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If you have a non-emergency, product-related question, or to report a suspected adverse event or product quality complaint, please call Mallinckrodt Medical Information at 1-800-778-78981-800-778-7898 or e-mail us at medinfo@mallinckrodt.com.

Alternatively, a suspected adverse event may be reported to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, or by mail using Form 3500 available at http://www.fda.gov/medwatch/index.html.

For questions regarding insurance coverage or reimbursement for Acthar, please call 1-888-435-22841-888-435-2284.

Acthar is indicated for 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.

Important Safety Information

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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

Important Safety Information

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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

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 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.

References


Mallinckrodt, the "M" brand mark and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company. Other brands are trademarks of a Mallinckrodt company or their respective owners.

© 2018 Mallinckrodt. By viewing this site you agree to our Terms of Use. The product information provided in this site is intended only for residents of the United States.

US-1800488   12/18

US-1800488   12/18

References:

Terms and Conditions:

  • The Acthar Commercial Co-pay Program provides drug co-pay assistance of up to $25,000 per calendar year for eligible patients
  • This program is valid for eligible, privately and commercially insured patients. For more details about the eligibility criteria, see below
  • This program is not valid for prescriptions for which payment may be made in whole or in part under federal or state health programs, including but not limited to Medicare or Medicaid
  • This program is not valid for uninsured patients
  • Program offer is limited to one membership per person and is not transferrable
  • Patients should consult their insurance provider concerning any limitations that may apply to this program under their insurance policy
  • The program does not represent prescription drug coverage or insurance and is not intended to substitute for such coverage
  • Patients are responsible for any co-payment or coinsurance costs above and beyond the program’s annual maximum benefit
  • Void where prohibited by law
  • Not valid outside the United States
  • Mallinckrodt ARD, Inc. reserves the right to terminate or modify this program at any time without notice

Eligibility Criteria:

  • Approved indication
  • US permanent resident
  • Patient (or patient’s legal representative) must be 18 years of age or older to opt in to program
  • Commercially or privately insured
  • Not insured by a federal or state healthcare plan or where prohibited by law

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See How Acthar Is Injected

Watch More Videos
 Replay video
Chapters

1. Injecting Acthar: Introduction

01:22

2. Getting Started With Acthar01:57

3. Preparing the Dose Ordered for You

01:00

4. Preparing to Inject

00:49

5. Drawing Up Acthar Into the Syringe

01:37

6. Choosing Where to Inject

02:57

7. Injecting Subcutaneously

02:07

8. Disposing of Used Materials

00:49

9. Storing Acthar

00:49

10. Patient Support Services

00:56

11. Important Safety Information

06:02
Chapters

1. Injecting Acthar: Introduction

01:19

2. Getting Started With Acthar

01:56

3. Preparing the Dose Ordered for You0:59

4. Preparing to Inject00:49

5. Drawing Up Acthar Into the Syringe

01:37

6. Choosing Where to Inject

02:19

7. Injecting Intramuscularly

02:01

8. Disposing of Used Materials

00:49

9. Storing Acthar

00:49

10. Patient Support Services

00:55

11. Important Safety Information

06:02

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