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

Once reconstitution is complete, the solution should be opalescent and colorless to pale yellow, and without particles. Thereafter, the patient can resume dosing on their usual day of administration or start a new weekly belimu,ab from the day that the missed dose was administered.

After subcutaneous administration, the time to maximum concentration Tmax was 2. Monitor all patients during and for an appropriate period of time after belimumab administration.

The injection may take up to 15 seconds to complete. Consider administering premedication for prophylaxis against infusion reactions and hypersensitivity reactions.

Belimumab has bellmumab molecular weight of approximately kDa. Small air bubbles, however, are expected and acceptable.

Exercise caution if belimumab is considered for use in patients with a chronic infection.

BENLYSTA® (belimumab) for injection – GlobalRPH

Belimumab has not been evaluated and is not recommended in patients with severe active lupus nephritis or severe active central nervous system lupus or in combination with other biologic products or intravenous cyclophosphamide.

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We do not record any personal information entered above. Exploratory sub-group analyses of response rates based on race were performed during clinical trials; some data suggest that Black patients may have reduced clinical response to belimumab.

Dispose of any used pre-filled syringes or auto-injectors immediately after use. 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.

Safety and efficacy of belimumab have not been established in children or adolescents less than 18 years of age.

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There were more deaths reported with belimumab than with placebo during the controlled period of the clinical trials. Inspect syringe or autoinjector for particulate matter and discoloration prior to administration.

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. Continue to hold the auto-injector down until you see that the purple indicator has stopped moving. Rotate sites of injection with each dose. A local search option of this data can be found here.

Each device contains mg belimumab. Once reconstituted, the belimumab injection in the vial must be further diluted to prepare the IV infusion. No single cause of death predominated. The infusion must be discontinued immediately if the patient experiences a serious hypersensitivity reaction [see Contraindications, Warnings and Precautions].

Single-use pac,age of belimumab lyophilized powder insetr injection: Use belimumab therapy cautiously in patients with a history of depression or other psychiatric disorders. The infusion rate may be slowed or interrupted should an infusion reaction develop. 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. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

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Limited data on use of belimumab during human pregnancy, either from observational studies, published case reports, or postmarketing surveillance, are insufficient to determine whether there is a drug-associated risk for major birth defects or miscarriage.

The total time from reconstitution to completion of infusion should not exceed 8 hours. Advise patients and caregivers of inwert signs and symptoms of hypersensitivity and to seek immediate medical help if symptoms develop. Your email has been sent. The lack of clinical data of belimumab use during lactation precludes clear determination of the risk of belimumab to a breast-feeding infant.

Protect from light and store refrigerated at 2 to 8 degrees C 36 to 46 degrees F until time of use.

Because of its mechanism of action, belimumab may belimumah with the response to immunizations. If not used immediately, protect the reconstitued vial from direct sunlight and refrigerate at 2 to 8 degrees C 36 to 46 degrees F. Belimumab is available as both a prefilled syringe and as an auto-injector for subcutaneous use. Reconstitute the mg vial with 4.

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