BELIMUMAB

Other

Brand names: BENLYSTA

Subcutaneous, Intravenous

Mechanism of Action

12.1 Mechanism of Action BENLYSTA is a BLyS-specific inhibitor that blocks the binding of soluble BLyS, a B-cell survival factor, to its receptors on B cells. BENLYSTA does not bind B cells directly, but by binding BLyS, BENLYSTA inhibits the survival of B cells, including autoreactive B cells, and reduces the differentiation of B cells into immunoglobulin-producing plasma cells.

Indications

1 INDICATIONS AND USAGE BENLYSTA is indicated for the treatment of patients 5 years of age and older with: • Active systemic lupus erythematosus (SLE) who are receiving standard therapy

Contraindications

• 4 CONTRAINDICATIONS BENLYSTA is contraindicated in patients who have had anaphylaxis with belimumab. Previous anaphylaxis to belimumab. ( 4 )

FDA Warnings

5 WARNINGS AND PRECAUTIONS • Serious Infections: Serious and sometimes fatal infections have occurred in patients receiving immunosuppressive agents, including BENLYSTA
1 ) • Hypersensitivity Reactions, including Anaphylaxis: Serious and fatal reactions have been reported
Assess for depression and risk of suicide before treatment with BENLYSTA and monitor during treatment
1 Serious Infections Serious and sometimes fatal infections have been reported in patients receiving immunosuppressive agents, including BENLYSTA

Known Side Effects

9 documented side effects by frequency

Fatigue

1-10%

Drug Not Working

1-10%

Headache

1-10%

Nausea

1-10%

General Unwellness

1-10%

Joint Pain

0.1-1%

Injection Site Pain

0.1-1%

Fever

0.1-1%

Rash

0.1-1%

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Formulations

Dosage Forms

Tablet

Route

Subcutaneous, Intravenous