Dosing and uses of HP Acthar Gel, Acthar Gel (corticotropin)
Adult dosage forms and strengths
injectable solution
- 80 units/mL
Verification of Adrenal Responsiveness
40-80 unit IM/SC q24-72hr
Acute Exacerbations of Multiple Sclerosis
80-120 unit IM qDay for 2-3 weeks may be administered
Nephrotic Syndrome
Induces diuresis or a remission of proteinuria in the nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus
40-80 units IM/SC q1-3days
Other Indications & Uses
Diagnostic: Testing of adrenal cortex function
Therapeutic: As corticosteroids
Edematous State: Indicated to induce diuresis or remission of proteinuria in nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus
Rheumatic Disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: psoriatic arthritis, rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy), ankylosing spondylitis
Collagen Diseases: During an exacerbation or as maintenance therapy in selected cases of: systemic lupus erythematosus, systemic dermatomyositis (polymyositis)
Dermatologic Diseases: Severe erythema multiforme, Stevens-Johnson syndrome
Allergic States: Serum sickness
Ophthalmic Diseases: 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
Respiratory Diseases: Symptomatic sarcoidosis
Infantile spasms (West syndrome): Indicated as monotherapy for the treatment of infantile spasms in infants and children <2 years
Pediatric dosage forms and strengths
injectable solution
- 80 unit/mL
Anti-Inflammatory/Immunosuppressant
0.8 unit/kg/day IM or 25 units/m²/day divided q12-24hr
Infantile Spasms (West Syndrome)
<2 years: 75 units/m² IM BID x2 weeks, THEN gradually taper over 2 weeks
Tapering schedule
- 30 units/m² IM qAM for 3 days, THEN
- 15 units/m² IM qAM for3 days, THEN
- 10 units/m² IM qAM for 3 days, THEN
- 10 units/m² every other morning for 6 days
Nephrotic Syndrome
Induces diuresis or a remission of proteinuria in the nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus
<2 years: Safety and efficacy not established
≥2 years: 40-80 units IM/SC q1-3days
HP Acthar Gel, Acthar Gel (corticotropin) adverse (side) effects
Frequency not defined
Common
- Edema, hypertension
- Psychotic disorder
- Disorder of skin
- Hyperglycemia
- Peptic ulcer disease
- Immune hypersensitivity reaction
- Muscle weakness
Serious
- Cardiomegaly, congestive heart failure, necrotizing arteritis
- Encephalitis due to human herpes simplex virus, relapse
- Decreased body growth, Children
- Pancreatitis
- Thromboembolic disorder
- Glaucoma
Warnings
Contraindications
Sensitivity to porcine proteins
IV administration is contraindicated; give only by IM or SC injection
Suspected congenital infections in infants
Live or live attenuated vaccines are contraindicated in patients receiving immunosuppressive doses of corticotropin
Scleroderma
Osteoporosis
Systemic fungal infections
Ocular herpes simplex
Recent surgery
Active/history of peptic ulcer
CHF, HTn
Cautions
Immunizations, diabetes, renal insufficiency, diverticulitis, myasthenia gravis, hypothyroidism, liver cirrhosis
Prolonged use in children will inhibit skeletal growth
Risks of: HTN; Na & water retention; hypokalemia; infections; cataracts & glaucoma
Pregnancy and lactation
Pregnancy category: C
Lactation: excretion in milk unknown; use with caution
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of HP Acthar Gel, Acthar Gel (corticotropin)
Half-Life: 15 min
Mechanism of action
Porcine ACTH, stimulates adrenocortical hormone production
