ACTHAR- repository corticotropin injection
Mallinckrodt ARD LLC
Acthar® Gel (AK-thar jel)
(repository corticotropin injection)
This Medication Guide provides information only about the use of Acthar Gel for the treatment of Infantile Spasms. If your doctor prescribes Acthar Gel for you or your child for any other reason, talk to your doctor for information about how this medicine is used to treat your medical condition.
Read this Medication Guide before your child receives Acthar Gel and each time you refill your child's prescription. There may be new information. This Medication Guide does not take the place of talking with your doctor about your child's medical condition or treatment.
Acthar Gel can cause serious side effects including:
Acthar Gel is a medicine that can affect your child's immune system. When your child is taking Acthar Gel, it can lower the ability of your child's immune system to fight infections.
Acthar Gel may:
When your child stops taking Acthar Gel, his or her body may not produce enough of a hormone called cortisol on its own (adrenal insufficiency). Your child may need to take steroid medicine to protect the body until the adrenal gland recovers and is working well again, especially to protect the body if they have surgery or trauma. Do not stop giving your child injections of Acthar Gel without talking to your doctor first.
Your doctor will tell you when and how to slowly stop giving the injections to avoid serious side effects.
While slowly stopping your child's injections of Acthar Gel or after you stop giving the injections, call your doctor right away if your child has any of the following:
When your child is taking Acthar Gel, his or her adrenal gland may produce too much cortisol. This can cause symptoms of Cushing's syndrome. Cushing's syndrome is more common in children who take Acthar Gel for a long time.
Symptoms of Cushing's syndrome include:
Your child may receive killed or inactivated vaccines while receiving Acthar Gel. Before your child receives any vaccines, talk to your doctor about which vaccines are safe for your child. Certain vaccines could cause your child to have serious side effects, or the vaccine may not be effective.
It may be more difficult for your doctor to diagnose other conditions or diseases in your child during treatment with Acthar Gel. During treatment and after treatment ends, tell your doctor if your child has:
Your child has an increased risk for bleeding from the stomach or having a stomach ulcer. Tell your doctor if your child has any pain in the stomach area (abdominal pain), vomits blood, or has bloody or black stools.
During treatment with Acthar Gel your child may be irritable, have rapid changes in his or her mood, be depressed, have other changes in his or her behavior, or have trouble sleeping.
Tell your doctor if your child has any of the side effects or symptoms listed above.
What is Acthar Gel?
Acthar Gel is a prescription medicine that is used to treat infantile spasms in infants and children under 2 years of age.
What should I tell my doctor before my child takes Acthar Gel?
Before your child takes Acthar Gel, read the section above "What is the most important information I should know about Acthar Gel?" and tell your doctor if your child has:
Tell your doctor about all the medicines your child takes, including prescription and non- prescription medicines, vitamins and herbal supplements. Do not start giving a new medicine to your child without first speaking to your doctor.
How should I give Acthar Gel to my child?
Acthar Gel is given as an injection into the muscle. Do not inject it under the skin, into a vein, or give it to your child by mouth.
Keep all of your child's follow-up appointments with your doctor
Infantile Spasms sometimes hides (masks) other seizures your child or infant may have. Once treated with Acthar Gel, the Infantile Spasms symptoms may disappear. This may allow the other seizures to become visible for the first time. Tell your child's doctor right away if you see a change in your child's seizures/spasms.
What are the possible side effects of Acthar Gel?
Acthar Gel can cause serious side effects.
The most common side effects of Acthar Gel for patients with infantile spasms include:
These are not all the possible side effects of Acthar Gel. Tell your doctor if your child has any side effect that bothers them or does not go away. For more information, ask your child's doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store Acthar Gel?
Throw away any vials after the expiration date printed on the label.
Keep Acthar Gel and all other medicines out of the reach of children
General information About Acthar Gel
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Acthar Gel for a condition for which it has not been prescribed. Do not give Acthar Gel to other people, even if they have the same symptoms. It may harm them.
This Medication Guide summarizes the most important information about Acthar Gel. If you would like more information, talk with your child's doctor. You can ask your child's doctor or pharmacist for information about Acthar Gel that is written for healthcare professionals. For more information, go to www.acthar.com or call 1-800-844-2830.
What are the ingredients in Acthar Gel?
Active ingredient: Corticotropin
Inactive ingredients: gelatin, phenol, cysteine, sodium hydroxide and/or acetic acid to adjust pH, and water for injection
Mallinckrodt ARD LLC
Bedminster, NJ 07921 USA
This Medication Guide has been approved by the U.S. Food and Drug Administration.
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