Safety Profile

Acthar has a well-established safety profile

  • Side effects are similar to those seen with corticosteroids, including fluid retention, alteration in glucose tolerance, elevation in blood pressure, behavioral and mood changes, increased appetite, and weight gain1
  • Prolonged use of Acthar may increase the risk of side effects
  • The safety profile for Acthar in the treatment of dermatomyositis and polymyositis was evaluated in a retrospective case series of 5 patients with dermatomyositis and polymyositis2
    • Patients receiving Acthar were examined for significant side effects, including:
      • Hyperglycemia
      • Diabetic ketoacidosis
      • Hyperosmolar states
    • No significant adverse events as defined in the study methods were reported by the investigator in any of the 5 patients

Please see Important Safety Information below. For a full list of indications, contraindications, warnings, precautions, and adverse events related to Acthar, please refer to the full Prescribing Information.

IMPORTANT SAFETY INFORMATION

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Contraindications

  • Acthar should never be administered intravenously
  • Administration of live or live attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of Acthar
  • Acthar is contraindicated where congenital infections are suspected in infants
  • Acthar 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, primary adrenocortical insufficiency, adrenocortical hyperfunction or sensitivity to proteins of porcine origins

INDICATIONS

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H.P. Acthar® Gel (repository corticotropin injection) is an adrenocorticotropic hormone (ACTH) analogue used for:

  • Treatment during an exacerbation or as maintenance therapy in selected cases of systemic dermatomyositis (polymyositis)
  • Treatment during an exacerbation or as maintenance therapy in selected cases of systemic lupus erythematosus
  • The treatment of symptomatic sarcoidosis
  • Adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy)