Select therapeutic use:

Allergies:

Indications for: ACTHAR GEL

Serum sickness.

Adults and Children:

See full labeling. Individualize. <2yrs: not recommended. ≥2yrs: Usually 40–80 Units by IM or SC inj every 24–72hrs.

ACTHAR GEL Contraindications:

Intravenous administration. Infants <2yrs of age with suspected congenital infections. Concomitant live or live attenuated vaccines. Scleroderma. Osteoporosis. Systemic fungal infections. Ocular herpes simplex. Recent surgery. History of or presence of peptic ulcer. CHF. Uncontrolled hypertension. Primary adrenocortical insufficiency or adrenocortical hyperfunction. Allergy to proteins of porcine origin.

ACTHAR GEL Warnings/Precautions:

Increased risk of infections (eg, viral, bacterial, fungal, protozoan or helminthic). Latent tuberculosis (monitor). Monitor for HPA axis suppression and Cushings syndrome after therapy withdrawal. Supplement with additional steroids during period of stress (eg, trauma, surgery). Hypertension. CHF. Renal insufficiency. Monitor BP, sodium and potassium levels. Monitor for signs of other underlying disease/disorders that may be masked. GI disorders. Diverticulitis. Intestinal anastomoses. Emotional instability. Psychotic tendencies. Diabetes. Myasthenia gravis. Monitor for ophthalmic effects. Immunogenicity potential. Hypothyroidism. Cirrhosis. Monitor growth in children on prolonged therapy. Risk of osteoporosis; monitor bone density (esp. long term therapy). Avoid abrupt cessation. Pregnancy (Cat.C). Nursing mothers: not recommended.

ACTHAR GEL Classification:

Adrenocorticotropic hormone (ACTH) analogue.

ACTHAR GEL Interactions:

See Contraindications. May accentuate the electrolyte loss associated with diuretic therapy.

Adverse Reactions:

Fluid retention, alteration in glucose tolerance, blood pressure elevation, behavioral/mood changes, increased appetite, weight gain; also children: increased risk of infections, convulsions, irritability, pyrexia, Cushingoid symptoms, cardiac hypertrophy; HPA axis suppression, adrenocortical insufficiency, glaucoma, cataracts, hypokalemia, hypocalcemia, GI perforation/bleeding, gastric ulcer, osteoporosis.

Generic Drug Availability:

NO

How Supplied:

Multi-dose vial (5mL)—1

Arthritis/rheumatic disorders:

Indications for: ACTHAR GEL

Short-term (acute episode or exacerbation) adjunctive therapy in psoriatic arthritis, rheumatoid arthritis, juvenile rheumatoid arthritis, ankylosing spondylitis.

Adults and Children:

See full labeling. Individualize. <2yrs: not recommended. ≥2yrs: Usually 40–80 Units by IM or SC inj every 24–72hrs.

ACTHAR GEL Contraindications:

Intravenous administration. Infants <2yrs of age with suspected congenital infections. Concomitant live or live attenuated vaccines. Scleroderma. Osteoporosis. Systemic fungal infections. Ocular herpes simplex. Recent surgery. History of or presence of peptic ulcer. CHF. Uncontrolled hypertension. Primary adrenocortical insufficiency or adrenocortical hyperfunction. Allergy to proteins of porcine origin.

ACTHAR GEL Warnings/Precautions:

Increased risk of infections (eg, viral, bacterial, fungal, protozoan or helminthic). Latent tuberculosis (monitor). Monitor for HPA axis suppression and Cushings syndrome after therapy withdrawal. Supplement with additional steroids during period of stress (eg, trauma, surgery). Hypertension. CHF. Renal insufficiency. Monitor BP, sodium and potassium levels. Monitor for signs of other underlying disease/disorders that may be masked. GI disorders. Diverticulitis. Intestinal anastomoses. Emotional instability. Psychotic tendencies. Diabetes. Myasthenia gravis. Monitor for ophthalmic effects. Immunogenicity potential. Hypothyroidism. Cirrhosis. Monitor growth in children on prolonged therapy. Risk of osteoporosis; monitor bone density (esp. long term therapy). Avoid abrupt cessation. Pregnancy (Cat.C). Nursing mothers: not recommended.

ACTHAR GEL Classification:

Adrenocorticotropic hormone (ACTH) analogue.

ACTHAR GEL Interactions:

See Contraindications. May accentuate the electrolyte loss associated with diuretic therapy.

Adverse Reactions:

Fluid retention, alteration in glucose tolerance, blood pressure elevation, behavioral/mood changes, increased appetite, weight gain; also children: increased risk of infections, convulsions, irritability, pyrexia, Cushingoid symptoms, cardiac hypertrophy; HPA axis suppression, adrenocortical insufficiency, glaucoma, cataracts, hypokalemia, hypocalcemia, GI perforation/bleeding, gastric ulcer, osteoporosis.

Generic Drug Availability:

NO

How Supplied:

Multi-dose vial (5mL)—1

Miscellaneous dermatological conditions:

Indications for: ACTHAR GEL

Severe erythema multiforme. Stevens-Johnson syndrome.

Adults and Children:

See full labeling. Individualize. <2yrs: not recommended. ≥2yrs: Usually 40–80 Units by IM or SC inj every 24–72hrs.

ACTHAR GEL Contraindications:

Intravenous administration. Infants <2yrs of age with suspected congenital infections. Concomitant live or live attenuated vaccines. Scleroderma. Osteoporosis. Systemic fungal infections. Ocular herpes simplex. Recent surgery. History of or presence of peptic ulcer. CHF. Uncontrolled hypertension. Primary adrenocortical insufficiency or adrenocortical hyperfunction. Allergy to proteins of porcine origin.

ACTHAR GEL Warnings/Precautions:

Increased risk of infections (eg, viral, bacterial, fungal, protozoan or helminthic). Latent tuberculosis (monitor). Monitor for HPA axis suppression and Cushings syndrome after therapy withdrawal. Supplement with additional steroids during period of stress (eg, trauma, surgery). Hypertension. CHF. Renal insufficiency. Monitor BP, sodium and potassium levels. Monitor for signs of other underlying disease/disorders that may be masked. GI disorders. Diverticulitis. Intestinal anastomoses. Emotional instability. Psychotic tendencies. Diabetes. Myasthenia gravis. Monitor for ophthalmic effects. Immunogenicity potential. Hypothyroidism. Cirrhosis. Monitor growth in children on prolonged therapy. Risk of osteoporosis; monitor bone density (esp. long term therapy). Avoid abrupt cessation. Pregnancy (Cat.C). Nursing mothers: not recommended.

ACTHAR GEL Classification:

Adrenocorticotropic hormone (ACTH) analogue.

ACTHAR GEL Interactions:

See Contraindications. May accentuate the electrolyte loss associated with diuretic therapy.

Adverse Reactions:

Fluid retention, alteration in glucose tolerance, blood pressure elevation, behavioral/mood changes, increased appetite, weight gain; also children: increased risk of infections, convulsions, irritability, pyrexia, Cushingoid symptoms, cardiac hypertrophy; HPA axis suppression, adrenocortical insufficiency, glaucoma, cataracts, hypokalemia, hypocalcemia, GI perforation/bleeding, gastric ulcer, osteoporosis.

Generic Drug Availability:

NO

How Supplied:

Multi-dose vial (5mL)—1

Miscellaneous immune disorders:

Indications for: ACTHAR GEL

During an exacerbation or as maintenance therapy in selected cases of systemic lupus erythematosus or systemic dermatomyositis (polymyositis).

Adults and Children:

See full labeling. Individualize. <2yrs: not recommended. ≥2yrs: Usually 40–80 Units by IM or SC inj every 24–72hrs.

ACTHAR GEL Contraindications:

Intravenous administration. Infants <2yrs of age with suspected congenital infections. Concomitant live or live attenuated vaccines. Scleroderma. Osteoporosis. Systemic fungal infections. Ocular herpes simplex. Recent surgery. History of or presence of peptic ulcer. CHF. Uncontrolled hypertension. Primary adrenocortical insufficiency or adrenocortical hyperfunction. Allergy to proteins of porcine origin.

ACTHAR GEL Warnings/Precautions:

Increased risk of infections (eg, viral, bacterial, fungal, protozoan or helminthic). Latent tuberculosis (monitor). Monitor for HPA axis suppression and Cushings syndrome after therapy withdrawal. Supplement with additional steroids during period of stress (eg, trauma, surgery). Hypertension. CHF. Renal insufficiency. Monitor BP, sodium and potassium levels. Monitor for signs of other underlying disease/disorders that may be masked. GI disorders. Diverticulitis. Intestinal anastomoses. Emotional instability. Psychotic tendencies. Diabetes. Myasthenia gravis. Monitor for ophthalmic effects. Immunogenicity potential. Hypothyroidism. Cirrhosis. Monitor growth in children on prolonged therapy. Risk of osteoporosis; monitor bone density (esp. long term therapy). Avoid abrupt cessation. Pregnancy (Cat.C). Nursing mothers: not recommended.

ACTHAR GEL Classification:

Adrenocorticotropic hormone (ACTH) analogue.

ACTHAR GEL Interactions:

See Contraindications. May accentuate the electrolyte loss associated with diuretic therapy.

Adverse Reactions:

Fluid retention, alteration in glucose tolerance, blood pressure elevation, behavioral/mood changes, increased appetite, weight gain; also children: increased risk of infections, convulsions, irritability, pyrexia, Cushingoid symptoms, cardiac hypertrophy; HPA axis suppression, adrenocortical insufficiency, glaucoma, cataracts, hypokalemia, hypocalcemia, GI perforation/bleeding, gastric ulcer, osteoporosis.

Generic Drug Availability:

NO

How Supplied:

Multi-dose vial (5mL)—1

Miscellaneous ocular agents:

Indications for: ACTHAR GEL

Severe acute/chronic allergic and inflammatory processes involving the eye and its adnexa such as keratitis, iritis, iridocyclitis, diffuse posterior uveitis and choroiditis, optic neuritis, chorioretinitis, and anterior segment inflammation.

Adults and Children:

See full labeling. Individualize. <2yrs: not recommended. ≥2yrs: Usually 40–80 Units by IM or SC inj every 24–72hrs.

ACTHAR GEL Contraindications:

Intravenous administration. Infants <2yrs of age with suspected congenital infections. Concomitant live or live attenuated vaccines. Scleroderma. Osteoporosis. Systemic fungal infections. Ocular herpes simplex. Recent surgery. History of or presence of peptic ulcer. CHF. Uncontrolled hypertension. Primary adrenocortical insufficiency or adrenocortical hyperfunction. Allergy to proteins of porcine origin.

ACTHAR GEL Warnings/Precautions:

Increased risk of infections (eg, viral, bacterial, fungal, protozoan or helminthic). Latent tuberculosis (monitor). Monitor for HPA axis suppression and Cushings syndrome after therapy withdrawal. Supplement with additional steroids during period of stress (eg, trauma, surgery). Hypertension. CHF. Renal insufficiency. Monitor BP, sodium and potassium levels. Monitor for signs of other underlying disease/disorders that may be masked. GI disorders. Diverticulitis. Intestinal anastomoses. Emotional instability. Psychotic tendencies. Diabetes. Myasthenia gravis. Monitor for ophthalmic effects. Immunogenicity potential. Hypothyroidism. Cirrhosis. Monitor growth in children on prolonged therapy. Risk of osteoporosis; monitor bone density (esp. long term therapy). Avoid abrupt cessation. Pregnancy (Cat.C). Nursing mothers: not recommended.

ACTHAR GEL Classification:

Adrenocorticotropic hormone (ACTH) analogue.

ACTHAR GEL Interactions:

See Contraindications. May accentuate the electrolyte loss associated with diuretic therapy.

Adverse Reactions:

Fluid retention, alteration in glucose tolerance, blood pressure elevation, behavioral/mood changes, increased appetite, weight gain; also children: increased risk of infections, convulsions, irritability, pyrexia, Cushingoid symptoms, cardiac hypertrophy; HPA axis suppression, adrenocortical insufficiency, glaucoma, cataracts, hypokalemia, hypocalcemia, GI perforation/bleeding, gastric ulcer, osteoporosis.

Generic Drug Availability:

NO

How Supplied:

Multi-dose vial (5mL)—1

Miscellaneous respiratory disorders:

Indications for: ACTHAR GEL

Symptomatic sarcoidosis.

Adults and Children:

See full labeling. Individualize. <2yrs: not recommended. ≥2yrs: Usually 40–80 Units by IM or SC inj every 24–72hrs.

ACTHAR GEL Contraindications:

Intravenous administration. Infants <2yrs of age with suspected congenital infections. Concomitant live or live attenuated vaccines. Scleroderma. Osteoporosis. Systemic fungal infections. Ocular herpes simplex. Recent surgery. History of or presence of peptic ulcer. CHF. Uncontrolled hypertension. Primary adrenocortical insufficiency or adrenocortical hyperfunction. Allergy to proteins of porcine origin.

ACTHAR GEL Warnings/Precautions:

Increased risk of infections (eg, viral, bacterial, fungal, protozoan or helminthic). Latent tuberculosis (monitor). Monitor for HPA axis suppression and Cushings syndrome after therapy withdrawal. Supplement with additional steroids during period of stress (eg, trauma, surgery). Hypertension. CHF. Renal insufficiency. Monitor BP, sodium and potassium levels. Monitor for signs of other underlying disease/disorders that may be masked. GI disorders. Diverticulitis. Intestinal anastomoses. Emotional instability. Psychotic tendencies. Diabetes. Myasthenia gravis. Monitor for ophthalmic effects. Immunogenicity potential. Hypothyroidism. Cirrhosis. Monitor growth in children on prolonged therapy. Risk of osteoporosis; monitor bone density (esp. long term therapy). Avoid abrupt cessation. Pregnancy (Cat.C). Nursing mothers: not recommended.

ACTHAR GEL Classification:

Adrenocorticotropic hormone (ACTH) analogue.

ACTHAR GEL Interactions:

See Contraindications. May accentuate the electrolyte loss associated with diuretic therapy.

Adverse Reactions:

Fluid retention, alteration in glucose tolerance, blood pressure elevation, behavioral/mood changes, increased appetite, weight gain; also children: increased risk of infections, convulsions, irritability, pyrexia, Cushingoid symptoms, cardiac hypertrophy; HPA axis suppression, adrenocortical insufficiency, glaucoma, cataracts, hypokalemia, hypocalcemia, GI perforation/bleeding, gastric ulcer, osteoporosis.

Generic Drug Availability:

NO

How Supplied:

Multi-dose vial (5mL)—1

Miscellaneous urogenital disorders:

Indications for: ACTHAR GEL

To induce diuresis or remission of proteinuria in nephrotic syndrome without idiopathic type uremia or that due to lupus erythematosus.

Adults and Children:

See full labeling. Individualize. <2yrs: not recommended. ≥2yrs: Usually 40–80 Units by IM or SC inj every 24–72hrs.

ACTHAR GEL Contraindications:

Intravenous administration. Infants <2yrs of age with suspected congenital infections. Concomitant live or live attenuated vaccines. Scleroderma. Osteoporosis. Systemic fungal infections. Ocular herpes simplex. Recent surgery. History of or presence of peptic ulcer. CHF. Uncontrolled hypertension. Primary adrenocortical insufficiency or adrenocortical hyperfunction. Allergy to proteins of porcine origin.

ACTHAR GEL Warnings/Precautions:

Increased risk of infections (eg, viral, bacterial, fungal, protozoan or helminthic). Latent tuberculosis (monitor). Monitor for HPA axis suppression and Cushings syndrome after therapy withdrawal. Supplement with additional steroids during period of stress (eg, trauma, surgery). Hypertension. CHF. Renal insufficiency. Monitor BP, sodium and potassium levels. Monitor for signs of other underlying disease/disorders that may be masked. GI disorders. Diverticulitis. Intestinal anastomoses. Emotional instability. Psychotic tendencies. Diabetes. Myasthenia gravis. Monitor for ophthalmic effects. Immunogenicity potential. Hypothyroidism. Cirrhosis. Monitor growth in children on prolonged therapy. Risk of osteoporosis; monitor bone density (esp. long term therapy). Avoid abrupt cessation. Pregnancy (Cat.C). Nursing mothers: not recommended.

ACTHAR GEL Classification:

Adrenocorticotropic hormone (ACTH) analogue.

ACTHAR GEL Interactions:

See Contraindications. May accentuate the electrolyte loss associated with diuretic therapy.

Adverse Reactions:

Fluid retention, alteration in glucose tolerance, blood pressure elevation, behavioral/mood changes, increased appetite, weight gain; also children: increased risk of infections, convulsions, irritability, pyrexia, Cushingoid symptoms, cardiac hypertrophy; HPA axis suppression, adrenocortical insufficiency, glaucoma, cataracts, hypokalemia, hypocalcemia, GI perforation/bleeding, gastric ulcer, osteoporosis.

Generic Drug Availability:

NO

How Supplied:

Multi-dose vial (5mL)—1

Multiple sclerosis:

Indications for: ACTHAR GEL

Acute exacerbations of multiple sclerosis.

Adult Dosage:

See full labeling. Individualize. 80–120 Units by IM or SC inj daily for 2–3 weeks.

Children Dosage:

Not recommended.

ACTHAR GEL Contraindications:

Intravenous administration. Infants <2yrs of age with suspected congenital infections. Concomitant live or live attenuated vaccines. Scleroderma. Osteoporosis. Systemic fungal infections. Ocular herpes simplex. Recent surgery. History of or presence of peptic ulcer. CHF. Uncontrolled hypertension. Primary adrenocortical insufficiency or adrenocortical hyperfunction. Allergy to proteins of porcine origin.

ACTHAR GEL Warnings/Precautions:

Increased risk of infections (eg, viral, bacterial, fungal, protozoan or helminthic). Latent tuberculosis (monitor). Monitor for HPA axis suppression and Cushings syndrome after therapy withdrawal. Supplement with additional steroids during period of stress (eg, trauma, surgery). Hypertension. CHF. Renal insufficiency. Monitor BP, sodium and potassium levels. Monitor for signs of other underlying disease/disorders that may be masked. GI disorders. Diverticulitis. Intestinal anastomoses. Emotional instability. Psychotic tendencies. Diabetes. Myasthenia gravis. Monitor for ophthalmic effects. Immunogenicity potential. Hypothyroidism. Cirrhosis. Monitor growth in children on prolonged therapy. Risk of osteoporosis; monitor bone density (esp. long term therapy). Avoid abrupt cessation. Pregnancy (Cat.C). Nursing mothers: not recommended.

ACTHAR GEL Classification:

Adrenocorticotropic hormone (ACTH) analogue.

ACTHAR GEL Interactions:

See Contraindications. May accentuate the electrolyte loss associated with diuretic therapy.

Adverse Reactions:

Fluid retention, alteration in glucose tolerance, blood pressure elevation, behavioral/mood changes, increased appetite, weight gain; also children: increased risk of infections, convulsions, irritability, pyrexia, Cushingoid symptoms, cardiac hypertrophy; HPA axis suppression, adrenocortical insufficiency, glaucoma, cataracts, hypokalemia, hypocalcemia, GI perforation/bleeding, gastric ulcer, osteoporosis.

Generic Drug Availability:

NO

How Supplied:

Multi-dose vial (5mL)—1

Seizure disorders:

Indications for: ACTHAR GEL

Monotherapy for the treatment of infantile spasms in infant and children <2yrs of age.

Clinical Trials:

Single Blinded Clinical Trial

  • The efficacy of Acthar Gel as a treatment for infantile spasms was evaluated in a single blinded (video EEG interpreter blinded) clinical trial. Patients were randomly assigned to receive either a 2 week course of treatment with Acthar Gel 75 Units/m2 IM twice daily or prednisone 1 mg/kg orally twice daily. 

  • The primary outcome was the number of patients who were treatment responders, defined as a patient having complete suppression of both clinical spasms and hypsarrhythmia on a full sleep cycle video EEG performed 2 weeks following treatment initiation, rated by an investigator blinded to treatment.

  • After 2 weeks, results showed that:

    • 13 of 15 patients (86.7%) responded to Acthar Gel compared with 4 of 14 patients (28.6%) who received prednisone (P <.002).

  • The 2-week treatment was followed by a 2-week taper, when nonresponders to prednisone were eligible to receive Acthar Gel. Among 8 patients who did not respond to prednisone, 7 (87.5%) responded to Acthar Gel.

  • Similarly, the 2 nonresponders from the Acthar Gel treatment were eligible to receive treatment with prednisone. Among the 2 patients who did not respond to Acthar Gel, 1 (50%) responded to prednisone.

Supportive Clinical Trial

  • Acthar Gel was also evaluated for the treatment of infantile spasms in infants and children less than 2 years of age in a supportive single-blind, randomized clinical trial. The trial compared a high-dose, long-duration treatment (150 U/m2 once daily for 3 weeks, n=30) of Acthar Gel with low-dose, short-duration treatment (20 U once daily for 2 weeks, n=29). Nonresponders (defined as in the previously described study) in the low-dose group received a dose escalation at 2 weeks to 30 U once daily. 

  • Results showed a nominal statistical superiority of the high dose treatment, as compared to the low dose treatment, observed for cessation of spasms but not for the resolution of hypsarrhythmia. 

Adult Dosage:

Not applicable.

Children Dosage:

<2yrs: 75 Units/m2 IM twice daily over a 2-week period; then gradually taper and discontinue over a 2-week period. ≥2yrs: not recommended.

ACTHAR GEL Contraindications:

Intravenous administration. Infants <2yrs of age with suspected congenital infections. Concomitant live or live attenuated vaccines. Scleroderma. Osteoporosis. Systemic fungal infections. Ocular herpes simplex. Recent surgery. History of or presence of peptic ulcer. CHF. Uncontrolled hypertension. Primary adrenocortical insufficiency or adrenocortical hyperfunction. Allergy to proteins of porcine origin.

ACTHAR GEL Warnings/Precautions:

Increased risk of infections (eg, viral, bacterial, fungal, protozoan or helminthic). Latent tuberculosis (monitor). Monitor for HPA axis suppression and Cushings syndrome after therapy withdrawal. Supplement with additional steroids during period of stress (eg, trauma, surgery). Hypertension. CHF. Renal insufficiency. Monitor BP, sodium and potassium levels. Monitor for signs of other underlying disease/disorders that may be masked. GI disorders. Diverticulitis. Intestinal anastomoses. Emotional instability. Psychotic tendencies. Diabetes. Myasthenia gravis. Monitor for ophthalmic effects. Immunogenicity potential. Hypothyroidism. Cirrhosis. Monitor growth in children on prolonged therapy. Risk of osteoporosis; monitor bone density (esp. long term therapy). Avoid abrupt cessation. Pregnancy (Cat.C). Nursing mothers: not recommended.

ACTHAR GEL Classification:

Adrenocorticotropic hormone (ACTH) analogue.

ACTHAR GEL Interactions:

See Contraindications. May accentuate the electrolyte loss associated with diuretic therapy.

Adverse Reactions:

Fluid retention, alteration in glucose tolerance, blood pressure elevation, behavioral/mood changes, increased appetite, weight gain; also children: increased risk of infections, convulsions, irritability, pyrexia, Cushingoid symptoms, cardiac hypertrophy; HPA axis suppression, adrenocortical insufficiency, glaucoma, cataracts, hypokalemia, hypocalcemia, GI perforation/bleeding, gastric ulcer, osteoporosis.

Generic Drug Availability:

NO

How Supplied:

Multi-dose vial (5mL)—1