BELIMUMAB PACKAGE INSERT PDF

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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Belimumab was detected in the milk of cynomolgus monkeys; however, due to species-specific differences in lactation physiology, these animal data may not predict drug concentrations in human milk.

Serious reactions have been reported. The risks and benefits should also be considered prior to administering live packwge live-attenuated vaccines to an infant exposed to belimumab in utero. Belimumab is produced by recombinant DNA technology in a mammalian cell inxert system. Major Live vaccines should not be given for 30 days before or concurrently with belimumab, as clinical safety has not been established. The total time from reconstitution to completion of infusion should not exceed 8 hours.

Reconstitute the mg vial with 1. 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.

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Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. Coadministration of steroids and angiotensin-converting enzyme ACE inhibitors resulted in an increase of systemic clearance of belimumab that was not clinically significant as the magnitude of the changes was well within the range of normal variability of clearance.

Each device contains mg belimumab. Disclaimer The authors make no claims of the accuracy of the information contained herein; belimkmab these suggested doses are not a substitute for clinical judgment. The manufacturer recommends using belimumab with caution in geriatric patients.

Then add the reconstituted solution of belimumab to the infusion bag or bottle. It is important to note that hypersensitivity reactions may present as infusion reactions. Belimumab has not been studied in combination with other biologic therapies including tumor necrosis factor modifiers TNF blockers. Patients should be instructed to contact their healthcare provider if they experience new or worsening depression, suicidal thoughts or other mood changes.

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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 ihsert. Intravenous and subcutaneous human monoclonal antibody that inhibits B lymphocyte stimulator BLyS Used with standard therapy for active autoantibody-positive, systemic lupus erythematosus SLE in adults Infusion reactions possible with IV use; serious hypersensitivity reactions and infections have been reported with subcutaneous and IV use.

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Gently swirl the vial for 60 seconds. Depression, psychiatric event, suicidal ideation. Consider discontinuation of immunosuppressant therapy, including belimumab, in patients with confirmed PML. To monitor maternal-fetal outcomes, be,imumab pregnancy registry has been established.

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Dilute the reconstituted product to mL in 0. The beliummab rate may be slowed or interrupted if the patient innsert an infusion reaction.

Belimumab is NOT compatible with Dextrose solutions. Among patients receiving subcutaneous belimumab in controlled trials, 5 deaths occurred 3 belimumab; 2 placebo. Gently invert the bag or bottle to mix the solution. While most hypersensitivity reactions have occurred acutely, some appear later. Cases of JC virus-associated progressive multifocal leukoencephalopathy PML have been reported, some fatal, nelimumab patients with systemic lupus erythematosus receiving immunosuppressants, including belimumab.

Reconstitute the mg vial with 4. Belimumab has not been studied in combination with other biologic therapies including B-cell targeted therapies such as ocrelizumab. In the controlled clinical trials, malignancies, excluding non-melanoma skin cancers, were observed in 0. When the injection is complete, lift the injector from the injection site.

The majority of patients who reported serious depression or suicidal ideation had a history of depression or other serious ihsert disorders and most were receiving psychoactive medications. A second “click” may be heard.