Acthar 80 unit/mL injection gel

Generic name:
Corticotropin - injection

Pronunciation
(KOR-ti-koe-TROE-pin)

Brand name(s)
Acthar

This medication is used to treat a certain type of seizure in children (infantile spasms). This medication is also used to treat conditions such as multiple sclerosis, arthritis, lupus, eye conditions, skin/kidney/lung diseases, and immune system disorders. It decreases your immune system's response to various diseases to reduce symptoms such as swelling, pain, and allergic-type reactions. Corticotropin is a hormone.

If you are using this medication to treat infantile spasms, read the Medication Guide provided by your pharmacist before you start using corticotropin and each time you get a refill. If you are using the pre-filled injector, read the Instructions for Use if available from your pharmacist. Ask your health care professional how to prepare and use this medication. If you have any questions, ask your doctor or pharmacist.

Inject this medication into a muscle or under the skin as directed by your doctor. For infantile spasms, this medication should be given by injection into a muscle. If you are using the pre-filled injector, it should only be injected under the skin. The dosage is based on your body size, medical condition, and response to treatment. Do not increase your dose or use this drug more often than prescribed without consulting your doctor. Your condition will not improve any faster, and your risk of side effects will increase.

Before use, take this medication out of the refrigerator. If you are using the vials, roll the vial in your hands for a few minutes. If you are using the pre-filled injector, let it warm up to room temperature for 45 minutes. Do not warm up this medication any other way (for example, do not heat it in the microwave, place it in hot water, or leave it in direct sunlight). Before using, check this product for particles or discoloration. If either is present, do not use the liquid. Before injecting each dose, clean the skin you are going to inject into (the injection site) with rubbing alcohol. Change the injection site each time to lessen injury under the skin. To lessen bruising, do not rub the injection site after a shot. Learn how to store and discard medical supplies safely.

Do not stop using this medication without consulting your doctor. Some conditions may become worse when this drug is suddenly stopped. Your dose may need to be gradually decreased.

Use this medication regularly to get the most benefit from it. To help you remember, use it at the same time(s) each day.

Tell your doctor if your condition gets worse.

Vomiting, diarrhea, trouble sleeping, appetite changes, or pain/redness/swelling at the injection site may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication may rarely make your blood sugar rise, which can cause or worsen diabetes. Tell your doctor right away if you have symptoms of high blood sugar, such as increased thirst/urination. If you already have diabetes, check your blood sugar regularly as directed and share the results with your doctor. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

This medication may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Tell your doctor right away if you have any signs of infection (such as fever, chills, sore throat that doesn't go away, cough, white patches in the mouth).

This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high.

Tell your doctor right away if you have any serious side effects, including:

• weakness
• puffy face
• unusual weight gain
• slow wound healing
• thinning skin
• bone pain
• menstrual period changes
• mental/mood changes (such as mood swings, depression, agitation)
• easy bruising/bleeding
• increased thirst/urination
• vision problems
• swelling ankles/feet/hands
• fast/slow/irregular heartbeat

This drug may rarely cause serious (rarely fatal) bleeding from the stomach or intestines. If you notice any of the following unlikely but serious side effects, get medical help right away:

• stomach/abdominal pain that doesn't go away
• black stools
• vomit that looks like coffee grounds

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using corticotropin, tell your doctor or pharmacist if you are allergic to it; or to pork products; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• adrenal gland problems
• brittle bones (osteoporosis)
• current/ past infections (such as those caused by tuberculosis, threadworm, herpes, fungus)
• stomach/intestinal problems (such as diverticulitis, ulcer, ulcerative colitis)
• heart problems (such as heart failure, recent heart attack)
• high blood pressure
• eye diseases (such as cataracts, glaucoma, herpes infection of the eye)
• diabetes
• kidney disease
• liver disease
• mental/mood conditions (such as psychosis, anxiety, depression)
• a certain skin/connective tissue disease (scleroderma)
• thyroid problems

This medication may cause stomach bleeding. Daily use of alcohol while using this medication may increase your risk for stomach bleeding. Limit alcoholic beverages. Consult your doctor or pharmacist for more information.

Corticotropin can make you more likely to get infections or may make current infections worse. Stay away from anyone who has an infection that may easily spread (such as chickenpox, COVID-19, measles, flu). Talk to your doctor if you have been exposed to an infection or for more details.

Tell your health care professional that you are using corticotropin before having any immunizations, vaccinations, or skin tests. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

Using this medication for a long time can make it more difficult for your body to respond to physical stress. Before having surgery or emergency treatment, or if you get a serious illness/injury, tell your doctor or dentist that you are using this medication or have used this medication within the past 12 months. Tell your doctor right away if you develop unusual/extreme tiredness or weight loss. If you will be using this medication for a long time, carry a warning card or medical ID bracelet that identifies your use of this medication.

Older adults may be more sensitive to the side effects of this drug, especially brittle bones (osteoporosis). Talk to your doctor about ways to prevent osteoporosis. See also Notes section.

This medication may slow down a child's growth if used for a long time. Consult the doctor or pharmacist for more details. See the doctor regularly so your child's height and growth can be checked.

During pregnancy, this medication should be used only when clearly needed. It may rarely harm an unborn baby. Discuss the risks and benefits with your doctor. Infants born to mothers who use this medication for a long time during pregnancy may have hormone problems. Tell your doctor right away if you notice symptoms such as nausea/vomiting that doesn't stop, severe diarrhea, or weakness in your newborn.

It is unknown if this medication passes into breast milk. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Do not share this medication with others.

Lab and/or medical tests (such as blood sugar/mineral levels, blood pressure, eye exams, bone density tests, height/weight measurements) should be done while you are using this medication. Consult your doctor for more details.

Lifestyle changes that help reduce the risk of bone loss (osteoporosis) during long-term treatment include increasing weight-bearing exercise, stopping smoking, limiting alcohol, and eating well-balanced meals that contain adequate calcium and vitamin D. Consult your doctor for specific advice.

It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule. Do not double the dose to catch up.

Store in the refrigerator. Different brands of this medication have different storage needs. Check the product package for instructions on how to store your brand, or ask your pharmacist. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.