BELIMUMAB PACKAGE INSERT PDF

Send the page " " to a friend, relative, colleague or yourself. We do not record any personal information entered above. Intravenous and subcutaneous human monoclonal antibody that inhibits B lymphocyte stimulator BLyS Used with standard therapy for active autoantibody-positive, systemic lupus erythematosus SLE Infusion reactions possible with IV use; serious hypersensitivity reactions and infections have been reported. Consider premedication to attenuate infusion- and hypersensitivity-related reactions. Discontinue the infusion immediately if the patient experiences a serious hypersensitivity reaction. If transitioning from intravenous to subcutaneous therapy, administer the first subcutaneous dose 1 to 4 weeks after the last intravenous dose.

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Please consult with or refer to the Evidence of Coverage document. FDA Approved Indications: Treatment of adult patients with active, autoantibody-positive, systemic lupus erythematosus SLE who are receiving standard therapy.

Coverage is Not Authorized For: Non-FDA approved indications, which are not listed in the Health Net Approved Indications and Usage Guidelines section, unless there is sufficient documentation of efficacy and safety in the published literature. Patients who are autoantibody negative. General Information: In a study that enrolled both autoantibody negative as well as autoantibody positive patients with SLE, no significant differences between any of the Benlysta groups and the placebo group were observed.

Further analysis revealed that Benlysta offered benefit to autoantibody positive patients. Because of this lack of efficacy of Benlysta in autoantibody negative patients and since the FDA has approved Benlysta in autoantibody positive patients, coverage will not be authorized for patients who are autoantibody negative.

Benlysta has not been studied in combination with other biologics or intravenous cyclophosphamide. Use of Benlysta is not recommended in these situations.

Benlysta should be administered by healthcare providers prepared to manage anaphylaxis. Product Availability: mg and mg single-use vials containing lyophilized powder. References: Benlysta [package insert]. Efficacy and safety of belimumab in patients with active systemic lupus erythematosus: a randomized, placebo-controlled, phase 3 trial. Accessed June 16, Overview of the therapy and prognosis of systemic lupus erythematosus in adults.

Bartels C, Muller D. Systemic Lupus Erythematosus. Accessed June 17, Lupus Foundation of America. Understanding lupus. Guidelines for referral and management of systemic lupus erythematosus in adults. Arthritis Rheum. Dubois EL. Antimalarials in the management of discoid and systemic lupus erythematosus.

Semin Arthritis Rheum. The material provided to you are guidelines used by this plan to authorize, modify or determine coverage for persons with similar illnesses or conditions. Specific care and treatment may vary depending on individual need and the benefits covered under your contract.

GARMIN NUVI 52LM MANUAL PDF

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You are about to leave a GSK website. By clicking this link, you will be taken to a website that is independent from GSK. The site you are linking to is not controlled or endorsed by GSK, and GSK is not responsible for the content provided on that site. Take a little time to explore all we have to offer. The IV formulation gained approval in for use in children 5 years and older. It is taken in addition to your other lupus medications and is available to adult patients in three options and to children ages 5 years and older in one option:.

MITSUBISHI FD630U PDF

Please consult with or refer to the Evidence of Coverage document. FDA Approved Indications: Treatment of adult patients with active, autoantibody-positive, systemic lupus erythematosus SLE who are receiving standard therapy. Coverage is Not Authorized For: Non-FDA approved indications, which are not listed in the Health Net Approved Indications and Usage Guidelines section, unless there is sufficient documentation of efficacy and safety in the published literature. Patients who are autoantibody negative. General Information: In a study that enrolled both autoantibody negative as well as autoantibody positive patients with SLE, no significant differences between any of the Benlysta groups and the placebo group were observed. Further analysis revealed that Benlysta offered benefit to autoantibody positive patients. Because of this lack of efficacy of Benlysta in autoantibody negative patients and since the FDA has approved Benlysta in autoantibody positive patients, coverage will not be authorized for patients who are autoantibody negative.

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