FDA label bfb4f9b9-1327-4ca1-971c-ce3aec2b7bdf

WARNINGS Chronic administration of corticotropin may lead to adverse effects which are not reversible. Corticotropin may only suppress symptoms and signs of chronic diseases without altering the natural course of the disease. H.P. Acthar Gel (Repository Corticotropin Injection) should not be administered for treatment until adrenal responsiveness has been verified with the route of administration which will be utilized during treatment, intramuscularly or subcutaneously. A rise in urinary and plasma corticosteroid values provides direct evidence of a stimulatory effect. Prolonged administration of corticotropin increases the risk of hypersensitivity reactions. Although the action of corticotropin is similar to that of exogenous adrenocortical steroids, the quantity of adrenocorticoid may be variable. In patients who receive prolonged corticotropin therapy, the additional use of rapidly acting corticosteroids before, during, and after an unusual stressful situation is indicated. Prolonged use of corticotropin may produce posterior subcapsular cataracts and glaucoma with possible damage to the optic nerves. Corticotropin may mask some signs of infection, and new infections including those of the eye due to fungi or viruses may appear during its use. There may be decreased resistance and inability to localize infection when corticotropin is used. Corticotropin can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium. Dietary salt restriction and potassium supplementation may be necessary. Corticotropin increases calcium excretion. While on corticotropin therapy, patients should not be vaccinated against smallpox. Other immunization procedures should be undertaken with caution in patients who are receiving corticotropin, especially when high doses are administered because of the possible hazards of neurological complications and lack of antibody response.

PRECAUTIONS 1. General Corticotropin injection should be used in the lowest dose for the shortest period of time to accomplish the therapeutic goal. Corticotropin should be used for treatment only when the disease is intractable to non-steroid treatment. There is an enhanced effect in patients with hypothyroidism and in those with cirrhosis of the liver. Sensitivity to porcine protein should be considered before starting therapy and during the course of treatment should symptoms arise. When an infection is present, appropriate antibiotic therapy should be given. Patients with latent tuberculosis should be observed closely, and if therapy is prolonged, chemoprophylaxis should be instituted. Psychic symptoms may appear with use of corticotropin or preexisting symptoms may be enhanced. These may range from mood alteration to a psychotic state. Patients with a secondary disease may have that disease worsened. Caution should be used when prescribing corticotropin in patients with diabetes, renal insufficiency, diverticulitis, and myasthenia gravis. Corticotropin often acts by suppressing symptoms without altering the course of the underlying disease. Since complications with corticotropin use are dependent on the dose and duration of treatment, a risk/benefit decision must be made in each case. Suppression of the pituitary adrenal axis occurs following prolonged therapy which may be slow in returning to normal. Patients should be protected from the stress of trauma or surgery by the use of corticosteroids during the period of stress. Since maximal corticotropin stimulation of the adrenals may be limited during the first few days of treatment, other drugs should be administered when an immediate therapeutic effect is desirable. Although controlled clinical trials have shown ACTH to be effective in speeding the resolution of acute exacerbations of multiple sclerosis, they do not show that it affects the ultimate outcome or natural history of the disease. The studies do show that relatively high doses of ACTH are necessary to demonstrate a significant effect. (See DOSAGE AND ADMINISTRATION section). Treatment of acute gouty arthritis should be limited to a few days. Since rebound attacks may occur when corticotropin is discontinued, conventional concomitant therapy should be administered during corticotropin treatment and for several days after it is stopped. Aspirin should be used cautiously in conjunction with corticotropin in hypoprothrombinemia.

ADVERSE REACTIONS Fluid and electrolyte disturbances: Sodium retention; fluid retention; potassium loss; hypokalemic alkalosis; calcium loss. Musculoskeletal: Muscle weakness; steroid myopathy; loss of muscle mass; osteoporosis; vertebral compression fractures; aseptic necrosis of femoral and humeral heads; pathologic fracture of long bones. Gastrointestinal: Peptic ulcer with possible perforation and hemorrhage; pancreatitis; abdominal distention; ulcerative esophagitis. Dermatologic: Impaired wound healing; thin fragile skin; petechiae and ecchymoses; facial erythema; increased sweating; suppression of skin test reactions; acne; hyperpigmentation. Cardiovascular: Hypertension; necrotizing angiitis; congestive heart failure. Neurological: Convulsions; increased intracranial pressure with papilledema, (pseudo-tumor cerebri) usually after treatment; headache; vertigo. Endocrine: Menstrual irregularities; development of Cushingoid state; suppression of growth in children; secondary adrenocortical and pituitary unresponsiveness, particularly in times of stress, as in trauma, surgery or illness; decreased carbohydrate tolerance; manifestations of latent diabetes mellitus; increased requirements for insulin or oral hypoglycemic agents in diabetics; hirsutism. Ophthalmic: Posterior subcapsular cataracts; increased intraocular pressure; glaucoma with possible damage to optic nerve; exophthalmos. Metabolic: Negative nitrogen balance due to protein catabolism. Allergic reactions: Especially in patients with allergic responses to proteins manifesting as dizziness, nausea and vomiting, shock, skin reactions. Miscellaneous: Abscess; prolonged use of ACTH may result in antibodies to it and resulting loss of stimulatory effect. Drug Abuse and Dependence: Although drug dependence does not occur, sudden withdrawal of corticotropin after prolonged use may lead to recurrent symptoms which make it difficult to stop. It may be necessary to taper the dose and increase the injection interval to gradually discontinue the medication.