Peginterferon Alfa-2b Injection (Sylatron)

IMPORTANT WARNING:

Receiving peginterferon alfa-2b injection may increase the risk that you will develop serious or life-threatening mental health problems, including severe depression that may cause you to think about, plan, or try to harm or kill yourself; psychosis (difficulty thinking clearly, understanding reality, and communicating and behaving appropriately); and encephalopathy (confusion, memory problems, and other difficulties caused by abnormal brain function). Tell your doctor if you have or have ever had a mental health problem and if you have ever thought about harming or killing yourself. If you experience any of the following symptoms, call your doctor immediately: feelings of sadness or hopelessness; thinking about, planning, or trying to kill or harm yourself; aggressive behavior; confusion; memory problems; frenzied, abnormal excitement; or seeing things or hearing voices that do not exist. Be sure that your family or caregiver knows which symptoms may be serious so they can seek treatment if you are unable to call on your own.

Keep all appointments with your doctor. Your doctor will probably want to talk with you about your mental health at least once every 3 weeks at the beginning of your treatment and once every 6 months as your treatment continues. Your doctor may tell you to stop using peginterferon alfa-2b injection if you develop signs of mental illness. However, if you develop mental health problems during your treatment, these problems may not go away when you stop receiving the medication.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with peginterferon alfa-2b 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.

Talk to your doctor about the risks of receiving peginterferon alfa-2b injection.

IMPORTANT NOTICE:

Peginterferon alfa-2b injection is also available as a different product (PEG-Intron) that is used to treat chronic hepatitis C (swelling of the liver caused by a virus). This monograph only gives information about peginterferon alfa-2b injection (Sylatron) that is used to decrease the chance that malignant melanoma will return after surgery to remove it. If you are using Peg-Intron, read the monograph entitled Peginterferon alfa-2b (PEG-Intron) to learn about that product.

WHY is this medicine prescribed?

Peginterferon alfa-2b injection is used in people with malignant melanoma (a life-threatening cancer that begins in certain skin cells) who have had surgery to remove the cancer. This medication is used to reduce the chance that malignant melanoma will come back and must be started within 84 days of the surgery. Peginterferon alfa-2b injection is in a class of medications called interferons. It works by stopping the growth of cancer cells to reduce the chance of malignant melanoma coming back.

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 alfa-2b injection comes as a powder to mix with a provided liquid and inject subcutaneously (under the skin). It is usually injected once a week for up to 5 years. Inject peginterferon alfa-2b injection on the same day every week. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use peginterferon alfa-2b 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 higher dose of peginterferon alfa-2b injection and decrease your dose after 8 weeks. Your doctor may also decrease your dose or tell you to stop using peginterferon alfa-2b injection temporarily or permanently if you develop serious side effects.

Continue to use peginterferon alfa-2b injection even if you feel well. Do not stop using peginterferon alfa-2b injection without talking to your doctor.

You may inject peginterferon alfa-2b yourself or have a friend or relative give the injections. You and the person who will be injecting the medication should read the manufacturer's directions for mixing and injecting the medication before you use it for the first time at home. Ask your doctor to show you or the person who will be injecting peginterferon alfa-2b how to mix and inject it.

Peginterferon alfa-2b comes in a kit that includes the syringes needed to mix and inject the medication. Do not use any other type of syringe to mix or inject your medication. Do not share or reuse the syringes that come with your medication. Dispose of needles, syringes, and vials in a puncture-resistant container after you use them once. Ask your doctor or pharmacist how to dispose of the puncture-resistant container.

Look at the vial of peginterferon alfa-2b before you prepare your dose. Check that it is labeled with the correct name and strength of medication and an expiration date that has not passed. The medication in the vial may look like a white or off-white tablet, or the tablet may be broken into pieces or powder. If you do not have the right medication, your medication is expired, or it does not look as it should, call your pharmacist and do not use that vial.

You should only mix one vial of peginterferon alfa-2b at a time. It is best to mix the medication right before you plan to inject it. However, you may mix the medication in advance, store it in the refrigerator, and use within 24 hours. If you need to refrigerate your medication, be sure to take it out of the refrigerator and allow it to come to room temperature before you inject it.

You can inject anywhere on your thighs, the outer surface of your upper arms, or your stomach except for the area around your naval or waistline. If you are very thin, you should not inject the medication in your stomach area. Choose a new spot each time you inject your medication. Do not inject into any area that is irritated, red, bruised, or infected or that has scars, lumps, or stretch marks.

You may experience flu-like symptoms such as fever, chills, muscle aches, joint pain, tiredness, and headache after you inject peginterferon alfa-2b injection. Your doctor will probably tell you to take acetaminophen (Tylenol) 30 minutes before you inject your first dose and possibly before you inject your next doses of peginterferon alfa-2b injection. Injecting your medication at bedtime may also help reduce these symptoms. Be sure to drink plenty of fluids if you experience flu-like symptoms.

What SPECIAL PRECAUTIONS should I follow?

Before injecting peginterferon alfa-2b injection,

• tell your doctor and pharmacist if you are allergic to peginterferon alfa-2b injection (PegIntron, Sylatron), interferon alfa-2b (Intron), any other medications, or any of the ingredients in peginterferon alfa-2b injection. 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, and herbal products you are taking or plan to take. Be sure to mention any of the following: amitriptyline, aripiprazole (Abilify), celecoxib (Celebrex), clomipramine (Anafranil), codeine, desipramine (Norpramin), dextromethorphan (in cough and cold medications, in Nuedexta), diclofenac ( Cambia, Cataflam, Flector, Voltaren, others), duloxetine (Cymbalta), flecainide (Tambocor), fluvastatin (Lescol), glipizide (Glucotrol), haloperidol (Haldol), ibuprofen (Motrin), imipramine (Tofranil), irbesartan (Avapro), losartan (Cozaar), mexiletine, naproxen (Anaprox, Naprosyn), ondansetron (Zofran), paroxetine (Paxil, Pexeva), phenytoin (Dilantin), piroxicam (Feldene), propafenone (Rhythmol), risperidone (Risperdal), rosiglitazone (Avandia), sulfamethoxazole (in Bactrim, in Septra), tamoxifen, thioridazine, timolol, tolbutamide, torsemide, tramadol (Conzip, Ultram, Ryzolt), venlafaxine (Effexor), and warfarin (Coumadin, Jantoven). 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 autoimmune hepatitis (condition in which the cells of the immune system attack the liver) or liver damage caused by a medication or an illness. Your doctor may tell you not to use peginterferon alfa-2b injection.

• tell your doctor if you have ever used street drugs or over-used prescription medications and if you have or have ever had retinopathy (damage to the eyes caused by diabetes or other conditions), diabetes, or thyroid disease.

• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking peginterferon alfa-2b 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?

Ask your doctor what you should do if you miss a dose. Do not inject a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Peginterferon alfa-2b injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• dizziness
• diarrhea
• nausea
• vomiting
• problems with taste or smell
• loss of appetite
• numbness, burning, or tingling of the arms, hands, legs, or feet
• cough
• rash
• hair loss

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately or get emergency medical treatment:

• fast or irregular heartbeat
• chest pain
• difficulty breathing
• yellowing of the skin or eyes
• swelling of the stomach
• difficulty concentrating
• feeling cold or hot all the time
• weight gain or loss
• increased thirst
• increased urination
• fruity breath
• decreased or blurred vision

Peginterferon alfa-2b injection may cause other side effects. Call your doctor if you have any unusual problems while taking 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 unmixed vials of medication at room temperature and away from excess heat and moisture (not in the bathroom). Store medication that has been mixed in the refrigerator and use within 24 hours. Do not allow the medication to freeze.

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.

Symptoms of overdose may include:

• extreme tiredness
• headache
• muscle pain
• sore throat, fever, chills, and other signs of infection
• unusual bruising or bleeding

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests before and during 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.