The safety profile of Acthar has been established over many years

Acthar Safety Profile1

  • 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
  • The following may be associated with Acthar: increased susceptibility to infections, hypothalamic-pituitary-axis suppression and adrenal insufficiency, Cushing’s Syndrome, elevated blood pressure, salt and water retention and hypokalemia, masking of symptoms of other disorders, gastrointestinal perforation and bleeding, behavioral and mood disturbances, worsening of comorbid diseases, ophthalmic effects, immunogenicity potential, negative effects on growth and physical development, decrease in bone density and embryocidal effect. Patients may need to be monitored for signs and symptoms
  • Common adverse reactions for Acthar are similar to those of corticosteroids and include fluid retention, alternation in glucose tolerance, elevation in blood pressure, behavioral and mood changes, increased appetite and weight gain
  • Specific adverse reactions reported in IS clinical trials in infants and children under 2 years of age included: infection, hypertension, irritability, Cushingoid symptoms, constipation, diarrhea, vomiting, pyrexia, weight gain, increased appetite, decreased appetite, nasal congestion, acne, rash, and cardiac hypertrophy

Please see Important Safety Information below. For a full list of indications, 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)