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.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of repository corticotropin injection to treat infantile spasms in babies and children younger than 2 years of age.

Geriatric

No information is available on the relationship of age to the effects of repository corticotropin injection in geriatric patients.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Rotavirus Vaccine, Live

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Bupropion

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Licorice
• Saiboku-To

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Adrenal problems or
• Allergy to pork proteins, history of or
• Congenital (inborn) infections or
• Congestive heart failure or
• Fungus infections, systemic or
• Herpes simplex of the eye or
• Hypertension (high blood pressure), uncontrolled or
• Osteoporosis (thinning of the bones) or
• Peptic ulcer, or history of or
• Scleroderma (autoimmune disease) or
• Surgery, recent—Should not be used in patients with these conditions.

• Cataracts or
• Cirrhosis (liver problem) or
• Cushing's syndrome (adrenal gland disorder) or
• Depression, history of or
• Diabetes or
• Edema (fluid retention or swelling) or
• Emotional problems or
• Eye infections (fungus, virus) or
• Glaucoma or
• Hypertension (high blood pressure), controlled or
• Hypokalemia (low potassium in the blood) or
• Hypothyroidism (underactive thyroid) or
• Kidney disease, severe or
• Mental illness (e.g., psychosis) or
• Myasthenia gravis (severe muscle weakness) or
• Stomach problems (ulcer, bleeding, or perforation) or
• Tuberculosis, latent—Use with caution. May make these conditions worse.

• Infection (bacteria, virus, parasite, or protozoa)—May decrease your body's ability to fight infection.

• Lennox-Gastaut syndrome—May cause this condition to occur while using this medicine to treat infantile spasms.

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.

Applies to corticotropin: injection gel/jelly

Along with its needed effects, corticotropin (the active ingredient contained in Acthar) 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 while taking corticotropin:

• 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 of corticotropin 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

Acute exacerbations of Multiple Sclerosis: 80 to 120 units daily intramuscularly or subcutaneously for 2 to 3 weeks.

Other indications for Adults and Children over 2 years of age: 40-80 units given intramuscularly or subcutaneously every 24 to 72 hours.

Other indications for Adults and Children over 2 years of age: 40-80 units given intramuscularly or subcutaneously every 24 to 72 hours.

Other indications for Adults and Children over 2 years of age: 40-80 units given intramuscularly or subcutaneously every 24 to 72 hours.

Corticotropin is contraindicated for intravenous administration.

Corticotropin is contraindicated in infants with congenital infections.

Live or live attenuated vaccines are contraindicated in patients receiving corticotropin.

Corticotropin is contraindicated in patients with scleroderma, osteoporosis, systemic fungal infections, ocular herpes simplex, recent surgery, history or presence of peptic ulcer, congestive heart failure, uncontrolled hypertension, primary adrenocortical insufficiency, adrenocortical hyperfunction, or sensitivity to proteins of porcine origin.

Corticotropin can increase the risks related to infection. Patients with latent tuberculosis or tuberculin reactivity should be closely monitored.

Monitor for signs and symptoms of hypothalamic-pituitary-axis (HPA) and Cushing's syndrome.

After stopping corticotropin, monitor for signs of adrenal insufficiency. Since these symptoms can be difficult to identify in infants, parents and caregivers should be instructed to monitor for and recognize them. Tapering the dose of corticotropin when discontinuing treatment can minimize adrenal insufficiency.

Corticotropin can increase blood pressure, salt and water retention, and the excretion of potassium and calcium. Monitor patients with hypertension, congestive heart failure, or renal insufficiency.

Monitor patients during and for a period following corticotropin therapy for signs of infection, abnormal cardiac function, hypertension, hyperglycemia, change in body weight and fecal blood loss.

Prolonged corticotropin therapy can have negative effects on growth and physical development in children that should be monitored.

Bone density should be monitored during long term therapy.

Sudden discontinuation of corticotropin can lead to adrenal insufficiency or recurrent symptoms, therefore consider tapering the dose and increasing the injection interval to gradually discontinue.

Safety and effectiveness have not been established in pediatric patients (less than 18 years of age).