Corticotropin

DEA Class; Rx

Common Brand Names; H.P. Acthar Gel, Purified Cortrophin Gel

Indicated for the treatment of infantile spasms.

Sensitivity to porcine proteins

IV administration

Infants <2 years suspected of congenital infections

Coadministration of live or live-attenuated vaccines with immunosuppressive doses of corticotropin

Scleroderma

Osteoporosis

Systemic fungal infections

Ocular herpes simplex

Recent surgery

Active/history of peptic ulcer

CHF, HTN

Common

• Edema, hypertension

• Psychotic disorder

• Disorder of skin

• Hyperglycemia

• Peptic ulcer disease

• Immune hypersensitivity reaction

• Muscle weakness

Serious

• Cardiomegaly, congestive heart failure, necrotizing arteritis

• Encephalitis due to human herpes simplex virus, relapse

• Decreased body growth, Children

• Pancreatitis

• Thromboembolic disorder

• Glaucoma

Increases susceptibility to new infection and risk of exacerbation, dissemination or reactivation of latent infections; signs and symptoms of infection may be masked

Adrenal insufficiency may occur after prolonged therapy; monitor for effects of hypothalamic-pituitary-axis suppression after stopping treatment

Cushing’s syndrome may occur after prolonged therapy; monitor for signs and symptoms

Elevated blood pressure, salt and water retention and hypokalemia may occur; monitor blood pressure and sodium and potassium levels

Do not administer live or live-attenuated vaccines to patients on immunosuppressive doses

May mask symptoms of other underlying disease/disorders; monitor patients for signs of other underlying disease/disorders that may be masked

Gastrointestinal perforation and bleeding may occur; there is a risk for gastric ulcers and bleeding; there is an increased risk of perforation in patients with certain GI disorders; signs and symptoms may be masked; monitor for signs of perforation and bleeding

Behavioral and mood disturbances may occur; may include euphoria, insomnia, mood swings, personality changes, severe depression, and psychosis; existing conditions may be aggravated; effects are reversible once therapy stopped

Symptoms of diabetes and myasthenia gravis may be worsened with treatment Monitor for cataracts, infections and glaucoma

In patients with hypothyroidism or liver cirrhosis, may result in an enhanced effect

Monitor pediatric patients on long term therapy for growth and physical development

Monitor for osteoporosis in patients on long term therapy

May have embryocidal effect in pregnancy; apprise women of potential harm to the fetus

Gel is immunogenic; limited available data suggest that a patient may develop antibodies to the gel after chronic administration and loss of endogenous ACTH and gel activity

Prolonged administration of the gel may increase risk of hypersensitivity reactions; cases of anaphylaxis have been reported in the postmarketing setting

Use in patients with sensitivity to porcine protein is contraindicated, and the possibility of sensitivity should be considered during the course of treatment should symptoms arise

Pregnancy Category: C

Lactation: excretion in milk unknown; use with caution