Mallinckrodt Ard Inc.

Mallinckrodt Ard Inc. Drugs

• H.p. Acthar
  

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  H.p. Acthar

  

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  2.1 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

  2.2 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.

  2.3 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.

  2.4 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.

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