Benlysta Side Effects

Generic name: belimumab

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

Some side effects of Benlysta 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 belimumab: intravenous powder for injection

Some people receiving a belimumab (the active ingredient contained in Benlysta) injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel nauseated, light-headed, itchy, or have muscle pain, severe headache, or slow heartbeats.

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

Call your doctor at once if you have a serious side effect such as:

• new or worsening depression, anxiety, mood or behavior changes, trouble sleeping, or thoughts about hurting yourself or others;

• chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling.

• wheezing, chest tightness, trouble breathing; or

Serious and sometimes fatal infections may occur during treatment with belimumab. Call your doctor right away if you have signs of infection such as:

• fever, chills, flu symptoms, night sweats, weight loss;

• increased urination, pain or burning when you urinate;

• cough with yellow or green mucus, stabbing chest pain, feeling short of breath;

• swelling, pain, tenderness, or redness anywhere on your body; or

• bloody diarrhea.

Less serious side effects of belimumab may include:

• nausea, diarrhea, stomach pain;

• mild pain in your arms or legs; or

• mild cold symptoms such as stuffy nose, sneezing, sore throat.

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 belimumab: intravenous powder for injection

Hypersensitivity

Hypersensitivity side effects have included anaphylaxis. Manifestations included hypotension, angioedema, urticaria or other rash, pruritus, and dyspnea. Due to overlap in signs and symptoms, it was not possible to distinguish between hypersensitivity reactions and infusion reactions in all cases. Postmarketing reports have included fatal anaphylaxis.

General

General side effects have included increased mortality, malignancy and serious, sometimes fatal infections.

Immunologic

Immunologic side effects have included bradycardia, myalgia, headache, rash, urticaria, and hypotension. The most common infusion reactions were headache, nausea, and skin reactions.

Psychiatric

Psychiatric side effects have included new or worsening depression, suicidal thoughts, and other mood changes.

Gastrointestinal

Gastrointestinal side effects have included nausea, diarrhea and gastroenteritis viral.

Respiratory

Respiratory side effects have included nasopharyngitis, bronchitis and pharyngitis.

Nervous system

Nervous system side effects have included insomnia, migraine and pain in extremity.

Hematologic

Hematologic side effects have included leukopenia.

Genitourinary

Genitourinary side effects have included cystitis.

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