FDA approved Acthar Gel (repository corticotropin injection) for Infantile Spasms and Multiple SclerosisFDA approved Acthar Gel for Infantile Spasms and Multiple Sclerosis Flares

Not reported in label.

Acthar Gel is indicated as monotherapy for the treatment of infantile spasms in infants and children under 2 years of age. It is indicated for the treatment of acute exacerbations of multiple sclerosis in adults. It may be used for the following disorders and diseases: rheumatic disorders (as adjunctive therapy for short-term administration in psoriatic arthritis, rheumatoid arthritis including juvenile rheumatoid arthritis, and ankylosing spondylitis); collagen diseases (during exacerbation or as maintenance therapy in selected cases of systemic lupus erythematosus, systemic dermatomyositis, polymyositis); dermatologic diseases (severe erythema multiforme, Stevens-Johnson syndrome); allergic states (serum sickness); ophthalmic diseases (severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as keratitis, iritis, iridocyclitis, diffuse posterior uveitis and choroiditis, optic neuritis, chorioretinitis, anterior segment inflammation); respiratory diseases (symptomatic sarcoidosis); and edematous state (to induce diuresis or remission of proteinuria in nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus).

Acthar Gel vial is for either intramuscular or subcutaneous injection. The single-dose pre-filled SelfJect injector is for subcutaneous administration by adults only and should only be used to administer single doses of 40 units or 80 units. For infantile spasms, Acthar Gel must be administered intramuscularly using the multi-dose vial; the SelfJect injector is not to be used. The recommended dose is 150 U/m2 daily divided into twice-daily intramuscular injections of 75 U/m2 for 2 weeks, followed by a gradual taper over 2 weeks. A suggested taper: 30 U/m2 in the morning for 3 days; 15 U/m2 in the morning for 3 days; 10 U/m2 in the morning for 3 days; and 10 U/m2 every other morning for 6 days. For acute exacerbations of multiple sclerosis, the recommended dose is 80 to 120 units daily intramuscularly or subcutaneously for 2 to 3 weeks. For other disorders and diseases, the usual dose is 40 to 80 units intramuscularly or subcutaneously every 24 to 72 hours. Dosage should be individualized. Tapering may be necessary upon discontinuation.

Controlled clinical trials have shown Acthar Gel to be effective in speeding the resolution of acute exacerbations of multiple sclerosis. However, there is no evidence that it affects the ultimate outcome or natural history of the disease. Trial data not available in label for other indications.

Not reported in label.

Acthar Gel is approved as monotherapy for infantile spasms in infants and children under 2 years of age and for acute exacerbations of multiple sclerosis in adults. It is also indicated for a range of other conditions as adjunctive or symptomatic therapy. For multiple sclerosis, it may speed resolution of exacerbations but does not alter the disease course. Dosing must be individualized, and gradual tapering is recommended after prolonged use to avoid adrenal insufficiency.