Acthar

Do not take it if

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

• Acthar Gel vial is for either intramuscular or subcutaneous injection.
• ( 2.1 ) Acthar Gel single-dose pre-filled SelfJect injector:
• is for subcutaneous administration by
• adults only.
• ( 2.1 ) used to administer single doses of 40 units or 80 units only.
• ( 2.1 ) Infantile spasms:
• doses must be administered intramuscularly using the Acthar gel vial.
• The recommended dose is 150 U/m 2 divided into twice daily injections of 75 U/m 2 .
• After 2 weeks of treatment dosing should be gradually tapered and discontinued over a 2-week period.
• Acthar Gel single-dose pre-filled SelfJect injector is not to be used for the treatment of infantile spasms ( 2.2 ) Acute exacerbations of multiple sclerosis:
• daily intramuscular or subcutaneous doses of 80 to 120 units for 2-3 weeks may be administered.
• It may be necessary to taper the dose.
• ( 2.3 ) Other disorders and diseases:
• individualize dosing depending on the disease and patient.
• The usual dose is 40 to 80 units given intramuscularly or subcutaneously every 24 to 72 hours.
• It may be necessary to taper the dose.
• ( 2.4 )
• 2.1 Important Information Acthar Gel vial is intended for either intramuscular or subcutaneous injection.
• Acthar Gel single-dose pre-filled SelfJect injector is for subcutaneous administration by
• adults (18 years of age and older) only.
• The single-dose pre-filled SelfJect injector should only be used to administer single doses of either 40 units or 80 units.
• For administration of doses other than 40 units or 80 units, use the Acthar Gel multi-dose vial.
• Recommended Dosage for Infantile Spasms in Infants and
• Children Under 2 Years of Age In the treatment of infantile spasms, Acthar Gel must be administered intramuscularly using the Acthar gel vial.
• Do not use the Acthar Gel single-dose pre-filled SelfJect injector for the treatment of infantile spasms.
• The recommended regimen is a daily dose of 150 U/m 2 (divided into twice daily intramuscular (IM) injections of 75 U/m 2 ) administered over a 2-week period.
• Dosing with Acthar Gel should then be gradually tapered over a 2-week period to
• avoid adrenal insufficiency.
• The following is one suggested tapering schedule:
• 30 U/m 2 in the morning for 3 days; 15 U/m 2 in the morning for 3 days; 10 U/m 2 in the morning for 3 days; and 10 U/m 2 every other morning for 6 days.
• Acthar Gel is typically dosed based on body surface area (BSA).
• For calculation of body surface area, use the following formula: Equation Formula
• Recommended Dosage for the Treatment of Acute Exacerbations in
• Adults with Multiple Sclerosis The recommended dose is daily intramuscular or subcutaneous doses of 80 to 120 units for 2-3 weeks for acute exacerbations.
• Dosage should be individualized according to the medical condition of each patient.
• Frequency and dose of the drug should be determined by considering the severity of the disease and the initial response of the patient.
• Although drug dependence does not occur, sudden withdrawal of Acthar Gel after prolonged use may lead to adrenal insufficiency or recurrent symptoms which make it difficult to stop the treatment.
• It may be necessary to taper the dose and increase the injection interval to gradually discontinue the medication.
• Recommended Dosage for Other Indications for
• Adults and Children Over 2 Years of Age Dosage should be individualized according to the disease under treatment and the general medical condition of each patient.
• Frequency and dose of the drug should be determined by considering severity of the disease and the initial response of the patient.
• The usual dose of Acthar Gel is 40 to 80 units given intramuscularly or subcutaneously every 24 to 72 hours.
• Although drug dependence does not occur, sudden withdrawal of Acthar Gel after prolonged use may lead to adrenal insufficiency or recurrent symptoms which make it difficult to stop the treatment.
• It may be necessary to taper the dose and increase the injection interval to gradually discontinue the medication.
• 2.5 Preparation and Administration Visually inspect the liquid for particulate matter and discoloration prior to administration.
• Acthar Gel must not be injected if the solution is cloudy or contains particulate matter.
• Acthar Gel Multi-Dose Vial Warm to room temperature before using.
• Take caution to not over-pressurize the vial prior to withdrawing the product.
• Acthar Gel Single-Dose Pre-filled SelfJect Injector Preparation Prior to injection, remove from the refrigerator and sealed tray and allow to sit for 45 minutes to warm to room temperature.
• Administration Read the FDA-approved Instructions for Use carefully before administering.
• Administer by subcutaneous injection only.
• Acthar Gel single-dose pre-filled SelfJect injector is not for intramuscular injection.
• Inject in the upper thigh, abdomen, or back of arm.
• Avoid injecting within 1 inch of navel, knee, or groin area.
• Avoid areas with scars, tattoos, warts, birthmarks, or stretch marks, or where the skin is irritated.
• Rotate injection sites.
• Do not use the same site more than one time per week.

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

Quoted from the official label, section “Drug Interactions”.

Use in children

• Acthar Gel is indicated as monotherapy for the treatment of infantile spasms in infants and children less than 2 years of age.
• Both serious and other adverse reactions can occur in this population [see Warnings and Precautions (5) and Adverse Reactions (6.1) ] .
• The efficacy of Acthar Gel for the treatment of infantile spasms in infants and children less than 2 years of age was evaluated in a randomized, single blinded (video EEG interpreter blinded) clinical trial and an additional active control supportive trial [see Clinical Studies (14) ] .
• A responding patient was defined as having both complete cessation of spasms and elimination of hypsarrhythmia.
• Safety in the pediatric population for infantile spasms was evaluated by retrospective chart reviews and data from non-sponsor conducted clinical trials [see Adverse Reactions (6.1) ] .
• While the types of adverse reactions seen in infants and
• children under 2 years of age treated for infantile spasms are similar to those seen in older patients, their frequency and severity may be different due to the very young age of the infant, the underlying disorder, the duration of therapy and the dosage regimen.
• Effects on growth are of particular concern [see Warnings and Precautions (5.12) ] .
• Serious adverse reactions observed in
• adults may also occur in children [see Warnings and Precautions (5) ] .

Quoted from the official label, section “Pediatric Use”.

Side effects

• The following clinically significant adverse reactions are described elsewhere in the labeling:
• Infections [see Warnings and Precautions (5.1) ] Cushing's Syndrome and Adrenal Insufficiency Upon Withdrawal [see Warnings and Precautions (5.2) ] Elevated Blood Pressure, Salt and Water Retention, and Hypokalemia [see Warnings and Precautions (5.3) ] Masking Symptoms of Other Diseases [see Warnings and Precautions (5.5) ] Gastrointestinal Perforation and Bleeding [see Warnings and Precautions (5.6) ] Behavioral and Mood Disturbances [see Warnings and Precautions (5.7) ] Ophthalmic Effects [see Warnings and Precautions (5.9) ] Immunogenicity Potential [see Warnings and Precautions (5.10) ] Negative Effects on Growth and Physical Development [see Warnings and Precautions (5.12) ] Decrease in Bone Density [see Warnings and Precautions (5.13) ] Commonly reported postmarketing adverse reactions for Acthar Gel include injection site reaction, asthenic conditions (including fatigue, malaise, asthenia and lethargy), fluid retention (including peripheral swelling), insomnia, headache, and blood glucose increased.
• ( 6.2 ) The most common adverse reactions (5% or greater in the recommended twice daily dosing group) for the treatment of infantile spasms are increased risk of infections, convulsions, hypertension, irritability, and pyrexia.
• ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Mallinckrodt at 1-800-844-2830 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
• 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
• Adverse Reactions in Infants and
• Children Under 2 Years of Age While the types of adverse reactions seen in infants and
• children under age 2 treated for infantile spasms are similar to those seen in older patients, their frequency and severity may be different due to the very young age of the infant, the underlying disorder, the duration of therapy and the dosage regimen.
• Below is a summary of adverse reactions specifically tabulated from source data derived from retrospective chart reviews and clinical trials in
• children under 2 years of age treated for infantile spasms.
• The number of patients in controlled trials at the recommended dose was too few to provide meaningful incidence rates or to permit a meaningful comparison to the control groups.
• The most common adverse reactions (5% or greater in the recommended twice daily dosing group) for the treatment of infantile spasms are increased risk of infections, convulsions, hypertension, irritability, and pyrexia.
• TABLE:
• Incidence (%) of Adverse Reactions Occurring in ≥2% of Infants and
• Children Under 2 Years of Age Treated with Acthar Gel Adverse Reactions Recommended 75 U/m 2 twice daily n=122, (%) 150 U/m 2 once daily n=37 (%) Cardiac disorders Cardiac Hypertrophy 3 0 Endocrine disorders Cushingoid 3 22 Gastrointestinal disorders Diarrhea 3 14 Vomiting 3 5 Constipation 0 5 General disorders and administration site conditions Irritability 7 19 Pyrexia 5 8 Infections and infestations Infection Specific infections that occurred at ≥2% were candidiasis, otitis media, pneumonia and upper respiratory tract infections. 20 46 Investigations Weight gain 1 3 Metabolism and nutrition disorders Increased appetite 0 5 Decreased appetite 3 3 Nervous system disorders Convulsion In the treatment of infantile spasms, other types of seizures/convulsions may occur because some patients with infantile spasms progress to other forms of seizures (for example, Lennox-Gastaut Syndrome).
• Additionally, the spasms sometimes mask other seizures and once the spasms resolve after treatment, the other seizures may become visible. 12 3 Respiratory, thoracic and mediastinal disorders Nasal Congestion 1 5 Skin and subcutaneous tissue disorders Acne 0 14 Rash 0 8 Vascular disorders Hypertension 11 19 These adverse reactions may also be seen in
• adults and children over 2 years of age when treated for other purposes and with different doses and regimens.
• 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of Acthar Gel.
• Because adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
• Allergic Reactions Allergic responses have presented as dizziness, nausea, and anaphylaxis (anaphylactic shock, hypotension, respiratory compromise, urticaria, edema).
• Cardiovascular Necrotizing angitis (adults only), congestive heart failure, atrial fibrillation, and palpitations.
• Dermatologic Skin thinning (adults only), facial erythema, and increased sweating (adults only).
• Endocrine Decreased carbohydrate tolerance (infants only), hirsutism, and menstrual irregularities.
• Gastrointestinal Pancreatitis (adults only), abdominal distention, and ulcerative esophagitis.
• General Disorders and Administration Site Conditions Injection site reaction and asthenic conditions (including fatigue, malaise, asthenia, and lethargy).
• Infections and Infestations Abscess.
• Investigations Blood glucose increased.
• Metabolic Hypokalemic alkalosis (infants only) and fluid retention (including peripheral swelling).
• Musculoskeletal Muscle weakness and vertebral compression fractures (infants only).
• Neurological Headache (adults only), vertigo (adults only), subdural hematoma, intracranial hemorrhage (adults only), and reversible brain shrinkage (usually secondary to hypertension) (infants only).
• Psychiatric Disorders Insomnia.
• 6.3 Possible Additional Steroidogenic Effects Based on steroidogenic effects of Acthar Gel certain adverse events may be expected due to the pharmacological effects of corticosteroids.
• The adverse events that may occur but have not been reported for Acthar Gel are:
• Dermatologic Impaired wound healing, petechiae and ecchymoses, and suppression of skin test reactions.
• Metabolic Negative nitrogen balance due to protein catabolism and alteration in glucose tolerance.
• Musculoskeletal Loss of muscle mass and aseptic necrosis of femoral and humeral heads.
• Neurological Increased intracranial pressure with papilledema, (pseudo-tumor cerebri) usually after treatment, and subdural effusion.
• Ophthalmic Exophthalmos.

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

• Advise caretakers of patients with infantile spasms to read the FDA-approved patient labeling (Medication Guide [for infantile spasms]).
• Advise caretakers or patients 18 years of age or older to read the FDA-approved Instructions for Use when administering Acthar Gel single-dose pre-filled SelfJect injector.
• Use and Monitoring Patients should be instructed to take Acthar Gel only as prescribed.
• They should not stop treatment suddenly unless instructed by their healthcare provider to do so.
• Patients, their caregivers and families should be advised as to the importance of the need for careful monitoring while on and during titration from Acthar Gel treatment and the importance of not missing scheduled doctor's appointments.
• Infections Advise patients, their caregivers, and families to contact their healthcare provider if the patient develops an infection or fever.
• Inform patients and caregivers that a fever may not necessarily be present during infection and to try to limit contact with other people with infections to minimize the risk of infection while taking Acthar Gel [see Warnings and Precautions (5.1) and Adverse Reactions (6.1) ] .
• Cushing's Syndrome and Adrenal Insufficiency Upon Withdrawal Advise patients to contact their healthcare provider if they develop signs or symptoms of Cushing's Syndrome, such as fat increases in the face (moon face) or trunk area, cutaneous striae, easy bruisability, weight gain, muscle weakness, hyperglycemia, and hypertension [see Warnings and Precautions (5.2) ] .
• Inform patients that adrenal insufficiency can occur upon withdrawal of Acthar Gel.
• Advise patients to contact their healthcare provider if they develop weakness, hyperpigmentation, weight loss, hypotension, or abdominal pain.
• Advise caregivers of patients with infantile spasms that symptoms of adrenal insufficiency may be difficult to identify and that additional symptoms may include anorexia, fatigue, or lethargy [see Warnings and Precautions (5.2) ] .
• Elevated Blood Pressure, Salt and Water Retention, and Hypokalemia Advise patients, their caregivers and families to contact their healthcare provider if the patient experiences an increase in blood pressure or water retention [see Warnings and Precautions (5.3) and Adverse Reactions (6.1) ] .
• Vaccinations Advise patients and caregivers of patients to not to be vaccinated with live or live attenuated vaccines during treatment with Acthar Gel.
• Additionally, other immunization procedures in patients or in family members who will be in contact with the patient should be undertaken with caution while the patient is taking Acthar Gel [see Warnings and Precautions (5.4) ] .
• Masking Symptoms of Other Diseases Inform patients, their caregivers, and families that Acthar Gel may mask symptoms of other diseases/disorders without altering the course of the other disease/disorder.
• Monitor the patient carefully during and for a period following discontinuation of therapy and inform their healthcare provider if signs of infection, abnormal cardiac function, hypertension, hyperglycemia, change in body weight, or fecal blood loss occur [see Warnings and Precautions (5.5) ] .
• Gastrointestinal Perforation and Bleeding Advise patients, their caregivers and families to contact their healthcare provider if the patient or the caregiver notices blood or a change in color of the patient's stool [see Warnings and Precautions (5.6) ] .
• Behavioral and Mood Disturbances Inform patients, their caregivers and families that signs of irritability, sleep disturbances, mood swings, personality changes, or severe depression may occur.
• These effects are reversible once Acthar Gel therapy is stopped [see Warnings and Precautions (5.7) and Adverse Reactions (6.1) ] .
• Negative Effects on Growth and Physical Development Advise patients, their caregivers and families that changes in appetite, most often leading to weight gain, are seen with Acthar Gel therapy, becoming more frequent as the dose or treatment period increases.
• These effects are reversible once Acthar Gel therapy is stopped [see Warnings and Precautions (5.12) and Adverse Reactions (6.1) ] .
• Decrease in Bone Density Advise patients, their caregivers and families that prolonged use of Acthar Gel may inhibit skeletal growth in children and adolescents and may cause osteoporosis and decreased bone density at any age.
• If prolonged use is necessary, Acthar Gel should be given intermittently along with careful observation [see Warnings and Precautions (5.13) and Adverse Reactions (6.1) ] .
• Infantile Spasms Additional Information Inform caregivers that, in the treatment of infantile spasms, other types of seizures may occur because some patients with infantile spasms progress to other forms of seizures (for example, Lennox-Gastaut Syndrome).
• Additionally, the spasms sometimes mask other seizures and once the spasms resolve after treatment with Acthar Gel, the other seizures may become visible.
• Advise parents and caregivers to inform the patient's healthcare provider of any new onset of seizures so that appropriate management can then be instituted [see Adverse Reactions (6.1) ] .
• Pregnancy Advise pregnant women of the potential risk to a fetus [see Use in Specific Populations ( 8.1) ].
• Mallinckrodt, the "M" brand mark, SelfJect, the Mallinckrodt Pharmaceuticals logo and other brands are trademarks of a Mallinckrodt company. © 2024 Mallinckrodt.

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

• FORMS AND STRENGTHS Injection available as:
• 400 USP Units/5 mL (80 USP Units/mL) in a multi-dose vial for subcutaneous or intramuscular injection. 40 USP Units/0.5 mL in a single-dose pre-filled SelfJect injector for subcutaneous injection. 80 USP Units/mL in a single-dose pre-filled SelfJect injector for subcutaneous injection.
• Acthar Gel (repository corticotropin injection) is a clear light amber solution mobile at room temperature.
• Injection available as:
• 5 mL multi-dose vial containing 80 USP units/mL, for intramuscular or subcutaneous use.
• ( 3 ) 40 USP Units/0.5 mL Acthar Gel single-dose pre-filled SelfJect injector for subcutaneous injection.
• ( 3 ) 80 USP Units/mL Acthar Gel single-dose pre-filled SelfJect injector for subcutaneous injection.
• ( 3 )

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

• 16.1 How Supplied Acthar Gel (repository corticotropin injection) is a clear light amber solution mobile at room temperature.
• Acthar Gel is supplied in the following configurations:
• Strength Package size NDC number 80 USP Units/mL 5 mL multi-dose vial (1 count) 63004-8710-1 40 USP Units/0.5 mL Single-dose pre-filled SelfJect injector (4 count) 63004-8712-4 80 USP Units/mL Single-dose pre-filled SelfJect injector (4 count) 63004-8711-4
• 16.2 Storage and Handling Store Acthar Gel vial and Acthar Gel single-dose pre-filled SelfJect injector under refrigeration between 2°C to 8°C (36°F to 46°F) in the carton to protect from light.
• After removing the single-dose pre-filled SelfJect injector from the refrigerator, it can be stored at room temperature between 20°C to 25°C (68°F to 77°F) for up to 24 hours.
• Do not heat, freeze, or put the Acthar Gel single-dose pre-filled SelfJect injector into direct sunlight.
• Dispense single-dose pre-filled SelfJect injectors in the original sealed carton with the enclosed Instructions for Use.

Quoted from the official label, section “How Supplied”.

How to store it

• Store Acthar Gel vial and Acthar Gel single-dose pre-filled SelfJect injector under refrigeration between 2°C to 8°C (36°F to 46°F) in the carton to protect from light.
• After removing the single-dose pre-filled SelfJect injector from the refrigerator, it can be stored at room temperature between 20°C to 25°C (68°F to 77°F) for up to 24 hours.
• Do not heat, freeze, or put the Acthar Gel single-dose pre-filled SelfJect injector into direct sunlight.
• Dispense single-dose pre-filled SelfJect injectors in the original sealed carton with the enclosed Instructions for Use.

Quoted from the official label, section “Storage and Handling”.

What is in it

• Acthar Gel is a naturally sourced complex mixture of adrenocorticotropic hormone analogs and other pituitary peptides.
• The Acthar Gel manufacturing process converts the initial porcine pituitary extract with low ACTH content into a mixture having modified porcine ACTH and other related peptide analogs solubilized in gelatin.
• A major component in the formulated complex mixture is N-25 deamidated porcine ACTH (1-39).
• Acthar Gel is supplied as a sterile preparation in 16% gelatin to provide a prolonged release after intramuscular or subcutaneous injection.
• Acthar Gel also contains 0.5% phenol, not more than 0.1% cysteine (added), sodium hydroxide and/or acetic acid to adjust pH and Water for Injection.

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

Details

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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Other strengths and forms

2 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

See every product with Repository Corticotropin