The Power to Lower Proteinuria

For patients who are not adequately controlled with first-line treatment, Acthar effectively lowers proteinuria in Nephrotic Syndrome.

H.P. Acthar^® Gel is indicated 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.

There are clinical data showing that a synthetic adrenocorticotropin (ACTH) analog is an effective therapy for patients with Nephrotic Syndrome and recently, a new set of data has been published based on several clinicians experience of using Acthar, a natural, highly purified ACTH, in patients with Nephrotic Syndrome in the US.*[1] Twenty-one patients with Nephrotic Syndrome were treated with Acthar with a minimum of six months of follow-up. In a subset of 10 of those patients with Nephrotic Syndrome due to idiopathic membranous nephropathy, 90% of patients achieved a complete or partial remission:

On average, patients experienced a 4084 mg/day drop in proteinuria with Acthar from baseline (mean baseline proteinuria: 6621 mg/day)
All 10 patients had failed an average of 2 immunosuppresive regimens including steroids, calcineurin inhibitor, cyclophosphamide, and mycophenolate mofetil
Adverse events from this study were relatively mild, similar to those seen with steroids, and reversible

Acthar offers a different treatment option.

Acthar is a formulation of adrenocorticotropin hormone (ACTH) in 16% gelatin designed to provide a prolonged release after it is injected.

*Complete remission is defined as stable or improved renal function with final proteinuria falling to <500 mg/day. Partial remission is defined as stable or improved renal function with ≥50% reduction in proteinuria and final proteinuria 500–3500 mg/day.

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 warnings, precautions, and adverse events related to Acthar, please refer to the full Prescribing Information including Medication Guide for the treatment of Infantile Spasms.

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