HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use H.P. Acthar Gel safely and effectively. See full prescribing information for H.P. Acthar Gel.
H.P. Acthar Gel (repository corticotropin injection) INJECTION, GEL for INTRAMUSCULAR | SUBCUTANEOUS use
Initial U.S. Approval: 1952
 
RECENT MAJOR CHANGES
Indications and Usage, (1) 10/10
Dosage and Administration, (2) 10/10 
Contraindications, Infantile Spasms (4) 10/10
Warnings and Precautions (5) 10/10
 
INDICATIONS AND USAGE
H.P. Acthar Gel is an adrenocorticotropic hormone (ACTH) analogue indicated as monotherapy for the treatment of infantile spasms in infants and children under 2 years of age. (1.1)
H.P. Acthar Gel is indicated for the treatment of exacerbations of multiple sclerosis in adults. (1.2)
H.P. Acthar Gel may be used for the following disorders and diseases: rheumatic; collagen; dermatologic; allergic states; ophthalmic; respiratory; and edematous state; (1.3 to 1.9)

DOSAGE AND ADMINISTRATION
In the treatment of infantile spasms, the recommended dose is 150 U/m2 divided into twice daily intramuscular injections of 75 U/m2. After 2 weeks of treatment, dosing should be gradually tapered and discontinued over a 2-week period. (2.1)
In the treatment of acute exacerbations of multiple sclerosis, daily intramuscular or subcutaneous doses of 80-120 units for 2-3 weeks may be administered. It may be necessary to taper the dose. (2.2)
In the treatment of other disorders and diseases, dosing will need to be individualized depending on the disease under treatment and the medical condition of the patient. It may be necessary to taper the dose. (2.3)

DOSAGE FORMS AND STRENGTHS
5 mL multi-dose vial containing 80 USP units per mL (3)

CONTRAINDICATIONS
H.P. Acthar Gel should never be given intravenously.
H.P. Acthar 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, uncontrolled hypertension, or sensitivity to proteins of porcine origin.
Administration of live or live attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of H.P Acthar Gel.
H.P. Acthar Gel is contraindicated in children under 2 years of age with suspected congenital infections. (4)
Treatment of conditions listed within the INDICATIONS section is contraindicated when they are accompanied by primary adrenocortical insufficiency or adrenocortical hyperfunction. (4)
 
WARNINGS AND PRECAUTIONS
Infections: Increased susceptibility to new infection and increased risk of exacerbation, dissemination or reactivation of latent infections. Signs and symptoms of infection may be masked. (5.1)
Adrenal Insufficiency after Prolonged Therapy: Monitor for effects of hypothalamic-pituitary-axis suppression after stopping treatment. (5.2)
Cushing's Syndrome: May occur after prolonged therapy. Monitor for signs and symptoms. (5.2)
Elevated Blood Pressure, Salt and Water Retention and Hypokalemia: Monitor blood pressure and sodium and potassium levels. (5.3)
Vaccination: Do not administer live or attenuated vaccines to patients on immunosuppressive doses. (5.4)
Masking of Symptoms of Other Underlying Disease/Disorders. Monitor patients for signs of other u