Corticotropin, ACTH Gel for Injection

What is this medication?

CORTICOTROPIN (kor ti koh TROH pen) is used in children and infants less than 2 years old to treat infantile spasms. It may also be used to treat inflammation of the skin, joints, lungs, and other organs.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Acthar, CORTROPHIN, H.P. Acthar

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Cushing's syndrome
• diabetes
• heart disease
• high blood pressure
• infection especially a viral infection such as chickenpox, cold sores, or herpes
• kidney disease
• mental health disease
• myasthenia gravis
• osteoporosis, weak bones
• recent or upcoming vaccine
• recent surgery
• seizures
• stomach ulcer or intestine disease including colitis and diverticulitis
• thyroid problem
• an unusual or allergic reaction to corticotropin, corticosteroids, pork proteins, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

This medicine is injected under the skin or into a muscle. You will be taught how to prepare and give it. Take it as directed on the prescription label. Keep taking it unless your health care provider tells you to stop.

It is important that you put your used needles and syringes in a special sharps container. Do not put them in a trash can. If you do not have a sharps container, call your pharmacist or health care provider to get one.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

This medicine comes with INSTRUCTIONS FOR USE. Ask your pharmacist for directions on how to use this medicine. Read the information carefully. Talk to your pharmacist or health care provider if you have questions.

Talk to your pediatrician regarding the use of this medicine in children. While this medicine may be prescribed for children as young as infants for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

• diuretics
• vaccines

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your health care provider for regular checks on your progress. Tell your health care provider if your symptoms do not start to get better or if they get worse.

If you are taking this medicine for a long time, carry an identification card with your name, address, the type and dose of your medicine, and your doctor's name and address.

This medicine may increase your risk of getting an infection. Call your health care provider for advice if you get a fever, chills, sore throat, or other symptoms of a cold or flu. Do not treat yourself. Try to avoid being around people who are sick. If you have not had the measles or chickenpox vaccines, tell your health care provider right away if you are around someone with these viruses.

This medicine can decrease the response to a vaccine. If you need to get vaccinated, tell your health care provider that you are taking this medicine.

If you are going to have surgery, tell your doctor or health care professional that you have received this medicine within the last 12 months.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• bloody or black, tarry stool
• changes in emotions or moods
• eye pain
• high blood sugar (increased hunger, thirst or urination; unusually weak or tired, blurry vision)
• increased blood pressure
• infection (fever, chills, cough, sore throat, pain or trouble passing urine)
• slow growth in children (if used for longer periods of time)
• swelling of ankles, feet
• stomach pain
• trouble breathing
• unusually weak or tired
• weak bones (if used for longer periods of time)

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• acne
• change in appetite
• irritable
• weight gain

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store in a refrigerator between 2 and 8 degrees C (36 and 46 degrees F). Get rid of any unused medicine after the expiration date.

To get rid of medicines that are no longer needed or have expired:

• Take the medicine to a medicine take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medicine, ask your pharmacist or health care provider how to get rid of this medicine safely.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.