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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Preparation of Solutions BENLYSTA is 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:. The drug is contraindicated in patients who have had anaphylaxis with belimumab.

Belimumab binds BLyS and prevents it from binding to its receptors on B cells. Remove prefilled syringe or auto-injector from refrigerator and allow 30 minutes to reach room temperature.

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Consider administering premedication for prophylaxis against infusion reactions and hypersensitivity reactions. Please review the latest applicable package insert for additional information and possible updates. The needle will automatically rise up into the needle guard. Memory cells increased initially and slowly declined toward baseline concentrations by week Belimumab should be clear to opalescent and colorless to pale yellow.

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. There may be an increased risk of mortality in patients receiving belimumab. After subcutaneous administration, the time to maximum concentration Tmax was 2.

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Reconstitution is typically complete within 10 to 15 minutes after the sterile water has been added, but it may take up to 30 minutes. The infusion rate may be slowed or interrupted should an infusion reaction develop. Do not initiate belimumab therapy in patients receiving any therapy for chronic infection. Your email has been sent. 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.

Discard the solution if any particulate matter or discoloration is observed. 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. Consider premedication to attenuate such responses. Serious reactions have been reported.

The mechanism of action of belimumab could increase the risk for the development of malignancies.

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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.

The most common infusion reactions were headache, nausea, and skin reactions. Advise female patients of childbearing potential packge contact their physician immediately if they become pregnant or suspect they may be pregnant.

When reconstituting, direct the stream of sterile water toward the side of the vial to minimize foaming. Use belimumab therapy cautiously in patients with a history of depression or other psychiatric disorders. 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.

A serious psychiatric event was reported in 0. Reconstitute the mg vial with 1. While keeping your hold on the syringe, beljmumab move your thumb back, allowing the plunger to rise up.

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Each beliumab vial delivers mg of belimumab. Gently swirl the vial for 60 seconds. Each device contains mg belimumab. 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 an infant belimumxb a belimumab-treated mother for B-cell reduction and other immune dysfunction after birth.

Potential concerns with use of these drugs together insett an increased susceptibility to immunosuppression and serious infections, some of which might be fatal. No data are available on the secondary transmission of packagge from persons receiving live vaccines to patients receiving belimumab or on the effect of belimumab on new immunizations.

Clinical studies did not include sufficient numbers of patients more than 65 years of age to determine whether they respond differently than younger patients; most patients in clinical trials were adults 45 years of age and younger.

No data are available on the secondary transmission of infection from persons receiving live vaccines.

Then add the reconstituted solution of belimumab to the infusion bag or bottle. Live virus vaccines should generally not be administered to an immunosuppressed patient. The clinical relevance of insdrt these biomarkers has not been definitively established. There were more deaths reported with belimumab than with placebo during the controlled period of the clinical trials. A local search option of this data can be found here.

Gently invert the bag or bottle to mix the solution.