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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Benlysta (belimumab) dose, indications, adverse effects, interactions from

Serious and sometimes fatal infections have been reported in clinical packkage with belimumab or other immunosuppressive agents. Consultation with a unsert or other appropriate specialist may be warranted. From the diluent infusion bag, withdraw and discard a volume equal to the volume of the reconstituted solution of belimumab required for the patient’s dose.

Maternal antibodies are known to be present in human milk; however, data are limited regarding use of belimumab during breast-feeding, and its excretion in human milk is unknown.

BENLYSTA® (belimumab) for injection – GlobalRPH

Patients should be instructed to contact their healthcare provider if they experience new or worsening depression, suicidal thoughts or other mood changes. The stream of sterile water should be directed toward the side of the vial to minimize foaming. Vaccination with live vaccines should not be given for 30 days before or concurrently with belimumab, as clinical safety has not been established.

Therefore, belimumab use is not recommended in combination with TNF blockers. Patients may use the lnsert syringe or auto-injector after proper training. If not used immediately, protect the reconstitued vial from direct sunlight and refrigerate at 2 to 8 degrees C 36 to 46 degrees F. Do not give 2 doses on the same day. Concomitant use of mycophenolate, azathioprine, methotrexate, antimalarials, NSAIDs, aspirin, and HMG-CoA reductase inhibitors “statins” did not significantly influence belimumab pharmacokinetics.

Advise patients and caregivers of the signs and symptoms of hypersensitivity and to seek immediate medical help if symptoms develop. Do not initiate belimumab therapy in packaye receiving any therapy for chronic infection.

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It is important to note that hypersensitivity reactions may present as infusion reactions. Consider discontinuation of immunosuppressant therapy, including belimumab, in patients with confirmed PML. Human Genome Sciences, Inc. Belimumab should be clear to opalescent and colorless to pale yellow.

Then add the reconstituted solution of belimumab to ppackage infusion bag or bottle.

Major Avoid use together. 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.

Small air bubbles, however, are expected and acceptable.

The needle will automatically rise up into the needle guard. It is normal to see 1 or more air bubbles in the solution. 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:. Use with caution in patients with chronic infections. Monitor all patients during and for an appropriate period of time after belimumab administration.

There is 1 case report published of belimumab use throughout pregnancy in a mother with SLE; use led to well-controlled SLE in the mother, but with the presence of mild Ebstein’s anomaly of the heart in the baby. Dilute the reconstituted product to mL in 0.

If a dose is missed, administer as soon as possible. If a mechanical reconstitution device swirler is used to reconstitute BENLYSTA, it should not exceed rpm and the vial swirled for no longer than 30 minutes.

Protect reconstituted solution from sunlight. Once reconstitution is complete, the solution should be opalescent and colorless to pale yellow, and without particles. Administer belimumab by intravenous infusion only; do not give as an IV push or bolus. 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.

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Do not use the autoinjector or prefilled syringe if dropped on a hard surface. The clinical relevance of normalizing these biomarkers has not been definitively established.

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Major Live vaccines should not be given for 30 days before or concurrently with belimumab, as clinical safety has not been established. There were more deaths reported with belimumab than with placebo during the controlled period of the clinical trials.

After subcutaneous administration, the time to maximum concentration Tmax was 2. Out of 2, patients receiving intravenous belimumab in 3 clinical trials, a total of 14 deaths occurred during the placebo-controlled, double-blind treatment periods: Based ;ackage these data, the immune system of neonates or infants of treated mothers may be adversely affected; the risks and benefits should be considered prior pcakage administering live or live-attenuated vaccines to infants exposed to belimumab in utero.

Push the plunger all the way down until all of the solution is injected. There are also risks to the mother and fetus associated with the underlying maternal condition, systemic lupus erythematosus SLE.

Belimumab may cause leukopenia, and patients with immunosuppression may be more bleimumab to infection. 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.

To monitor maternal-fetal outcomes, a pregnancy registry has been established. 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 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.

Only healthcare providers prepared to manage anaphylaxis should administer belimumab by infusion. Reconstitute the mg vial with 1.