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.

Acthar has clinical experience across various etiologies of nephrotic syndrome

Interact with the rows in this chart to learn more about each clinical experience with Acthar.

Author Journal Publication
Year
Research Site Type of
Dataset
Sample
Size
Etiologies
Included
Bomback, Canetta, Beck, Ayalon, Radhakrishnan, Appel, 20121 American Journal of Nephrology 2012 Columbia Medical Center Prospective, non-blinded, open-label trial 15 iMN, FSGS, MCD, lgAN
Filippone, Dopson, Rivers, Monk, Udani, Jafari, Huang, Melhem, Assioun, Schmitz, 20162   International Medical Case Reports Journal   2016   Thomas Jefferson University, Washington Health System, Southwestern Nephrology, Inc, University of Tennessee, University of Rochester Medical Center, University of Chicago, University of California, Los Angeles Medical Center, and Saint Louis University   Retrospective, multicenter case series   13   MCD, FSGS
Hladunewich, Cattran, Beck, Odutayo, Sethi, Ayalon, Leung, Reich, Fervenza, 20143 Nephrology, Dialysis, Transplantation 2014 Mayo Clinic and University of Toronto Prospective, randomized trial 20 iMN
Hogan, Bomback, Mehta, Canetta, Rao, Appel, Radhakrishnan, Lafayette, 20134 Clinical Journal of the American Society of Nephrology 2013 Columbia University and Stanford University medical centers Combined prospective trial and retrospective review 24* FSGS
Bomback, Tumlin, Baranski, Bourdeau, Besarab, Appel, Radhakrishnan, Appel, 20115 Drug Design, Development and Therapy 2011 Columbia University, Henry Ford Health System, University of Tennessee, and private nephrology practices Retrospective case series 21 iMN, MPGN, MCD, lgAN, SLE, GN, DPGN, unbiopsied NS

SLE GN=class V systemic lupus erythematosus glomerulonephritis.
DPGN=monoclonal diffuse proliferative glomerulonephritis.
NS=nephrotic syndrome.

*Included 4 patients from previous datasets: 1 patient from 2011 dataset and 3 patients from 2012 trial; the Hogan dataset includes longer-term follow-up data for these patients.

These datasets are subject to limitations. The data combined retrospective observational data with prospective data of patients who were not randomly assigned to therapy. There was no comparison group for interpretation of safety and efficacy findings with Acthar. Most patients were on multiple therapies during Acthar treatment, and the clinical outcomes may not be solely attributable to 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

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