According to the FDA (2024), Corticotropin is specifically indicated for the treatment of infantile spasms in children under 2 years of age.
A clinical review published in the Journal of Child Neurology (2022) highlights ACTH as a gold-standard therapy for West Syndrome.
Corticotropin stimulates the adrenal cortex to produce cortisol, aldosterone, and androgens, unlike synthetic steroids which only provide one type of hormone.
The American Academy of Neurology (AAN) suggests Corticotropin as an option for managing acute MS relapses when corticosteroids are not appropriate.
Data from the FDA-approved labeling (2023) warns that Corticotropin can cause hypertrophic cardiomyopathy in pediatric patients, requiring cardiac monitoring.
Corticotropin must be administered via IM or SC injection; it is not available in an oral tablet form due to protein degradation in the stomach.
According to the NIH (2023), patients on Corticotropin should avoid live vaccines due to the risk of infection from immunosuppression.
The repository gel formulation allows for a prolonged therapeutic effect of 12 to 24 hours per dose.
Long-term use of Corticotropin is associated with an increased risk of osteoporosis and cataracts, similar to other steroid-based therapies.
This page is for informational purposes only and does not replace medical advice. Before using any prescription or over-the-counter medication for Purified Cortrophin Gel, you must consult a qualified healthcare professional.
Clinical Information
Detailed information about Purified Cortrophin Gel
ℹ️Overview
Corticotropin (Adrenocorticotropic Hormone or ACTH) is a hormone-based medication used to treat infantile spasms, multiple sclerosis exacerbations, and various inflammatory conditions by stimulating the body's natural production of corticosteroids.
💊Usage & Dosage
Adult Dosage
Dosage of Corticotropin must be highly individualized based on the disease being treated and the patient's response. According to clinical guidelines, the following are standard ranges:
Multiple Sclerosis Exacerbations: The typical adult dose is 80 to 120 units administered intramuscularly (IM) or subcutaneously (SC) daily for 2 to 3 weeks. In some cases, a tapering schedule is used to gradually reduce the dose before discontinuation.
Other Inflammatory/Allergic Conditions: The usual dose is 40 to 80 units every 24 to 72 hours. Your healthcare provider will adjust the dose to the lowest effective level to minimize the risk of side effects.
Pediatric Dosage
Infantile Spasms: This is the primary pediatric indication. The standard recommended dose is 75 units/m² (units per square meter of body surface area) administered IM twice daily for 2 weeks. Following this 2-week period, the dose is typically tapered over another 2 weeks (e.g., 30 units/m² in the morning for 3 days, then 15 units/m² in the morning for 3 days, then 10 units/m² in the morning for 3 days, and finally 10 units/m² every other morning for 6 days).
Other Uses: Safety and effectiveness for conditions other than infantile spasms have not been established in pediatric patients under the age of 2.
Dosage Adjustments
Renal Impairment
There are no specific dosage adjustment guidelines for patients with renal (kidney) impairment. However, since Corticotropin can cause fluid retention and electrolyte imbalances, patients with kidney disease should be monitored closely for worsening of their condition.
Hepatic Impairment
Specific adjustments for hepatic (liver) impairment are not established. Because the drug is metabolized by proteolytic enzymes rather than liver-specific pathways, significant changes in clearance are not typically expected, but clinical caution is advised.
Elderly Patients
In geriatric patients, the dose should be selected with caution, usually starting at the low end of the dosing range. This is due to the higher frequency of decreased hepatic, renal, or cardiac function, and concomitant diseases or other drug therapies common in this population.
How to Take Corticotropin
1Preparation: Corticotropin gel should be warmed to room temperature before injection to make the solution easier to draw and inject. Do not use a microwave or hot water; simply hold the vial in your hands.
2Administration Route: This medication is for intramuscular (IM) or subcutaneous (SC) use only. It must NEVER be given intravenously (IV).
3Injection Site: Rotate injection sites (thigh, upper arm, or buttocks) to prevent skin issues or muscle damage. Do not inject into areas that are red, bruised, or scarred.
4Technique: Use a clean, sterile needle and syringe for every dose. Your healthcare provider will demonstrate the proper technique for self-administration or administration to your child.
5Storage: Store the vials in a refrigerator between 2°C to 8°C (36°F to 46°F). Keep the medication out of direct light.
Missed Dose
If you miss a dose, contact your healthcare provider immediately for instructions. Do not double the dose to catch up. Consistency is critical, especially in the treatment of infantile spasms, to maintain therapeutic levels of the hormone.
Overdose
Signs of acute overdosage may include severe fluid retention, rapid weight gain, and symptoms of Cushing's syndrome (such as a rounded face or 'moon face'). In the event of a suspected overdose, seek emergency medical attention or contact a poison control center immediately. Treatment is generally supportive, focusing on managing electrolyte imbalances and fluid status.
> Important: Follow your healthcare provider's dosing instructions exactly. Do not adjust your dose or stop taking the medication without medical guidance, as sudden discontinuation can lead to adrenal insufficiency.
⚠️Side Effects
Common Side Effects (>1 in 10)
Corticotropin stimulates the production of natural steroids, and many of its side effects mimic those of long-term corticosteroid use. Common reactions include:
Fluid Retention and Edema: Swelling in the hands, ankles, or feet due to sodium and water retention.
Increased Appetite and Weight Gain: Often occurring rapidly after starting treatment.
Cushingoid Features: Development of a 'moon face' (rounded face), 'buffalo hump' (fat deposit between the shoulders), and central obesity.
Insomnia and Irritability: Difficulty sleeping and mood swings are frequently reported, especially in pediatric patients.
Increased Blood Pressure
🔴Warnings
Important Safety Information
Corticotropin is a potent hormonal agent that requires diligent medical supervision. It should only be used by patients who can be monitored regularly for complications. Because it stimulates the adrenal glands, it can affect nearly every organ system in the body. Patients should be aware that this medication can suppress the immune system, making them more vulnerable to infections and potentially making infections harder to detect.
Black Box Warnings
No FDA black box warnings for Corticotropin. However, clinical warnings regarding infantile spasms and MS treatment are prominent in the prescribing information.
Major Precautions
Infection Risk: Corticotropin can hide the symptoms of an infection. Do not start this medication if you have a systemic fungal infection. Use with caution in patients with latent tuberculosis or herpes simplex of the eye.
🔄Interactions
Contraindicated Combinations (Do Not Use Together)
Live Vaccines: (e.g., MMR, Varicella, Yellow Fever). Corticotropin suppresses the immune system, which can lead to a severe or fatal reaction to live virus vaccines. The vaccine will also likely fail to provide immunity.
Systemic Fungal Infections: Corticotropin should not be used in patients with systemic fungal infections as it can worsen the infection and lead to disseminated disease.
Serious Interactions (Monitor Closely)
Diuretics (Water Pills): Drugs like furosemide or hydrochlorothiazide can cause the body to lose potassium. When taken with Corticotropin, the risk of severe hypokalemia (dangerously low potassium) increases, which can lead to heart rhythm problems.
Amphotericin B
🚫Contraindications
Absolute Contraindications
Corticotropin must NEVER be used in the following circumstances:
1Systemic Fungal Infections: The drug's immunosuppressive properties allow fungal infections to spread unchecked throughout the body.
2Scleroderma: In patients with scleroderma, Corticotropin has been associated with an increased risk of renal crisis (sudden kidney failure and severe high blood pressure).
3Recent Surgery: Because it impairs wound healing, it should not be used immediately following major surgery.
4Known Hypersensitivity
👥Special Populations
Pregnancy
Corticotropin is classified as FDA Pregnancy Category C. This means that animal reproduction studies have shown an adverse effect on the fetus, and there are no adequate and well-controlled studies in humans.
Risks: Prolonged use during pregnancy may lead to fetal adrenal insufficiency or low birth weight.
Clinical Use: Corticotropin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not typically used for fertility treatments.
Breastfeeding
It is not known whether Corticotropin is excreted in human milk. However, because many drugs are excreted in milk and because of the potential for serious adverse reactions in nursing infants (such as growth suppression), a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
🧬Pharmacology
Mechanism of Action
Corticotropin is an 39-amino acid peptide that acts as a potent agonist at the Melanocortin Receptor 2 (MC2R), located primarily in the zona fasciculata of the adrenal cortex. Binding to MC2R activates the G-protein-coupled receptor, which stimulates the enzyme adenylate cyclase. This increases intracellular levels of cyclic AMP (cAMP), which in turn activates protein kinase A (PKA). PKA facilitates the transport of cholesterol into the mitochondria via the Steroidogenic Acute Regulatory (StAR) protein. Once inside the mitochondria, cholesterol is converted to pregnenolone, the precursor for cortisol, aldosterone, and adrenal androgens.
Pharmacodynamics
The primary pharmacodynamic effect of Corticotropin is the rapid increase in plasma cortisol levels. Onset of adrenal stimulation occurs within minutes of injection, but the therapeutic anti-inflammatory effects take longer to manifest. In the treatment of infantile spasms, the exact mechanism is not fully understood but is thought to involve the suppression of corticotropin-releasing hormone (CRH) in the brain, which may reduce neuronal excitability. Tolerance to the adrenal-stimulating effects is rare, but the body's response can be limited by the maximum secretory capacity of the adrenal glands.
Pharmacokinetics
Frequently Asked Questions
Common questions about Purified Cortrophin Gel
What is Corticotropin used for?
Corticotropin is primarily used to treat infantile spasms (West Syndrome) in children under 2 years old and acute flare-ups of multiple sclerosis in adults. It is also FDA-approved for various inflammatory and autoimmune conditions, such as rheumatoid arthritis, lupus, and severe allergic reactions, when other treatments are not suitable. By stimulating the adrenal glands to produce natural steroids, it helps reduce inflammation and modulate the immune system. Your doctor will determine if it is the best option based on your specific diagnosis and medical history.
What are the most common side effects of Corticotropin?
The most common side effects include fluid retention (swelling), increased appetite, weight gain, and the development of a 'moon face' appearance. Patients often experience mood changes such as irritability or insomnia, and an increase in blood pressure is frequently observed. In children, it can lead to temporary growth suppression and irritability. Because it increases cortisol levels, it can also cause high blood sugar. Most of these effects are dose-dependent and may resolve after the medication is gradually discontinued.
Can I drink alcohol while taking Corticotropin?
It is strongly advised to avoid alcohol while taking Corticotropin. Alcohol can increase the risk of gastrointestinal irritation and stomach ulcers, which is already a concern with hormonal therapies. Furthermore, alcohol can interfere with blood sugar regulation and worsen the mood swings or sleep disturbances caused by the medication. Combining alcohol with Corticotropin may also place unnecessary stress on the liver and kidneys. Always consult your healthcare provider regarding lifestyle choices during treatment.
Is Corticotropin safe during pregnancy?
Corticotropin is categorized as Pregnancy Category C, meaning its safety in human pregnancy has not been well-established. Animal studies suggest potential risks to the fetus, including adrenal insufficiency if used for long periods. It should only be used during pregnancy if the potential benefits clearly outweigh the risks to the unborn baby. If you are pregnant or planning to become pregnant, you must discuss the risks and benefits with your doctor. They may consider alternative treatments that have more safety data available.
How long does it take for Corticotropin to work?
The time it takes for Corticotropin to work depends on the condition being treated. For infantile spasms, some improvement may be seen within 7 to 14 days of starting the high-dose regimen. In the case of multiple sclerosis exacerbations, patients may notice a reduction in symptoms within a few days, though the full course of treatment usually lasts 2 to 3 weeks. Because it works by stimulating the body's own hormone production, the response time can vary between individuals. Your doctor will monitor your progress closely during the initial weeks.
Can I stop taking Corticotropin suddenly?
No, you should never stop taking Corticotropin abruptly. Doing so can cause your body to go into an 'adrenal crisis' because your natural hormone production has been suppressed during treatment. Symptoms of sudden withdrawal include severe fatigue, weakness, dizziness, and low blood pressure. Your doctor will provide a specific tapering schedule to slowly reduce the dose, allowing your adrenal glands to restart their normal function safely. Always follow the exact schedule provided by your medical team.
What should I do if I miss a dose of Corticotropin?
If a dose is missed, you should contact your healthcare provider or pharmacist immediately for guidance. Do not take two doses at once to make up for the missed one, as this can increase the risk of serious side effects. For conditions like infantile spasms, maintaining a consistent schedule is vital for the medication's effectiveness. It is helpful to set a daily alarm or use a medication log to ensure doses are given on time. Your doctor will advise you on whether to give the dose late or wait until the next scheduled time.
Does Corticotropin cause weight gain?
Yes, weight gain is a very common side effect of Corticotropin therapy. This occurs for two main reasons: increased appetite and significant fluid retention. The medication causes the body to hold onto sodium and water, leading to swelling and rapid weight changes. Additionally, the hormonal changes can lead to a redistribution of body fat, often resulting in a rounded face or increased fat around the abdomen. Most patients find that their weight and appetite return to normal after the medication is tapered and stopped.
Can Corticotropin be taken with other medications?
Corticotropin can interact with many other drugs, so it is essential to provide your doctor with a full list of your medications. It specifically interacts with 'water pills' (diuretics), which can lead to dangerously low potassium levels. It also increases the risk of stomach ulcers if taken with NSAIDs like ibuprofen. If you have diabetes, your insulin or oral medication doses may need to be adjusted because Corticotropin raises blood sugar. Always check with your pharmacist before starting any new over-the-counter supplements or vitamins.
Is Corticotropin available as a generic?
Currently, Corticotropin is primarily available as the brand-name repository injection H.P. Acthar Gel. There are very few generic versions available due to the complexity of manufacturing a purified, long-acting hormone derived from animal sources. Because it is a biological product rather than a simple chemical pill, the FDA has specific pathways for 'biosimilar' or 'follow-on' versions. Patients should check with their insurance provider and pharmacist for the most current information on available formulations and cost-assistance programs.
Similar Medications
Other drugs with the same active ingredient (Corticotropin)
: Hypertension (high blood pressure) is common and may require monitoring.
Less Common Side Effects (1 in 100 to 1 in 10)
Glucose Intolerance: Elevated blood sugar levels (hyperglycemia), which may unmask latent diabetes mellitus.
Muscle Weakness: Known as steroid myopathy, affecting the proximal muscles (shoulders and hips).
Skin Changes: Thinning of the skin, acne, and impaired wound healing.
Electrolyte Imbalance: Specifically hypokalemia (low potassium levels), which can cause fatigue or heart palpitations.
Rare Side Effects (less than 1 in 100)
Osteoporosis: Significant loss of bone density, leading to an increased risk of fractures with prolonged use.
Cataracts and Glaucoma: Increased intraocular pressure and clouding of the lens.
Psychosis: Severe mood disturbances, including hallucinations or intense depression.
Hypertrophic Cardiomyopathy: In infants, the heart muscle may thicken, which usually reverses after the drug is stopped.
Serious Side Effects — Seek Immediate Medical Attention
> Warning: Stop taking Corticotropin and call your doctor immediately if you experience any of these symptoms:
Signs of Infection: Fever, cough, sore throat, or painful urination. Corticotropin can mask the signs of infection and weaken your immune system.
Severe Allergic Reaction (Anaphylaxis): Hives, difficulty breathing, swelling of the face, lips, or tongue.
Gastrointestinal Perforation: Severe abdominal pain, black or tarry stools, or vomiting blood.
Vision Changes: Sudden blurred vision, eye pain, or seeing halos around lights.
Congestive Heart Failure: Shortness of breath, rapid weight gain, and severe swelling.
Adrenal Insufficiency: If the medication is stopped suddenly, symptoms like severe fatigue, dizziness, and nausea may occur.
Long-Term Side Effects
Prolonged use of Corticotropin can lead to permanent changes in the body. These include stunted growth in children (suppression of the pituitary-gonadal axis), permanent bone loss (osteoporosis), and a persistent susceptibility to infections. Chronic use also increases the risk of developing Type 2 diabetes and cardiovascular disease due to the metabolic effects of elevated cortisol levels.
Black Box Warnings
There are currently no FDA Black Box Warnings for Corticotropin. However, the FDA emphasizes the risk of serious infections and the need for careful monitoring of blood pressure and electrolytes during therapy.
Report any unusual symptoms or changes in mood/behavior to your healthcare provider immediately. Regular follow-up appointments are necessary to monitor for these side effects.
Adrenal Suppression: Long-term use of Corticotropin suppresses the body's natural ability to produce ACTH. If the medication is stopped abruptly, the body may not be able to produce enough cortisol to handle stress (surgery, injury, or illness), leading to a life-threatening adrenal crisis.
Cardiovascular and Renal Effects: The drug causes sodium and water retention and potassium loss. This can worsen heart failure, high blood pressure, or kidney disease. Monitoring of blood pressure and weight is mandatory.
Gastrointestinal Risks: There is an increased risk of stomach ulcers and bleeding, especially when used with other drugs like NSAIDs (e.g., ibuprofen, aspirin).
Behavioral and Mood Changes: Patients may experience euphoria, insomnia, mood swings, personality changes, or even severe depression and psychosis.
Vaccinations: Do not receive 'live' or 'live-attenuated' vaccines while using Corticotropin. The drug's immunosuppressive effects may cause the vaccine to be ineffective or, in rare cases, cause the patient to contract the disease from the vaccine.
Monitoring Requirements
Your doctor will order regular tests to ensure the medication is working safely:
Blood Pressure: Checked at every visit.
Electrolytes: Monitoring for low potassium and high sodium.
Blood Glucose: Regular checks for hyperglycemia, especially in diabetic patients.
Growth Monitoring: In children, height and weight must be tracked closely to detect growth suppression.
Eye Exams: Periodic checks for cataracts and glaucoma if used long-term.
Echocardiograms: Recommended for infants to monitor for heart muscle thickening.
Driving and Operating Machinery
Corticotropin may cause dizziness, blurred vision, or mood changes. Do not drive or operate heavy machinery until you know how this medication affects you.
Alcohol Use
Alcohol should be avoided or strictly limited. Alcohol increases the risk of stomach irritation and gastrointestinal bleeding when taking hormonal therapies like Corticotropin. It can also worsen the mood-altering effects of the drug.
Discontinuation
NEVER stop taking Corticotropin suddenly. Your doctor will provide a tapering schedule to slowly lower the dose over several days or weeks. This allows your adrenal glands to resume their natural function. Sudden withdrawal can cause 'steroid withdrawal syndrome,' characterized by joint pain, weakness, and severe fatigue.
> Important: Discuss all your medical conditions, including a history of ulcers, heart disease, or mental health issues, with your healthcare provider before starting Corticotropin.
: This antifungal medication also depletes potassium; combining it with Corticotropin significantly elevates the risk of cardiac arrhythmias.
Antidiabetic Agents: Corticotropin increases blood sugar levels. Patients taking insulin or oral diabetes medications (like metformin or glipizide) will likely need their doses adjusted to maintain glycemic control.
NSAIDs and Salicylates: Taking aspirin, ibuprofen, or naproxen with Corticotropin increases the risk of developing stomach ulcers and gastrointestinal bleeding.
Moderate Interactions
Anticonvulsants: Certain seizure medications (like phenytoin or carbamazepine) may increase the clearance of corticosteroids, potentially reducing the effectiveness of Corticotropin.
Anticoagulants: Corticotropin can alter the body's response to blood thinners like warfarin. Close monitoring of the INR (International Normalized Ratio) is required to prevent bleeding or clotting complications.
Oral Contraceptives: Estrogens may increase the levels of cortisol-binding globulin, which can change the amount of active cortisol produced in response to Corticotropin.
Food Interactions
Sodium (Salt): High salt intake can worsen the fluid retention and high blood pressure caused by Corticotropin. Patients are often advised to follow a low-sodium diet.
Potassium-Rich Foods: Your doctor may recommend increasing your intake of potassium (e.g., bananas, spinach) to counteract the potassium-wasting effects of the medication.
Grapefruit: While not as significant as with other drugs, grapefruit can occasionally interfere with the metabolism of steroids; consult your doctor before consuming large amounts.
Herbal/Supplement Interactions
St. John's Wort: May induce enzymes that speed up the breakdown of steroids, potentially lowering the drug's efficacy.
Licorice Root: Contains glycyrrhizic acid, which can mimic some effects of steroids and worsen potassium loss and high blood pressure.
Echinacea: May interfere with the immunosuppressive goals of Corticotropin therapy.
Lab Test Interactions
Corticotropin can interfere with several diagnostic tests:
Skin Tests: It may suppress reactions to allergy skin tests.
Thyroid Function Tests: It may decrease levels of TSH (Thyroid Stimulating Hormone).
Urine Tests: It can cause false results in tests for urinary 17-ketosteroids.
> Important: Tell your doctor about ALL medications, supplements, and herbal products you are taking to prevent dangerous interactions.
: If you have had a previous allergic reaction to porcine (pig) proteins or any component of the Corticotropin injection, you must not use this drug.
5Ocular Herpes Simplex: Use is contraindicated due to the risk of corneal perforation.
6Congestive Heart Failure: In severe cases where fluid retention would be life-threatening.
7Uncontrolled Hypertension: High blood pressure that is not managed with medication.
Relative Contraindications
Your healthcare provider will perform a careful risk-benefit analysis if you have:
Diabetes Mellitus: Due to the risk of severe hyperglycemia.
Osteoporosis: Because the drug causes further bone loss.
Diverticulitis or Peptic Ulcer: Due to the risk of intestinal perforation.
Myasthenia Gravis: Initial treatment may temporarily worsen muscle weakness.
Psychiatric Disorders: Especially a history of depression or psychosis, which the drug can exacerbate.
Cross-Sensitivity
Corticotropin used in the United States is typically derived from porcine (pig) pituitary glands. Patients with a known allergy to pork or pork products may experience cross-allergic reactions, ranging from mild rashes to life-threatening anaphylaxis. Always inform your doctor of any food or animal allergies.
> Important: Your healthcare provider will evaluate your complete medical history before prescribing Corticotropin to ensure it is safe for you.
Pediatric Use
Approved Use: Corticotropin is specifically approved for the treatment of infantile spasms in infants and children under 2 years of age.
Growth Effects: Long-term use in children can lead to permanent growth suppression. Height and weight must be monitored at every clinical visit.
Heart Health: There is a risk of hypertrophic cardiomyopathy (thickening of the heart muscle) in infants. Regular echocardiograms are often recommended during treatment.
Bone Health: Children are at risk for decreased bone mineral density.
Geriatric Use
Clinical studies of Corticotropin did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
Risks: Elderly patients are at a significantly higher risk for developing hypertension, edema, and osteoporosis while on this medication.
Polypharmacy: Older adults are more likely to be taking medications that interact with Corticotropin, such as diuretics or NSAIDs. Dose selection should be cautious.
Renal Impairment
Patients with renal insufficiency should be monitored closely. Corticotropin causes the body to hold onto salt and water, which can lead to edema (swelling) and worsen kidney function. While the drug itself is not primarily cleared by the kidneys, its physiological effects can be dangerous for those with pre-existing kidney disease.
Hepatic Impairment
In patients with cirrhosis or other forms of liver disease, there may be an enhanced effect of the steroids produced by Corticotropin. This is because the liver is responsible for metabolizing the cortisol produced by the adrenals. If the liver is not functioning well, cortisol levels may stay high for longer, increasing the risk of side effects.
> Important: Special populations require individualized medical assessment and frequent monitoring by a specialist.
| Parameter | Value |
|---|---|
| Bioavailability | High (via IM/SC injection) |
| Protein Binding | Minimal (acts as a free peptide) |
| Metabolism | Proteolytic degradation in various tissues |
| Excretion | Minimal renal excretion of intact peptide |
Chemical Information
Molecular Formula: C210H314N56O57S (for human ACTH)
Molecular Weight: ~4541.1 g/mol
Solubility: Soluble in water and physiological saline.
Structure: A single-chain polypeptide containing 39 amino acids. The first 24 amino acids are identical across species and are responsible for the biological activity.
Drug Class
Corticotropin is classified as an Adrenocorticotropic Hormone [EPC]. It is unique among hormonal therapies because it acts as a trophic hormone (a hormone that stimulates another endocrine gland). Related medications include synthetic ACTH analogs like Cosyntropin, which is primarily used for diagnostic testing (the ACTH stimulation test) rather than long-term therapy.