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Unresolved MS Relapse Symptoms may require an alternative treatment to speed relief

Acthar demonstrated more rapid and complete improvement in MS relapse patients with optic neuritis symptoms compared to placebo10,11

In a double-blind prospective study, 50 patients with optic neuritis were randomized to receive daily intramuscular doses of Acthar (40 units) or an inert gel (placebo) for 30 days.10 Patients were assessed at least once a week for 30 days. At each visit, a visual acuity assessment was made on the Jaeger chart* (with correcting lens, if necessary).10

Optic neuritis study

  • Treatment with Acthar resulted in more rapid and complete improvement vs placebo at days 8, 15, 22, and 3010§
  • At a 12-month follow-up assessment, 96% of people treated with Acthar vs 80% of those in the control group showed improvement11‖
Chart title: Percentage of patients with visual acuity J 1-J2 (N=50)†‡

* The Jaeger scale is one method used to measure visual acuity; a more commonly used method is the Snellen chart. For reference, J14 is equivalent to approximately 20/200 on the Snellen chart. The exact chemical form of ACTH used in this study is unknown.

Patients were considered to have normal vision if they achieved a clinical assessment of 1 or 2 on the Jaeger scale. On day 1 of the study, 47 of the 50 patients had visual acuity worse than J1-J2. Ten patients were in the range J3-J15, 22 were J16-J20, 12 were F/C-P/L (finger counting, perception of light), and 3 were blind. The 3 patients who began the study with visual acuity of J2 had clinical retrobulbar neuritis, and all 3 improved to J1 at day 30.

The differences between the ACTH and placebo group for days 8, 15, 22, and 30 when divided by the respective standard error were all more than 3 times their related standard error, making it very unlikely (P<0.01) that the differences between the 2 groups were due to chance.

§ The exact chemical form of ACTH used in this study is unknown.

While the percentage difference between control and treated groups at the end of 12 months does not reach technical significance, these analyses do not mean that the difference has to be automatically dismissed as a chance effect. They do, however, show that present data cannot exclude the latter possibility and hence call for caution in their interpretation.

Acthar was demonstrated to be effective as an alternative MS relapse treatment in various situations and patient types

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Indication

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

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

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

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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