used alone or with other RA treatments other than Janus kinase (JAK) inhibitors or biologic disease-modifying antirheumatic drugs (bDMARDs) such as tumor necrosis factor (TNF) antagonists.

The concomitant use of ORENCIA with other potent immunosuppressants, for example, bDMARDs, JAK inhibitors, is not recommended.

Your Guide to Self-Injection

Mary Jo: Hi, my name is Mary Jo and I'm a nurse.

As a nurse, I've had the experience of helping many people learn how to take their medication. It's an important part of my job.

If you and your doctor have decided that taking ORENCIA self-injection is appropriate for you, I'd like you to meet my patient, Nicole, who with her doctor also chose self-injection.

When she first started ORENCIA, I gave her a hands-on demonstration and helped her with the first injection in the doctor's office.

Now she will show you how it's done and how it can become routine for you too. So let's meet Nicole.

Nicole: Hi, I'm Nicole and I have moderate to severe rheumatoid arthritis.

When my rheumatologist talked to me about biologic medications, we decided that I would take ORENCIA and that it would be through weekly self-injections.

It was a good choice for me—really.

I've given myself injections for a while now so I'm ready to show you how it's done.

To train me, my nurse, Mary Jo, took me through the process step by step.

(On-screen text: You should always receive your initial training at your doctor's office.)

You, however, could have been trained by your doctor or another healthcare professional.

If you're not comfortable doing the injection yourself, a family member or a friend who's also been trained by your doctor's office can do it for you.

Now, you might feel a little nervous about giving yourself an injection. I know I was.

But after a few times, it really does become much more routine.

Think about the time of day you'll do this. You want to focus on your injection, not juggling other things.

By the way, what I'm describing is an overview of how to inject. For detailed instructions, read the Instructions for Use manual located in the same box your syringes came in.

You can also call your doctor's office. And remember, if you still have questions, you can also call 1-800-ORENCIA and an ORENCIA nurse will be able to walk you through it.

Narrator: Possible side effects of ORENCIA (abatacept).

ORENCIA can cause serious side effects including: serious infections.

ORENCIA can make you more likely to get infections or make the infection that you have get worse. Some people have died from these infections.

Call your healthcare provider immediately if you feel sick or get any of the following signs of infection: fever; feel very tired; cough; feel flu-like; or warm, red, or painful skin.

Preparing for Your Injection

Nicole: Okay, first, preparing for your injection. Select your syringe and before you do anything else, check the expiration date.

If the date has passed, do not use it. Throw it away, which I'll explain how to do later, and select a new syringe.

After taking your syringe from the refrigerator, let it sit for 30 to 60 minutes before you inject.

This gives it a chance to warm up to room temperature. I already did this about 30 minutes ago because I knew I'd be injecting now.

Don't try to speed up the warming process in any way, such as using the microwave or placing the syringe in warm water.

ORENCIA is provided in a prefilled syringe with UltraSafe Passive Needle Guard. Do not remove the needle cover until you're ready to inject ORENCIA.

Meanwhile, think about where you'd like to inject your ORENCIA. Me, I do almost everything in my kitchen so this room was a natural fit for me.

But just pick a place where you have a lot of light and where you have a clean, flat space to spread out. Remember, this is going to be part of your routine.

Before every injection, hold the syringe with the covered needle pointing down and look at the ORENCIA liquid inside.

Not only should the liquid be clear and colorless to pale yellow, the drug level should also be above the fluid level indicator line on the syringe.

Do not inject ORENCIA if the liquid is cloudy, discolored, or has lumps or particles in it, or if the syringe does not have the correct amount of liquid.

Throw the syringe away and get a new one. Call 1-800-ORENCIA to report it.

So remember, never inject without examining your syringe. And by the way, it's normal to see an air bubble in the liquid. There's no reason to remove it.

Keep all of your supplies close by—alcohol swabs, cotton balls or gauze, your sharps container, adhesive bandages, should you need them, and your ORENCIA syringe.

Trust me, it helps to keep everything all tidy and organized.

Don't forget, wash up. It sounds like a no-brainer but really, before every injection, wash your hands thoroughly with soap and warm water.

You want to minimize the amount of germs you carry to your injection site.

Okay, next step is to choose your injection site. So what spot will you inject?

My nurse recommended the front of the thigh, but she also suggested my belly, except for a two-inch area around the navel.

Now, if someone else is injecting you, then it's okay to use the outer area of the upper arm, but don't try to inject here by yourself.

Every time you inject, change it up. That means move away from your last injection site by at least one inch.

You can also switch the site altogether. For instance, I did my thigh last time so I'm going to do my belly this time.

Don't remember where you injected last? Write it down when you're done.

If you have a tender or bruised area, or your skin is red, scaly, or hard, don't inject there.

Also, avoid any areas with scars or stretch marks.

Okay, I'm ready.

So wipe the area with your alcohol wipe in a circular motion to clean the area and let it dry naturally. But don't touch this area because you just cleaned it. Do NOT fan or blow on the clean area.

Narrator: Allergic reactions.

Allergic reactions can happen to people who use ORENCIA. Call your healthcare provider or get emergency medical help right away if you have any symptoms of an allergic reaction, which may include hives; swollen face, eyelids, lips, or tongue; or trouble breathing.

Nicole: Remember, only remove the needle cover when you're ready to inject, and don't use the needle if there are signs of damage or bending.

Hold the housing of the syringe with one hand and pull the needle cover straight off with your other hand.

Do not touch the plunger while you remove the needle cover. And don't touch the needle or put the needle cover back on the needle once removed.

Do not let the needle touch any surfaces, and don’t use the syringe if it is dropped with the needle exposed.

Throw away the needle cover in your household trash. Now, there may be a small air bubble in the syringe housing, and that's okay, you don't need to remove it.

You may also notice a drop of fluid leaving the needle. This is also normal and won't affect your dose.

You'll notice that the ORENCIA prefilled syringe with UltraSafe Passive Needle Guard has a square shape and extended finger grips. Hold the housing of the syringe in one hand, between your thumb and your index finger, but don't pull back on the plunger of the syringe.

Use your other hand and gently pinch the area of the skin you cleaned. Hold firmly, insert the needle with a quick motion into the pinched skin at a 45-degree angle.

To inject all of the medicine, use your thumb to push the plunger until the plunger head is pushed in as far as it will go.

Slowly lift your thumb from the plunger head. The needle is completely covered by the needle guard as it is removed from the skin.

Now just remove the syringe and let go of the surrounding skin.

That's it.

If there's a little bleeding, grab a cotton ball or gauze and press on the area. You can even place a bandage on it.

Do not rub the injection site. If you notice a little irritation around the site, that happens sometimes, and the discomfort should be mild to moderate.

If you have any pain, swelling, or discoloration near the injection site, call your doctor.

Now the last part, disposal and recordkeeping.

Narrator: Hepatitis B infection. If you are a carrier of the hepatitis B virus, a virus that affects the liver, the virus can become active while you use ORENCIA.

Your healthcare provider may do a blood test before you start treatment with ORENCIA.

Vaccinations. You should not receive ORENCIA with certain types of vaccines—live vaccines. You can receive non-live vaccines, such as pneumococcal and inactivated influenza (flu) vaccines.

ORENCIA may cause some vaccinations to be less effective. Talk to your healthcare provider about your vaccination plans.

Disposal and Recordkeeping

Nicole: Do not try to put the needle cover back on the needle.

Check with your healthcare provider or pharmacist for instructions about the right way to throw away used syringes. There may be special local or state laws about how to throw away used syringes.

Put the used syringe into a biohazard container made specifically for disposing of used syringes, called a sharps container.

You can also use a hard plastic container with a screw-on cap, such as an empty detergent bottle, or a metal container with a plastic lid, such as a coffee can.

Sharps containers can be purchased at your local pharmacy or many retail outlets. You can also sign up to get free sharps containers from the makers of ORENCIA.

When the container is full, tape around the cap or lid to make sure the cap or lid does not come off. And don't ever reuse a syringe.

Also, keep your syringes and the disposable container out of the reach of children and pets.

So now you need to write down what you just did.

Write the date, time, and specific part of the body where you injected yourself.

I find it helpful to write down my questions about the injection so I can ask my healthcare provider.

Guess what?

We're done!

I hope this helped you feel more comfortable with your ORENCIA injections.

Remember, if you have any questions, talk to your doctor.

For any questions or concerns about your ORENCIA syringe, call an ORENCIA nurse at 1-800-ORENCIA (1-800-673-6242).

I know this process may seem like a lot to take in but you're not alone. Trust me, you will get the hang of it.

I did.

Mary Jo: And now, for a brief review. First, get ready for the injection. Then choose and prepare an injection site.

Inject ORENCIA. And finally, dispose of your syringe properly and record your injection.

Narrator:

Indications/Usage, and Important Safety Information for ORENCIA.

Indications/Usage.

Adult Rheumatoid Arthritis (RA): ORENCIA is a prescription medicine that reduces signs and symptoms in adults with moderate to severe RA, including those who have not been helped enough by other medicines for RA.

ORENCIA may prevent further damage to your bones and joints and may help your ability to perform daily activities.

In adults, ORENCIA may be used alone or with other RA treatments other than Janus kinase (JAK) inhibitors or biologic disease-modifying antirheumatic drugs (bDMARDs), such as tumor necrosis factor (TNF) antagonists.

Polyarticular Juvenile Idiopathic Arthritis (pJIA): ORENCIA reduces signs and symptoms in patients two years of age and older with moderate to severe polyarticular JIA. ORENCIA may be used alone or with methotrexate (MTX).

Adult Psoriatic Arthritis (PsA):

ORENCIA is a prescription medicine that reduces signs and symptoms in adults with active psoriatic arthritis. In adults, ORENCIA may be used alone or with other PsA treatments.

The concomitant use of ORENCIA with other potent immunosuppressants, for example, bDMARDs, JAK inhibitors, is not recommended.

Important Safety Information. Inform your healthcare provider of the following before you receive treatment with ORENCIA:

Infections: If you have any kind of infection, even if it is small, such as an open cut or sore, an infection that is in your whole body, such as the flu, an infection that will not go away, or a history of infections that keep coming back.

ORENCIA may make your immune system less able to fight infections, so you may be more likely to get infections or any infection you have may get worse.

Tuberculosis: If you have had tuberculosis (TB), a positive skin test for TB, or if you have recently been in close contact with someone who has had TB. If you get any of the symptoms of TB—a cough that does not go away, weight loss, fever, night sweats—call your healthcare provider right away.

Before you start ORENCIA, your healthcare provider may examine you for TB or perform a skin test.

If you have or have had viral hepatitis. Before you use ORENCIA, your healthcare provider may examine you for hepatitis.

If you have a history of chronic obstructive pulmonary (lung) disease (COPD).

If you are scheduled to have surgery.

Allergies to the ingredients of ORENCIA: The ingredients of intravenous (IV) ORENCIA are: abatacept, maltose, monobasic sodium phosphate, and sodium chloride for administration.

The ingredients of subcutaneous (SC) ORENCIA are: abatacept, sucrose, poloxamer 188, monobasic sodium phosphate monohydrate, dibasic sodium phosphate anhydrous, and water for injection.

Vaccinations: If you have recently received a vaccination or are scheduled for any vaccination. If you are receiving ORENCIA, and for three months after you stop receiving ORENCIA, you should not take live vaccines.

Diabetes: If you have diabetes and use a blood glucose monitor to check your sugar levels. The infusion of ORENCIA contains maltose, a sugar that can give falsely high blood glucose readings with some monitors on the day you receive your infusion.

Your healthcare provider may tell you to use a different way to monitor your blood sugar levels.

ORENCIA for SC injection does not contain maltose; therefore you do not need to change the way you monitor your blood sugar if you are taking ORENCIA subcutaneously.

Pregnancy: If you are pregnant or plan to become pregnant.

It is not known if ORENCIA can harm your unborn baby. If you took ORENCIA during pregnancy, talk to your healthcare provider before your baby receives any vaccines.

There is a registry for pregnant women exposed to ORENCIA. The purpose of this registry is to check the health of the pregnant mother and her child. Women are encouraged to call the registry themselves or ask their healthcare provider to contact the registry for them by calling 1-877-311-8972.

Breastfeeding: It is not known if ORENCIA passes into your breastmilk. Talk to your healthcare provider about the best way to feed your baby if you use ORENCIA.

Skin cancer: Some people treated with ORENCIA have developed skin cancer. Tell your healthcare provider if you have a family or personal history of skin cancer, and if you see any growths or changes in the appearance of your skin during or after your treatment with ORENCIA.

If you take any other kinds of medicine, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

If you are taking other biologic medicines, such as Enbrel (etanercept), Humira (adalimumab), Remicade (infliximab), Kineret (anakinra), Rituxan (rituximab), Simponi (golimumab), Cimzia (certolizumab pegol), or Actemra (tocilizumab). You may have a higher chance of getting a serious infection if you take ORENCIA with other biologic medicines.

Possible side effects of ORENCIA (abatacept).

ORENCIA can cause serious side effects including: serious infections. ORENCIA can make you more likely to get infections or make the infection that you have get worse.

Some people have died from these infections. Call your healthcare provider immediately if you feel sick or get any of the following signs of infection: fever; feel very tired; cough; feel flu-like; or warm, red, or painful skin.

Allergic reactions. Allergic reactions can happen to people who use ORENCIA. Call your healthcare provider or get emergency medical help right away if you have any symptoms of an allergic reaction, which may include hives; swollen face, eyelids, lips, or tongue; or trouble breathing.

Hepatitis B infection. If you are a carrier of the hepatitis B virus—a virus that affects the liver— the virus can become active while you use ORENCIA.

Your healthcare provider may do a blood test before you start treatment with ORENCIA.

Vaccinations. You should not receive ORENCIA with certain types of vaccines—live vaccines.

You can receive non-live vaccines, such as pneumococcal and inactivated influenza (flu) vaccines. ORENCIA may cause some vaccinations to be less effective. Talk to your healthcare provider about your vaccination plans.

Respiratory problems in people with COPD. You may get certain respiratory problems more often if you receive ORENCIA and have COPD, including worsened COPD, cough, or trouble breathing.

Cancer (malignancies). Certain kinds of cancer have been reported in people receiving ORENCIA. It is not known if ORENCIA increases your chance of getting certain kinds of cancer.

Common side effects with ORENCIA are headache, upper respiratory tract infection, sore throat, and nausea. Other side effects in children and adolescents may include diarrhea, cough, fever, and abdominal pain.

These are not all the possible side effects of ORENCIA.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

There are three ways to receive your dose of ORENCIA, and each way is approved for different ages:

ORENCIA prefilled SC syringe is approved for patients two years and older;

ORENCIA IV is approved for patients six years and older. ORENCIA IV has not been studied in children younger than six years of age.

PJIA patients may self-inject with ORENCIA or the patient's caregiver may administer ORENCIA if both the healthcare practitioner and the parent/legal guardian determines it is appropriate.

The ability of pediatric patients to self-inject with the ClickJect Autoinjector has not been tested.

Please talk to your healthcare provider about the best way to receive ORENCIA.

Please read the Patient Information in the Full Prescribing Information found on ORENCIA.com.

This is a transcript for the “What to Expect From Your IV Infusion” video found on the ORENCIA resources page.

Narrator: Indications/Usage and Important Safety Information for ORENCIA (abatacept).

Indications/Usage:

Adult Rheumatoid Arthritis (RA):

ORENCIA is a prescription medicine that reduces signs and symptoms in adults with moderate to severe RA, including those who have not been helped enough by other medicines for RA. ORENCIA may prevent further damage to your bones and joints and may help your ability to perform daily activities.

In adults, ORENCIA may be used alone or with other RA treatments other than Janus kinase (JAK) inhibitors, or biologic disease-modifying antirheumatic drugs (bDMARDs), such as tumor necrosis factor (TNF) antagonists.

Polyarticular Juvenile Idiopathic Arthritis (pJIA): ORENCIA reduces signs and symptoms in patients two years of age and older with moderate to severe polyarticular JIA. ORENCIA may be used alone or with methotrexate (MTX).

Adult Psoriatic Arthritis (PsA): ORENCIA is a prescription medicine that reduces signs and symptoms in adults with active psoriatic arthritis (PsA). In adults, ORENCIA may be used alone or with other PsA treatments.

The concomitant use of ORENCIA with other potent immunosuppressants, for example, bDMARDs, JAK inhibitors, is not recommended.

Your Guide to IV Infusion

Mary Jo: Hi. My name is Mary Jo, and I am a nurse. As a nurse, I've had the experience of helping many people learn how to take their medication. It's an important part of my job.

If you and your doctor have decided that getting ORENCIA IV infusion is appropriate for you, I'd like you to meet my patient, Rena.

She and her doctor also chose IV infusion. When she first started ORENCIA, I met her at the Infusion Center and showed her what to expect.

Now, we see each other every four weeks. Because Rena has been here quite a few times, she'll show you how she made infusions part of her routine.

Rena: Hi, I'm Rena. I'm here, at the infusion center of my rheumatologist's office where I've been receiving my IV infusion of ORENCIA every four weeks for a while now. I chose the IV infusion option because I like getting it done in my doctor's office.

Overall, I'm here about an hour, but the actual infusion lasts about thirty minutes. I like to think of this as time when I can read my book or my favorite magazine. Sometimes, I bring music or a podcast to listen to, and sometimes, I just like to talk to the other people here.

I also like having my nurse Mary Jo checking in on me and catching me up on her family and her book club discussions.

Mary Jo: It's important to remember that not all infusion facilities are the same. You may receive IV infusions of ORENCIA in a rheumatologist's office, hospital, or infusion center, and your experience may be different than Rena's.

Rena: Mary Jo, explain what an IV infusion is exactly, like you did for me.

Mary Jo: OK. An IV infusion is a process in which medicines are delivered intravenously, that is, through a needle placed in a vein in your arm.

Narrator: Serious infections: ORENCIA can make you more likely to get infections or make the infection that you have get worse. Some people have died from these infections.

Call your healthcare provider immediately if you feel sick or get any of the following signs of infection: fever, feel very tired, cough, feel flu-like, or warm, red or painful skin.

Rena: Basically, when I'm receiving my infusion of ORENCIA, I feel a small pinch at first, and then I sit there for a half hour or so with my arm resting comfortably. I do different things during the infusion: read, talk on the phone... A few times, I even took a short nap.

Mary Jo: Before Rena began her first treatment with ORENCIA, I reviewed her full medical history and performed the appropriate tests. Now, before each IV infusion, I always ask a few questions to help me gauge how she's doing.

To begin, I check Rena's vital signs, things like her blood pressure, pulse and her temperature.

Then, I ask how she's doing with ORENCIA.

Rena, have you felt any difference in your joint stiffness or pain?

Rena: Yes. Actually, I've noticed an improvement in my symptoms.

Mary Jo: I then check to see if there have been any problems or changes in the last month or anything else that would keep her from receiving her IV infusion that day.

Rena: She asked me if I've had a fever, cold, any infection or other health issues since I was last here. Or if I've been on any other medicines, vitamins and herbal supplements.

Mary Jo: That's right. It's important to know if she's had any of these because an infection could put Rena at risk for serious side effects with ORENCIA.

Narrator: Allergic reactions: Allergic reactions can happen to people who use ORENCIA. Call your healthcare provider or get emergency medical help right away if you have any symptoms of an allergic reaction, which may include hives, swollen face, eyelids, lips or tongue, or trouble breathing.

Mary Jo: Then, I note our discussion in Rena's chart. Based on our conversation, I'll discuss it with Rena's rheumatologist to see whether it's appropriate to give her an IV infusion today or reschedule it.

Mary Jo: Oh, and another thing, I always inform my patients with diabetes that on the day of treatment, they may get a false high reading with certain types of blood glucose monitors because the infusion of ORENCIA contains maltose, a type of sugar. To avoid this, we may recommend that these patients use a different testing monitor.

This is the ORENCIA medication. As you can see, it's a small bag. There's less than a half cup of liquid in there. An IV infusion of ORENCIA takes about thirty minutes.

Narrator: Vaccinations: You should not receive ORENCIA with certain types of vaccines, live vaccines. You can receive non-live vaccines, such as pneumococcal and inactivated influenza (flu) vaccines.

ORENCIA may cause some vaccinations to be less effective. Talk to your healthcare provider about your vaccination plans.

Respiratory problems in people with COPD: You may get certain respiratory problems more often if you receive ORENCIA and have COPD, including worsened COPD, cough, or trouble breathing.

Mary Jo: During the treatment, I like to check on Rena to make sure that everything's going smoothly. Once the infusion is complete, I'll check her vitals one more time, and then she's free to leave.

Overall, it's important for Rena and for all my patients to trust me enough to share concerns or issues right up front. My goal is to make sure that Rena is feeling relaxed and comfortable.

Rena: So, this is what happens at my infusion center. Now, hopefully, you've got a better idea of what to expect.

Mary Jo: If you have any questions or just want to talk about the infusion experience, contact an ORENCIA care counselor at 1-800-ORENCIA.

Remember, you're not alone. You take care.

Narrator: Indications/Usage, and Important Safety Information for ORENCIA.

Indications/Usage:

Adult Rheumatoid Arthritis (RA): ORENCIA is a prescription medicine that reduces signs and symptoms in adults with moderate to severe RA, including those who have not been helped enough by other medicines for RA. ORENCIA may prevent further damage to your bones and joints and may help your ability to perform daily activities.

In adults, ORENCIA may be used alone or with other RA treatments other than Janus kinase (JAK) inhibitors, or biologic disease-modifying antirheumatic drugs (bDMARDs) such as tumor necrosis factor (TNF) antagonists.

Polyarticular Juvenile Idiopathic Arthritis (pJIA): ORENCIA reduces signs and symptoms in patients two years of age and older with moderate to severe polyarticular JIA. ORENCIA may be used alone or with methotrexate (MTX).

Adult Psoriatic Arthritis (PsA): ORENCIA is a prescription medicine that reduces signs and symptoms in adults with active psoriatic arthritis (PsA). In adults, ORENCIA may be used alone or with other PsA treatments.

The concomitant use of ORENCIA with other potent immunosuppressants, for example, bDMARDs, JAK inhibitors, is not recommended.

Important Safety Information:

Inform your healthcare provider of the following before you receive treatment with ORENCIA.

Infections: If you have any kind of infection, even if it is small, such as an open cut or sore, an infection that is in your whole body, such as the flu, an infection that will not go away or a history of infections that keep coming back, ORENCIA may make your immune system less able to fight infections, so you may be more likely to get infections or any infection you have may get worse.

Tuberculosis: If you have had tuberculosis (TB), a positive skin test for TB, or if you recently have been in close contact with someone who has had TB, if you get any of the symptoms of TB, a cough that does not go away, weight loss, fever, night sweats, call your healthcare provider right away. Before you start ORENCIA, your healthcare provider may examine you for TB or perform a skin test.

If you have or have had viral hepatitis, before you use ORENCIA, your healthcare provider may examine you for hepatitis.

If you have a history of Chronic Obstructive Pulmonary (lung) Disease, COPD.

If you're scheduled to have surgery.

Allergies to the ingredients of ORENCIA: The ingredients of intravenous (IV) ORENCIA are: abatacept, maltose, monobasic sodium phosphate, and sodium chloride for administration.

The ingredients of subcutaneous (SC) ORENCIA are: abatacept, sucrose, poloxamer 188, monobasic sodium phosphate monohydrate, dibasic sodium phosphate anhydrous, and water for injection.

Vaccinations: If you have recently received a vaccination or are scheduled for any vaccination. If you are receiving ORENCIA and for three months after you stop receiving ORENCIA, you should not take live vaccines.

Diabetes: If you have diabetes and use a blood glucose monitor to check your sugar levels, the infusion of ORENCIA contains maltose, a sugar that can give falsely high blood glucose readings with some monitors on the day you receive your infusion. Your healthcare provider may tell you to use a different way to monitor your blood sugar levels.

ORENCIA for SC injection does not contain maltose. Therefore, you do not need to change the way you monitor your blood sugar if you are taking ORENCIA subcutaneously.

Pregnancy: If you are pregnant or plan to become pregnant, it is not known if ORENCIA can harm your unborn baby. If you took ORENCIA during pregnancy, talk to your healthcare provider before your baby receives any vaccines.

There is a registry for pregnant women exposed to ORENCIA. The purpose of this registry is to check the health of the pregnant mother and her child. Women are encouraged to call the registry themselves or ask their healthcare provider to contact the registry for them by calling 1-877-311-8972.

Breastfeeding: it is not known if ORENCIA passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you use ORENCIA.

Skin cancer: Some people treated with ORENCIA have developed skin cancer. Tell your healthcare provider if you have a family or personal history of skin cancer and if you see any growths or changes in the appearance of your skin during or after your treatment with ORENCIA.

If you take any other kinds of medicine, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

If you are taking other biologic medicines such as Enbrel (etanercept), Humira (adalimumab), Remicade (infliximab), Kineret (anakinra), Rituxan (rituximab), Simponi (golimumab), Cimzia (certolizumab pegol), or Actemra (tocilizumab). You may have a higher chance of getting a serious infection if you take ORENCIA with other biologic medicines.

Possible side effects of ORENCIA (abatacept).

ORENCIA can cause serious side effects, including serious infections. ORENCIA can make you more likely to get infections or make the infection that you have get worse. Some people have died from these infections.

Call your healthcare provider immediately if you feel sick or get any of the following signs of infection: fever, feel very tired, cough, feel flu-like, or warm, red or painful skin.

Allergic reactions: Allergic reactions can happen to people who use ORENCIA. Call your healthcare provider or get emergency medical help right away if you have any symptoms of an allergic reaction which may include hives, swollen face, eyelids, lips or tongue, or trouble breathing.

Hepatitis B infection: If you are a carrier of the hepatitis B virus, a virus that affects the liver, the virus can become active while you use ORENCIA. Your healthcare provider may do a blood test before you start treatment with ORENCIA.

Vaccinations: You should not receive ORENCIA with certain types of vaccines (live vaccines). You can receive non-live vaccines such as pneumococcal and inactivated influenza (flu), vaccines.

ORENCIA may cause some vaccinations to be less effective. Talk to your healthcare provider about your vaccination plans.

Respiratory problems in people with COPD. You may get certain respiratory problems more often if you receive ORENCIA and have COPD, including worsened COPD, cough, or trouble breathing.

Cancer (malignancies): Certain kinds of cancer have been reported in people receiving ORENCIA. It is not known if ORENCIA increases your chance of getting certain kinds of cancer.

Common side effects with ORENCIA are headache, upper respiratory tract infection, sore throat, and nausea. Other side effects in children and adolescents may include diarrhea, cough, fever, and abdominal pain.

These are not all the possible side effects of ORENCIA.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

There are three ways to receive your dose of ORENCIA, and each way is approved for different ages.

ORENCIA prefilled SC syringe is approved for patients two years and older;

ORENCIA IV is approved for patients six years and older. ORENCIA IV has not been studied in children younger than six years of age.

PJIA patients may self-inject with ORENCIA, or the patient's caregiver may administer ORENCIA if both the healthcare practitioner and the parent/legal guardian determines it is appropriate.

The ability of pediatric patients to self-inject with the ClickJect Autoinjector has not been tested.

Please talk to your healthcare provider about the best way to receive ORENCIA.

Please read the Patient Information in the Full Prescribing Information found on ORENCIA.com.