DailyMed Label: Purified Cortrophin Gel

DailyMed Label: Purified Cortrophin Gel

2023

DailyMed Prescription

Purified Cortrophin Gel

Repository Corticotropin

ANI Pharmaceuticals, Inc.

NDC: 62559-860

NDC: 62559-860

Purified Cortrophin Gel is a porcine derived purified corticotropin (ACTH) in a sterile solution of gelatin. It is made up of a complex mixture of ACTH, ACTH related peptides and other porcine pituitary derived peptides. The drug product is a sterile preparation containing 80 USP units per mL and it contains 0.5% phenol (as preservative), 15.0% gelatin (for prolonged activity), water for injection, and the pH is adjusted with hydrochloric acid and sodium hydroxide. Purified Cortrophin Gel contains the porcine derived ACTH (1-39) with the following amino acid sequence: Structure

Purified Cortrophin Gel is indicated in the following disorders: 1. Rheumatic disorders:   As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: Psoriatic arthritis. Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). Ankylosing spondylitis. Acute gouty arthritis. 2. Collagen diseases:   During an exacerbation or as maintenance therapy in selected cases of: Systemic lupus erythematosus. Systemic dermatomyositis (polymyositis). 3. Dermatologic diseases:   Severe erythema multiforme (Stevens-Johnson syndrome). Severe psoriasis. 4. Allergic states:   Atopic dermatitis Serum sickness. 5. 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. Anterior segment inflammation. 6. Respiratory diseases:   Symptomatic sarcoidosis. 7. Edematous states:   To induce a diuresis or a remission of proteinuria in the nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus. 8. Nervous system:   Acute exacerbations of multiple sclerosis.

Standard tests for verification of adrenal responsiveness to corticotropin may utilize as much as 80 units as a single injection or one or more injections of a lesser dosage. Verification tests should be performed prior to treatment with corticotropins. The test should utilize the route(s) of administration proposed for treatment. Following verification dosage should be individualized according to the disease under treatment and the general medical condition of each patient. Frequency and dose of the drug should be determined by considering severity of the disease, plasma and urine corticosteroid levels and the initial response of the patient. Only gradual change in dosage schedules should be attempted, after full drug effects have become apparent. In the treatment of acute exacerbations of multiple sclerosis daily intramuscular doses of 80-120 units for 2-3 weeks. The chronic administration of more than 40 units daily may be associated with uncontrollable adverse effects. When reduction in dosage is indicated this should be accomplished gradually by either reducing the amount of each injection, or administering injections at longer intervals, or by a combination of both of the above. During reduction of dosage, careful consideration should be given to the disease being treated, the general medical condition of the patient and the duration over which corticotropin was administered. This product may be administered subcutaneously or intramuscularly. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

Purified Cortrophin Gel is contraindicated for intravenous administration. Purified Cortrophin Gel is contraindicated in patients with scleroderma, osteoporosis, systemic fungal infections, ocular herpes simplex, recent surgery, history of or the presence of a peptic ulcer, congestive heart failure, hypertension, or sensitivity to proteins derived from porcine sources. Purified Cortrophin Gel is contraindicated in patients with primary adrenocortical insufficiency or adrenocortical hyperfunction.

Patients with latent tuberculosis or tuberculin reactivity who receive corticotropin should be closely observed as reactivation of the disease may occur. During prolonged corticotropin therapy, these patients should receive chemoprophylaxis. Skin testing should be performed prior to treatment of all patients with suspected sensitivity to porcine protein. Immediately following intramuscular or subcutaneous administration of corticotropin all patients should be observed carefully for sensitivity reactions. Relative adrenocortical insufficiency induced by prolonged corticotropin therapy may be minimized by gradual reduction of corticotropin dosage. This type of insufficiency may persist for months after discontinuation of therapy; therefore, in any situation of stress during that period, hormone therapy should be reinstituted. There is an enhanced effect of corticotropin in patients with hypothyroidism and in those with cirrhosis. The lowest possible dosage of corticotropin should be used to control the condition under treatment, and when reduction in dosage is possible the reduction should be gradual. Corticotropin should be administered for treatment only when the disease is intractable to more conventional therapy. Corticotropin should be adjunctive and not the sole therapy in the treatment of a disease. 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. When infection is present appropriate anti-infective therapy should be administered during corticotropin and following discontinuation of corticotropin therapy. 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. Psychic derangements may appear when corticotropin is used, ranging from euphoria, insomnia, mood swings, personality changes, and depression, to frank psychotic manifestations. Also, existing emotional instability or psychotic tendencies may be aggravated by corticotropin. Corticotropin should be used with caution in patients with diabetes, abscess, pyogenic infections, diverticulitis, renal insufficiency, and myasthenia gravis. Growth and development of infants and children on prolonged corticotropin therapy should be carefully observed. 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. Since complications of treatment with ACTH are dependent on the size of the dose and the duration of treatment, a risk/benefit decision must be made in each individual case as to dose and duration of treatment. Aspirin should be used cautiously in conjunction with corticotropin in hypoprothrombinemia. Since fetal abnormalities have been observed in experimental animals, use of this drug in pregnancy, nursing mothers, or women of childbearing potential requires that the potential benefits of the drug be weighed against the potential hazards to the mother and embryo or fetus. Infants born of mothers who have received substantial doses of corticotropin during pregnancy should be carefully observed for signs of hypoadrenalism.

Aspirin should be used cautiously in conjunction with corticotropin in hypoprothrombinemia.

Purified Cortrophin Gel is supplied sterile in 1 mL and 5 mL multiple-dose vials. Package Size Total Volume NDC 1 mL multiple-dose vial 80 USP units/mL 62559-860-11 5 mL multiple-dose vial 400 USP units/5 mL 62559-860-15

Purified Cortrophin Gel is the anterior pituitary hormone which stimulates the functioning adrenal cortex to produce and secrete adrenocortical hormones. Following administration of a single intramuscular injection of 80 Units of Cortrophin Gel to healthy volunteers (n=20) in an open label pharmacodynamic study, the median time (range) to reach peak cortisol concentration was 8 (3-12) hours. The baseline corrected geometric mean maximum (CV%) cortisol levels were 34.52 µg/dL (28.2%).

NDC 62559-860-15 Purified Cortrophin ® Gel (repository corticotropin injection USP) 400 USP units/5 mL (80 USP units/mL) For intramuscular or subcutaneous use. 5 mL, multiple-dose vial Rx only 5mL_carton