Acthar Gel offers flexible dosing for your patients

Dosage and frequency should be individualized according to the medical condition, severity of the disease, and initial response of the patient1

  • Acthar Gel can be self-administered as a subcutaneous (SC) or intramuscular (IM) injection, or be given by a caregiver
  • The gel formulation is designed to prolong the release of medication after injection
  • The usual dose of Acthar Gel is 40 to 80 units given every 24 to 72 hours
  • Although drug dependence does not occur, sudden withdrawal of Acthar Gel after prolonged use may lead to adrenal insufficiency or recurrent symptoms that make it difficult to stop the treatment. It may be necessary to taper the dose and increase the injection interval to gradually discontinue the medication
Recommended dosing from Acthar Gel label1 Additional dosing from clinical experience with Acthar Gel (published data)1-4
FDA-approved indications Ophthalmic indication Symptomatic sarcoidosis Rheumatic indications Symptomatic sarcoidosis Indicated for symptomatic sarcoidosis Systemic lupus erythematosus Indicated during an exacerbation or as maintenance therapy in selected cases Dermatomyositis and polymyositis Indicated for use during an exacerbation or as maintenance therapy in selected cases
Source Acthar Gel Prescribing Information Retrospective chart review (N=47)2 Prospective, open-label study (N=10)3 Retrospective case series (N=5)4
Injection Subcutaneous or intramuscular Subcutaneous or intramuscular Subcutaneous Subcutaneous
Dose 40 to 80 units 80 units (1 mL) 80 units (1 mL) 80 units (1 mL)
Schedule Every 1 to 3 days Twice weekly Daily Twice weekly or once weekly
Recommended dosing from Acthar Gel label1
FDA-approved indications Ophthalmic indication Symptomatic sarcoidosis Rheumatic indications
Source Acthar Gel Prescribing Information
Injection Subcutaneous or intramuscular
Dose 40 to 80 units
Schedule Every 1 to 3 days
Additional dosing from clinical experience with Acthar Gel (published data)1-4
FDA-approved indications Symptomatic sarcoidosis Indicated for symptomatic sarcoidosis
Source Retrospective chart review dosage (N=47)2
Injection Subcutaneous or intramuscular
Dose 80 units (1 mL)
Schedule Twice weekly
FDA-approved indications Systemic lupus erythematosus Indicated during an exacerbation or as maintenance therapy in selected cases
Source Prospective, open-label study (N=10)3
Injection Subcutaneous
Dose 80 units (1 mL)
Schedule Daily
FDA-approved indications Dermatomyositis and polymyositis Indicated for use during an exacerbation or as maintenance therapy in selected cases
Source Retrospective case series (N=5)4
Injection Subcutaneous
Dose 80 units (1 mL)
Schedule Twice weekly or once weekly

Storage for Acthar Gel1

  • Acthar Gel is supplied as a 5-mL multi-dose vial (63004-8710-1) containing 80 USP units per mL
  • Acthar Gel should be stored under refrigeration between 2°C and 8°C (36°F to 46°F)
    • Acthar Gel is a gel when refrigerated; vials should be warmed to room temperature before using
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INDICATION

Acthar® Gel (repository corticotropin injection) is indicated for severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: keratitis, iritis, iridocyclitis, diffuse posterior uveitis and choroiditis, optic neuritis, chorioretinitis, anterior segment inflammation.

Important Safety information

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

INDICATION

Acthar® Gel (repository corticotropin injection) is indicated for severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: keratitis, iritis, iridocyclitis, diffuse posterior uveitis and choroiditis, optic neuritis, chorioretinitis, anterior segment inflammation.

Important Safety information

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.