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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Protect the reconstituted solution belimmumab sunlight. Infection was the most common cause of death. Belimumab is produced by recombinant DNA technology in a mammalian cell expression system. Vaccination with live vaccines should not be given for 30 days before or concurrently with belimumab, as clinical safety has not been established. The impact of treatment with belimumab on the development of a new primary malignancy is not known.

Recipient’s Email Separate multiple email address with a comma Please enter valid email address Recipient’s email is required. Discuss the potential reproductive risk of belimumab and contraception requirements in females of childbearing potential. Once diluted, the infusion may be stored at 2 to 8 degrees C 36 to 46 degrees F or room temperature. The stream of sterile water should be directed toward the side of the vial to minimize foaming.

Belimumab has not been studied in combination with other biologic therapies including B-cell targeted therapies such as intravenous cyclophosphamide.

Belimumab is administered by intravenous infusion or subcutaneous injection. Belimumab has not been evaluated and is not recommended in patients with severe active lupus nephritis or severe active central nervous system lupus or in combination with other biologic products or intravenous cyclophosphamide. Advise female patients of childbearing potential to contact their physician immediately if they become pregnant or suspect they may be pregnant.

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Do not freeze and do not use if the injection has been frozen. Discard the solution if any particulate matter or discoloration is observed. The infusions were administered at 2-week intervals for the first 3 doses and at 4-week intervals thereafter. Memory cells increased initially and slowly declined toward baseline concentrations by week Depression, psychiatric event, suicidal ideation.

Live virus vaccines should generally not be administered to an immunosuppressed patient. Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit. Dilute the reconstituted product to mL in 0. Serious depression was reported in 0. We do not record any personal information entered above. The lack of clinical data of belimumab use during lactation precludes clear determination of the risk of belimumab to a breast-feeding infant.

Belimumab has not been studied in combination with other biologic therapies including B-cell targeted therapies such as ocrelizumab.

While most hypersensitivity reactions have occurred acutely, some appear later. Avoid exposure to heat.

BENLYSTA® (belimumab) for injection – GlobalRPH

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. Immunosuppression, infection, progressive multifocal leukoencephalopathy.

If transitioning from intravenous to subcutaneous therapy, administer the first subcutaneous dose 1 to 4 weeks after the last intravenous dose. Major Live vaccines should not be given for 30 days before or concurrently with belimumab, as clinical safety has not been established. It is unknown if treatment with belimumab is associated with increased risk for these events. 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.

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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.

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Exercise caution if belimumab is considered for use in patients with a chronic infection. The mechanism of action of belimumab could increase the risk for the development of malignancies.

Based on inset data, the immune system of neonates or infants of treated mothers may be adversely affected; the risks and benefits should be considered prior to administering live or live-attenuated vaccines to infants exposed to belimumab in utero.

If a dose is missed, administer as soon as possible. Serious and sometimes fatal indert have been reported in clinical trials with belimumab or other immunosuppressive agents. Live virus vaccines may induce beliummab illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The authors make no claims of the accuracy of the information contained herein; and these suggested doses are not a substitute for clinical judgment.

Monitor all patients during and for an appropriate period of time after belimumab administration. 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.

Belimumab has a molecular weight of approximately kDa.

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