Safety Profile

The safety profile of Acthar has been demonstrated over many years

  • Side effects are similar to those seen with corticosteroids, including fluid retention, alteration in glucose tolerance, elevation in blood pressure, behavioral and mood changes, increased appetite, and weight gain1
  • Prolonged use of Acthar may increase the risk of side effects
  • The safety profile for Acthar in the treatment of dermatomyositis and polymyositis was established in a retrospective case series of 5 patients with dermatomyositis and polymyositis2
    • Patients receiving Acthar were examined for significant side effects, including:
      • Hyperglycemia
      • Diabetic ketoacidosis
      • Hyperosmolar states
    • No significant adverse events as defined in the study methods were reported by the investigator in any of the 5 patients

Please see Important Safety Information below. For a full list of indications, contraindications, warnings, precautions, and adverse events related to Acthar, please refer to the full Prescribing Information.

Acthar is indicated for use during an exacerbation or as maintenance therapy in selected cases of systemic dermatomyositis (polymyositis).

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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

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.

Indications

H.P. Acthar® Gel (repository corticotropin injection) is an adrenocorticotropic hormone (ACTH) analogue used for:

  • Treatment during an exacerbation or as maintenance therapy in selected cases of systemic lupus erythematosus
  • Treatment during an exacerbation or as maintenance therapy in selected cases of systemic dermatomyositis (polymyositis)
  • Adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy)
  • Adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in psoriatic arthritis
  • The treatment of symptomatic sarcoidosis
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.

ARDUS/01-06/0616/0018a(3)

ARDUS/01-06/0616/0018a(3)

References:

  1. H.P. Acthar® Gel (repository corticotropin injection) prescribing information. Mallinckrodt ARD, Inc.
  2. Levine T. Treating refractory dermatomyositis or polymyositis with adrenocorticotropic hormone (ACTH) gel: a retrospective case series. Drug Des Devel Ther. 2012;6:133-139.
 
 

See How Acthar Is Injected

Watch More Videos
 Replay video
Chapters

1. Injecting Acthar: Introduction

01:22

2. Getting Started With Acthar

01:57

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

01:00

11. Important Safety Information

07:18
Chapters

1. Injecting Acthar: Introduction

01:19

2. Getting Started With Acthar

01:56

3. Preparing the Dose Ordered for You

00:59

4. Preparing to Inject

00:49

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

01:00

11. Important Safety Information

07:18
Chapters

1. La inyección de Acthar: Introducción

01:57

2. Los primeros pasos con Acthar03:15

3. Preparación de la dosis prescrita

01:23

4. Preparación para la inyección

01:16

5. Toma de Acthar con la jeringa

02:38

6. Elección del lugar dónde inyectar

04:41

7. Inyección subcutánea de Acthar

03:14

8. Cómo deshacerse de los materiales utilizados

01:17

9. Almacenamiento de Acthar

01:05

10. Servicios de apoyo a pacientes

01:36

11. Información importante para los
pacientes

11:34
Chapters

1. La inyección de Acthar: Introducción

01:56

2. Los primeros pasos con Acthar

03:18

3. Preparación de la dosis prescrita01:23

4. Preparación para la inyección1:16

5. Toma de Acthar con la jeringa

02:38

6. Elección del lugar dónde inyectar

03:31

7. Inyección intramuscular de Acthar

03:03

8. Cómo deshacerse de los materiales utilizados

01:17

9. Almacenamiento de Acthar

01:05

10. Servicios de apoyo a pacientes

01:36

11. Información importante para los
pacientes

11:33

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