Acthar Gel multidose vial
- Strengths
- 80 USP units/mL; 400 units/5 mL vial
- Product note
- For IESS, use this vial IM. No oral formulation.
ACTH (repository corticotropin)
Acthar Gel
Time-limited hormonal treatment for IESS under specialist supervision, followed by a taper. “Limited use” describes the treatment scope and duration; it is not an evidence rating.
DailyMed-verified antiseizure indications
Indication / use
- Label / evidence summary
- Acthar Gel: monotherapy for infantile epileptic spasms syndrome (IESS), termed “infantile spasms” in the U.S. label, in children younger than 2 years. Use the multidose vial intramuscularly; SelfJect is not for this indication.
- Role
- Limited-course therapy
- Class
- Hormonal therapy — ACTH / melanocortin receptor agonism
Indications checked 26 September 2026. Product, route, age, and treatment-role limits apply. A DailyMed listing alone does not establish FDA approval.
- Acthar Gel multidose vial U.S. label
Infantile epileptic spasms syndrome (IESS) · Younger than 2 years · Limited-course therapyFinite hormonal course; label requires age younger than 2 years, IM administration, and a taper. SelfJect excluded.
Formulations & strengths
U.S. products unless another country is named. Strengths are per unit or stated volume.
Acthar Gel SelfJect
- Strengths
- 40 units/0.5 mL; 80 units/1 mL
- Product note
- Adult subcutaneous device only; NOT for IESS.
Purified Cortrophin Gel multidose vials
- Strengths
- 80 USP units/mL; 1 mL and 5 mL vials
- Product note
- Different repository corticotropin product for other indications; IESS is not included in its U.S. label. Do not substitute for Acthar’s IESS regimen.
Purified Cortrophin Gel prefilled syringe
- Strengths
- 40 units/0.5 mL; 80 units/1 mL
- Product note
- Subcutaneous presentation for other indications; not an IESS product.
Brand & formulation labels
Each link names the product and formulation it covers. Archived labels do not establish current availability.
Dosing & administration
- Adult / product-specific schedule
- No adult epilepsy regimen in this profile. Adult labeled indications use different schedules.
- Pediatric
- Acthar IESS regimen (U.S. label: infantile spasms): 150 USP units/m²/day IM, divided as 75 units/m² per dose twice daily for 14 days, followed by a gradual taper over approximately 2 weeks.
- Titration / repeat dosing
- Calculate body surface area and verify USP units and mL independently. Use the vial only. Do not abruptly stop; follow a written specialist taper and adrenal-insufficiency plan. Confirm complete clinical and sleep-EEG response at about 14 days; escalate promptly if incomplete.
Practical administration
- Product instructions
- Refrigerate the vial; warm between the hands as instructed. IM use for IESS; never IV. Train caregivers in measuring the dose, injection technique, infection precautions and stress-dose/adrenal instructions.
Dose adjustment & concentrations
- Renal impairment
- No standard renal dose algorithm established; review product precautions and monitor clinical status.
- Hepatic impairment
- Individualize with specialist review; consult the exact product label.
- Serum reference information
- No established antiseizure therapeutic serum concentration target.
Safety
- Boxed warning
- No boxed warning in the current Acthar label; major infection and endocrine risks still apply.
- Contraindications
- IV administration; suspected congenital infection in infants under 2; live/live-attenuated vaccines at immunosuppressive doses; porcine-protein sensitivity; systemic fungal infection; ocular herpes simplex; scleroderma; osteoporosis; recent surgery; peptic ulcer history/presence; heart failure; uncontrolled hypertension; primary adrenal insufficiency or adrenal hyperfunction.
- Serious precautions & monitoring
- Monitor infection, blood pressure, glucose, sodium/potassium, weight/edema and adrenal suppression. Infection may be masked. Provide a steroid alert and illness/stress plan; review varicella exposure/immunity and immunizations before treatment. Withdrawal can precipitate adrenal crisis.
Common / selected adverse effects
- Infection
- Irritability and sleep/behavior changes
- Hypertension, edema, weight gain
- Hyperglycemia and hypokalemia
- Cushingoid effects and adrenal suppression
Drug interactions: toxicity & clinical action
| Partner / combination | Clinical effect | Clinical action |
|---|---|---|
| Potassium-wasting diuretics | Greater electrolyte loss, especially hypokalemia. | Monitor potassium, blood pressure and fluid status. |
| Live vaccines / other immunosuppressants | Live vaccines can cause infection during immunosuppressive treatment; vaccine response may be blunted. | Avoid live vaccines at immunosuppressive doses; coordinate immunization/infection planning. Formal drug-interaction studies are lacking. |
Pregnancy & contraception
- Fetal / neonatal risk
- Maternal repository corticotropin stimulates corticosteroid production and may cause fetal harm. Reported corticosteroid-associated concerns include impaired fetal growth and neonatal adrenal suppression; these maternal-exposure risks are distinct from treating an infant with ACTH.
- Pregnancy / postpartum monitoring
- After maternal use, observe the newborn for adrenal insufficiency.
Clinical evidence
Research summaries describe studied populations and outcomes; they do not add indications or constitute treatment recommendations.
Direct pivotal trial Guideline-supported off-label use
Trial summary
- Primary endpoint
- For infantile epileptic spasms syndrome, clinically meaningful response requires complete cessation of spasms plus resolution of the pathologic EEG pattern, assessed promptly under a syndrome-specific protocol; partial frequency reduction is not an adequate endpoint.
- Results
- The current profile does not pool dissimilar ACTH products, doses, or study definitions into one effect estimate. Open the U.S. product label and U.S. infantile-spasms sources for regimen-specific results.
- Confidence intervals
- A single applicable confidence interval is not reported across the heterogeneous product-label and syndrome studies cited here.
- Discontinuations
- A single trial-specific discontinuation rate is not reported across the cited ACTH evidence; infection, hypertension, hyperglycemia, adrenal suppression, and product-specific adverse reactions require active monitoring.
- Exposure duration
- Acute-response trials and protocols generally assess clinical and EEG response over approximately 2 weeks, followed by a prescribed product-specific taper; this is not chronic maintenance exposure.
- Seizure freedom
- For IESS, assess complete clinical AND EEG response; partial seizure reduction is insufficient.
Trial publications
- PubMed · ACTH versus prednisone · infantile spasms (1996) ↗
- PubMed · UKISS · hormonal therapy versus vigabatrin (includes synthetic ACTH) (publication) ↗
Comparative evidence
- Findings
- See the linked syndrome guidance and studies; do not infer equivalent efficacy across different hormone products, doses or syndromes.
Mechanism of action
- Repository corticotropin stimulates the adrenal cortex to secrete glucocorticoids and other corticosteroids. It also binds melanocortin receptors.
- The mechanism suppressing IESS is not established; do not describe ACTH as simply a GABA receptor drug or assume its efficacy is identical to oral corticosteroids.
- Acthar is a porcine-derived mixture of ACTH-related peptides in a depot formulation; synthetic ACTH products and diagnostic cosyntropin are not interchangeable dosing substitutes.
Pharmacology
Adult values unless specified. Vd/F denotes apparent oral distribution volume.
Pharmacokinetics
- Bioavailability
- Repository corticotropin gel: absolute IM bioavailability has not been adequately characterized. Oral bioavailability is not applicable to this injectable peptide product.
- Elimination half-life
- Acthar Gel product pharmacokinetics are not adequately characterized. The label cites about 15 minutes for circulating ACTH after IV administration; that is NOT the half-life of the IM repository gel.
- Volume of distribution
- Not adequately characterized for repository corticotropin gel in the product label.
- Active metabolite(s)
- No established active drug-metabolite contribution. Stimulated adrenal corticosteroids are endogenous downstream hormones, not metabolites of corticotropin.
- Active-metabolite half-life
- Not established / not applicable to a defined active drug metabolite.
- Protein binding
- Not adequately characterized for the repository product.
- Metabolism / elimination
- Peptide disposition is not adequately characterized for the gel; pharmacologic effects include stimulation of adrenal steroid production.
The duration of adrenal stimulation and the prescribed taper cannot be inferred from the short circulating-ACTH half-life.
Molecular structure
Repository corticotropin is a peptide mixture; a single small-molecule structural drawing does not represent the product.
Product history
- Initial U.S. approval
- Initial Acthar approval 1952; infantile-spasms indication added 2010.
- Market / formulation history
- Availability varies by product and jurisdiction.
- Brands
- Acthar Gel
- Manufacturer / marketer
- Acthar Gel
- Generic availability
- Product-dependent.
- Related drugs
- See mechanism and syndrome guidance.
Sources & review status
Indications and DailyMed PDFs checked: 2026-09-26. Other profile sources reviewed: 2026-09-15 · label revision noted at that review: See linked product label. This is a draft reference; final review is pending.