H.P. Acthar

Repository corticotropin injection is used to treat infantile spasms (seizures) in babies and children younger than 2 years of age. It is also used to treat multiple sclerosis in adults.

This medicine is also used to treat joint disorders (e.g., psoriatic arthritis, rheumatoid arthritis, ankylosing spondylitis); autoimmune diseases (e.g., systemic lupus erythematosus or SLE, polymyositis); and certain conditions of the skin (e.g., erythema multiforme, Stevens-Johnson syndrome), eyes (e.g., keratitis, optic neuritis), and lungs (e.g., sarcoidosis). It is also used to treat certain allergies (e.g., serum sickness) and swelling (edema) of the body.

This medicine is available only with your doctor's prescription.

It is very important that your doctor check the progress of you or your child at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for any unwanted effects.

Do not receive live vaccines while you or your child are using this medicine.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

This medicine may increase your risk of developing infections. Avoid being near people who are sick or have infections while you are using this medicine. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.

Using too much of this medicine or using it for a long time may increase your risk of having adrenal gland problems (e.g., Cushing's syndrome). The risk is greater for children and patients who use large amounts for a long time. Talk to your doctor right away if you or your child have more than one of these symptoms while you are using this medicine: blurred vision; dizziness or fainting; a fast, irregular, or pounding heartbeat; fractures; increased thirst or urination; irritability; round or "moon" face, neck, or trunk; stomach pain; thin skin or easy bruising; weight gain or loss; or unusual tiredness or weakness.

This medicine may cause fluid retention (edema) in some patients. Carefully follow your doctor's instructions about any special diet (especially on salt intake).

This medicine may mask or hide symptoms of other diseases while you are using it. Check with your doctor if you or your child have symptoms of infection; black, tarry stools; changes in body weight; difficulty with breathing; fast heart rate; increased thirst; stomach pain; unusual tiredness; or vomiting.

Check with your doctor right away if you start having severe abdominal or stomach burning, cramps, or pains; bloody or black, tarry stools; constipation or diarrhea; heartburn; indigestion; nausea; or vomiting of material that looks like coffee grounds. These could be symptoms of a serious stomach or bowel problem.

This medicine may cause changes in mood and behavior. Check with your doctor if you or your child have trouble sleeping, feeling depressed or irritable, mood swings, or other changes in behavior.

Check with your doctor right away if you or your child have any changes to your eyes, such as redness, itching, swelling, or vision changes while you are using this medicine. Your doctor may want you to have your eyes checked by an eye doctor.

This medicine may decrease bone mineral density when used for a long time. A low bone mineral density can cause slow growth and may lead to osteoporosis at any age. If you have any questions about this ask your doctor.

Do not stop using this medicine suddenly without checking first with your doctor. Your doctor may want you or your child to gradually reduce the amount you are using before stopping it completely.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Backache
• blurred vision
• body aches or pain
• chest pain
• cough
• difficulty with breathing
• dizziness
• ear congestion
• earache
• facial hair growth in females
• fever or chills
• fractures
• full or round face, neck, or trunk
• headache
• increased thirst or urination
• irritability
• loss of sexual desire or ability
• loss of voice
• menstrual irregularities
• muscle wasting
• nasal congestion
• nervousness
• pounding in the ears
• redness or swelling in the ear
• runny nose
• shortness of breath
• slow or fast heartbeat
• sneezing
• sore throat
• tightness in the chest
• troubled breathing
• unusual tiredness or weakness
• wheezing
• white patches in the mouth or throat or on the tongue
• white patches with diaper rash

• Convulsions (seizures)

• Accumulation of pus
• bruising
• bulging soft spot on the head of an infant
• change in the ability to see colors, especially blue or yellow
• cold, clammy skin
• confusion
• decreased range of motion
• decreased urine output
• dilated neck veins
• extreme fatigue
• eyeballs bulge out of eye sockets
• fast, weak pulse
• full or bloated feeling
• heartburn
• insomnia
• irregular breathing
• irregular heartbeat
• joint pain
• large, flat, blue, or purplish patches in the skin
• lightheadedness
• limp
• loss of appetite
• nausea and vomiting
• pressure in the stomach
• severe headache
• small red or purple spots on the skin
• sweating
• swelling of abdominal or stomach area
• swelling of the face, fingers, feet, or lower legs
• swollen, red, or tender area of infection
• trouble healing
• weight gain
• wheezing

• Bloating
• chills
• confusion
• constipation
• coughing up blood
• darkened urine
• fast heartbeat
• fever
• headache
• headache, sudden and severe
• increased sweating
• indigestion
• loss of appetite
• pain in the muscles
• pains in the stomach, side, or abdomen, possibly radiating to the back
• redness of the face
• skin rash
• unusual weight loss
• weakness
• yellow eyes or skin

• Decreased carbohydrate tolerance
• hypokalemic alkalosis
• reversible brain shrinkage

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Blemishes on the skin
• diarrhea
• pimples

• Increased or decreased appetite

• Increased hair growth, especially on the face
• menstrual changes
• muscle weakness

• Feeling of constant movement of self or surroundings
• sensation of spinning
• thinning of the skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.