Corticotropin, Repository Injection

WHY is this medicine prescribed?

Corticotropin repository injection is used to treat the following conditions:

• infantile spasms (seizures that usually begin during the first year of life and may be followed by developmental delays) in infants and children younger than 2 years of age;
• episodes of symptoms in people who have multiple sclerosis (MS; a disease in which the nerves do not function properly and people may experience weakness, numbness, loss of muscle coordination, and problems with vision, speech, and bladder control);
• episodes of symptoms in people who have rheumatoid arthritis (a condition in which the body attacks its own joints, causing pain, swelling, and loss of function);
• episodes of symptoms in people who have psoriatic arthritis (a condition that causes joint pain and swelling and scales on the skin);
• episodes of symptoms in people who have ankylosing spondylitis (a condition in which the body attacks the joints of the spine and other areas, causing pain and joint damage);
• lupus (a condition in which the body attacks many of its own organs);
• systemic dermatomyositis (condition that causes muscle weakness and skin rash) or polymyositis (condition that causes muscle weakness but not skin rash);
• serious allergic reactions that affect the skin including Stevens-Johnson syndrome (a severe allergic reaction that may cause the top layer of skin to blister and shed);
• serum sickness (a serious allergic reaction that occurs several days after taking certain medications and causes skin rash, fever, joint pain, and other symptoms);
• allergic reactions or other conditions that cause swelling of the eyes and the area around them;
• sarcoidosis (condition in which small clumps of immune cells form in various organs such as the lungs, eyes, skin, and heart and interfere with the function of these organs);
• nephrotic syndrome (a group of symptoms including protein in the urine; low levels of protein in the blood; high levels of certain fats in the blood; and swelling of the arms, hands, feet, and legs).

Corticotropin repository injection is in a class of medications called hormones. It treats many conditions by decreasing the activity of the immune system so that it will not cause damage to the organs. There is not enough information to tell how corticotropin repository injection works to treat infantile spasms.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Corticotropin repository injection comes as a long acting gel to inject subcutaneously (under the skin) or intramuscularly (into a muscle). When corticotropin repository injection is used to treat infantile spasms, it is usually injected into a muscle twice a day for two weeks and then injected on a gradually decreasing schedule for another two weeks. When corticotropin repository injection is used to treat multiple sclerosis, it is usually injected once a day for 2 to 3 weeks, and then the dose is gradually decreased. When corticotropin repository injection is used to treat other conditions, it is injected once every 24 to 72 hours, depending on the condition being treated and how well the medication works to treat the condition. Inject corticotropin repository injection at around the same time(s) of day on every day that you are told to inject it. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use corticotropin repository injection exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

Continue to use corticotropin repository injection as long as it has been prescribed by your doctor. Do not stop using corticotropin repository injection without talking to your doctor. If you suddenly stop using corticotropin repository injection, you may experience symptoms such as weakness, tiredness, pale skin, changes in skin color, weight loss, stomach pain, and loss of appetite. Your doctor will probably decrease your dose gradually.

You can inject corticotropin repository injection yourself or have a relative or friend inject the medication. You or the person who will be performing the injections should read the manufacturer's directions for injecting the medication before you inject it for the first time at home. Your doctor will show you or the person who will be injecting the medication how to perform the injections, or your doctor can arrange for a nurse to come to your home to show you how to inject the medication.

Corticotropin repository injection comes as a vial where you will use a syringe to withdraw the prescribed dose before injecting or as an autoinjector (prefilled syringe).Ask your doctor which type of needle and syringe you should use to inject corticotropin repository injection from the vial. Do not share needles or syringes or use them more than once. Dispose of used needles and syringes in a puncture-proof container. Ask your doctor or pharmacist how to dispose of the puncture-proof container.

If you are injecting corticotropin repository injection under your skin, you can inject it anywhere in your upper thigh, upper arm, or stomach area except for your navel (belly button) and the 1 inch area around it. If you are injecting corticotropin repository injection into a muscle, you can inject it anywhere on your upper arm or upper outer thigh. If you are giving the injection to a baby you should inject it into the upper outer thigh. Choose a new spot at least 1 inch away from a spot where you have already injected the medication each time you inject it. Do not inject the medication into any area that is red, swollen, painful, hard, or sensitive, or that has tattoos, warts, scars, or birthmarks. Do not inject the medication into your knee or groin areas.

If using the vial to inject your corticotropin repository injection, follow these directions to give the dose:

• Look at the vial of corticotropin repository injection before you prepare your dose. Be sure that the vial is labeled with the correct name of the medication and an expiration date that has not passed.
• The medication in the vial should be clear and colorless and should not be cloudy or contain flecks or particles. If you do not have the right medication, if your medication is expired, or if it does not look as it should, call your pharmacist and do not use that vial.
• Allow your medication to warm to room temperature before you inject it. You can warm the medication by rolling the vial between your hands or holding it under your arm for a few minutes.

If using the autoinjector to administer corticotropin repository injection, remove the autoinjector from the refrigerator and allow to warm to room temperature for 45 minutes before injecting. Corticotropin repository autoinjector is only for subcutaneous injection. Rotate area or site for each injection and do not use the same site more than one time per week.

Read the directions that come with the autoinjector and make sure you understand how to inject it.

If you are giving corticotropin repository injection to your child, you can hold your child on your lap or have your child lie flat while you are giving the injection. You may find it helpful to have someone else hold the child in position or distract the child with a noisy toy while you are injecting the medication. You can help decrease your child's pain by placing an ice cube on the spot where you will inject the medication before or after the injection.

If you are giving corticotropin repository injection to your child to treat infantile spasms, your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when your child begins treatment with corticotropin repository injection and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.

What SPECIAL PRECAUTIONS should I follow?

Before using corticotropin repository injection,

• tell your doctor and pharmacist if you are allergic to corticotropin repository injection, any other medications, any of the ingredients in corticotropin repository injection, or porcine (pig) proteins. Ask your pharmacist or check the Medication Guide for a list of the ingredients.

• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, or herbal products you are taking or plan to take while receiving corticotropin repository injection. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you have scleroderma (abnormal growth of connective tissue which may cause tightening and thickening of the skin and damage to the blood vessels and internal organs), osteoporosis (condition in which the bones become thin and weak and break easily), a fungal infection that has spread through your body, a herpes infection in your eye, heart failure, high blood pressure, or any condition that affects the way your adrenal glands (small glands next to the kidneys) work. Also tell your doctor if you have recently had surgery and if you have or have ever had a stomach ulcer. If you will be giving corticotropin repository injection to your baby, tell your doctor if your baby had an infection before or during his or her birth. Your doctor may tell you not to use corticotropin repository injection or give it to your child if you or your child have any of these conditions.

• tell your doctor if you know that you have any type of infection, if you have a fever, cough, vomiting, diarrhea, flu-symptoms, or any other signs of infection, or if you have a family member who has an infection or signs of infection. Also tell your doctor if you have tuberculosis (TB; a severe lung infection), if you know that you have been exposed to TB, or if you have ever had a positive skin test for TB. Also tell your doctor if you have or have ever had diabetes, an underactive thyroid gland, conditions that affect your nerves or muscles such as myasthenia gravis (MG; a condition that causes weakness of certain muscles), problems with your stomach or intestines, emotional problems, psychosis (difficulty recognizing reality), or liver or kidney disease.

• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using corticotropin repository injection, call your doctor.

• do not have any vaccinations without talking to your doctor. Also tell your doctor if any members of your family are scheduled to receive vaccinations during your treatment.

• you should know that your blood pressure may increase during your treatment with corticotropin repository injection. Your doctor will check your blood pressure regularly during your treatment.

• you should know that using corticotropin repository injection may increase the risk that you will get an infection. Be sure to wash your hands often and stay away from people who are sick during your treatment.

What SPECIAL DIETARY instructions should I follow?

Your doctor may tell you to follow a low sodium or high potassium diet. Your doctor may also tell you to take a potassium supplement during your treatment. Ask your doctor for more information.

What should I do IF I FORGET to take a dose?

Inject the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not inject a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Corticotropin repository injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• increased or decreased appetite
• weight gain
• irritability
• changes in mood or personality
• abnormally happy or excited mood
• difficulty falling asleep or staying asleep

Some side effects can be serious. If you experience any of these symptoms during or after your treatment, call your doctor immediately or get emergency medical treatment:

• sore throat, fever, cough, vomiting, diarrhea, or other signs of infection
• open cuts or sores
• puffiness or fullness of the face
• increased fat around the neck, but not the arms or legs
• thin skin
• stretch marks on the skin of the abdomen, thighs, and breasts
• easy bruising
• muscle weakness
• stomach pain
• vomit that is bloody or looks like coffee grounds
• bright red blood in stools
• black or tarry stools
• depression
• difficulty recognizing reality
• vision problems
• excessive tiredness
• increased thirst
• fast heartbeat
• rash
• swelling of the face, tongue, lips, or throat
• difficulty breathing
• new or different seizures

Corticotropin repository injection may slow growth and development in children. Your child's doctor will watch his or her growth carefully. Talk to your doctor about the risks of giving this medication to your child.

Using corticotropin repository injection may increase the risk that you will develop osteoporosis. Your doctor may order tests to check your bone density during your treatment. Talk to your doctor about the risks of using this medication and about things you can do to decrease the chance that you will develop osteoporosis.

Corticotropin repository injection may cause other side effects. Call your doctor if you have any unusual problems while using this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it in the refrigerator.

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor. Your doctor will monitor your health closely during and after your treatment.

Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.