Medication Guide

Please instruct the parents or caregivers of your patients to read the full Medication Guide before using Acthar.

Download the Medication Guide here

Safety Profile

Acthar side effects are clinically recognizable

Side effects are typically reversible and resolve once treatment is stopped

Patients may need careful monitoring during treatment with Acthar and for a period following the discontinuation of therapy[11]
Side effects are similar to those seen with corticosteroids[11]
Prolonged use of Acthar may increase the risk of side effects[11]

Acthar has a known adverse event profile

Safety data were evaluated from 4 clinical trials

The safety profile of Acthar was established in 331 infants with IS from 4 clinical studies[19]

Incidence of treatment-emergent adverse events occurring in ≥2% of Acthar patients who received the daily dose of 150 U/m²*[11]

Acthar Efficacy

*Above is a summary of adverse reactions specifically tabulated from source data derived from retrospective chart reviews and clinical trials in children under 2 years of age treated for infantile spasms. The number of patients in controlled trials at the recommended dose was too few to provide meaningful comparison to the control groups. Data represents patients who received the daily dose of 150 U/m².
^†Specific infections that occurred at ≥2% were candidiasis, otitis media, pneumonia, and upper respiratory tract infections.
^‡In the treatment of infantile spasms, other types of seizures/convulsions may occur because some patients with infantile spasms progress to other forms of seizures (for example, Lennox-Gastaut syndrome). Additionally, the spasms sometimes mask other seizures and once the spasms resolve after treatment, the other seizures may become visible.

Questcor

Indications for Use

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

Monotherapy treatment of infantile spasms (IS) in infants and children under 2 years of age.
The treatment of exacerbations of multiple sclerosis in adults.
For inducing a diuresis or a remission of proteinuria in the nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus.
The following: rheumatic disorders; collagen diseases; dermatologic diseases; allergic states; ophthalmic diseases and respiratory diseases.

Important Safety Information

Acthar should never be given intravenously. It 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 or adrenocortical hyperfunction or sensitivity to proteins of porcine origin. Acthar is contraindicated in children under 2 years of age with suspected congenital infections. Administration of live or live attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of Acthar.

The adverse effects that may occur with Acthar are related primarily to its steroidogenic effects and are similar to corticosteroids. There may be increased susceptibility to new infection and increased risk of reactivation of latent infections. Adrenal insufficiency may occur after abrupt withdrawal of the drug following prolonged therapy. Cushing’s syndrome, elevated blood pressure, salt and water retention, and hypokalemia may be seen. Masking of symptoms of other underlying disease/disorders may occur. There is a risk of gastrointestinal perforation and bleeding with increased risk of perforation in patients with certain GI disorders. Onset or worsening of euphoria, insomnia, irritability (especially in infants), mood swings, personality changes, depression, and psychosis may occur. Caution should be used when prescribing Acthar to patients with diabetes or myasthenia gravis. Prolonged use may produce cataracts, ocular infections or glaucoma. Use in patients with hypothyroidism or liver cirrhosis may result in an enhanced effect. There may be negative effects on growth and physical development and decreases in bone density.

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. Convulsions were also reported, but these may actually be occurring because some IS patients progress to other forms of seizures and IS sometimes mask other seizures, which become visible once the clinical spasms from IS resolve.

Other adverse reactions in adults and children over 2 years of age included: abdominal distension, anxiety, asthma, chest discomfort, congestive heart failure, dizziness, dyspnea, erythema, fatigue, flushing, headache, hyperhidrosis, hypersensitivity or allergic reactions, injection site pain, muscle weakness, palpitations, peripheral edema, tachycardia, and weakness.

This is a summary only. For a full list of indications, contraindications, warnings, precautions, and adverse events related to Acthar, please refer to the full Prescribing Information. For parents and caregivers of IS patients please also see Medication Guide.

H.P. Acthar^® Gel and Questcor^® are registered trademarks of Questcor Pharmaceuticals, Inc.

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