Dosing and Administration

Acthar is a highly purified sterile preparation of the adrenocorticotropic hormone in 16% gelatin to provide a prolonged release after subcutaneous (SC) or intramuscular (IM) injection.

Flexible dosing for patients who need it

  • Dosage and frequency should be individualized according to the medical condition, severity of the disease, and initial response of the patient1
  • The usual dosage of Acthar is 40–80 units given intramuscularly or subcutaneously every 24–72 hours1
    • In the 4 separate datasets, the most common Acthar dosing regimen was 80 units SC BIW2–4
    • In a retrospective case series of 21 patients with nephrotic syndrome with various etiologies, the most common dosing regimen for Acthar was 80 units given subcutaneously twice weekly for 6 months5

The chart below shows dosing examples of prescribed units converted into milliliters (mL). The dosages listed here are only examples. Not intended to be a complete list of all possible prescribed dosing amounts.

Dosing considerations

  • Dosage should be individualized according to the general medical condition of each patient1
  • Frequency and dose of the drug should be determined by considering severity of the disease and the initial response of the patient1
  • Common side effects include fluid retention, alteration in glucose tolerance, elevation in blood pressure, behavioral and mood changes, increased appetite, and weight gain1

Please see Important Safety Information below. For a full list of indications, contraindications, warnings, precautions, and adverse events related to Acthar, please refer to the full Prescribing Information.

Dosing and administration support from Mallinckrodt

As part of our commitment to nephrotic syndrome patients, Mallinckrodt provides a variety of home injection training and treatment support services:

  • Self-administration educational materials, including downloadable instructions and online videos for you to use with your staff and for patient training (view our Video Library)
  • The ActharPACT Program—An optional, no-cost program that provides ongoing telephone support from a registered nurse coach trained in kidney disease, proteinuria, and common questions about Acthar treatment
  • Home Injection Training Services (HITS)—A no-cost, optional service available through A.S.A.P., where patients can request a home visit from a registered nurse to provide one-on-one injection training
  • The Acthar patient site offers self-injection instructions to help patients learn on their own time

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