Acthar

Name: Acthar

Proper Use of corticotropin

This section provides information on the proper use of a number of products that contain corticotropin. It may not be specific to Acthar. Please read with care.

A nurse or other trained health professional will give you or your child this medicine. This medicine is given as a shot under your skin or into one of your muscles.

Repository corticotropin injection may sometimes be given at home to patients who do not need to be in the hospital. If you are using this medicine at home, your or your child's doctor will teach you how to prepare and inject the medicine. Be sure that you understand exactly how the medicine is prepared and injected.

If your child is receiving repository corticotropin injection to treat infantile spasms, this medicine usually comes with a Medication Guide. It is very important that you read and follow the instructions carefully. Be sure to ask your child's doctor about anything you do not understand.

You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. This will help prevent skin problems from the injections.

To use:

  • Take the vial from the refrigerator and let it warm to room temperature before using it. Do not over-pressurize the vial before withdrawing the medicine.
  • Wash your hands before and after using this medicine.
  • Wipe the injection site with a new sterile alcohol wipe and let it dry before giving an injection.
  • Clean the top of the rubber stopper vial with a new sterile alcohol wipe.
  • Use a new needle or syringe to get the prescribed amount of medicine to be injected.
  • Give the medicine the way your doctor has instructed you.
  • Return the vial to the refrigerator after using it.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For injection dosage form (gel):
    • For infantile spasms:
      • Children 2 years of age and older—Use and dose must be determined by your doctor.
      • Infants and children younger than 2 years of age—Dose is based on body size and must be determined by your child's doctor. The dose is 150 units per square meter (U/m2) of body size divided into two equal doses injected into a muscle per day for 2 weeks. Your child's doctor will adjust the dose as needed.
    • For multiple sclerosis:
      • Adults—The dose is usually 80 to 120 units injected under your skin or into a muscle per day for 2 to 3 weeks. Your doctor will adjust your dose as needed.
      • Children—Use and dose must be determined by your doctor.
    • For other indications (joint disorders, autoimmune diseases, allergies, swelling, and certain conditions of the skin, eyes, and lungs):
      • Adults—The dose is usually 40 to 80 units injected under your skin or into a muscle every 24 to 72 hours. Your doctor will adjust your dose as needed.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

This medicine needs to be given on a fixed schedule. If you miss a dose or forget to use your medicine, call your doctor or pharmacist for instructions.

Storage

Store in the refrigerator. Do not freeze.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

For Healthcare Professionals

Applies to corticotropin: injectable powder for injection, injectable solution

Cardiovascular

Very Common (10% or more): Hypertension
Common (1% to 10%): Cardiac hypertrophy
Frequency not reported: Fluid retention
Postmarketing reports: Necrotizing angitis (adults only), congestive heart failure[Ref]

Dermatologic

Very common (10% or more): Acne
Common (1% to 10%): Rash
Postmarketing reports: Skin thinning (adults only), facial erythema, increased sweating (adults only)[Ref]

Endocrine

Very common (10% or more): Cushingoid
Common (1% to 10%): Cushingoid
Postmarketing reports: Decreased carbohydrate tolerance (infants only), hirsutism[Ref]

Gastrointestinal

Very common (10% or more): Diarrhea
Common (1% to 10%): Constipation, diarrhea, vomiting
Postmarketing reports: Pancreatitis (adults only), abdominal distention, ulcerative esophagitis[Ref]

Hypersensitivity

Postmarketing reports: Allergic responses presenting as dizziness, nausea, and shock (adult only).[Ref]

Metabolic

Common (1% to 10%): Increased appetite, decreased appetite, weight gain
Frequency not reported: Alteration in glucose tolerance
Postmarketing reports: Hypokalemic alkalosis (infants only)[Ref]

Musculoskeletal

Postmarketing reports: Muscle weakness, vertebral compression fractures (infants only)[Ref]

Nervous system

Very Common (10% to more): Convulsions
Common (1% to 10%): Convulsions
Postmarketing reports: Headache (adults only), vertigo (adults only), subdural hematoma, intracranial hemorrhage (adults only), reversible brain shrinkage (secondary to hypertension in infants only)[Ref]

Other

Very Common (10% or more): Infection
Common (1% or 10%): Pyrexia, candidiasis, otitis media[Ref]

Psychiatric

Very common (10% or more): Irritability
Common (1% to 10%): Irritability
Frequency not reported: Behavioral and mood changes[Ref]

Respiratory

Common (1% or 10%): Nasal congestion, pneumonia, upper respiratory infections.[Ref]

Some side effects of Acthar may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Usual Adult Dose for Sarcoidosis

Other indications for Adults and Children over 2 years of age: 40-80 units given intramuscularly or subcutaneously every 24 to 72 hours.

Usual Adult Dose for Iritis

Other indications for Adults and Children over 2 years of age: 40-80 units given intramuscularly or subcutaneously every 24 to 72 hours.

Usual Adult Dose for Psoriatic Arthritis

Other indications for Adults and Children over 2 years of age: 40-80 units given intramuscularly or subcutaneously every 24 to 72 hours.

Usual Adult Dose for Serum Sickness

Other indications for Adults and Children over 2 years of age: 40-80 units given intramuscularly or subcutaneously every 24 to 72 hours.

Usual Pediatric Dose for West Syndrome

Infantile spasms for children under 2 years of age: 75 units/m2 twice daily intramuscular administered over a 2 week period, then gradually tapered over a 2 week period to avoid adrenal insufficiency.

Renal Dose Adjustments

Data not available.

Other Comments

Refrigerate corticotropin between 36 to 46 degrees Fahrenheit (2 to 8 degrees Celsius).

Corticotropin should be warmed to room temperature prior to use.

The manufacturer's product information should be consulted for complete reconstitution and dilution recommendations.

Corticotropin Breastfeeding Warnings

A decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother. Excreted into human milk: Unknown Excreted into animal milk: Unknown The effects in the nursing infant are unknown.

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