nderlying 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)
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide
Revised: 09/2011
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Back to Highlights and TabsFULL PRESCRIBING INFORMATION: CONTENTS*
* Sections or subsections omitted from the full prescribing information are not listed
1 INDICATIONS AND USAGE
1.1 Infantile spasms:
1.2 Multiple Sclerosis:
1.3 Rheumatic Disorders:
1.4 Collagen Diseases:
1.5 Dermatologic Diseases:
1.6 Allergic States:
1.7 Ophthalmic Diseases:
1.8 Respiratory Diseases:
1.9 Edematous State:
2 DOSAGE AND ADMINISTRATION
2.1 Specific Recommended Dosage Regimen for Infantile Spasms in Infants and Children Under 2 Years of Age
2.2 Recommended Dosage Regimen for the Treatment of Acute Exacerbations in Adults with Multiple Sclerosis.
2.3 Recommended Dosage Regimen for Other Indications for Adults and Children Over 2 Years of Age
2.4 Preparation
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
