1-800-ORENCIAThis 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.