Acthar Gel, H.P. is a hormone that is 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.

Acthar Gel, H.P. is also used to treat infantile spasms in children younger than 2 years old.

Acthar Gel, H.P. can reduce the symptoms of many disorders, but it is not a cure for these conditions. This medicine is also not expected to slow the progress of any disease.

Acthar Gel, H.P. may also be used for purposes not listed in this medication guide.

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

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Acthar Gel, H.P. is injected into a muscle or under the skin. A healthcare provider may teach you how to properly use the medication by yourself.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you don't understand all instructions. Prepare an injection only when you are ready to give it.

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. Do not change your dose or dosing schedule without your doctor's advice.

Acthar Gel, H.P. doses are based on body surface area (height and weight). Your dose needs may change if you gain or lose weight or if you are still growing.

In some people, Acthar Gel, H.P. 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.

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

You should not stop using Acthar Gel, H.P. suddenly. Follow your doctor's instructions about tapering your dose.

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

Use a needle and syringe only once and then place them in a puncture-proof "sharps" container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

You should not use Acthar Gel, H.P. if you are allergic to it, or if you have:

• a fungal infection anywhere in your body;

• herpes infection of the eyes;

• untreated or uncontrolled high blood pressure;

• scleroderma;

• osteoporosis;

• adrenal insufficiency (Addison's disease);

• a past or present stomach ulcer;

• congestive heart failure;

• if you are allergic to pork proteins;

• if you have recently had surgery; or

• if you are scheduled to receive a vaccine.

Acthar Gel, H.P. can worsen an infection you already have, or reactivate an infection you recently had. Before using Acthar Gel, H.P., tell your doctor about any illness or infection you have had within the past several weeks.

Acthar Gel, H.P. should not be used in a child younger than 2 who has an infection that was passed from the mother during pregnancy or childbirth.

Tell your doctor if you have ever had:

• high blood pressure, heart problems;

• liver disease (such as cirrhosis);

• kidney disease;

• a thyroid disorder;

• diabetes;

• tuberculosis;

• a muscle disorder such as myasthenia gravis;

• glaucoma or cataracts;

• depression or mental illness;

• a stomach or intestinal disorder; or

• a condition for which you take a diuretic or "water pill."

Acthar Gel, H.P. may harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

You should not breastfeed while using Acthar Gel, H.P..

Do not give this medicine to a child without medical advice.

Call your doctor for instructions if you miss a dose of Acthar Gel, H.P..

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

Do not receive a "live" vaccine while using Acthar Gel, H.P.. The vaccine may not work as well 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.

Get emergency medical help if you have signs of an allergic reaction: hives; nausea, feeling light-headed; difficulty breathing; swelling of your face, lips, tongue, or throat.

Acthar Gel, H.P. may cause serious side effects. Call your doctor at once if you have:

• fever, chills, sore throat, skin warmth or redness, or other signs of an infection;

• unusual changes in mood or behavior;

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

• a seizure;

• decreased or increased adrenal gland hormones--changes in weight or appetite, tiredness, muscle weakness, skin discoloration, thinning skin, increased body hair, menstrual changes, loss of appetite, stomach pain;

• high blood pressure--severe headache, blurred vision, pounding in your neck or ears;

• high blood sugar--increased thirst, increased urination, dry mouth, fruity breath odor;

• low potassium level--leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling;

• signs of eye infection--swelling, redness, severe discomfort, crusting or drainage; or

• signs of stomach bleeding--bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds.

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

Acthar Gel, H.P. can affect growth in children. Tell your doctor if your child is not growing at a normal rate while using Acthar Gel, H.P..

Common side effects of Acthar Gel, H.P. may include:

• increased blood pressure;

• thinning skin, increased sweating;

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

• 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.

Other drugs may affect Acthar Gel, H.P., including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.