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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Do not use the autoinjector or prefilled syringe if dropped on a hard surface. There is 1 case report published of belimumab use throughout pregnancy in a mother with SLE; use led to insertt SLE in the mother, but with the presence of mild Ebstein’s anomaly of the heart in the baby. Avoid exposure to heat. The impact of treatment with belimumab on the development of a new primary malignancy is not known.

Reconstitute the mg vial with 1. If a dose is missed, administer as soon as possible. Any unused solution in the vials must be discarded.

Human Belimumsb Sciences, Inc. The mechanism of action of belimumab could increase the risk for the development of malignancies. Belimumab has not been studied in combination with other biologic therapies including B-cell targeted therapies such as ocrelizumab.

Each 5-mL vial delivers mg of belimumab. Please review the latest applicable package insert for additional information and possible updates. With weekly administration there were minor fluctuations around the average concentration with the minimum concentration being only slighly below the average concentration. Reductions in naive and the SLE B-cell subset were observed as early as week 8 and were ;ackage to week Unknown No formal drug interaction studies have belimumwb conducted with belimumab.

The injection may take up to 15 seconds to complete. Safety and efficacy of belimumab have not been established in children or adolescents less than 18 years of age.

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Monitor all patients during and for an appropriate period of time after belimumab administration. It is unknown if treatment with belimumab is associated with increased risk for these events.

The manufacturer recommends using belimumab with caution in geriatric patients. Consider interrupting belimumab in patients who develop a new infection during treatment. Out of 2, patients receiving intravenous belimumab in 3 clinical trials, a total of belimkmab deaths occurred during the placebo-controlled, double-blind treatment periods: Tumor Apckage Factor modifiers: Do not warm in any other way.

Exercise caution if belimumab is considered for use in patients with a chronic infection. Belimumab may cause leukopenia, and patients with immunosuppression may be more susceptible to infection.

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Recipient’s Email Separate multiple email address with a comma Please enter valid email address Recipient’s email is required. 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. Hypersensitivity Reactions, Including Anaphylaxis: There are also risks to the mother and fetus associated with the underlying maternal condition, systemic lupus erythematosus SLE.

Consider administering premedication for inserf against infusion reactions and hypersensitivity reactions. Protect the reconstituted solution from sunlight. Administer belimumab by intravenous infusion only; do not give as an IV push or bolus.

Gently swirl the vial for 60 seconds. These findings were reversible within 3 to 12 months after the drug was discontinued. 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. 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.

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. Continue to hold the auto-injector down until you see that the purple indicator has stopped moving.

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If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Among patients receiving subcutaneous belimumab in controlled trials, 5 deaths occurred 3 belimumab; 2 placebo.

Belimumab use carries a risk of serious hypersensitivity reactions or anaphylaxis. The needle will automatically rise up into the needle guard. Protect from light and store refrigerated at 2 to 8 degrees C 36 to 46 degrees F until time of use. The authors make no claims of the accuracy of the information contained herein; and these suggested doses are not a substitute for clinical judgment.

While most hypersensitivity reactions have occurred acutely, some appear later. Belimumab has not been studied in combination with other biologic therapies including B-cell targeted therapies such as intravenous cyclophosphamide. Live virus vaccines should generally not be administered to an immunosuppressed patient.

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Make sure the gold needle guard is flat on the skin. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system.

We do not record any personal information entered above. Belimumab is produced by recombinant DNA technology in a mammalian cell expression system.

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

Belimumab has a molecular weight of approximately kDa. In the controlled clinical trials, malignancies including non-melanoma skin cancers were reported in 0.

No data are available on the secondary transmission of infection from persons beelimumab live vaccines. Once reconstituted, the belimumab injection in the vial must be further diluted to prepare the IV infusion. Treatment with immunosuppressants and impaired immune function are risk factors for PML.