Acthar Gel, H.P.

Acthar Gel, H.P. is a hormone used to treat many inflammatory and immune conditions, such as psoriasis, Stevens-Johnson syndrome, psoriatic or rheumatoid arthritis, ankylosing spondylitis, lupus, polymyositis, severe allergic reactions, symptomatic sarcoidosis, and inflammatory conditions of the eyes.

Acthar Gel, H.P. is also used to treat acute episodes of multiple sclerosis in adults.

Some Acthar Gel, H.P. products are used to treat infantile spasms in children younger than 2 years old. The prefilled injector is not used to treat infantile spasms.

Acthar Gel, H.P. can reduce the symptoms of an illness, but it is not a cure for these conditions.

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

You may get infections more easily. Call your doctor if you have any signs of infection (fever, cough, skin sores, painful urination).

You may not be treated with Acthar Gel, H.P. if you are allergic to it, or if you have:

• a fungal infection that affects your whole body;
• herpes infection of the eyes;
• high blood pressure;
• scleroderma;
• osteoporosis;
• problems with adrenal gland;
• a stomach ulcer;
• congestive heart failure;
• an allergy to pork products; or
• recent surgery.

Acthar Gel, H.P. should not be used in children under 2 years of age if they had certain infections passed from the mother during pregnancy or childbirth.

Acthar Gel, H.P. may make it easier for you to get an infection or worsening an infection you already have. Tell your doctor about any illness or infection you had within the past several weeks.

Tell your doctor if you have or have ever had:

• an active or recent infection (in you or a family member);
• high blood pressure, heart problems;
• a thyroid disorder;
• diabetes;
• seizure (convulsions);
• tuberculosis (or if you have close contact with someone who has tuberculosis);
• a nerve-muscle disorder, such as myasthenia gravis;
• a perforation (a hole or tear) in your esophagus, stomach, or intestines;
• diverticulitis;
• glaucoma or cataracts;
• mental illness or psychosis;
• a stomach or intestinal disorder, stomach bleeding;
• cirrhosis or other liver disease; or
• kidney disease.

Tell your doctor if you or a family member recently received a vaccine or are scheduled to receive a vaccine.

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

Ask a doctor if it is safe to breastfeed while using Acthar Gel, H.P..

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

Get emergency medical help if you have signs of an allergic reaction: hives, difficult 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:

• unusual changes in mood or behavior;
• blurred vision, eye pain or redness, seeing halos around lights;
• a seizure;
• sudden pain or trouble moving your hip, wrist, or back;
• high blood pressure--severe headache, blurred vision, pounding in your neck or ears;
• new or worsening signs of infection--fever, chills, sore throat, body aches, unusual tiredness, loss of appetite, bruising or bleeding;
• decreased or increased adrenal gland hormones--changes in weight or appetite, tiredness, muscle weakness, skin discoloration, thinning skin, increased body hair, menstrual changes, stomach pain;
• new or worsening symptoms of high blood sugar--increased thirst, increased urination, dry mouth, fruity breath odor;
• low blood potassium--leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling;
• fluid retention--shortness of breath (even while lying down), swelling, rapid weight gain (especially in your face and midsection);
• signs of eye infection--swelling, redness, severe discomfort, crusting or drainage; or
• stomach or intestinal problems--fever, severe stomach pain, change in bowel habits, bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds.

Acthar Gel, H.P. can affect growth and appetite. Tell your doctor if you notice changes in weight or appetite, or 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:

• pain, bruising, swelling, or irritation where the medicine was injected;
• high blood sugar levels, seizures (convulsions), increased blood pressure;
• swelling in your hands or feet, puffiness in your face;
• unusual changes in mood or behavior, irritability;
• tiredness, lack of energy, sleep problems (insomnia), headache; or
• fever and infections.

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.

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.

Your doctor will perform tests to make sure Acthar Gel, H.P. is the right treatment for you.

Acthar Gel, H.P. may be injected into a muscle or under the skin, depending on the product prescribed for you. Some prefilled products are for injection under the skin only. A healthcare provider may give you this injection or may teach you how to properly use this medicine by yourself.

The prefilled injector is for adults 18 years and older and is injected under the skin only.

Prepare an injection only when you are ready to give it. Call your pharmacist if the medicine looks cloudy, has changed colors or has particles in it.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you don't understand all instructions.

Your dose needs may change during times of stress, serious illness, surgery or medical emergency. Do not change your dose, dosing schedule, or stop using Acthar Gel, H.P. suddenly without your doctor's advice. Follow your doctor's instructions about tapering your dose.

Dosing for certain indications is based on body surface area (height and weight) in children under 2 years old. Your child's dose may change if the child gains or loses weight or if they are still growing.

Call your doctor if your symptoms do not improve, or if they get worse.

You may need frequent medical tests, and your doctor will need to check your progress on a regular basis.

Store this medicine in the refrigerator. Protect from light, heat and do not freeze. You may store a prefilled injector at room temperature for up to 24 hours. Do not warm the medicine with hot water, sunlight, or a microwave.

Take the prefilled injector out of the refrigerator and let it reach room temperature for 45 minutes before using. Do not leave the medicine out for longer than 24 hours.

Throw away a prefilled injector after one use, even if there is still medicine left inside. Do not reuse a needle or syringe. Place them in a puncture-proof "sharps" container and dispose of it following state or local laws. Keep out of the reach of children and pets.

Call your doctor for instructions if you miss a dose.

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

Some Acthar Gel, H.P. products should not be used with live or live-attenuated vaccines. Do not get a smallpox vaccine while using this medicine. Ask your doctor before getting any other vaccine.

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Tell your doctor about all your other medicines, especially:

• aspirin; or
• a diuretic or "water pill".

This list is not complete. Other drugs may affect Acthar Gel, H.P., including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.