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H.P. ACTHAR GEL
Corticosteroid-responsive 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:
Questcor Pharmaceuticals

e-Prescribe this drug via Surescripts


Therapeutic Use:

Indications for H.P. ACTHAR GEL:

Corticosteroid-responsive disorders.

Adults and Children's Dose:

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

Pharmacological Class:

Adrenocorticotropic hormone (ACTH) analogue.

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.

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 Dose for H.P. ACTHAR GEL:

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

Children's Dose for H.P. ACTHAR GEL:

Not recommended.

Pharmacological Class:

Adrenocorticotropic hormone (ACTH) analogue.

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.

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 <2 years of age.

Adult Dose for H.P. ACTHAR GEL:

Not applicable.

Children's Dose for H.P. ACTHAR GEL:

<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.

Pharmacological Class:

Adrenocorticotropic hormone (ACTH) analogue.

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.

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