Peptide education
Corticotropin
ACTH · Adrenocorticotropic hormone · Repository corticotropin
Corticotropin, also called ACTH, is a hormone made by the pituitary gland. Prescription repository corticotropin gels contain ACTH-related peptides from porcine sources.
Acthar Gel is labeled for infantile spasms in children under two and for adult multiple sclerosis exacerbations, among other conditions. Its risks include infection and adrenal suppression; the labeled infant regimen uses a vial and an intramuscular route.
Overview
Quick answer
Acthar Gel is a therapeutic repository preparation. Cosyntropin is a shorter synthetic ACTH fragment used in adrenal testing. A product's name, route, indication, and dose cannot be transferred to the other.
What does ACTH do?
It stimulates a functioning adrenal cortex to produce corticosteroids. The precise mechanism of Acthar in infantile spasms is not established.
Are the two repository gels labeled for the same conditions?
Their labels overlap, but they are separate products. Acthar lists infantile spasms in children under two; the cited Purified Cortrophin Gel label does not list that indication.
What did the infantile-spasms trial find?
In a small randomized trial, 13 of 15 infants assigned to ACTH and 4 of 14 assigned to prednisone had both clinical spasms and the abnormal EEG pattern resolve after two weeks.
Does Acthar change the long-term course of multiple sclerosis?
The label reports faster resolution of acute exacerbations but says an effect on the ultimate outcome or natural history has not been shown.
Evidence
Evidence snapshot
A combined clinical and EEG response favored high-dose ACTH over the prednisone regimen studied.
Age, condition, product form, and route determine how the labeled information applies.
The label does not claim a change in long-term disease course.
The label describes tapering and monitoring after treatment.
Claims
Common claims vs evidence
| Claim | Human evidence | Verdict |
|---|---|---|
| ACTH was better than every steroid treatment for infantile spasms. | The randomized study compared one high-dose ACTH course with one prednisone course in 29 infants. | The result supports that comparison, not every possible steroid or treatment schedule. |
| An ACTH gel can be exchanged for a diagnostic cosyntropin vial. | The Acthar label describes therapeutic indications; Cortrosyn is labeled for screening adrenal insufficiency with other diagnostic tests. | These are different products with different preparations, uses, and dosing units. |
| Corticotropin is free of steroid-related risks because it is not a steroid. | The Acthar label warns about infections, high blood pressure, adrenal suppression, and effects on growth and metabolism. | Stimulating adrenal steroid production has clinically important risks. |
Bottom line
Main takeaway
An ACTH gel is a prescription medicine, not a general wellness product.
The Acthar vial and adult-only prefilled injector have different route and age restrictions.
The infant study used a combined clinical and EEG endpoint and compared specific ACTH and prednisone regimens.
Identity
What it is
ACTH is a 39-amino-acid hormone; repository products are porcine-derived mixtures rather than purified synthetic cosyntropin.
The Acthar vial is for intramuscular or subcutaneous use. Its prefilled injector is for subcutaneous use in adults only.
Use context
Routes, doses, and cycle patterns
The Acthar label and infantile-spasms trial describe different treatment contexts, with doses based on age and indication.
Human studies and product labels
Acthar vial, infantile spasms
- Purpose
- Monotherapy in infants and children under two
- Context
- U.S. prescription label
- Route
- Intramuscular
- Amount
- 150 units per square meter of body surface area per day, divided into 75 units per square meter per injection
- Frequency
- Twice daily
- Duration
- Two weeks, followed by a gradual two-week taper
The label specifies the vial for this use and excludes the prefilled injector.
Acthar, adult multiple sclerosis exacerbation
- Purpose
- Acute exacerbations in adults
- Context
- U.S. prescription label
- Route
- Intramuscular or subcutaneous
- Amount
- 80 to 120 units
- Frequency
- Daily
- Duration
- Two to three weeks
Dosing is individualized; tapering may be needed. The prefilled injector only delivers 40 or 80 units per dose.
Infantile-spasms trial
- Purpose
- Compare ACTH with prednisone
- Context
- Published study regimen
- Route
- Intramuscular ACTH
- Amount
- 150 units per square meter per day, divided into two injections
- Frequency
- Twice daily
- Duration
- Two weeks, followed by a taper for responders
The comparator was oral prednisone at 2 mg per kg per day. The response assessment was at two weeks.
What varies
- Acthar doses for other listed indications are individualized. The label describes a usual range of 40 to 80 units every 24 to 72 hours for adults and children over two.
Research
Research evidence
Evidence is strongest for specific labeled uses and cannot be assumed to apply equally to all inflammatory conditions or ACTH products.
| Study / evidence area | Population | Design | Product context | Main outcome | Limitations | Weight |
|---|---|---|---|---|---|---|
| ACTH versus prednisone in infantile spasms | 29 infants with spasms and hypsarrhythmia, median age six months | Randomized comparison with blinded outcome assessment | Two weeks of high-dose ACTH versus oral prednisone | Combined clinical and EEG response in 13 of 15 ACTH recipients versus 4 of 14 prednisone recipients | Small study; only one regimen of each medicine was compared | Controlled human study |
| Acthar label, multiple sclerosis | Adults with acute multiple sclerosis exacerbations | Prescribing information describing controlled trials | Repository corticotropin gel | The label reports faster resolution of acute exacerbations | No evidence of an effect on ultimate outcome or natural history | Labeled indication with a long-term evidence boundary |
Cautions
Safety and unknowns
- Acthar can increase infection risk and may mask signs of infection. Infants with suspected congenital infections are among those for whom it is contraindicated.
- Treatment can suppress the adrenal axis; stopping after prolonged use can cause adrenal insufficiency. The infant label specifies a gradual taper.
- High blood pressure, fluid retention, elevated blood sugar, growth effects, and serious allergic reactions are important label concerns.
- Acthar is contraindicated for intravenous use, in infants under two with suspected congenital infections, and with live or live attenuated vaccines during immunosuppressive dosing.
- Both gel labels list scleroderma, osteoporosis, systemic fungal infection, ocular herpes simplex, recent surgery, current or past peptic ulcer, congestive heart failure, primary adrenal insufficiency, adrenal hyperfunction, and hypersensitivity to corticotropin, product ingredients, or porcine proteins as contraindications.
- Acthar lists uncontrolled hypertension as a contraindication; Purified Cortrophin Gel lists hypertension without that qualifier.
- Purified Cortrophin Gel is contraindicated for intravenous use. Its label also requires checking adrenal responsiveness by the intended intramuscular or subcutaneous route before treatment.
Product quality
Product identity and quality
Repository corticotropin gels are prescription preparations with distinct labels and delivery devices.
Product and route
The Acthar infantile-spasms regimen uses the vial intramuscularly; the prefilled injector is for subcutaneous administration by adults.
Unit and body surface area
Infant dosing is expressed in units per square meter, not a fixed number of units or a cosyntropin mass dose.
Mechanism
How it is proposed to work
ACTH signals the adrenal glands to make corticosteroids when the adrenal cortex is functioning.
Acthar's label states that its mechanism in infantile spasms remains unknown.
FAQ
Common questions
Is cosyntropin the same treatment as repository corticotropin?
No. Cosyntropin is a synthetic ACTH fragment used in adrenal testing; repository corticotropin gel is a separate formulation with therapeutic indications.
Details
Technical details
Sources
References
- 1.
DailyMed. Acthar Gel prescribing information
Repository corticotropin indications, formulation-specific routes, doses, and warnings.
- 2.
DailyMed. Purified Cortrophin Gel prescribing information
Porcine-derived repository product, composition, and labeled indications.
- 3.
DailyMed. Cortrosyn prescribing information
Synthetic ACTH fragment and its diagnostic indication.
- 4.
PubMed. High-dose corticotropin versus prednisone for infantile spasms
doi:10.1542/peds.97.3.375 PMID:8604274
Small randomized comparison in previously untreated infants with spasms and hypsarrhythmia.