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H.P. Acthar Gel

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H.P. Acthar Gel

Indications
Dosage
How Supplied

INDICATIONS

Infantile spasms

H.P. Acthar Gel (repository corticotropin injection) is indicated as monotherapy for the treatment of infantile spasms in infants and children under 2 years of age.

Multiple Sclerosis

H.P. Acthar Gel (repository corticotropin injection) is indicated for the treatment of acute exacerbations of multiple sclerosis in adults. Controlled clinical trials have shown H.P. Acthar Gel to be effective in speeding the resolution of acute exacerbations of multiple sclerosis. However, there is no evidence that it affects the ultimate outcome or natural history of the disease.

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.

Collagen Diseases

During an exacerbation or as maintenance therapy in selected cases of: systemic lupus erythematosus, systemic dermatomyositis (polymyositis).

Dermatologic Diseases

Severe erythema multiforme, Stevens-Johnson syndrome.

Allergic States

Serum sickness.

Ophthalmic Diseases

Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: keratitis, iritis, iridocyclitis, diffuse posterior uveitis and choroiditis, optic neuritis, chorioretinitis, anterior segment inflammation.

Respiratory Diseases

Symptomatic sarcoidosis.

Edematous State

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.

DOSAGE AND ADMINISTRATION

Specific Recommended Dosage Regimen for Infantile Spasms in Infants and Children Under 2 Years of Age

In the treatment of infantile spasms, H.P. Acthar Gel must be administered intramuscularly. The recommended regimen is a daily dose of 150 U/m² (divided into twice daily intramuscular injections of 75 U/m²) administered over a 2-week period. Dosing with H.P. Acthar Gel should then be gradually tapered over a 2-week period to avoid adrenal insufficiency. The following is one suggested tapering schedule: 30 U/m² in the morning for 3 days; 15 U/m² in the morning for 3 days; 10 U/m² in the morning for 3 days; and 10 U/m² every other morning for 6-days.

H.P. Acthar Gel is typically dosed based on body surface area (BSA). For calculation of body surface area, use the following formula:

BSA (m²) =√ weight (kg) x height (cm) / 3600

Recommended Dosage Regimen for the Treatment of Acute Exacerbations in Adults with Multiple Sclerosis.

The recommended dose is daily intramuscular or subcutaneous doses of 80-120 units for 2-3 weeks for acute exacerbations.

Dosage should be individualized according to the medical condition of each patient. Frequency and dose of the drug should be determined by considering the severity of the disease and the initial response of the patient.

Although drug dependence does not occur, sudden withdrawal of H.P. Acthar Gel after prolonged use may lead to adrenal insufficiency or recurrent symptoms which make it difficult to stop the treatment. It may be necessary to taper the dose and increase the injection interval to gradually discontinue the medication.

Recommended Dosage Regimen for Other Indications for Adults and Children Over 2 Years of Age

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 and the initial response of the patient.

The usual dose of H.P. Acthar Gel is 40-80 units given intramuscularly or subcutaneously every 24-72 hours.

Although drug dependence does not occur, sudden withdrawal of H.P. Acthar Gel after prolonged use may lead to adrenal insufficiency or recurrent symptoms which make it difficult to stop the treatment. It may be necessary to taper the dose and increase the injection interval to gradually discontinue the medication.

Preparation

H.P. Acthar Gel should be warmed to room temperature before using.

Caution should be taken not to over-pressurize the vial prior to withdrawing the product.

HOW SUPPLIED

Dosage Forms And Strengths

5 mL multi-dose vial containing 80 USP Units per mL.

Storage And Handling

H.P. Acthar Gel (repository corticotropin injection) is supplied as 5 mL multi-dose vial (63004-7731-1) containing 80 USP Units per mL. H.P. Acthar Gel (repository corticotropin injection) should be warmed to room temperature before using. Do not over pressurize the vial prior to withdrawing the product.

Store H.P. Acthar Gel (repository corticotropin injection) under refrigeration between 2°-8°C (36°-46°F). Product is stable for the period indicated on the label when stored under the conditions described.

Manufactured for Questcor Pharmaceuticals, Inc., Questcor Pharmaceuticals, Inc. 26118 Research Road, Hayward, CA 94545 USA, phone (800) 411-3065 (510) 400-0700 fax (510) 400-0799. Issued: 06/2011

Last reviewed on RxList: 10/30/2012
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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