Acthar Gel

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Prescription Required

  • Product Details

    Description

    Acthar Gel (repository corticotropin injection) is given via an intramuscular or subcutaneous injection to treat the following:

    • Infantile spasms in infants and children younger than 2 years of age
    • Exacerbations of multiple sclerosis in adults
    • Rheumatic, collagen, dermatologic, allergic states, ophthalmic, and respiratory disorders and diseases and edematous (swelling) state

    Acthar Gel comes in multi-dose vials and single-dose, prefilled SelfJect injectors. The SelfJect injectors are for subcutaneous (underneath the skin) injection only.

    Directions

    Administer Acthar Gel as prescribed by the treating physician. A qualified healthcare provider should teach you or your caregiver how to properly store, prepare, administer, and discard Acthar Gel.

    Do not share products, needles, or syringes with others.

    Tell the treating physician if you have any questions or concerns.

    Ingredients

    The active ingredient in Acthar Gel is repository corticotropin.

    Contraindications

    Acthar Gel should not be administered:

    • Intravenously (IV)
    • To patients under 2 years old with suspected congenital infections
    • With live or live attenuated vaccines in patients receiving doses of Acthar Gel that suppress the immune system
    • In patients with scleroderma, osteoporosis, systemic fungal infections, ocular herpes simplex, recent surgery, prior or active peptic ulcer, congestive heart failure, uncontrolled high blood pressure, primary adrenocortical insufficiency, adrenocortical hyperfunction, or sensitivity to proteins of porcine (swine, pig) origin

    Cautions

    • Before you or your child begins receiving Acthar Gel injections, talk to the treating physician doctor about you or your child’s:
      • Medications
      • Allergies
      • Current health problems and past medical history
      • Status of pregnancy or breastfeeding
    • Acthar Gel contains the following warnings and precautions:
      • Increased susceptibility to infections and increased risk of worsening, spread, or reactivation of latent infections; signs and symptoms of infection may be masked
      • Adrenal insufficiency after prolonged therapy
      • Cushing’s syndrome
      • High blood pressure, salt and water retention, low blood potassium levels
      • Masking of symptoms of underlying diseases or disorders
      • Gastrointestinal perforation and bleeding
      • Behavioral and mood changes
      • Worsening symptoms of diabetes and myasthenia gravis
      • Cataracts, eye infections, and glaucoma
      • Immunogenicity potential
      • Enhanced effect is possible in patients with hypothyroidism or liver cirrhosis
      • Negative growth and physical development effects; pediatric patients should be monitored if they are receiving long-term therapy
      • Reduction in bone mineral density that can lead to osteoporosis

    Side Effects

    Injection site reaction, fatigue, general discomfort, weakness, lethargy, fluid retention (including peripheral swelling), problems with sleep, headache, and increased blood glucose are common Acthar Gel side effects.

    Increased infection risk, convulsions, high blood pressure, irritability, and fever are the most common side effects that have been reported in pediatric patients receiving Acthar Gel for infantile spasms.

    Contact a doctor right away if you or your child develops side effects that become bothersome or won't go away.

    Talk to your doctor about Acthar Gel.

    Reference

    1. Acthar Gel. Bridgewater, NJ: Mallinckrodt ARD LLC; 2024.



    IMPORTANT NOTE: The above information is intended to increase awareness of health information and does not suggest treatment or diagnosis. This information is not a substitute for individual medical attention and should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. See your health care professional for medical advice and treatment.

    Product Code : 14201

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