Acthar is used to induce a diuresis or a remission of proteinuria in nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus.

Learn about patients treated with Acthar

Learn about patients treated with Acthar

Acthar Case Studies

Overview of Acthar clinical experience

Clinical experience from a prospective, non-blinded, open-label study of Acthar reducing proteinuria in nephrotic syndrome

A prospective, non-blinded, open-label trial assessed the safety of Acthar in 15 adult patients with proteinuria due to nephrotic syndrome in 3 pre-specified subgroups1*
Bomback et al, 2012
  • All patients had confirmed nephrotic-range proteinuria at the initial study visit and were treated with Acthar 80 units subcutaneously twice weekly for 6 months
  • Baseline proteinuria was calculated by the average of the first 3 weeks’ urine protein:creatinine ratio (UPCR) values
  • Most patients were previously treated with at least 1 other commonly used therapy for proteinuria due to nephrotic syndrome
View full study.
Subgroups
iMN MCD/FSGS IgA Nephropathy
Outcome
Partial remission was achieved in 2 of 5 patients Partial remission was achieved in 2 of 5 patients ≥50% reduction in proteinuria was seen in 2 of 5 patients

Three patients discontinued therapy early due to adverse events. 2 iMN patients withdrew from the study due to worsening glycemic control and 1 IgAN patient withdrew due to evidence of worsening kidney function. The authors reported there were no cases of significant infection.

These results are based on a prospective, non-blinded, open-label study of 15 patients and may not be fully representative of outcomes in the overall patient population. Most patients were on multiple therapies. The clinical outcomes may not be attributable to Acthar.
Review more Acthar clinical data.

*Results from a prospective, non-blinded, open-label study designed to evaluate the efficacy and safety of Acthar in 3 prespecified subgroups: patients with idiopathic membranous nephropathy (iMN), patients with either focal segmental glomerulosclerosis (FSGS) or minimal change disease (MCD), and patients with immunoglobulin A (IgA) nephropathy. 15 patients with nephrotic syndrome were treated with Acthar 80 units subcutaneously twice weekly for 6 months: 5 with MN, 5 with FSGS or MCD, and 5 with IgA nephropathy.

Dosage and frequency may be individualized according to the medical condition, severity of the disease, and initial response to treatment.2

  • •  The usual dose of Acthar is 40 to 80 units given intramuscularly or subcutaneously every 24 to 72 hours

Remission was defined as stable or improved renal function with ≥50% reduction in UPCR to <0.50 g/g (complete remission) or 0.50–3.50 g/g (partial remission).

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

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

Warnings and Precautions

  • The adverse effects of Acthar are related primarily to its steroidogenic effects
  • Acthar may increase susceptibility to new infection or reactivation of latent infections
  • Suppression of the hypothalamic-pituitary-axis (HPA) may occur following prolonged therapy with the potential for adrenal insufficiency after withdrawal of the medication. Adrenal insufficiency may be minimized by tapering of the dose when discontinuing treatment. During recovery of the adrenal gland patients should be protected from the stress (e.g. trauma or surgery) by the use of corticosteroids. Monitor patients for effects of HPA suppression after stopping treatment
  • Cushing’s syndrome may occur during therapy but generally resolves after therapy is stopped. Monitor patients for signs and symptoms
  • Acthar can cause elevation of blood pressure, salt and water retention, and hypokalemia. Blood pressure, sodium and potassium levels may need to be monitored
  • Acthar often acts by masking symptoms of other diseases/disorders. Monitor patients carefully during and for a period following discontinuation of therapy
  • Acthar can cause GI bleeding and gastric ulcer. There is also an increased risk for perforation in patients with certain gastrointestinal disorders. Monitor for signs of bleeding
  • Acthar may be associated with central nervous system effects ranging from euphoria, insomnia, irritability, mood swings, personality changes, and severe depression, and psychosis. Existing conditions may be aggravated
  • Patients with comorbid disease may have that disease worsened. Caution should be used when prescribing Acthar in patients with diabetes and myasthenia gravis
  • Prolonged use of Acthar may produce cataracts, glaucoma and secondary ocular infections. Monitor for signs and symptoms
  • Acthar is immunogenic and prolonged administration of Acthar may increase the risk of hypersensitivity reactions. Neutralizing antibodies with chronic administration may lead to loss of endogenous ACTH activity
  • There is an enhanced effect in patients with hypothyroidism and in those with cirrhosis of the liver
  • Long-term use may have negative effects on growth and physical development in children. Monitor pediatric patients
  • Decrease in bone density may occur. Bone density should be monitored for patients on long-term therapy
  • Pregnancy Class C: Acthar has been shown to have an embryocidal effect and should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus

Adverse Reactions

  • Common adverse reactions for Acthar are similar to those of corticosteroids and include fluid retention, alteration 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. 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 events reported are included in the full Prescribing Information.

Please see full Prescribing Information.

Indication

H.P. Acthar® Gel (repository corticotropin injection) is indicated to induce a diuresis or a remission of proteinuria in nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus.

References