BELIMUMAB PACKAGE INSERT PDF

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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Therefore, belimumab use is not recommended in combination with biologic therapies. Because of its mechanism of action, belimumab may interfere with the response to packagee. Exercise caution if belimumab is considered for use in patients with a chronic infection.

For the auto-injector, position the auto-injector straight belimmumab the injection site at a degree angle. Live virus vaccines should generally not be administered to an immunosuppressed patient. Do not administer where skin is tender, bruised, erythematous, or hard. The needle will automatically rise up into the needle guard. Patients receiving belimumab should be instructed to contact their healthcare provider if they experience new or worsening depression, suicidal thoughts, or other changes in moods or behaviors.

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

Push the plunger all the way down until all of the solution is injected.

When reconstituting, direct the stream of sterile water toward the side of the vial to minimize foaming. To monitor maternal-fetal outcomes, a pregnancy registry has been established.

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Benlysta (belimumab) dose, indications, adverse effects, interactions from

Belimumab use carries a risk of serious hypersensitivity reactions or anaphylaxis. Consider administering premedication for prophylaxis against infusion reactions and hypersensitivity reactions.

Consider discontinuation of immunosuppressant therapy, including belimumab, in patients with confirmed PML. Protect reconstituted solution from sunlight.

These findings were reversible within 3 to belikumab months after the drug was discontinued. Each 5-mL vial delivers mg of belimumab. Reconstitution is typically complete within 10 to 15 minutes after the sterile water has been added, but it may take up to 30 minutes. Use belimumab therapy cautiously in patients with a history of depression or other psychiatric disorders.

The stream of sterile water should be directed toward the side of the vial to minimize foaming. Administration of belimumab requires an experienced clinician prepared to manage anaphylaxis and infusion-related reactions.

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Preparation of Solutions BENLYSTA belimumqb provided as a lyophilized powder in a single-use vial for intravenous infusion only and should be reconstituted and diluted by a healthcare professional using aseptic technique as follows:. Safety and efficacy of belimumab have not been established in children or adolescents less than 18 years of age. 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 anomaly of the heart in the blimumab.

Belimumab is produced by recombinant DNA technology in a mammalian cell expression system. Do not administer belimumab concomitantly in the same IV line with other agents. Belimumab has not been evaluated and is not recommended in patients with severe active lupus nephritis or severe active central nervous system lupus pxckage in combination with other biologic products or intravenous cyclophosphamide.

Rotate sites of injection with each dose. Insertt has not been studied in combination with other biologic therapies including tumor necrosis factor modifiers TNF blockers. Related Drug Information Drug Summary. The most common infusion reactions were headache, nausea, and skin reactions.

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BENLYSTA® (belimumab) for injection – GlobalRPH

Belimumab binds BLyS and prevents it from binding to its receptors on B cells. Discuss the potential reproductive risk of belimumab and contraception requirements in females of childbearing potential. The manufacturer recommends using belimumab with caution in geriatric patients. If a mechanical reconstitution device swirler is used to reconstitute belimumab, it should not exceed rpm and the vial swirled for no longer than 30 minutes.

Avoid exposure to heat. 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.

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Each device contains mg belimumab. If serious hypersensitivity reactions develop during belimumab administration, discontinue the infusion immediately and treat accordingly.

There may be an increased risk of mortality in patients receiving belimumab. Health care brlimumab are encouraged to register patients and pregnant women are encouraged to enroll in the registry by calling Vials should be protected from light and stored in the original carton until use. Monoclonal antibodies, such as belimumab, are actively transported across the placenta during the third trimester of pregnancy and may affect immune response in the in utero-exposed fetus.

Reductions in naive and the SLE B-cell subset were observed as blimumab as week 8 and were sustained to week