Safety Information
Safety Profile Established Over 25 Years
H.P. Acthar® Gel (repository corticotropin injection) is indicated for the treatment of acute exacerbations in patients with multiple sclerosis, for the diagnosis of adrenocortical function, and for several other uses.
Corticotropin stimulates the adrenal cortex to release cortisol and other hormones. Elevated levels of these hormones may lead to adverse reactions in several organ systems similar to the effects of high-dose or long-term corticosteroid treatment.
Common adverse reactions associated with the use of Acthar include:
- diarrhea
- fluid retention
- headache
- hirsutism
- increased sweating
- injection site reaction
- mood alteration
- palpitations
- skin reactions
- tachycardia
- vertigo
The following potentially serious adverse reactions may also occur:
- abscess
- anaphylaxis
- congestive heart failure
- convulsions
- Cushingoid state
- electrolyte disturbances
- glucose intolerance
- hypertension
- impaired wound healing
- increased intraocular pressure
- muscle weakness
- osteoporosis
- pancreatitis
- peptic ulcer
- posterior subcapsular cataracts
- psychotic state
- severe allergic reaction
- suppression of growth in children
- ulcerative esophagitis
Contraindications
Corticotropin 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, hypertension, or sensitivity to proteins of porcine origin. Treatment of approved indications is contraindicated when they are accompanied by primary adrenocortical insufficiency or adrenocortical hyperfunction. Intravenous administration of corticotropin is contraindicated.
This is a summary only. For a full list of adverse events, precautions, and warnings for Acthar, please refer to the full prescribing information.