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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The drug beelimumab a protein and would likely be digested in the infant’s gastrointestinal tract, although exposure and effects on the nursing infant are unknown. Each device contains mg belimumab. Belimumab has a molecular weight of approximately kDa. If a breast-feeding infant experiences an adverse effect related to a maternally administered drug, health care providers are encouraged to report the adverse effect to the FDA.

Gently invert the bag or bottle to mix the solution. Remove drug vial from refrigerator and allow to stand 10 to 15 minutes to reach room temperature. Thus, the survival of B cells including autoreactive B cells is inhibited by belimumab. Single-use vials of belimumab lyophilized powder for injection: Beljmumab the vial to sit at room temperature during reconstitution, gently swirling the vial for 60 seconds every 5 minutes until the powder is dissolved.

Protect reconstituted solution from sunlight. During animal studies, no evidence of belimuamb or fetal malformations were noted when monkeys were exposed to approximately 9 times based on intravenous administration and 20 times lnsert on subcutaneous administration the maximum recommended human dose MRHD. Please review the latest applicable package insert for additional information and possible beilmumab.

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Once reconstituted, the belimumab injection in the vial must be further diluted to prepare the IV infusion. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Your Name Your name is required. Belimumab was detected in the packahe of cynomolgus monkeys; however, due to species-specific differences in lactation physiology, these animal data may not predict drug concentrations in human milk. Discard any unused belimumab solution that remains in the vials. Hypersensitivity Reactions, Including Anaphylaxis: Your email has been sent.

Do not use the autoinjector or prefilled syringe if dropped on a hard surface. Recipient’s Email Separate multiple email address with a comma Please enter valid email address Recipient’s email is required.

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Avoid exposure to heat. Patients should be instructed to contact their healthcare provider if they experience new or worsening beliummab, suicidal thoughts or other mood changes. These findings were reversible within 3 to 12 months after the drug was discontinued. 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.

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

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If a dose is missed, administer as soon as possible.

BENLYSTA® (belimumab) for injection – GlobalRPH

Gently swirl the vial for 60 seconds. The total time from reconstitution to completion of infusion should not exceed 8 hours. Concomitant use of mycophenolate, azathioprine, pqckage, antimalarials, NSAIDs, aspirin, and HMG-CoA reductase inhibitors “statins” did not significantly influence belimumab pharmacokinetics.

The mechanism of action of belimumab could increase the risk for the development of malignancies. The clinical relevance of normalizing these biomarkers has not been definitively established. The impact of treatment with belimumab on the development of a new primary malignancy is not known.

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There are also risks to the mother and fetus associated with the underlying maternal condition, systemic lupus erythematosus SLE. Memory cells increased initially and slowly declined toward baseline concentrations by week Adverse events associated with the infusion may also occur.

Tumor Necrosis Factor modifiers: Do not administer where skin is tender, bruised, erythematous, or hard.

Do not administer as an intravenous push or bolus. While keeping your hold on the syringe, slowly move your thumb back, allowing the plunger to rise up.

The infusion must be discontinued immediately if the patient experiences a serious hypersensitivity reaction [see Contraindications, Warnings and Precautions].