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H.P. ACTHAR GEL
Allergies
Arthritis/rheumatic disorders
Miscellaneous dermatological conditions
Miscellaneous immune disorders
Miscellaneous ocular agents
Miscellaneous respiratory disorders
Miscellaneous urogenital disorders
Multiple sclerosis
Seizure disorders
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Drug Name:

H.P. ACTHAR GEL Rx

Generic Name and Formulations:
Repository corticotrophin 80 Units/mL; gel for IM or SC Inj.

Company:
Mallinckrodt, Inc.

Therapeutic Use:

Indications for H.P. 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.

Contraindications:

Intravenous administration. Infants with suspected congenital infections. Live vaccination. 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.

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. Peptic ulcer. 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.

Interactions:

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

Pharmacological Class:

Adrenocorticotropic hormone (ACTH) analogue.

Adverse Reactions:

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

Generic Availability:

NO

How Supplied:

Multi-dose vial (5mL)—1

Indications for H.P. 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.

Contraindications:

Intravenous administration. Infants with suspected congenital infections. Live vaccination. 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.

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. Peptic ulcer. 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.

Interactions:

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

Pharmacological Class:

Adrenocorticotropic hormone (ACTH) analogue.

Adverse Reactions:

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

Generic Availability:

NO

How Supplied:

Multi-dose vial (5mL)—1

Indications for H.P. 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.

Contraindications:

Intravenous administration. Infants with suspected congenital infections. Live vaccination. 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.

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. Peptic ulcer. 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.

Interactions:

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

Pharmacological Class:

Adrenocorticotropic hormone (ACTH) analogue.

Adverse Reactions:

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

Generic Availability:

NO

How Supplied:

Multi-dose vial (5mL)—1

Indications for H.P. 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.

Contraindications:

Intravenous administration. Infants with suspected congenital infections. Live vaccination. 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.

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. Peptic ulcer. 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.

Interactions:

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

Pharmacological Class:

Adrenocorticotropic hormone (ACTH) analogue.

Adverse Reactions:

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

Generic Availability:

NO

How Supplied:

Multi-dose vial (5mL)—1

Indications for H.P. 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.

Contraindications:

Intravenous administration. Infants with suspected congenital infections. Live vaccination. 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.

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. Peptic ulcer. 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.

Interactions:

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

Pharmacological Class:

Adrenocorticotropic hormone (ACTH) analogue.

Adverse Reactions:

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

Generic Availability:

NO

How Supplied:

Multi-dose vial (5mL)—1

Indications for H.P. 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.

Contraindications:

Intravenous administration. Infants with suspected congenital infections. Live vaccination. 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.

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. Peptic ulcer. 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.

Interactions:

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

Pharmacological Class:

Adrenocorticotropic hormone (ACTH) analogue.

Adverse Reactions:

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

Generic Availability:

NO

How Supplied:

Multi-dose vial (5mL)—1

Indications for H.P. 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.

Contraindications:

Intravenous administration. Infants with suspected congenital infections. Live vaccination. 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.

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. Peptic ulcer. 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.

Interactions:

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

Pharmacological Class:

Adrenocorticotropic hormone (ACTH) analogue.

Adverse Reactions:

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

Generic Availability:

NO

How Supplied:

Multi-dose vial (5mL)—1

Indications for H.P. ACTHAR GEL:

Treatment of acute exacerbations of multiple sclerosis.

Adult:

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

Children:

Not recommended.

Contraindications:

Intravenous administration. Infants with suspected congenital infections. Live vaccination. 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.

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. Peptic ulcer. 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.

Interactions:

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

Pharmacological Class:

Adrenocorticotropic hormone (ACTH) analogue.

Adverse Reactions:

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

Generic Availability:

NO

How Supplied:

Multi-dose vial (5mL)—1

Indications for H.P. ACTHAR GEL:

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

Adult:

Not applicable.

Children:

<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.

Contraindications:

Intravenous administration. Infants with suspected congenital infections. Live vaccination. 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.

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. Peptic ulcer. 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.

Interactions:

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

Pharmacological Class:

Adrenocorticotropic hormone (ACTH) analogue.

Adverse Reactions:

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

Generic Availability:

NO

How Supplied:

Multi-dose vial (5mL)—1

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