BENLYSTA PRESCRIBING INFORMATION PDF

Benlysta mg solution for injection in pre-filled syringe. 2. available information, dose adjustment is not required in patients with mild, moderate or severe. Learn about BENLYSTA (belimumab), an FDA-approved prescription infusion or self-injectable lupus medication to help treat your Request your FREE Info Kit. Belimumab (Benlysta) is a biologic reference with prescribing information, dosage, medication administration, and possible side effects.

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Lupus Nephritis Margiotta and colleagues stated that the treatment of lupus nephritis LN is an unmet need in the management of patients with SLE.

Belimumab (Benlysta) – Medical Clinical Policy Bulletins | Aetna

Circulating antibody-secreting cells were enumerated using enzyme-linked immunospot assay. The outcome variable was the clinical response, either complete or partial, based on clinical judgement. Jnformation and clinical studies suggest that belimumab can reduce autoantibody levels in SLE. Early diagnosis is important for effective treatment and multiple biomarkers have been identified; however, prescriibing has been yet validated for clinical use.

The fact that smokers responded better opened the door to further studying the combination of mepacrine-hydroxychloroquine as a 1st-line therapy in such patients.

Belimumab in kidney transplantation: The future of uveitis treatment. Combined mepacrine-hydroxychloroquine treatment in patients with systemic lupus erythematosus and refractory cutaneous and articular activity. Changes in gene expression informafion consistent with mechanism of action and showed that clinical response to treatment with belimumab was associated with a significant decrease in pro-fibrotic genes and pathways.

This was due to a decrease in naive and transitional B cells.

Belimumab (Benlysta)

American College of Ifnormation guidelines for screening, treatment, and management of lupus nephritis. B-cell depletion using rituximab has been of benefit, mainly in relation to extra-glandular features, and to some extent in relation to hypo-salivation where there is still residual salivary function.

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Sjogren’s Syndrome Mariette et al evaluated the safety and effectiveness of belimumab in patients with primary Sjogren’s syndrome pSS. Biologics in oral medicine: Case series and literature review.

GSK; revised July Rpescribing of relevant studies were searched by hand. The disease affects many parts of the body including the brain, heart, joints, kidneys, lungs, and the skin. Evidence from animal models and in-vitro studies indicated that T-cells and B-cells activate fibroblasts to produce collagen.

However, the unmet need in vasculitis therapy remains large and newer therapies either alone or in combination will need to both improve efficacy and permit reductions in glucocorticoid and immunosuppressive exposure. One of the following: Erythematosus raised patches with adherent keratotic scaling and follicular plugging: Jin and Ding summarized up-to-date pharmacological and clinical data of belimumab in the treatment of rheumatoid arthritis RA.

GSK; July 21, Treatment strategies for myasthenia gravis: Method of analysis was by modified intention-to-treat. A B-lymphocyte stimulator inhibitor for systemic lupus erythematosus. ICD codes covered if selection criteria are met: Finnish Medical Society Duodecim.

The most common side effects associated with the use of belimumab include diarrhea, fever, and nausea. She presented initially with chronic dacryoadenitis and screening showed nephrotic-range proteinuria.

Emerging therapeutics for rheumatoid arthritis. Safety and effectiveness were analyzed during the 1-year period of treatment. Significant differences between the treatment and placebo groups were not attained for either primary end point, and no dose response was observed.

In contrast, memory B cells and plasma cells are less susceptible to selective BLyS inhibition. The primary efficacy end-point was mean change from baseline in the Quantitative Myasthenia Gravis QMG scale at week 24; safety assessments included the frequency and severity of adverse events AEs and serious AEs. Dobrowolski Prescirbing, Erkan D. Patients were included in this bi-centric prospective 1-year open-label trial if they fulfilled American European Consensus group criteria, were anti-Sjogren’s syndrome A-positive and had informatio systemic complications or salivary gland enlargement, or early disease less than 5 yearsor biomarkers of B cell activation.

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Most currently available molecules target TNF-alpha with different strategies i. New treatments for inflammatory rheumatic disease.

Furuta S, Jayne D. O’Neill I, Scully C. A multi-modality treatment approach was common, typically involving a combination of intravenous immune globulin IVIGplasmapheresis PPrituximab, and bortezomib or carfilzomib. Belimumab is administered intravenously over a 1-hour period; it should not be administered with live vaccines. Further, small molecules have been recently developed to target intra-cellular signaling, such as janus kinases for tofacitinib, the first FDA-approved small molecule for RA.

Aetna considers belimumab Benlysta medically necessary for the treatment of adults aged 18 years or older with active systemic lupus erythematosus SLE and positive autoantibody test e. Careful patient selection may be necessary for belimumab to achieve optimal clinical outcomes in RA. Rituximab was relatively safe compared to placebo. Belimumab was well-tolerated in the treatment of RA over 24 weeks. For example, reducing relapse risk and glucocorticoid toxicity; newer therapies are needed.

The American College of Rheumatology’s guidelines for screening, treatment, and management of lupus nephritis Hahn et al, notes that alternative therapies e. Rituximab has not proven itself in large, placebo-controlled trials, although it is still being used in refractory cases of lupus nephritis.

Research progress on B cell surface molecules targeted therapy in rheumatoid arthritis. Links to various non-Aetna sites are provided for your convenience only. A major advance is the development of consensus guidelines to precisely define AMR among lung transplant. The rates of adverse events and serious adverse events were similar in the belimumab and placebo groups.