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Acthar Patient Support is available. Learn more.
Recommended dosing from the label1
Acthar Gel offers flexible dosing, with a recommended 40-80 units every 1-3 days across multiple indications. In MS, flexible dosing is also available, with a recommended 80-120 units daily for 2-3 weeks.
- For RA, SLE, DM/PM, PsA, symptomatic sarcoidosis, nephrotic syndrome, and ophthalmic diseases: 40 to 80 units (0.5 to 1 mL) given intramuscularly or subcutaneously every 1 to 3 days*†
- For MS relapse: 80 to 120 units (1 to 1.5 mL) given intramuscularly or subcutaneously daily for 2 to 3 weeks*†
- For IS: 150 units/m2 divided into twice daily intramuscular injections of 75 units/m2 over a 2-week period.*‡
You can download the IS Dosing Calculator from the Apple App Store or Google Play Store - Dosage and frequency should be individualized according to the medical condition, severity of the disease, and initial response of the patient
- Acthar Gel is administered as a self-injection or by a caregiver, which gives patients the flexibility to take it at home or wherever is best for them
- Acthar Gel is a gel preparation designed to provide a prolonged release of medication after injection
Welcome to the IS Dosing Calculator.
This is a convenient and complete way to calculate the dosage of Acthar Gel for the treatment of IS, from per-injection volume to a complete treatment regimen.
Choose initial dose or tapered dose and then enter measurements to determine the corresponding per-injection volume of Acthar Gel for a patient with IS.
INITIAL DOSE
TAPERED DOSE #1
Calculation information
For Infantile Spasms, the Acthar IS Dosing Calculator generates per-injection volume (mL) of Acthar bybody surface area (BSA) using the following Mosteller formula calculation22:
To determine per-injection volume of Acthar:
To determine total daily dose:
Input exceeds the FDA-recommended dose
The FDA approved Acthar for IS with the following recommended dosing regimen1:
- Two daily intramuscular injections of 75 U/m2 for 2 weeks
- After 2 weeks of treatment, Acthar should be gradually tapered over 2 weeks, decreasing the dose to help avoid adrenal insufficiency
Input is below the FDA-recommended dose
The FDA approved Acthar for IS with the following recommended dosing regimen1:
- Two daily intramuscular injections of 75 U/m2 for 2 weeks
- After 2 weeks of treatment, Acthar should be gradually tapered over 2 weeks, decreasing the dose to help avoid adrenal insufficiency
Input exceeds the preceding total daily dose
After 2 weeks of treatment, Acthar should be gradually tapered, decreasing the dose to help avoid adrenal insufficiency. The FDA approved Acthar for IS with the following recommended taper schedule1:
30 U/m2 in the morning for 3 days; 15 U/m2 in the morning for 3 days; 10 U/m2 in the morning for 3 days; and 10 U/m2 every other morning for 6 days.
The previous dose is outside the FDA-approved recommendation for dose range; therefore, the default taper dose may need assessment
After 2 weeks of treatment, Acthar should be gradually tapered, decreasing the dose to help avoid adrenal insufficiency. The FDA approved Acthar for IS with the following recommended taper schedule1:
30 U/m2 in the morning for 3 days; 15 U/m2 in the morning for 3 days; 10 U/m2 in the morning for 3 days; and 10 U/m2 every other morning for 6 days.
Input differs from the FDA-recommended frequency of treatment
The FDA approved Acthar for IS with the following recommended dosing regimen1:
- Two daily intramuscular injections of 75 U/m2 for 2 weeks
- After 2 weeks of treatment, Acthar should be gradually tapered over 2 weeks, decreasing the dose to help avoid adrenal insufficiency
Input differs from the FDA-approved tapering schedule recommendation
After 2 weeks of treatment, Acthar should be gradually tapered, decreasing the dose to help avoid adrenal insufficiency. The FDA approved Acthar for IS with the following recommended taper schedule1:
30 U/m2 in the morning for 3 days; 15 U/m2 in the morning for 3 days; 10 U/m2 in the morning for 3 days; and 10 U/m2 every other morning for 6 days.
The symptoms of adrenal insufficiency in infants treated for infantile spasms can be difficult to identify. The symptoms are non-specific and may include anorexia, fatigue, lethargy, weakness, excessive weight loss, hypotension and abdominal pain. It is critical that parents and caregivers be made aware of the possibility of adrenal insufficiency when discontinuing Acthar Gel and should be instructed to observe for, and be able to recognize, these symptoms.
Input exceeds the preceding total daily dose
After 2 weeks of treatment, Acthar should be gradually tapered, decreasing the dose to help avoid adrenal insufficiency. The FDA approved Acthar for IS with the following recommended taper schedule1:
30 U/m2 in the morning for 3 days; 15 U/m2 in the morning for 3 days; 10 U/m2 in the morning for 3 days; and 10 U/m2 every other morning for 6 days.
Input exceeds the preceding total daily dose
After 2 weeks of treatment, Acthar should be gradually tapered, decreasing the dose to help avoid adrenal insufficiency. The FDA approved Acthar for IS with the following recommended taper schedule1:
30 U/m2 in the morning for 3 days; 15 U/m2 in the morning for 3 days; 10 U/m2 in the morning for 3 days; and 10 U/m2 every other morning for 6 days.
Input exceeds the FDA-recommended total daily dose
The FDA approved Acthar for IS with the following recommended dosing regimen1:
- Two daily intramuscular injections of 75 U/m2 for a total daily dose of 150 U/m2 for 2 weeks
- After 2 weeks of treatment, Acthar should be gradually tapered over 2 weeks, decreasing the dose to help avoid adrenal insufficiency
Please note that there are no data to support the use of Acthar at a total daily dose exceeding 150 U/m2. This dosing calculator is not a substitute for clinical judgment. Medical discretion is required to determine any appropriate daily dose and treatment course of Acthar for your IS patients.
Input is below the FDA-recommended total daily dose
The FDA approved Acthar for IS with the following recommended dosing regimen1:
- Two daily intramuscular injections of 75 U/m2 for a total daily dose of 150 U/m2 for 2 weeks
- After 2 weeks of treatment, Acthar should be gradually tapered over 2 weeks, decreasing the dose to help avoid adrenal insufficiency
Input differs from the FDA-recommended days on therapy
The FDA approved Acthar for IS with the following recommended dosing regimen1:
- Two daily intramuscular injections of 75 U/m2 for 2 weeks
- After 2 weeks of treatment, Acthar should be gradually tapered over 2 weeks, decreasing the dose to help avoid adrenal insufficiency
Input differs from the FDA-approved tapering schedule recommendation
After 2 weeks of treatment, Acthar should be gradually tapered, decreasing the dose to help avoid adrenal insufficiency. The FDA approved Acthar for IS with the following recommended taper schedule1:
30 U/m2 in the morning for 3 days; 15 U/m2 in the morning for 3 days; 10 U/m2 in the morning for 3 days; and 10 U/m2 every other morning for 6 days.
The symptoms of adrenal insufficiency in infants treated for infantile spasms can be difficult to identify. The symptoms are non-specific and may include anorexia, fatigue, lethargy, weakness, excessive weight loss, hypotension and abdominal pain. It is critical that parents and caregivers be made aware of the possibility of adrenal insufficiency when discontinuing H.P. Acthar Gel and should be instructed to observe for, and be able to recognize, these symptoms.
ADD TAPERED DOSE
REMOVE THIS DOSE
VIEW MY SUMMARY
USING THE CALCULATOR
Calculation information
For infantile spasms, the Acthar IS Dosing Calculator generates per-injection volume (mL) of Acthar by body surface area (BSA) using the following Mosteller formula calculation22:
To determine per-injection volume of Acthar:
To determine total daily dose:
Calculation information
To determine total volume of Acthar required to complete your selected course of treatment:
To determine number of vials needed:
DM/PM=dermatomyositis/polymyositis; IS=infantile spasms; MS=multiple sclerosis; PsA=psoriatic arthritis; RA=rheumatoid arthritis; SLE=systemic lupus erythematosus.
*Acthar Gel is provided as a 5-mL multidose vial containing 80 USP units per mL.
†It may be necessary to taper the dose or increase the injection interval to gradually discontinue treatment.
‡Dosing should then be gradually tapered over a 2-week period to avoid adrenal insufficiency.
No-cost, one-on-one injection training is available for your patients.
Simply call Acthar Patient Support at 1-877-503-7746
Monday through Friday, 8 AM to 9 PM ET
Saturday, 9 AM to 2 PM ET
Additional dosing from clinical experience with Acthar Gel
| Indication | Source | Injection route | Dose* | Schedule† |
|---|---|---|---|---|
| RA2 | Phase 4, two-part, multicenter, randomized withdrawal study (N=259) | Subcutaneous | 80 units (1 mL) | Twice weekly for 12 to 24 weeks |
| DM/PM3 | Prospective, open-label proof-of-concept study (N=10)§ | Subcutaneous | 80 units (1 mL) | Twice weekly for 24 weeks |
| Symptomatic sarcoidosis4 | Retrospective chart review (N=47) | Subcutaneous or intramuscular | 40 to 80 units (0.5 to 1 mL) | Twice weekly for ≥6 months |
| Nephrotic syndrome5-11 |
Multiple clinical datasets | Subcutaneous | 80 units (1 mL) | Twice weekly for 6 months |
| Keratitis12 | Phase 4, multicenter, open-label study (N=36) | Subcutaneous | 80 units (1 mL) | Twice weekly for 12 weeks |
This chart does not include all studies available. These studies are subject to various limitations.
Disclosure statement: Funding to support some of these studies was provided by Mallinckrodt Pharmaceuticals.
*Acthar Gel is provided as a 5-mL multidose vial containing 80 USP units per mL.
†It may be necessary to taper the dose or increase the injection interval to gradually discontinue treatment.
§Ten of the 11 enrolled patients completed the study. One patient dropped out due to heart block unrelated to the study drug and was not included in the efficacy analysis, as she did not complete the minimum 8 weeks of the study drug required for outcome assessment per study protocol.
INDICATIONS
Acthar Gel is indicated for:
- Treatment during an exacerbation or as maintenance therapy in selected cases of dermatomyositis (polymyositis)
- Treatment during an exacerbation or as maintenance therapy in selected cases of systemic lupus erythematosus
- Adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy); ankylosing spondylitis
- Symptomatic sarcoidosis
- Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: keratitis, iritis, iridocyclitis, diffuse posterior uveitis and choroiditis, optic neuritis, chorioretinitis, anterior segment inflammation
- Inducing a diuresis or a remission of proteinuria in nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus
- Treatment of acute exacerbations of multiple sclerosis in adults. Controlled clinical trials have shown Acthar to be effective in speeding the resolution of acute exacerbations of multiple sclerosis. However, there is no evidence that it affects the ultimate outcome or natural history of the disease
- Monotherapy for the treatment of infantile spasms in infants and children under 2 years of age
Important Safety
information
Contraindications
Acthar is contraindicated:
- For intravenous administration
- In infants under 2 years of age who have suspected congenital infections
- With concomitant administration of live or live attenuated vaccines in patients receiving immunosuppressive doses of Acthar
- In patients with scleroderma, osteoporosis, systemic fungal infections, ocular herpes simplex, recent surgery, history of or the presence of a peptic ulcer, congestive heart failure, uncontrolled hypertension, primary adrenocortical insufficiency, adrenocortical hyperfunction, or sensitivity to proteins of porcine origin
Warnings and Precautions
- The adverse effects of Acthar are related primarily to its steroidogenic effects
- Acthar may increase susceptibility to new infection or reactivation of latent infections
- Suppression of the hypothalamic-pituitary-adrenal (HPA) axis may occur following prolonged therapy with the potential for adrenal insufficiency after withdrawal of the medication. Adrenal insufficiency may be minimized by tapering of the dose when discontinuing treatment. During recovery of the adrenal gland patients should be protected from the stress (e.g., trauma or surgery) by the use of corticosteroids. Monitor patients for effects of HPA axis suppression after stopping treatment
- Cushing’s syndrome may occur during therapy but generally resolves after therapy is stopped. Monitor patients for signs and symptoms
- Acthar can cause elevation of blood pressure, salt and water retention, and hypokalemia. Monitor blood pressure and sodium and potassium levels
- Acthar often acts by masking symptoms of other diseases/disorders. Monitor patients carefully during and for a period following discontinuation of therapy
- Acthar can cause gastrointestinal (GI) bleeding and gastric ulcer. There is also an increased risk for perforation in patients with certain GI disorders. Monitor for signs of perforation and bleeding
- Acthar may be associated with central nervous system effects ranging from euphoria, insomnia, irritability, mood swings, personality changes, and severe depression to psychosis. Existing conditions may be aggravated
- Patients with comorbid disease may have that disease worsened. Caution should be used when prescribing Acthar in patients with diabetes and myasthenia gravis
- Prolonged use of Acthar may produce cataracts, glaucoma, and secondary ocular infections. Monitor for signs and symptoms
- Acthar is immunogenic and prolonged administration of Acthar may increase the risk of hypersensitivity reactions. Cases of anaphylaxis have been reported in the postmarketing setting. Neutralizing antibodies with chronic administration may lead to loss of endogenous ACTH and Acthar activity
- There may be an enhanced effect in patients with hypothyroidism and in those with cirrhosis of the liver
- Long-term use may have negative effects on growth and physical development in children. Monitor pediatric patients
- Decrease in bone density may occur. Bone density should be monitored in patients on long-term therapy
Adverse Reactions
- Commonly reported postmarketing adverse reactions for Acthar include injection site reaction, asthenic conditions (including fatigue, malaise, asthenia, and lethargy), fluid retention (including peripheral swelling), insomnia, headache, and blood glucose increased
- The most common adverse reactions for the treatment of infantile spasms (IS) are increased risk of infections, convulsions, hypertension, irritability, and pyrexia. Some patients with IS progress to other forms of seizures; IS sometimes masks these seizures, which may become visible once the clinical spasms from IS resolve
Pregnancy
- Acthar may cause fetal harm when administered to a pregnant woman
Please see full Prescribing Information for additional Important Safety Information.
INDICATIONS
Acthar Gel is indicated for:
- Treatment during an exacerbation or as maintenance therapy in selected cases of dermatomyositis (polymyositis)
- Treatment during an exacerbation or as maintenance therapy in selected cases of systemic lupus erythematosus
- Adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy); ankylosing spondylitis
- Symptomatic sarcoidosis
- Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: keratitis, iritis, iridocyclitis, diffuse posterior uveitis and choroiditis, optic neuritis, chorioretinitis, anterior segment inflammation
- Inducing a diuresis or a remission of proteinuria in nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus
- Treatment of acute exacerbations of multiple sclerosis in adults. Controlled clinical trials have shown Acthar to be effective in speeding the resolution of acute exacerbations of multiple sclerosis. However, there is no evidence that it affects the ultimate outcome or natural history of the disease
- Monotherapy for the treatment of infantile spasms in infants and children under 2 years of age
INDICATIONS
Acthar Gel is indicated for:
- Treatment during an exacerbation or as maintenance therapy in selected cases of dermatomyositis (polymyositis)
- Treatment during an exacerbation or as maintenance therapy in selected cases of systemic lupus erythematosus
- Adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy); ankylosing spondylitis
- Symptomatic sarcoidosis
- Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: keratitis, iritis, iridocyclitis, diffuse posterior uveitis and choroiditis, optic neuritis, chorioretinitis, anterior segment inflammation
- Inducing a diuresis or a remission of proteinuria in nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus
- Treatment of acute exacerbations of multiple sclerosis in adults. Controlled clinical trials have shown Acthar to be effective in speeding the resolution of acute exacerbations of multiple sclerosis. However, there is no evidence that it affects the ultimate outcome or natural history of the disease
- Monotherapy for the treatment of infantile spasms in infants and children under 2 years of age
Important Safety information
Contraindications
Acthar is contraindicated:
- For intravenous administration
- In infants under 2 years of age who have suspected congenital infections
- With concomitant administration of live or live attenuated vaccines in patients receiving immunosuppressive doses of Acthar
- In patients with scleroderma, osteoporosis, systemic fungal infections, ocular herpes simplex, recent surgery, history of or the presence of a peptic ulcer, congestive heart failure, uncontrolled hypertension, primary adrenocortical insufficiency, adrenocortical hyperfunction, or sensitivity to proteins of porcine origin
Warnings and Precautions
- The adverse effects of Acthar are related primarily to its steroidogenic effects
- Acthar may increase susceptibility to new infection or reactivation of latent infections
- Suppression of the hypothalamic-pituitary-adrenal (HPA) axis may occur following prolonged therapy with the potential for adrenal insufficiency after withdrawal of the medication. Adrenal insufficiency may be minimized by tapering of the dose when discontinuing treatment. During recovery of the adrenal gland patients should be protected from the stress (e.g., trauma or surgery) by the use of corticosteroids. Monitor patients for effects of HPA axis suppression after stopping treatment
- Cushing’s syndrome may occur during therapy but generally resolves after therapy is stopped. Monitor patients for signs and symptoms
- Acthar can cause elevation of blood pressure, salt and water retention, and hypokalemia. Monitor blood pressure and sodium and potassium levels
- Acthar often acts by masking symptoms of other diseases/disorders. Monitor patients carefully during and for a period following discontinuation of therapy
- Acthar can cause gastrointestinal (GI) bleeding and gastric ulcer. There is also an increased risk for perforation in patients with certain GI disorders. Monitor for signs of perforation and bleeding
- Acthar may be associated with central nervous system effects ranging from euphoria, insomnia, irritability, mood swings, personality changes, and severe depression to psychosis. Existing conditions may be aggravated
- Patients with comorbid disease may have that disease worsened. Caution should be used when prescribing Acthar in patients with diabetes and myasthenia gravis
- Prolonged use of Acthar may produce cataracts, glaucoma, and secondary ocular infections. Monitor for signs and symptoms
- Acthar is immunogenic and prolonged administration of Acthar may increase the risk of hypersensitivity reactions. Cases of anaphylaxis have been reported in the postmarketing setting. Neutralizing antibodies with chronic administration may lead to loss of endogenous ACTH and Acthar activity
- There may be an enhanced effect in patients with hypothyroidism and in those with cirrhosis of the liver
- Long-term use may have negative effects on growth and physical development in children. Monitor pediatric patients
- Decrease in bone density may occur. Bone density should be monitored in patients on long-term therapy
Adverse Reactions
- Commonly reported postmarketing adverse reactions for Acthar include injection site reaction, asthenic conditions (including fatigue, malaise, asthenia, and lethargy), fluid retention (including peripheral swelling), insomnia, headache, and blood glucose increased
- The most common adverse reactions for the treatment of infantile spasms (IS) are increased risk of infections, convulsions, hypertension, irritability, and pyrexia. Some patients with IS progress to other forms of seizures; IS sometimes masks these seizures, which may become visible once the clinical spasms from IS resolve
Pregnancy
- Acthar may cause fetal harm when administered to a pregnant woman
Please see full Prescribing Information for additional Important Safety Information.
INDICATIONS
Acthar Gel is indicated for:
- Treatment during an exacerbation or as maintenance therapy in selected cases of dermatomyositis (polymyositis)
- Treatment during an exacerbation or as maintenance therapy in selected cases of systemic lupus erythematosus
- Adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy); ankylosing spondylitis
- Symptomatic sarcoidosis
- Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: keratitis, iritis, iridocyclitis, diffuse posterior uveitis and choroiditis, optic neuritis, chorioretinitis, anterior segment inflammation
- Inducing a diuresis or a remission of proteinuria in nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus
- Treatment of acute exacerbations of multiple sclerosis in adults. Controlled clinical trials have shown Acthar to be effective in speeding the resolution of acute exacerbations of multiple sclerosis. However, there is no evidence that it affects the ultimate outcome or natural history of the disease
- Monotherapy for the treatment of infantile spasms in infants and children under 2 years of age
Important Safety information
Contraindications
Acthar is contraindicated:
- For intravenous administration
- In infants under 2 years of age who have suspected congenital infections
- With concomitant administration of live or live attenuated vaccines in patients receiving immunosuppressive doses of Acthar
- In patients with scleroderma, osteoporosis, systemic fungal infections, ocular herpes simplex, recent surgery, history of or the presence of a peptic ulcer, congestive heart failure, uncontrolled hypertension, primary adrenocortical insufficiency, adrenocortical hyperfunction, or sensitivity to proteins of porcine origin
Warnings and Precautions
- The adverse effects of Acthar are related primarily to its steroidogenic effects
- Acthar may increase susceptibility to new infection or reactivation of latent infections
- Suppression of the hypothalamic-pituitary-adrenal (HPA) axis may occur following prolonged therapy with the potential for adrenal insufficiency after withdrawal of the medication. Adrenal insufficiency may be minimized by tapering of the dose when discontinuing treatment. During recovery of the adrenal gland patients should be protected from the stress (e.g., trauma or surgery) by the use of corticosteroids. Monitor patients for effects of HPA axis suppression after stopping treatment
- Cushing’s syndrome may occur during therapy but generally resolves after therapy is stopped. Monitor patients for signs and symptoms
- Acthar can cause elevation of blood pressure, salt and water retention, and hypokalemia. Monitor blood pressure and sodium and potassium levels
- Acthar often acts by masking symptoms of other diseases/disorders. Monitor patients carefully during and for a period following discontinuation of therapy
- Acthar can cause gastrointestinal (GI) bleeding and gastric ulcer. There is also an increased risk for perforation in patients with certain GI disorders. Monitor for signs of perforation and bleeding
- Acthar may be associated with central nervous system effects ranging from euphoria, insomnia, irritability, mood swings, personality changes, and severe depression to psychosis. Existing conditions may be aggravated
- Patients with comorbid disease may have that disease worsened. Caution should be used when prescribing Acthar in patients with diabetes and myasthenia gravis
- Prolonged use of Acthar may produce cataracts, glaucoma, and secondary ocular infections. Monitor for signs and symptoms
- Acthar is immunogenic and prolonged administration of Acthar may increase the risk of hypersensitivity reactions. Cases of anaphylaxis have been reported in the postmarketing setting. Neutralizing antibodies with chronic administration may lead to loss of endogenous ACTH and Acthar activity
- There may be an enhanced effect in patients with hypothyroidism and in those with cirrhosis of the liver
- Long-term use may have negative effects on growth and physical development in children. Monitor pediatric patients
- Decrease in bone density may occur. Bone density should be monitored in patients on long-term therapy
Adverse Reactions
- Commonly reported postmarketing adverse reactions for Acthar include injection site reaction, asthenic conditions (including fatigue, malaise, asthenia, and lethargy), fluid retention (including peripheral swelling), insomnia, headache, and blood glucose increased
- The most common adverse reactions for the treatment of infantile spasms (IS) are increased risk of infections, convulsions, hypertension, irritability, and pyrexia. Some patients with IS progress to other forms of seizures; IS sometimes masks these seizures, which may become visible once the clinical spasms from IS resolve
Pregnancy
- Acthar may cause fetal harm when administered to a pregnant woman
Please see full Prescribing Information for additional Important Safety Information.
References:
- Data on file: REF-04586. Mallinckrodt ARD LLC.
- Acthar Gel (repository corticotropin injection) [prescribing information]. Bedminster, NJ: Mallinckrodt ARD LLC.
References:
- Acthar Gel (repository corticotropin injection) [prescribing information]. Bedminster, NJ: Mallinckrodt ARD LLC.
- Huang JY, Galen K, Zweifel B, Brooks LR, Wright AD. Distinct binding and signaling activity of Acthar Gel compared to other melanocortin receptor agonists. J Recept Signal Transduct Res. 2020;1-9. doi:10.1080/10799893.2020.1818094.
- Healy LM, Jang JH, Lin YH, Rao V, Antel JP, Wright D. Melanocortin receptor mediated anti-inflammatory effect of repository corticotropin injection on human monocyte-derived macrophages [ECTRIMS-ACTRIMS abstract EP1481]. Mult Scler J. 2017;23(suppl 3):777.
- Wright D, Zweifel B, Sharma P, Galen K, Fitch R. Reduced steroidogenic activity of repository corticotropin injection induces a distinct cytokine response following T cell activation in vivo [EULAR abstract AB0082]. Ann Rheum Dis. 2019b;78(suppl 2):1504.
- Olsen NJ, Decker DA, Higgins P, et al. Direct effects of HP Acthar Gel on human B lymphocyte activation in vitro. Arthritis Res Ther. 2015;17:300. doi:10.1186/s13075-015-0823-y.
- U.S. National Library of Medicine. DailyMed website. https://dailymed.nlm.nih.gov/dailymed/. Accessed March 3, 2022.
References:
- Acthar Gel (repository corticotropin injection) [prescribing information]. Bedminster, NJ: Mallinckrodt ARD LLC.
- Catania A, Lonati C, Sordi A, Carlin A, Leonardi P, Gatti S. The melanocortin system in control of inflammation. ScientificWorldJournal. 2010;10:1840-1853. doi:10.1100/tsw.2010.173.
- Huang YJ, Galen K, Zweifel B, Brooks LR, Wright AD. Distinct binding and signaling activity of Acthar Gel compared to other melanocortin receptor agonists. J Recept Signal Transduct Res. 2021;41(5):425-433.
- Olsen NJ, Decker DA, Higgins P, et al. Direct effects of HP Acthar Gel on human B lymphocyte activation in vitro. Arthritis Res Ther. 2015;17:300. doi:10.1186/s13075-015-0823-y.
- Healy LM, Jang JH, Lin YH, Rao V, Ante! JP, Wright D. Melanocortin receptor mediated anti-inflammatory effect of repository corticotropin injection on human monocyte-derived macrophages [ECTRIMS-ACTRIMS abstract EP1481]. Mult Scler J. 2017;23(suppl 3):777.
- Wright D, Zweifel B, Sharma P, Galen K, Fitch R. Reduced steroidogenic activity of repository corticotropin injection induces a distinct cytokine response following T cell activation in vivo [EULAR abstract AB0082]. Ann Rheum Dis. 2019b;78(suppl 2):1504.
- Benko AL, McAloose CA, Becker PM, et al. Repository corticotrophin injection exerts direct acute effects on human B cell gene expression distinct from the actions of glucocorticoids. Clin Exp Immunol. 2018;192(1):68‐81.
- Gong R. The renaissance of corticotropin therapy in proteinuric nephropathies. Nat Rev Nephrol. 2011;8(2):122-128.
- Caruso V, Lagerström MC, Olszewski PK, Fredriksson R, Schiöth HB. Synaptic changes induced by melanocortin signalling. Nat Rev Neurosci. 2014;15(2):98‐110.
- Zhong Q, Sridhar S, Ruan L, et al. Multiple melanocortin receptors are expressed in bone cells. Bone. 2005;36(5):820‐831.
- Lisak RP, Benjamins JA. Melanocortins, melanocortin receptors and multiple sclerosis. Brain Sci. 2017;7(104):1‐18.
- Taylor AW, Lee D. Applications of the role of α‐MSH in ocular immune privilege. Adv Exp Med Biol. 2010;681:143‐149.
- Artuc M, Grützkau A, Luger T, Henz BM. Expression of MC1‐ and MC5‐receptors on the human mast cell line HMC‐1. Ann N Y Acad Sci. 1999;885:364‐367.
- Chang M, Chen B, Shaffner J, Dworkin LD, Gong R. Melanocortin system in kidney homeostasis and disease: novel therapeutic opportunities. Front Physiol. 2021;12:651236.
- Lisak R, Bealmear B, Nedlekoska L, et al. Schwann cells express melanocortin receptor subtypes: activation by ACTH 1–39 and alpha‐MSH enhances proliferation [abstract P1.430]. Neurology. 2018;90(suppl 15):1‐2.
- Kaneva MK, Kerrigan MJ, Grieco P, Curley GP, Locke IC, Getting SJ. Chondroprotective and anti‐inflammatory role of melanocortin peptides in TNF‐α activated human C‐20/A4 chondrocytes. Br J Pharmacol. 2012;167(1):67‐79.
- Grässel S, Opolka A, Anders S, et al. The melanocortin system in articular chondrocytes: melanocortin receptors, pro‐opiomelanocortin, precursor proteases, and a regulatory effect of alpha‐melanocyte‐stimulating hormone on proinflammatory cytokines and extracellular matrix components. Arthritis Rheum. 2009;60(10):3017‐3027.
References:
- Acthar Gel (repository corticotropin injection) [prescribing information]. Bedminster, NJ: Mallinckrodt ARD LLC.
- Poola N, Due B, Wright D, Brooks LR, Zaman F. Pharmacokinetics and pharmacodynamics of repository corticotropin injection compared with synthetic ACTH1-24 depot and methylprednisolone in healthy subjects [published online ahead of print]. Clin Pharmacol Drug Dev. 2021. doi:10.1002/cpdd.1020.
- Data on file: REF-03003. Mallinckrodt ARD LLC.
References:
- Acthar Gel (repository corticotropin injection) [prescribing information]. Bedminster, NJ: Mallinckrodt ARD LLC.
- Olsen NJ, Decker DA, Higgins P, et al. Direct effects of HP Acthar Gel on human B-lymphocyte activation in vitro. Arthritis Res Ther. 2015;17:300.
- Data on file: REF-04768. Mallinckrodt ARD LLC
- Healy LM, Jang JH, Lin YH, Rao V, Antel JP, Wright D. Melanocortin receptor mediated anti-inflammatory effect of repository corticotropin injection on human monocyte-derived macrophages [ECTRIMS-ACTRIMS abstract EP14841]. Mult Scler J. 2017;23(suppl 3):777.
- Healy LM, Lin YH, Jang JH, Rao V, Antel JP, Wright D. Melanocortin receptor mediated anti-inflammatory effect of repository corticotropin injection on human monocyte-derived macrophages. Poster presented at: 7th Joint ECTRIMS-ACTRIMS Meeting; October 25-28, 2017; Paris, France. Poster EP1481.
References:
- Acthar Gel (repository corticotropin injection) [prescribing information]. Bedminster, NJ: Mallinckrodt ARD LLC.
- Fleischmann R, Furst DE, Connolly-Strong E, Liu J, Zhu J, Brasington R. Repository corticotropin injection for active rheumatoid arthritis despite aggressive treatment: a randomized controlled withdrawal trial. Rheumatol Ther. 2020;7(2):327-344.
- Aggarwal R, Marder G, Koontz DC, Nandkumar P, Qi Z, Oddis CV. Efficacy and safety of adrenocorticotropic hormone gel in refractory dermatomyositis and polymyositis. Ann Rheum Dis. 2017;77(5):720-727.
- Baughman RP, Barney JB, O'Hare L, Lower EE. A retrospective pilot study examining the use of Acthar gel in sarcoidosis patients. Respir Med. 2016;110:66-72.
- Hladunewich MA, Cattran D, Beck LH, et al. A pilot study to determine the dose and effectiveness of adrenocorticotrophic hormone (Acthar® Gel) in nephrotic syndrome due to idiopathic membranous nephropathy. Nephrol Dial Transplant. 2014;29(8):1570-1577.
- Bomback AS, Canetta PA, Beck LH Jr, Ayalon R, Radhakrishnan J, Appel GB. Treatment of resistant glomerular diseases with adrenocorticotropic hormone gel: a prospective trial. Am J Nephrol. 2012;36(1):58-67.
- Madan A, Mijovic-Das S, Stankovic A, Teehan G, Milward AS, Khastgir A. Acthar gel in the treatment of nephrotic syndrome: a multicenter retrospective case series. BMC Nephrol. 2016;17:37.
- Tumlin J, Galphin C, Santos R, Rovin B. Kidney Int Rep. 2017;2(5):924-932.
- Bomback AS, Tumlin JA, Baranski J, et al. Treatment of nephrotic syndrome with adrenocorticotropic hormone (ACTH) gel. Drug Des Devel Ther. 2011;5:147-153.
- Filippone EJ, Dopson SJ, Rivers DM, et al. Adrenocorticotropic hormone analog use for podocytopathies. Int Med Case Rep J. 2016;9:125-133.
- Hogan J, Bomback AS, Mehta K, et al. Treatment of idiopathic FSGS with adrenocorticotropic hormone gel. Clin J Am Soc Nephrol. 2013;8(12):2072-2081.
- Wirta D, McLaurin E, Ousler G, Liu J, Kacmaz RO, Grieco J. Repository corticotropin injection (Acthar® Gel) for refractory severe noninfectious keratitis: efficacy and safety from a phase 4, multicenter, open-label study. Ophthalmol Ther. 2021;10(4):1077-1092.
References:
- Acthar Gel (repository corticotropin injection) [prescribing information]. Bedminster, NJ: Mallinckrodt ARD LLC.
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- Bryan MS, Sergott RC. Changes in visual acuity and retinal structures following repository corticotropin injection (RCI) therapy in patients with acute demyelinating optic neuritis: improvement in low contrast visual acuity in both affected and contralateral eyes in a single-armed open-label study. J Neurol Sci. 2019;407:116505. doi:10.1016/j.jns.2019.116505.
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- Data on File – Ref-05336. Mallinckrodt Pharmaceuticals.
- Fleischmann R, Furst DE, Connolly-Strong E, Liu J, Zhu J, Brasington R. Repository corticotropin injection for active rheumatoid arthritis despite aggressive treatment: a randomized controlled withdrawal trial. Rheumatol Ther. 2020;7(2):327-344.
- Chopra I, Qin Y, Kranyak J, et al. Repository corticotropin injection in patients with advanced symptomatic sarcoidosis: retrospective analysis of medical records. Ther Adv Respir Dis. 2019;13:1753466619888127. doi:10.1177/1753466619888127.
- Wirta D, McLaurin E, Ousler G, Liu J, Kacmaz RO, Grieco J. Repository corticotropin injection (Acthar® Gel) for refractory severe noninfectious keratitis: efficacy and safety from a phase 4, multicenter, open-label study. Ophthalmol Ther. 2021;10(4):1077-1092.
- Zand L, Canetta P, Lafayette R, et al. An open-label pilot study of adrenocorticotrophic hormone in the treatment of IgA nephropathy at high risk of progression. Kidney Int Rep. 2020;5(1):58-65.
- Kaplan J, Miller T, Baker M, Due B, Zhao E. A prospective observational registry of repository corticotropin injection (Acthar® Gel) for the treatment of multiple sclerosis relapse. Front Neurol. 2020;11:598496.doi:10.3389/fneur.2020.598496.
References:
- Alhamad T, Manllo Dieck J, Younus U, et al. ACTH gel in resistant focal segmental glomerulosclerosis after kidney transplantation. Transplantation. 2019;103(1):202-209.
- Acthar Gel (repository corticotropin injection) [prescribing information]. Bedminster, NJ: Mallinckrodt ARD LLC.
- Hladunewich MA, Cattran D, Beck LH, et al. A pilot study to determine the dose and effectiveness of adrenocorticotrophic hormone (Acthar® Gel) in nephrotic syndrome due to idiopathic membranous nephropathy. Nephrol Dial Transplant. 2014;29(8):1570-1577.
- Bomback AS, Canetta PA, Beck LH Jr, Ayalon R, Radhakrishnan J, Appel GB. Treatment of resistant glomerular diseases with adrenocorticotropic hormone gel: a prospective trial. Am J Nephrol. 2012;36(1):58-67.
- Madan A, Mijovic-Das S, Stankovic A, Teehan G, Milward AS, Khastgir A. Acthar Gel in the treatment of nephrotic syndrome: a multicenter retrospective case series. BMC Nephrol. 2016;17:37.
- Tumlin J, Galphin C, Santos R, Rovin B. Kidney Int Rep. 2017;2(5):924-932.
- Bomback AS, Tumlin JA, Baranski J, et al. Treatment of nephrotic syndrome with adrenocorticotropic hormone (ACTH) gel. Drug Des Devel Ther. 2011;5:147-153.
- Filippone EJ, Dopson SJ, Rivers DM, et al. Adrenocorticotropic hormone analog use for podocytopathies. Int Med Case Rep J. 2016;9:125-133.
- Hogan J, Bomback AS, Mehta K, et al. Treatment of idiopathic FSGS with adrenocorticotropic hormone gel. Clin J Am Soc Nephrol. 2013;8(12):2072-2081.
References:
- Zand L, Canetta P, Lafayette R, et al. An open-label pilot study of adrenocorticotrophic hormone in the treatment of lgA nephropathy at high risk of progression. Kidney Int Rep. 2020;5(1):58-65.
- Acthar Gel (repository corticotropin injection) [prescribing information]. Bedminster, NJ: Mallinckrodt ARD LLC.
References:
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- Acthar Gel (repository corticotropin injection) [prescribing information]. Bedminster, NJ: Mallinckrodt ARD LLC.
References:
- Data on file: REF-MNK14084113. Mallinckrodt ARD LLC.
References:
- Bryan MS, Sergott RC. Changes in visual acuity and retinal structures following repository corticotropin injection (RCI) therapy in patients with acute demyelinating optic neuritis: improvement in low contrast visual acuity in both affected and contralateral eyes in a single-armed open-label study. J Neurol Sci. 2019;407:116505. doi:10.1016/j.jns.2019.116505.
References:
- Fiechtner JJ, Montroy T, June J. A single-site, investigator initiated open-label trial of H.P. Acthar® Gel (repository corticotropin injection) an adrenocorticotropic hormone (ACTH) analogue in subjects with moderately to severely active psoriatic arthritis (PsA). J Dermatol Res Ther. 2016;2(5):1-7.
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References:
- Tumlin J, Galphin C, Santos R, Rovin B. Kidney Int Rep. 2017;2(5):924-932.
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- Nelson WW, Lima AF, Kranyak J, et al. Retrospective medical record review to describe use of repository corticotropin injection among patients with uveitis in the United States. J Ocul Pharmacol Ther. 2019;35(3):182-188.
References:
- Wirta D, McLaurin E, Ousler G, Liu J, Kacmaz RO, Grieco J. Repository corticotropin injection (Acthar® Gel) for refractory severe noninfectious keratitis: efficacy and safety from a phase 4, multicenter, open-label study. Ophthalmol Ther. 2021;10(4):1077-1092.
- Data on file: REF-04498. Mallinckrodt ARD LLC.
- US Food and Drug Administration Center for Drug Evaluation and Research. Clinical outcome assessment review. 2016. Accessed January 19, 2021. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208073Orig1s000MedR.pdf.
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References:
- Rahaghi FF, Sweiss NJ, Saketkoo LA, et al. Management of repository corticotrophin injection therapy for pulmonary sarcoidosis: a Delphi study. Eur Respir Rev. 2020;29(155):190147. doi:10.1183/16000617.0147-2019.
- Baughman RP, Scholand MB, Rahaghi FF. Clinical phenotyping: role in treatment decisions in sarcoipdosis. Eur Respir Rev. 2020;29(155):190145. doi:10.1183/16000617.0145-2019.
- Acthar Gel (repository corticotropin injection) [prescribing information]. Bedminster, NJ: Mallinckrodt ARD LLC.
- Rahaghi FF, Baughman RP, Saketkoo LA, et al. Delphi consensus recommendations for a treatment algorithm in pulmonary sarcoidosis. Eur Respir Rev. 2020;29(155):190146. doi:10.1183/16000617.0146-2019.
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