BELIMUMAB PACKAGE INSERT PDF

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Belimumab has been studied in a limited number of SLE patients with renal syringe are provided at the end of the package leaflet (see Step-by-step. Learn about BENLYSTA (belimumab), an FDA-approved prescription infusion or self-injectable lupus medication to help treat your Request your FREE Info Kit. Keep in the original package until time of use to protect from light. Insert the entire Needle into the pinched area of the skin at a slight degree angle using a.

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Tumor Necrosis Factor modifiers: The infusion rate may be slowed or interrupted should an infusion reaction develop.

The drug is a protein and would likely be digested in the infant’s gastrointestinal tract, although exposure and effects on the nursing infant are unknown. Clinical studies did not include sufficient numbers of patients more than 65 years of age to determine whether they respond differently than younger patients; most patients in clinical trials were adults 45 years of age and younger.

Do not initiate belimumab therapy in patients inser any therapy for chronic infection. Any unused solution in the vials must be discarded.

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Then add the reconstituted solution of belimumab to the infusion bag or bottle. Reconstitue, dilute and administer as an intravenous infusion only, over a period of 1 hour. Advise female patients of childbearing potential to contact their physician immediately if they become pregnant or suspect they may be pregnant. Related Drug Information Drug Summary. Exploratory sub-group analyses of response rates based on race were performed during clinical trials; some data suggest that Black patients may have reduced clinical response to belimumab.

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Non-acute hypersensitivity reactions including rash, nausea, fatigue, myalgia, headache, and facial edema, have been reported and typically occurred up to a week following the most recent infusion. Avoid exposure to heat. It is important to note that hypersensitivity reactions may present as infusion reactions. For the auto-injector, position the auto-injector straight over the injection site at a degree angle.

Belimumab has not been studied in combination with other biologic therapies including B-cell targeted therapies such as ocrelizumab. Infuse over 1 hour; administration may be slowed or interrupted if infusion reaction occurs. Consultation with a neurologist or other appropriate specialist may be belimymab. Potential concerns with use of these drugs together include an increased susceptibility to immunosuppression and serious infections, some of which might be fatal.

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While keeping your hold on the syringe, slowly move your thumb back, allowing the plunger to rise up. Gently swirl the vial for 60 seconds. Therefore, belimumab use is not recommended in combination with pacmage therapies.

Depression, psychiatric event, suicidal ideation. The most common infusion reactions were headache, nausea, and skin reactions. Etiologies included infection, cardiovascular disease, and suicide.

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Protect from light and store refrigerated at 2 to 8 degrees C 36 to 46 degrees F until time of use. Belimumab has not been studied in combination with other biologic therapies including rituximab.

A “click” will be heard at the start of the injection.

For the pre-filled syringe, insert the entire needle into the pinched area of the skin at a slight degree angle using a dart-like motion. Reconstitute the mg vial with 4.

Consider premedication to attenuate infusion- and hypersensitivity-related reactions. Therefore, belimumab use is not recommended in combination with TNF blockers. There is 1 case report published of belimumab use throughout pregnancy in a mother with SLE; use led to well-controlled SLE in the mother, but with the presence of mild Ebstein’s packaye of the heart in the baby.

Further, the differentiation of B cells into immunoglobulin-producing plasma cells is reduced. Allow the vial to sit at room temperature during reconstitution, gently swirling the vial for 60 seconds every 5 minutes until the powder is dissolved.

If a knsert reconstitution device swirler is used to reconstitute BENLYSTA, it should not exceed rpm and the vial swirled for no longer than 30 minutes.