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Don't let an MS relapse rage. Accelerate relief with Acthar.

Acthar speeds MS relapse relief in adults7

In a randomized, double-blind, placebo-controlled clinical study, Acthar delivered more rapid efficacy vs placebo.8

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Overall Patient Condition

70% of patients treated with Acthar showed improvement in their overall condition at 1 week compared to only 49% of patients treated with placebo, a trend that continued throughout the study.8*†

70% of patients treated with Acthar showed improvement in their overall condition at 1 week compared to only 49% of patients treated with placebo, a trend that continued throughout the study.8*†

Disability Status Scale

At 4 weeks, the majority (65%) of Acthar-treated patients improved by ≥1 Disability Status Scale (DSS) step at week 4 compared to 48% of placebo-treated patients8*§

At  4 weeks, the majority (65%) of Acthar-treated patients improved by ≥ 1 Disability Status Scale (DSS) step at week 4 compared to 48% of placebo-treated patients.8*§

The authors of this study determined the significance of specified outcomes; however, the methods of calculating significance were not provided and cannot be verified.

*In a randomized, double-blind, placebo-controlled study, patients with acute MS relapses were given ACTH gel (n=103) or placebo gel (n=94) intramuscularly 40 units twice daily for 7 days, 20 units twice daily for 4 days, and 20 units daily for 3 days. Neurologic evaluations were performed within 24 hours before treatment, on days 7 and 14 during treatment, and on days 7 and 14 after treatment. Clinical assessments included: 1) an overall clinical assessment of neurologic impairment and change, 2) a detailed Standard Neurological Examination, 3) the Disability Status Scale, 4) tabulation of subjective symptoms by type, severity, and duration, and 5) a battery of quantitative tests administered by physical therapists.

The estimate in overall condition is a subjective measure designed to evaluate change in the patient’s condition as a whole, regardless of the nature or extent of the specific neurologic deficits that may have changed. Clinicians used their experience to judge whether a patient’s pretreatment condition was improved, worse, or the same as the last examination. Estimate of overall condition was at each weekly exam vs pretreatment exam according to treatment (cumulative frequency percentages). The methods of calculating significance were not provided and cannot be verified.

§The DSS is a scale measured from 0 to 10 in 1-point increments, in which increasing numbers indicate increasing severity of disease. Clinically, the scale measures up to 9, and 10 represents death. The numeric difference in DSS between visits determines whether the patient is getting better (Vx - Vx – 1 <0), is the same (Vx – Vx-1 = 0), or is worse (Vx – Vx-1 >0), where Vx = DSS of the current visit and Vx-1 = DSS of the previous visit. Today, the DSS has generally been replaced by the EDSS to assess the severity of disease.9

Relapse Reality

Efficacy of Acthar

Dr. David Brandes leads this MS conversation about the efficacy of Acthar in providing more rapid relief from MS relapse.

For MS relapse patients experiencing symptoms of optic neuritis, Acthar may be an option

View Optic Neuritis Study

Indication

H.P. Acthar® Gel (repository corticotropin injection) is indicated for the 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.

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Important Safety Information

Contraindications
  • Acthar should never be administered intravenously.
  • Administration of live or live attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of Acthar.
  • Acthar is contraindicated where congenital infections are suspected in infants.
  • Acthar is contraindicated 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 origins.

Indication

H.P. Acthar® Gel (repository corticotropin injection) is indicated for the 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.

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-axis (HPA) 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 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. Blood pressure, sodium and potassium levels may need to be monitored.
  • 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 GI bleeding and gastric ulcer. There is also an increased risk for perforation in patients with certain gastrointestinal disorders. Monitor for signs of bleeding.
  • Acthar may be associated with central nervous system effects ranging from euphoria, insomnia, irritability, mood swings, personality changes, and severe depression, and 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. Neutralizing antibodies with chronic administration may lead to loss of endogenous ACTH activity.
  • There is 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 for patients on long-term therapy.
  • Pregnancy Class C: Acthar has been shown to have an embryocidal effect and should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Adverse Reactions
  • Common adverse reactions for Acthar are similar to those of corticosteroids and include fluid retention, alteration in glucose tolerance, elevation in blood pressure, behavioral and mood changes, increased appetite and weight gain.
  • Specific adverse reactions reported in IS clinical trials in infants and children under 2 years of age included: infection, hypertension, irritability, Cushingoid symptoms, constipation, diarrhea, vomiting, pyrexia, weight gain, increased appetite, decreased appetite, nasal congestion, acne, rash, and cardiac hypertrophy. Convulsions were also reported, but these may actually be occurring because some IS patients progress to other forms of seizures and IS sometimes mask other seizures, which become visible once the clinical spasms from IS resolve.

Other adverse events reported are included in the full Prescribing Information.

Please see full Prescribing Information.

Indication

H.P. Acthar® Gel (repository corticotropin injection) is indicated for the 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.

View Full

Important Safety Information

Contraindications
  • Acthar should never be administered intravenously.
  • Administration of live or live attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of Acthar.
  • Acthar is contraindicated where congenital infections are suspected in infants.
  • Acthar is contraindicated 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 origins.

Indication

H.P. Acthar® Gel (repository corticotropin injection) is indicated for the 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.

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-axis (HPA) 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 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. Blood pressure, sodium and potassium levels may need to be monitored.
  • 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 GI bleeding and gastric ulcer. There is also an increased risk for perforation in patients with certain gastrointestinal disorders. Monitor for signs of bleeding.
  • Acthar may be associated with central nervous system effects ranging from euphoria, insomnia, irritability, mood swings, personality changes, and severe depression, and 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. Neutralizing antibodies with chronic administration may lead to loss of endogenous ACTH activity.
  • There is 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 for patients on long-term therapy.
  • Pregnancy Class C: Acthar has been shown to have an embryocidal effect and should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Adverse Reactions
  • Common adverse reactions for Acthar are similar to those of corticosteroids and include fluid retention, alteration in glucose tolerance, elevation in blood pressure, behavioral and mood changes, increased appetite and weight gain.
  • Specific adverse reactions reported in IS clinical trials in infants and children under 2 years of age included: infection, hypertension, irritability, Cushingoid symptoms, constipation, diarrhea, vomiting, pyrexia, weight gain, increased appetite, decreased appetite, nasal congestion, acne, rash, and cardiac hypertrophy. Convulsions were also reported, but these may actually be occurring because some IS patients progress to other forms of seizures and IS sometimes mask other seizures, which become visible once the clinical spasms from IS resolve.

Other adverse events reported are included in the full Prescribing Information.

Please see full Prescribing Information.

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The information in the following section is intended for US healthcare professionals only.