Corticotropin

ACTHAR GEL

Open Corticotropin in the interactive console ↗

Corticotropin ballicule: receptor binding, kinetics and half-life diagram — Mechanism of action: Corticotropin ballicule

What it isRepository ACTH gel stimulating adrenal cortisol production; infantile spasms, MS relapses, and inflammatory disease.

Why this oneIts strongest niche is infantile spasms, where a finite hormonal course can rapidly suppress the epileptic syndrome.

What limits itExtreme cost and reliance on an intact adrenal axis limit use; hypertension, hyperglycemia, and immunosuppression remain.

Corticotropin molecular structure (skeletal formula) — Molecular structure: Corticotropin

FDA-approved for

infantile spasms (2010)
multiple sclerosis relapses
various inflammatory and rheumatic conditions

Off-label

refractory epilepsies beyond infantile spasms

Principal riskExtreme cost; it needs an intact adrenal axis

Classes and tags

Clinical profile

Therapeutic safety burden2 / 4

Overdose danger1 / 4

Weight-gain liability0 / 4

Sedation liability0 / 4

QT / Torsades0 / 4

Direct muscarinic antagonism0 / 4

Embryofetal risk2 / 4

Legacy pregnancy categoryUnknown / historical label unavailable

Defining liabilityGenerally tolerated at therapeutic doses; clinically important risks are agent-specific and increase with interactions or organ impairment.

FDA label

Read the full label on DailyMed ↗

NO BOXED WARNINGS

FDA dosing	Population	Start	Target	Max
Infantile spasms	Infants/children <2 y	150 U/m² per day IM (75 U/m² BID) ×2 wk, then taper over 2 wk	150 U/m²/day IM	150 U/m²/day
Acute exacerbations of multiple sclerosis	Adults	80–120 U/day IM or SC ×2–3 wk	80–120 U/day	120 U/day
Other disorders/diseases	Adults	40–80 U IM or SC q24–72h	40–80 U q24–72h	80 U

Renal Undefined

Hepatic May have enhanced effect in liver cirrhosis; monitor

Instructions

Taper dose to avoid adrenal insufficiency after prolonged therapy
Infantile spasms must be given IM using the vial; suggested taper: 30 U/m² AM ×3 d, 15 U/m² AM ×3 d, 10 U/m² AM ×3 d, then 10 U/m² every other AM ×6 d
SelfJect pre-filled injector is SC, adults only, for single 40 U or 80 U doses

Available strengths

inj 80 units/mL

Contraindications

Intravenous administration
Infants under 2 years with suspected congenital infections
Concomitant live or live-attenuated vaccines in patients on immunosuppressive doses
Scleroderma, osteoporosis, systemic fungal infections, ocular herpes simplex
Recent surgery; history of or present peptic ulcer
Congestive heart failure; uncontrolled hypertension
Primary adrenocortical insufficiency or adrenocortical hyperfunction
Sensitivity to proteins of porcine origin

Cautions

Increased susceptibility to/masking of infections
Adrenal insufficiency after prolonged therapy withdrawal; Cushing's syndrome
Elevated blood pressure, salt/water retention, hypokalemia
GI perforation and bleeding
Behavioral/mood disturbances (euphoria, insomnia, psychosis, depression)
Ophthalmic effects (cataracts, glaucoma); decreased bone density; growth suppression in children

Adverse reactions

Injection site reactions
Fatigue/malaise/asthenia
Fluid retention/peripheral swelling
Insomnia, headache, increased blood glucose
(Infantile spasms) infections, convulsions, hypertension, irritability, pyrexia

Pregnancy May cause fetal harm via steroidogenic effect; hypoadrenalism reported in infants; observe newborns

Lactation No data on presence in human milk; weigh benefit vs risk

Cost

Corticotropin (ACTHAR GEL)

Strength		#/mo	generic $/unit	CostPlus
80 units/mL	inj	per unit		not offered

NADAC is a voluntary CMS survey of what retail community pharmacies pay for the drugs they stock. Corticotropin is administered under clinical supervision and dispensed outside retail pharmacies, so it rarely appears on surveyed invoices.

Generic entry1984

Open Corticotropin in the interactive console ↗

Self-check

Which intact hormonal system is needed for corticotropin to work?
Adrenal axis.
What is corticotropin’s strongest stated clinical niche?
Infantile spasms.