FDA approved Purified Cortrophin Gel (corticotropin) for Multiple Inflammatory and Autoimmune DisordersFDA approved Purified Cortrophin Gel for Many Inflammatory Conditions

Corticotropin stimulates the adrenal cortex to produce and secrete corticosteroids. A rise in urinary and plasma corticosteroid values provides direct evidence of a stimulatory effect. The action is similar to that of exogenous adrenocortical steroids, but the quantity of adrenocorticoid produced may be variable.

Purified Cortrophin Gel is indicated for: - Rheumatic disorders: adjunctive therapy for short-term administration in psoriatic arthritis, rheumatoid arthritis (including juvenile rheumatoid arthritis), ankylosing spondylitis, and acute gouty arthritis. - Collagen diseases: during exacerbation or as maintenance therapy in selected cases of systemic lupus erythematosus and systemic dermatomyositis (polymyositis). - Dermatologic diseases: severe erythema multiforme (Stevens-Johnson syndrome) and severe psoriasis. - Allergic states: atopic dermatitis and serum sickness. - Ophthalmic diseases: severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa, such as allergic conjunctivitis, keratitis, iritis and iridocyclitis, diffuse posterior uveitis and choroiditis, optic neuritis, chorioretinitis, and anterior segment inflammation. - Respiratory diseases: symptomatic sarcoidosis. - Edematous states: to induce diuresis or remission of proteinuria in nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus. - Nervous system: acute exacerbations of multiple sclerosis.

Standard tests for verification of adrenal responsiveness may utilize up to 80 units as a single injection or one or more injections of a lesser dosage. Verification tests should be performed prior to treatment and should use the route of administration proposed for treatment. Following verification, dosage should be individualized based on the disease, severity, plasma and urine corticosteroid levels, and initial response. Only gradual changes in dosage should be attempted after full drug effects are apparent. Administration is subcutaneous or intramuscular for the vial, and subcutaneous for the prefilled syringe. For acute exacerbations of multiple sclerosis, daily subcutaneous or intramuscular doses of 80-120 units for 2-3 weeks are recommended. Chronic administration of more than 40 units daily may be associated with uncontrollable adverse effects. Dosage reduction should be gradual, by reducing the amount of each injection, increasing intervals, or both. Injection sites include abdomen, upper thigh, or upper arm; do not inject within 2 inches of the navel. The product is a clear, light amber liquid gel at room temperature; it solidifies when refrigerated and must be warmed before administration (vials: roll between hands; prefilled syringes: leave at room temperature for 45 minutes). Inspect visually for particulate matter and discoloration; do not use if discolored, cloudy, or contains particulate matter.

Trial data not available in label.

Chronic administration may lead to irreversible adverse effects. Adrenal responsiveness must be verified before treatment. Corticotropin may mask symptoms of other diseases and only suppress symptoms without altering the natural course. It is immunogenic; patients may develop antibodies after chronic administration, leading to loss of endogenous ACTH and drug activity. Prolonged administration may increase risk of hypersensitivity reactions, including anaphylaxis (reported postmarketing). Sensitivity to porcine protein should be considered. Ophthalmic effects include posterior subcapsular cataracts and glaucoma with possible optic nerve damage. It may mask signs of infection, and new infections (including fungal or viral eye infections) may appear; decreased resistance and inability to localize infection may occur. It can cause elevated blood pressure, salt and water retention, and hypokalemia. Additional use of rapidly acting corticosteroids is indicated before, during, and after unusual stress in patients on prolonged therapy