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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Continue to hold the auto-injector down until you see that the purple indicator has stopped moving. There may be an increased risk of mortality in patients bslimumab belimumab.

Once reconstituted, the belimumab injection in the vial must be further diluted to prepare the IV infusion.

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The injection may take up to 15 seconds to complete. 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. Dispose of any used pre-filled syringes or auto-injectors immediately after belimumag. Based on these data, the immune system of beljmumab 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 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.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Due to overlap in signs and symptoms, it was not possible to distinguish between hypersensitivity reactions and infusion reactions in all cases. Belimumav events associated with the infusion may also occur.

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If transitioning from intravenous to subcutaneous therapy, administer the first subcutaneous dose belimumba to 4 weeks after the last intravenous dose. Serious reactions belimuab been reported. Once reconstitution is complete, the solution should be opalescent and colorless to pale yellow, and without particles.

Gently invert the bag or bottle to mix the solution. Each 5-mL vial delivers mg of belimumab. There were more deaths reported with belimumab than with placebo during the controlled period of the clinical trials.

Belimumab should be clear to opalescent and colorless to pale yellow. Rotate sites of injection with each dose.

The mechanism of action of belimumab could increase the risk for the development of malignancies. The risks and benefits should also be considered prior to administering inesrt or live-attenuated vaccines to an infant exposed to belimumab in utero.

Therefore, belimumab use is not recommended in combination with biologic therapies. While keeping your hold on the syringe, slowly move your thumb back, allowing the plunger to rise up. Reconstitute the mg vial with 4.

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 Belimumab was detected in the milk belimymab cynomolgus monkeys; however, due to species-specific differences in lactation physiology, these animal data may not predict drug concentrations in human milk. Reconstitution is typically complete within 10 to 15 minutes after the sterile water has been added, but it may take up to 30 minutes.

In the controlled clinical trials, malignancies, excluding non-melanoma skin cancers, were observed in 0. Safety and efficacy of belimumab have not been established in children or adolescents less than 18 years of age. A local search option of this data can be found here. Any unused solution in the vials must be discarded.

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To monitor maternal-fetal outcomes, a pregnancy registry has been established. For the pre-filled syringe, insert the entire needle into the pinched jnsert of the skin at a slight degree angle using a dart-like motion. With weekly administration there were minor fluctuations around the average concentration with the minimum concentration being only slighly below the average concentration.

A diagnosis of PML should be considered in any patient presenting with new-onset or deteriorating neurological signs and symptoms.

Do not warm in any other way.

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Protect the reconstituted solution from sunlight. The impact of treatment with belimumab on the development of a new primary malignancy is not known. Tumor Necrosis Factor modifiers: Preparation for use of the prefilled syringe or auto-injector: Monitor all patients during and for an appropriate period of time after belimumab administration.

Administration of IV infusion: Infuse over 1 hour; administration may be slowed or interrupted if infusion reaction occurs. Therefore, belimumab use is not recommended in combination with intravenous cyclophosphamide.

Affected cytochrome P CYP enzymes and drug transporters: Please review the latest applicable package insert for additional information and possible updates. Do not inject within 2 inches of the umbilicus. Small air bubbles, however, are expected and acceptable. Do not give 2 doses on the same day. The lack of clinical data of belimumab use during lactation precludes clear determination of the risk of belimumab to a breast-feeding infant.