Transcript for "How to Use the Prefilled Syringe"

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.

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.

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.

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.

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.