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Acthar Gel, H.P.

Generic Name: corticotropin (KOR ti koe TROE pin)
Brand Name: Acthar Gel, H.P.

What is Acthar Gel, H.P. (corticotropin)?

Corticotropin is a man-made form of a hormone that occurs naturally in the body.

Corticotropin is also used to treat many different conditions such as multiple sclerosis, psoriatic or rheumatoid arthritis, ankylosing spondylitis, lupus, severe allergic reactions, breathing disorders, and inflammatory conditions of the eyes. Corticotropin is also used to treat infantile spasms in children younger than 2 years old.

Corticotropin can reduce the symptoms of many disorders, but it is not a cure for these conditions. Corticotropin is also not expected to slow the progress of any disease.

Corticotropin may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Acthar Gel, H.P. (corticotropin)?

You should not use corticotropin if you have adrenal insufficiency (Addison's disease), scleroderma, a fungal infection, herpes infection of the eyes, osteoporosis, a past or present stomach ulcer, congestive heart failure, uncontrolled high blood pressure, recent surgery, or if you are allergic to pork proteins

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What should I discuss with my healthcare provider before using Acthar Gel, H.P. (corticotropin)?

You should not use corticotropin if you are allergic to it, or if you have:

  • adrenal insufficiency (Addison's disease);

  • scleroderma;

  • a fungal infection anywhere in your body;

  • herpes infection of the eyes;

  • osteoporosis;

  • past or present stomach ulcer;

  • congestive heart failure;

  • untreated or uncontrolled high blood pressure;

  • if you have recently had surgery; or

  • if you are allergic to pork proteins.

This medicine should not be used in a child younger than 2 with an infection that was passed from the mother during pregnancy or childbirth.

Corticotropin can worsen an infection you already have, or reactivate an infection you recently had. Before using this medicine, tell your doctor about any illness or infection you have had within the past several weeks.

To make sure corticotropin is safe for you, tell your doctor if you have:

  • liver disease (such as cirrhosis);

  • kidney disease;

  • a thyroid disorder;

  • diabetes;

  • a history of tuberculosis;

  • a muscle disorder such as myasthenia gravis;

  • glaucoma or cataracts;

  • depression or mental illness;

  • a stomach or intestinal disorder; or

  • if you take a diuretic or "water pill."

FDA pregnancy category C. It is not known whether corticotropin will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

It is not known whether corticotropin passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Corticotropin can affect growth in children. Talk with your doctor if you think your child is not growing at a normal rate while using this medication.

How is corticotropin given?

Corticotropin is injected into a muscle or under the skin. You may be shown how to use injections at home. Do not self-inject this medicine if you do not understand how to give the injection and properly dispose of used needles and syringes.

Corticotropin is sometimes given daily, or every 2 to 3 days. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

This medicine comes with patient instructions for safe and effective use in treated infantile spasms. If you are the infant's caregiver, follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Your dose needs may change during times of stress, serious illness, surgery or medical emergency. Tell your doctor if any of these situations affect you.

If you use this medication long-term, you may need frequent medical tests, including bone scans to check for osteoporosis.

In some people, corticotropin can trigger an immune response to the medicine, making it less effective. Call your doctor if your condition gets worse or if it seems like this medicine does not work as well.

Use a disposable needle only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.

Store in the refrigerator, do not freeze.

Take the medication out of the refrigerator and allow it to reach room temperature before preparing your dose.

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose of corticotropin.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

An overdose of corticotropin is not expected to produce life threatening symptoms. However, long term use of high steroid doses can lead to symptoms such as thinning skin, easy bruising, changes in the shape or location of body fat (especially in your face, neck, back, and waist), increased acne or facial hair, slow wound healing, menstrual problems, impotence, or loss of interest in sex.

What should I avoid while using Acthar Gel, H.P. (corticotropin)?

Do not receive a "live" vaccine while using corticotropin. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

Acthar Gel, H.P. (corticotropin) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

In some people, corticotropin can trigger an immune response to the medicine, making it less effective. Call your doctor if your condition gets worse or if it seems like this medicine does not work as well.

Call your doctor at once if you have:

  • bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;

  • severe depression, mood changes, sleep problems, unusual thoughts or behavior;

  • blurred vision, tunnel vision, eye pain, or seeing halos around lights;

  • eye swelling, redness, severe discomfort, crusting or drainage;

  • signs of infection--fever, chills, sore throat, flu symptoms, swelling, redness, unusual discharge, mouth sores, skin sores;

  • low potassium--confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling; or

  • dangerously high blood pressure--severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure.

Be sure your family, caregivers, and close friends also know how to help you watch for these side effects.

Common side effects of corticotropin may include:

  • fluid retention (swelling in your hands or feet);

  • mood changes, irritability;

  • increased appetite; or

  • weight gain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

What other drugs will affect Acthar Gel, H.P. (corticotropin)?

Other drugs may interact with corticotropin, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Where can I get more information?

  • Your pharmacist can provide more information about corticotropin.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 2.01. Revision Date: 2014-03-16, 11:22:38 PM.

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