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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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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 Once diluted, the infusion may be stored at 2 to 8 degrees C 36 to 46 degrees F or belimummab temperature. These findings were reversible within 3 to 12 months after the drug was discontinued.

If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. A second “click” may be heard. Serious infusion reactions excluding hypersensitivity reactions were reported in 0.

Therefore, belimumab use is not recommended in combination with biologic therapies. No data are available on the secondary transmission of infection from persons receiving live lackage.

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Send the page ” ” to a friend, relative, colleague or yourself. Consider interrupting belimumab in patients who develop a new infection during treatment.

Belimumab is produced by recombinant DNA technology in a mammalian cell expression system. Among patients receiving subcutaneous belimumab in controlled trials, 5 deaths occurred 3 belimumab; 2 placebo. The lack of clinical data of belimumab use during lactation precludes clear determination of the risk of belimumab to a breast-feeding infant. Based on these 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.

There were more deaths reported with belimumab than with placebo during the controlled period of the clinical trials. Belimumab has a molecular weight of approximately kDa. Then add the reconstituted solution of belimumab to the infusion bag or bottle.

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.

Belimumab has not been studied in combination with other biologic therapies including tumor necrosis factor modifiers TNF blockers. Health care professionals are encouraged to register patients and pregnant women are encouraged to enroll in the registry by calling Do not initiate belimumab therapy in patients receiving any therapy for chronic infection.

Because of its mechanism of action, belimumab may interfere with the response to immunizations. Protect from light and store refrigerated at 2 to 8 degrees C 36 to 46 degrees F until time of use. Belimumab binds BLyS and prevents it from binding to its receptors on B cells. Reference s National Institutes of Health, U. Reconstitute the mg vial with 1.

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It is important to note that hypersensitivity reactions may present as infusion reactions. Each device contains mg belimumab. Do not warm in any other way. 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.

While most hypersensitivity reactions have occurred acutely, some appear later. A “click” will be heard at the start of the injection. The authors make no claims of the accuracy of the information contained herein; and these suggested doses are not a substitute for clinical judgment. Belimumab has not been studied in combination with other biologic therapies including rituximab.

Hypersensitivity Reactions, Including Anaphylaxis: After subcutaneous administration, the time to maximum concentration Tmax was 2. Gently invert the bag beliimumab bottle to mix the solution.