RECENT MAJOR CHANGES

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 underlying disease/disorders that may be masked. (5.5)
• Gastrointestinal Perforation and Bleeding: 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. (5.6)
• Behavioral and Mood Disturbances: May include euphoria, insomnia, mood swings, personality changes, severe depression and psychosis. Existing conditions may be aggravated (5.7)
• Comorbid Diseases: Symptoms of diabetes and myasthenia gravis may be worsened with treatment. (5.8)
• Ophthalmic Effects: Monitor for cataracts, infections and glaucoma. (5.9)
• Immunogenicity Potential: Neutralizing antibodies with chronic administration may lead to a loss of endogenous ACTH activity. (5.10)
• Use in Patients with Hypothyroidism or Liver Cirrhosis: May result in an enhanced effect. (5.11)
• Negative Effects on Growth and Physical Development: Monitor pediatric patients on long term therapy. (5.12)
• Decrease in Bone Density: Monitor for osteoporosis in patients on long term therapy. (5.13)
• Use in Pregnancy: Embryocidal effect. Apprise women of potential harm to the fetus. (5.14)

ADVERSE REACTIONS

• Common adverse reactions for H.P. Acthar Gel are similar to those of corticosteroids and include fluid retention, alteration in glucose tolerance, elevation in blood pressure, behavioral and mood changes, increased appetite and weight gain. (6)
• Specific adverse reactions resulting from drug use in children under 2 years of age are increased risk of infections, hypertension, irritability, Cushingoid symptoms, cardiac hypertrophy and weight gain. (6.1.1)

To report SUSPECTED ADVERSE REACTIONS, contact Questcor Pharmaceuticals, Inc. at (800) 411-3065 or (510) 400-0700 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

DRUG INTERACTIONS

• H.P. Acthar Gel may accentuate the electrolyte loss associated with diuretic therapy. (7)

USE IN SPECIFIC POPULATIONS

• Pregnancy: H.P. Acthar Gel has been shown to have an embryocidal effect and should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. (8.1)
• Pediatric Use: Prolonged use of H.P. Acthar Gel in children may inhibit skeletal growth. If use is necessary, it should be given intermittently with careful observation. (5.12 and 8.4)