belimumab, Benlysta (cont.)

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PREPARATIONS: Lyophilized powder for reconstitution: 120 mg (5 ml) and 400 mg (20 ml) single-use vials

STORAGE: Belimumab should be refrigerated between 2 C-8 C (36 F-46 F). It should not be frozen or exposed to heat. Vials should be stored in their original carton and protected from light.

PRESCRIBED FOR: Belimumab is used for the treatment of adults with active, antibody-positive SLE who are receiving other treatments for SLE. It has not been evaluated in patients with severe active inflammation of the kidney (nephritis) or the central nervous system (brain and spinal chord).

DOSING: The recommended dose of belimumab is 10 mg/kg at two-week intervals for the first three doses and at four-week intervals thereafter. Belimumab is administered intravenously over a one-hour period.

DRUG INTERACTIONS: Drug interactions have not been studied. Since belimumab reduces the activity of the immune system it may interfere with the response to immunizations. Live vaccines should not be administered concurrently with belimumab or at least 30 days before administration of belimumab.

PREGNANCY: Belimumab has not been adequately studied in pregnant women. Belimumab can cross the placenta. A pregnancy registry has been established for monitoring the safety of belimumab in pregnant women. The number for the registry is 1-877-681-6296.

NURSING MOTHERS: It is not known whether belimumab is excreted in human breast milk. Since antibodies are usually excreted in breast milk, mothers should consider not breastfeeding or discontinuing belimumab if they want to breastfeed.

SIDE EFFECTS: The most common adverse reactions of belimumab are nausea, diarrhea, vomiting, stomach pain, fever, stuffy or runny nose, cough (bronchitis), insomnia, leg or arm pain, migraine, and sore throat. Belimumab may also cause allergic or infusion-related reactions such as itching; swelling of the face, lips, tongue, mouth, or throat as well as difficulty breathing, low blood pressure, dizziness, or fainting. It can cause rash, redness, or swelling of the skin. Infections, heart problems, depression, and suicide have also occurred in patients taking belimumab. Like other drugs that reduce the activity of the immune system, belimumab may increase the risk of certain cancers.


FDA Prescribing Information

Last Editorial Review: 3/15/2011 1:02:43 PM

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