Orencia Side Effects

Generic name: abatacept

Note: This document contains side effect information about abatacept. Some of the dosage forms listed on this page may not apply to the brand name Orencia.

Some side effects of Orencia may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to abatacept: intravenous powder for injection, subcutaneous solution

Some people receiving an abatacept (the active ingredient contained in Orencia) 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 while taking abatacept: 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, chills, night sweats, flu symptoms, weight loss;

• feeling very tired;

• dry cough, sore throat; or

• warmth, pain, or redness of your skin.

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

• trouble breathing;

• stabbing chest pain, wheezing, cough with yellow or green mucus;

• pain or burning when you urinate; or

• signs of skin infection such as itching, swelling, warmth, redness, or oozing.

Less serious side effects of abatacept may include:

• nausea, diarrhea, stomach pain, indigestion; or

• headache, dizziness;

• cold symptoms such as stuffy nose, sneezing, sore throat, cough;

• back pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to abatacept: intravenous powder for injection, subcutaneous solution

Respiratory

Respiratory side effects have included upper respiratory tract infection (5.8% to 12.7%), nasopharyngitis (7.8% to 11.5%), sinusitis (6.2%), bronchitis (5.8%), and pneumonia. Patients with COPD treated with abatacept (the active ingredient contained in Orencia) developed adverse effects more frequently than those treated with placebo (97% vs. 88%, respectively). These have included COPD exacerbations, cough, rhonchi, dyspnea, and pneumonia. Bacterial pneumonia and influenzal pneumonia have been reported in 0.4% of patients.

Hypersensitivity

Hypersensitivity side effects have included anaphylaxis or anaphylactoid reactions. Other adverse events potentially associated with drug hypersensitivity, such as hypotension, urticaria, and dyspnea generally occurred within 24 hours of abatacept (the active ingredient contained in Orencia) infusion.

Oncologic

Oncologic side effects have included lymphomas and lung cancer. Other malignancies included skin, breast, bile duct, bladder, cervical, endometrial, lymphoma, melanoma, myelodysplastic syndrome, ovarian, prostate, renal, thyroid, and uterine cancers.

General

General side effects have included acute infusion-related adverse reactions occurring within one hour of the start of the infusion. The acute infusion-related events have included cardiopulmonary symptoms, such as hypotension, increased blood pressure, and dyspnea. The most frequently reported events were dizziness, headache, and hypertension. Other symptoms reported as mild to moderate included nausea, flushing, urticaria, cough, hypersensitivity, pruritus, rash, and wheezing. Back pain and pain in extremity have also been reported.

Immunologic

Immunologic side effects have included the development of binding antibodies to the entire abatacept (the active ingredient contained in Orencia) molecule or to the CTLA-4 portion of abatacept. No correlation of antibody development to clinical response or adverse effects has been observed. Streptococcal sepsis (0.4%) has been reported.

Gastrointestinal

Gastrointestinal side effects including nausea (6.6% to 11.5%), diarrhea (5.8% to 6.91%), diverticulitis (0.4%), peridiverticular abscess (0.4%), and dyspepsia have been reported.

Genitourinary

Genitourinary side effects have included urinary tract infection.

Dermatologic

Dermatologic side effects have included rash.

Nervous system

Nervous system side effects including headache (11.79%) have been reported.

Local

Local side effects including infusion reactions have been reported.

Other

Other side effects have included limb abscess (0.4%).

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