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|Acthar HP Gel

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Acthar HP Gel

Generic Name: Corticotropin Injection Gel (core-tih-koe-TROE-pin)
Brand Name: Acthar HP

Acthar HP Gel is used for:

Diagnosing adrenal gland function and treating low levels of certain hormones (eg, cortisol) in your body. It is also used to treat certain types of thyroid problems, immune system problems (eg, lupus, rheumatoid arthritis), eye problems, lung problems, blood problems, leukemia, fluid retention, and bowel problems (eg, ulcerative colitis). It may also be used for other conditions as determined by your doctor.

Acthar HP Gel is a hormone. It works by stimulating the body to produce more adrenocortical hormones (eg, corticosteroids, glucocorticoids).

Do NOT use Acthar HP Gel if:

you are allergic to any ingredient in Acthar HP Gel or to pork products
you have primary adrenocortical overactivity or underactivity
you have recently had surgery or trauma
you have certain skin problems (scleroderma), osteoporosis (weakened bones), a fungal infection, a herpes infection of the eye, congestive heart failure, high blood pressure, or a history of stomach ulcers
you have recently had or are scheduled to have a smallpox vaccination

Contact your doctor or health care provider right away if any of these apply to you.

Before using Acthar HP Gel:

Some medical conditions may interact with Acthar HP Gel. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding
if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
if you have allergies to medicines, foods, or other substances
if you have diabetes, glaucoma, diarrhea, an underactive thyroid, liver problems, kidney problems, diverticulitis (intestinal problem), myasthenia gravis, high blood sodium levels, low blood potassium levels, or a history of heart problems
if you have measles, tuberculosis (TB), a positive TB skin test, chickenpox, or shingles, or you have recently had or are planning to have a vaccination (especially for smallpox)

Some MEDICINES MAY INTERACT with Acthar HP Gel. Tell your health care provider if you are taking any other medicines, especially any of the following:

Clarithromycin or itraconazole because the side effects of Acthar HP Gel may be increased
Ritodrine because the risk of severe breathing problems (pulmonary edema) may be increased
Aspirin, diuretics (eg, furosemide), or smallpox vaccine because side effects may be increased by Acthar HP Gel
Carbamazepine or live vaccines because effectiveness may be decreased by Acthar HP Gel

This may not be a complete list of all interactions that may occur. Ask your health care provider if Acthar HP Gel may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Acthar HP Gel:

Use Acthar HP Gel as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Acthar HP Gel is usually administered as an injection at your doctor"s office, hospital, or clinic. If you are using Acthar HP Gel at home, carefully follow the injection procedures taught to you by your health care provider.
Check with your doctor before using any medicines that contain aspirin, ibuprofen, or naproxen.
Warm Acthar HP Gel to room temperature before using.
Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor or pharmacist to explain local regulations for proper disposal.
If you miss a dose of Acthar HP Gel, and you are using 1 dose every other day, use the missed dose the following morning. Then skip 1 day and go back to your regular dosing schedule of using a dose every other day. If you miss a dose of Acthar HP Gel, and you are using 1 or more doses each day, use it as soon as possible and go back to your regular dosing schedule.

Ask your health care provider any questions you may have about how to use Acthar HP Gel.

Important safety information:

Acthar HP Gel may lower your body"s ability to fight infection or illnesses, especially if you use it for an extended period of time. Prevent infection by avoiding contact with people with colds or other infections. If you are exposed to chickenpox, measles, or TB while taking Acthar HP Gel or during the 12 months after stopping Acthar HP Gel, call your doctor. Notify your doctor of any signs of infection, including fever, sore throat, pain during urination, muscle aches, rash, or chills for up to 12 months after stopping Acthar HP Gel.
Do not stop using Acthar HP Gel without first checking with your doctor. Serious side effects may occur if you suddenly stop using Acthar HP Gel.
Long-term use of Acthar HP Gel may cause eye problems, such as cataracts, glaucoma, and optic nerve damage. Do not use Acthar HP Gel for longer than prescribed. Contact your doctor immediately if you experience any changes in your vision.
Check with your doctor before having any vaccinations, especially for smallpox, while you are using Acthar HP Gel.
Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Acthar HP Gel.
Diabetes patients - Acthar HP Gel may affect your blood sugar. Check blood sugar levels closely and ask your doctor before adjusting the dose of your diabetes medicine.
LAB TESTS, including blood electrolytes, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
Use Acthar HP Gel with extreme caution in CHILDREN because they may be more sensitive to its effects.
Acthar HP Gel may affect growth rate in CHILDREN and adolescents in some instances. Your child"s growth may need to be checked regularly while using Acthar HP Gel.
PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Acthar HP Gel, discuss with your doctor the benefits and risks of using Acthar HP Gel during pregnancy. It is unknown if Acthar HP Gel is excreted in breast milk. Do not breast-feed while taking Acthar HP Gel.

If you suddenly stop taking Acthar HP Gel, you may experience WITHDRAWAL symptoms, including worsening of symptoms of the problem being treated.

Possible side effects of Acthar HP Gel:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Acne; changes in appetite; constipation; diarrhea; difficulty sleeping; headache; heartburn; nausea; restlessness; sweating; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); changes in mood; changes in vision; fever or chills; muscle pain or weakness; pain, redness, or swelling at the injection site; seizures; slow wound healing; sore throat.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately.

Proper storage of Acthar HP Gel:

Store Acthar HP Gel in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Acthar HP Gel out of the reach of children and away from pets.

General information:

If you have any questions about Acthar HP Gel, please talk with your doctor, pharmacist, or other health care provider.
Acthar HP Gel is to be used only by the patient for whom it is prescribed. Do not share it with other people.
If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Acthar HP Gel. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: November 1, 2006

Database Edition 06.4.1.002

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