Peginterferon Beta-1a Injection

WHY is this medicine prescribed?

Peginterferon beta-1a injection is used to treat adults with various forms of 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) including the following:

• clinically isolated syndrome (CIS; nerve symptom episodes that last at least 24 hours),
• relapsing-remitting forms (course of disease where symptoms flare up from time to time), or
• secondary progressive forms (course of disease where relapses occur more often).

Peginterferon beta-1a injection is in a class of medications called immunomodulators. It works by decreasing inflammation and preventing nerve damage that may cause symptoms of multiple sclerosis.

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?

Peginterferon beta-1a injection comes as a solution (liquid) in a dosing pen or a prefilled syringe to inject subcutaneously (under the skin) or intramuscularly (into the muscle) in a prefilled syringe. It is usually injected once every 14 days. Inject peginterferon beta-1a injection at around the same time of day each time you 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 peginterferon beta-1a injection exactly as directed. Do not inject more or less of it or inject it more often than prescribed by your doctor.

Your doctor will probably start you on a low dose of peginterferon beta-1a injection for the first two doses so that your body can adjust to the medication.

Your doctor may decide that you or a friend or relative can perform the injections at home. Your doctor will show you or the person who will be injecting the medication how to inject it. Carefully read the manufacturer's instructions for use that come with the medication. These instructions describe how to inject a dose of peginterferon beta-1a. Be sure to ask your doctor or pharmacist if you have any questions about how to inject the medication.

Peginterferon beta-1a injection may help to control multiple sclerosis but does not cure it. Continue to use peginterferon beta-1a injection even if you feel well. Do not stop using peginterferon beta-1a injection without talking to your doctor.

Use a new prefilled syringe or dosing pen each time you inject your medication. Do not reuse or share syringes or pens. Dispose of used syringes or pens in a puncture resistant container that is out of the reach of children. Talk to your doctor or pharmacist about how to dispose of the puncture-resistant container.

Before you are ready to inject peginterferon beta-1a, you will need to remove the medication from the refrigerator, and allow it to rest for around 30 minutes so that it can warm to room temperature. Do not try to warm the medication by heating it in a microwave, placing it in hot water, or through any other method.

Always look at the medication in your prefilled syringe or pen before you use it. Prefilled syringes and dosing pens for subcutaneous injection should be clear and colorless but may have small air bubbles. Prefilled syringes for intramuscular injection should be clear and colorless to pale yellow. If the medication is cloudy, colored, or contains particles or if the expiration date marked on the pen or syringe has passed, do not use that pen or syringe. If you are using a pen, also check to be sure that there are green stripes in the injection status window. Do not use the pen if it does not have green stripes in the injection status window.

If injecting peginterferon beta-1a subcutaneously, you can inject anywhere on your stomach, the back of your upper arms, or your thighs. If injecting peginterferon beta-1a intramuscularly, you can inject anywhere on your thighs. Choose a different spot each time you inject your medication. Do not inject your medication into skin that is irritated, bruised, reddened, infected, or scarred.

You may experience flu-like symptoms such as headaches, bone or muscle aches, fever, chills, and tiredness during your treatment with peginterferon beta-1a. You should drink plenty of water during your treatment to help prevent or control these symptoms. Your doctor may tell you to take a nonprescription medication that relieves pain and prevents fever before or after you inject your medication to help treat or prevent these symptoms. Talk to your doctor about which other medication(s) you should take during your treatment.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with peginterferon beta-1a 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 injecting peginterferon beta-1a injection,

• tell your doctor and pharmacist if you are allergic to peginterferon beta-1a injection, other interferon beta medications (Avonex, Betaseron, Extavia, Rebif), any other medications, or any of the ingredients in peginterferon beta-1a injection. Ask your pharmacist or check the Medication Guide for a list of the ingredients. Also tell your doctor if you or the person who will be helping you inject peginterferon beta-1a injection is allergic to latex or rubber.

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

• tell your doctor if you have or have ever had seizures; a mental illness such as depression, especially if you have ever thought about killing yourself or tried to do so; bleeding problems; low numbers of any type of blood cell; an autoimmune disease (condition in which the body attacks its own organs, causing swelling and loss of function); or heart, liver, thyroid, or kidney disease.

• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking peginterferon beta-1a injection, call your doctor.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

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

Call your doctor if you forget to inject a dose of this medication. Your doctor will tell you when to inject the missed dose and when to inject your next scheduled dose. Do not inject a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Peginterferon beta-1a injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• headache
• muscle or joint pain
• fever
• chills
• weakness

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

• yellowing of the skin or eyes
• dark urine
• pale stool
• nausea
• vomiting
• loss of appetite
• unusual bruising or bleeding
• excessive tiredness
• confusion
• irritability
• nervousness
• feeling hopeless or bad about yourself
• thinking about harming or killing yourself or planning or trying to do so
• seizures
• shortness of breath
• swelling of the feet, ankles, or lower legs
• pale skin
• fast or abnormal heartbeat
• chest pain
• rash
• hives
• itching
• swelling of the eyes, face, mouth, tongue, throat, hands, or arms
• hoarseness
• difficulty breathing or swallowing
• redness, warmth, swelling, pain, or infection in the place where you injected the medication that does not heal within a few days
• red or bloody stools or diarrhea
• stomach pain
• slow or difficult speech
• purple patches or pinpoint dots (rash) on the skin
• decreased urination or blood in the urine

Peginterferon beta-1a injection may cause other side effects. Call your doctor if you have any unusual problems while receiving 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 carton it came in, tightly closed, and out of reach of children. Store it in a refrigerator, but do not freeze it. If you cannot keep the medication in a refrigerator, you may store it at room temperature, away from heat, light, and moisture for up to 30 days. Dispose of any medication that has been frozen or that is outdated or no longer needed.

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

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.

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 and the laboratory. Your doctor will order certain lab tests to check your body's response to peginterferon beta-1a injection.

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.