Orencia

DRUG DESCRIPTION

ORENCIA (abatacept) is a soluble fusion protein that consists of the extracellular domain of human cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) linked to the modified Fc (hinge, CH2, and CH3 domains) portion of human immunoglobulin G1 (IgG1). Abatacept is produced by recombinant DNA technology in a mammalian cell expression system. The apparent molecular weight of abatacept is 92 kilodaltons.

ORENCIA (abatacept) is supplied as a sterile, white, preservative-free, lyophilized powder for parenteral administration. Following reconstitution with 10 mL of Sterile Water for Injection, USP, the solution of ORENCIA (abatacept) is clear, colorless to pale yellow, with a pH range of 7.2 to 7.8. Each single-use vial of ORENCIA provides 250 mg abatacept, 500 mg maltose, 17.2 mg monobasic sodium phosphate, and 14.6 mg sodium chloride for administration.

What are the possible side effects of abatacept (Orencia)?

Some people receiving an abatacept injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel dizzy, light-headed, itchy, or have a severe headache or trouble breathing within 1 hour after receiving the injection.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Serious infections may occur during treatment with abatacept. Stop using abatacept and call...

Read All Potential Side Effects and See Pictures of Orencia

What are the precautions when taking abatacept (Orencia)?

Before using abatacept, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: chronic obstructive pulmonary disease-COPD, current/recent/returning infection (e.g., tuberculosis, hepatitis virus), cut or open sore, cancer, immune system disorder (e.g., HIV infection, bone marrow disorder), diabetes (especially if you are checking your blood sugar level at home).

Before having surgery, tell your doctor or dentist that you are using this medication.

Do not have immunizations/vaccinations while...

Read All Potential Precautions of Orencia


Orencia Consumer (continued)

SIDE EFFECTS: Headache, nausea, dizziness, flushing, stuffy head/nose, or cough may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: shortness of breath, change in the amount of urine, pain when urinating, severe abdominal pain.

This medication can lower the body's ability to fight an infection. Tell your doctor promptly if you develop any signs of an infection such as fever, chills, or persistent sore throat.

The immune system is also important in preventing and controlling cancer. Very rarely, patients using abatacept have developed cancer (e.g., lymphoma, lung cancer). Tell your doctor immediately if you develop symptoms such as unusual lumps/growths, swollen glands, night sweats, unexplained weight loss, shortness of breath, wheezing, persistent cough.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using abatacept, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: chronic obstructive pulmonary disease-COPD, current/recent/returning infection (e.g., tuberculosis, hepatitis virus), cut or open sore, cancer, immune system disorder (e.g., HIV infection, bone marrow disorder), diabetes (especially if you are checking your blood sugar level at home).

Before having surgery, tell your doctor or dentist that you are using this medication.

Do not have immunizations/vaccinations while using this medication or up to 3 months after stopping this medication without the consent of your doctor. Also avoid contact with people who have recently received oral polio vaccine or flu vaccine inhaled through the nose.

It is recommended that children be up to date on all their childhood vaccinations before starting abatacept.

Wash your hands well to prevent the spread of infections. Avoid contact with people who have illnesses that may spread to others (e.g., flu, chickenpox).

Caution is advised when using this drug in the elderly because they may be more sensitive to its effects, especially increased risk of infections.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

This drug may pass into breast milk and could have undesirable effects on a nursing infant. Therefore, breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.


Orencia Patient Information Including Side Effects

Brand Names: Orencia

Generic Name: abatacept (Pronunciation: a BAY ta sept)

  • What is abatacept (Orencia)?
  • What are the possible side effects of abatacept (Orencia)?
  • What is the most important information I should know about abatacept (Orencia)?
  • What should I discuss with my healthcare provider before using abatacept (Orencia)?
  • How should I use abatacept (Orencia)?
  • What happens if I miss a dose (Orencia)?
  • What happens if I overdose (Orencia)?
  • What should I avoid while using abatacept (Orencia)?
  • What other drugs will affect abatacept (Orencia)?
  • Where can I get more information?

What is abatacept (Orencia)?

Abatacept is a man-made protein that prevents your body's immune system from attacking healthy tissues such as joints. The immune system helps your body fight infections. In people with autoimmune disorders, the immune system mistakes the body's own cells for invaders and attacks them.

Abatacept is used to treat the symptoms of rheumatoid arthritis, and to prevent joint damage caused by these conditions. It is also used to treat arthritis in children who are at least 6 years old.

Abatacept is not a cure for any autoimmune disorder and will only treat the symptoms of your condition.

Abatacept may also be used for other purposes not listed in this medication guide.

What are the possible side effects of abatacept (Orencia)?

Some people receiving an abatacept injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel dizzy, light-headed, itchy, or have a severe headache or trouble breathing within 1 hour after receiving the injection.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Serious infections may occur during treatment with abatacept. Stop using abatacept and call your doctor right away if you have signs of infection such as:

  • fever, sweating, chills, tired feeling;
  • feeling short of breath;
  • dry cough, sore throat; or
  • flu symptoms, weight loss.

Call your doctor at once if you have any of these other serious side effects:

  • trouble breathing;
  • easy bruising or bleeding, pale skin, unusual weakness;
  • pain or burning when you urinate; or
  • signs of skin infection such as itching, swelling, warmth, redness, or oozing.

Less serious side effects may include:

  • headache, dizziness;
  • cold symptoms such as stuffy nose, sneezing, sore throat, cough;
  • nausea, diarrhea, stomach pain, indigestion; or
  • back pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about abatacept (Orencia)?

You should not use this medication if you are allergic to abatacept, or if you are also using anakinra (Kineret), etanercept (Enbrel), adalimumab (Humira), or infliximab (Remicade).

Before using abatacept, tell your doctor if you have ever had tuberculosis, if anyone in your household has tuberculosis, or if you have recently traveled to an area where tuberculosis is common.

Also tell your doctor if you have a weak immune system, any type of infection (including skin infection or open sores), COPD, diabetes, a history of hepatitis, or if you have scheduled to receive any vaccinations.

Children using this medication should be current on all childhood immunizations before starting treatment with abatacept.

Serious infections may occur during treatment with abatacept. Contact your doctor right away if you have signs of infection such as: fever, cough, sweating, tired feeling, or if you feel short of breath.

Using abatacept may increase your risk of developing certain types of cancer such as lymphoma (cancer of the lymph nodes). This risk may be greater in older adults. Talk to your doctor about your specific risk.

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