BELIMUMAB PACKAGE INSERT PDF

Published by on April 7, 2021
Categories: Medical

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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There may be an increased risk of mortality in patients receiving belimumab. Monitor all patients during and for an appropriate period of time after belimumab administration. If a mechanical reconstitution device swirler blimumab used to reconstitute BENLYSTA, it should not exceed rpm and the vial swirled for no longer than 30 minutes.

When reconstituting, direct the stream of sterile water toward the side of the vial to minimize foaming. Vials should be protected from light and stored in the original carton until use. No data are available on the secondary transmission of infection from persons receiving live vaccines to patients receiving belimumab or on the effect of belimumab on new immunizations.

To monitor maternal-fetal outcomes, a pregnancy registry has been established. Hypersensitivity Reactions, Including Anaphylaxis: When the injection is complete, lift the injector from the injection site.

Therefore, belimumab use is not recommended in combination with intravenous cyclophosphamide.

Human Genome Sciences, Inc. These findings were reversible within 3 to 12 months after the drug was discontinued. For the auto-injector, position the packae straight over the injection site at a degree angle.

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The injection may take up to 15 seconds to complete. Discuss the potential reproductive risk of belimumab and contraception requirements in females of childbearing potential.

Receipt of belimumab also led to reductions in IgG and anti-dsDNA and to increases in complement C3 and C4 as early as week 8 and were sustained through week Consider the developmental and health benefits of breast-feeding and any potential adverse effects on the breastfed infant along with the mother’s clinical need for belimumab when considering belimumab therapy. Thereafter, the patient can resume dosing on their usual day of administration or start a new weekly schedule from the day that the missed dose was administered.

Consider premedication to attenuate infusion- and hypersensitivity-related reactions. Affected cytochrome P CYP enzymes and drug transporters: Belimumab is produced by recombinant DNA technology in a mammalian cell expression system.

The infusion rate may be slowed or interrupted should an infusion reaction develop. Due to overlap in signs and symptoms, it was not possible to distinguish between hypersensitivity reactions and infusion reactions in all cases. Belimumab has a molecular weight of approximately kDa.

Major Avoid use together. Do not administer belimumab concomitantly in the same IV line with other agents. The total time from reconstitution of belimumab to completion of infusion should not exceed beoimumab hours. Reference s National Institutes of Health, U. Do not use the autoinjector or prefilled syringe if dropped on a hard surface.

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Discard any unused belimumab solution that remains in the vials. Memory cells increased initially and slowly declined toward baseline concentrations by week Subcutaneous administration sites include the abdomen and thigh. The risks and benefits should also be considered prior to administering live or live-attenuated vaccines to an infant exposed to belimumab in utero. A local search bwlimumab of this data can be found here.

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To start the injection, firmly press the auto-injector all the way down onto the injection site and hold in place. Belimumab is NOT compatible ;ackage Dextrose solutions.

Protect reconstituted solution from sunlight.

Belimumab may cause leukopenia, and patients with immunosuppression may be more susceptible to infection. The most common infusion reactions were headache, nausea, and skin reactions.

During animal studies, no evidence of embryotoxicity or fetal malformations were noted when monkeys were exposed to approximately 9 times based on intravenous administration and 20 times based on subcutaneous administration the maximum recommended human dose MRHD.

Serious and sometimes fatal infections have been reported in clinical trials with belimumab or other immunosuppressive agents. There are also risks to the mother and fetus associated with the underlying maternal condition, systemic lupus erythematosus SLE. Consider discontinuation of immunosuppressant therapy, including belimumab, in patients with confirmed PML.

Belimumab has not been studied in combination with other biologic therapies including B-cell targeted therapies such as intravenous cyclophosphamide. Belimumab should be clear to opalescent and colorless to pale yellow.

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Adverse events associated with the infusion may also occur. Each mL vial delivers mg of belimumab. Small air bubbles, however, are expected and acceptable. Push the plunger all the way down until all of the solution is injected.