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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If not used immediately, protect the reconstitued vial from direct sunlight and refrigerate at 2 to 8 degrees C 36 to 46 degrees F. Further, the differentiation of B cells into immunoglobulin-producing inseert cells is reduced.

Patients should be instructed to contact their healthcare provider if they experience new or worsening depression, suicidal thoughts or other mood changes. Monitor an infant of a belimumab-treated mother for B-cell reduction and other immune dysfunction after birth.

BENLYSTA® (belimumab) for injection – GlobalRPH

Belimumab may cause leukopenia, and patients with immunosuppression may be more susceptible to infection. Dilute the reconstituted product to mL in 0. Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit.

After an assessment of benefit versus risk, if prevention of pregnancy is warranted, females should use effective contraception during treatment and for at least 4 months after the final treatment. Belimumab is available as both a prefilled syringe and as an auto-injector for subcutaneous use.

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Belimumab was detected in the milk of cynomolgus monkeys; however, beelimumab to species-specific differences in lactation physiology, these animal data may not predict drug concentrations in human milk. Belimumab is produced by recombinant DNA technology in a mammalian cell expression system. When reconstituting, direct the stream of sterile water toward the side of the vial to minimize foaming. Thus, the survival of B cells including autoreactive B cells is inhibited by belimumab.

We do not record any personal information entered above. Advise patients and caregivers of the signs and symptoms of hypersensitivity and to seek immediate medical help if symptoms develop. The lack of clinical data of belimumab use packgae lactation precludes clear determination of the risk of belimumab to a breast-feeding infant.

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 If a mechanical reconstitution device swirler is used to reconstitute BENLYSTA, it should not exceed rpm and the vial swirled for packave longer than 30 minutes. The clinical relevance of normalizing these biomarkers has not been definitively established.

Protect reconstituted solution from sunlight. Use with caution in patients with chronic infections. Belimumab use carries a risk of serious hypersensitivity reactions or anaphylaxis. If a dose is missed, administer as soon as possible.

No data are available on the secondary transmission of infection from persons receiving live vaccines. Depression, psychiatric event, suicidal ideation. A local search option of this data can be found here. With weekly administration there were minor fluctuations around the average concentration with the minimum concentration being only slighly below the average concentration.

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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. Infuse over 1 hour; administration may be slowed or interrupted if infusion reaction occurs.

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The most common infusion reactions were headache, nausea, and skin reactions. Do not use beyond the expiration date. The impact of treatment with belimumab on the development of a new primary malignancy is not known. Rotate sites of injection with each dose. Administration of IV infusion: Belinumab Genome Sciences, Inc. Belimumab has not been studied in combination with other biologic therapies including B-cell targeted therapies such as ofatumumab.

Gently invert the bag or bottle to mix the solution. To monitor maternal-fetal outcomes, a pregnancy registry has been established. Please review the latest applicable package insert for additional information and possible updates. Inspect syringe or autoinjector for particulate matter and discoloration prior to administration.

Protect from light and store refrigerated at 2 to 8 degrees C 36 to 46 degrees F until time of use. Reconstitue, dilute and administer as an intravenous infusion only, over a period of 1 hour. Each mL vial delivers mg of belimumab.

Affected cytochrome P CYP enzymes and drug transporters: Avoid exposure to heat. 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. Major Avoid use together.