Acthar Gel (repository corticotropin)

Acthar Gel can cause serious side effects, including:

• Acthar Gel may make certain other medical conditions worse, such as diabetes (may increase blood sugar).
• Eye problems. Your child can get cataracts, increased pressure in the eye (glaucoma), and possible damage to the optic nerve if treated with Acthar Gel for a long time.
• Allergic reactions to Acthar Gel. Your child may have an allergic reaction to Acthar Gel. Allergic reactions may not happen until your child has received several injections of Acthar Gel. Tell your doctor right away if your child has any of the following signs of an allergic reaction:
  • skin rash
  • swelling of the face, tongue, lips, or throat
  • trouble breathing
• Changes in growth and physical development. Acthar Gel may affect your child's growth and physical development and may weaken his or her bones. This is more likely to happen with long term use of Acthar Gel.
• Enlarged heart. Acthar Gel may cause an increase in the size of your child's heart. This is more likely to happen with long term use of Acthar Gel but usually goes away after Acthar Gel is stopped.

The most common side effects of Acthar Gel for patients with infantile spasms include:

• Infections
• muscle contractions that you cannot control (convulsions)
• increased blood pressure
• irritability and changes in behavior
• fever

These are not all the possible side effects of Acthar Gel. Tell your doctor if your child has any side effect that bothers them or does not go away. For more information, ask your child's doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Specific Recommended Dosage Regimen For Infantile Spasms In Infants And Children Under 2 Years Of Age

• In the treatment of infantile spasms, 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 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.
• Acthar Gel is typically dosed based on body surface area (BSA). For calculation of body surface area, use the following formula:

Body Surface Area (BSA) Calculation Formula - Illustration

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 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 Acthar Gel is 40-80 units given intramuscularly or subcutaneously every 24-72 hours.
• Although drug dependence does not occur, sudden withdrawal of 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.

• Formal drug-drug interaction studies have not been performed.
• Acthar Gel may accentuate the electrolyte loss associated with diuretic therapy.

• Acthar Gel has been shown to have an embryocidal effect.
• There are no adequate and well-controlled studies in pregnant women.
• Acthar Gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
• It is not known whether this drug is excreted in human milk.
• Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Acthar Gel, when treating a nursing mother, a decision should be made whether to discontinue nursing or to discontinue the drug, considering the risk and benefit to the mother.