Ropeginterferon alfa-2b

IMPORTANT WARNING:

Ropeginterferon alfa-2b may cause or worsen mental disorders, which may be serious or life-threatening. Tell your doctor if you have or have ever had mental illness including depression, mood and behavior problems, or thoughts of hurting or killing yourself or others. Your doctor may tell you not to use ropeginterferon alfa-2b injection. If you experience any of the following symptoms, call your doctor immediately: new or worsening depression; thinking about harming or killing yourself, or planning or trying to do so; extreme worry; agitation; panic attacks; difficulty falling asleep or staying asleep; aggressive behavior; irritability; acting without thinking; severe restlessness; or frenzied abnormal excitement.

Ropeginterferon alfa-2b may cause or worsen ischemic disorders (conditions in which there is poor blood supply to an area of the body), which may be serious or life-threatening. Tell your doctor if you have or have ever had atherosclerosis (narrowing of the blood vessels from fatty deposits); angina (chest pain), a heart attack, heart failure, an irregular heartbeat, or other heart problems; high blood pressure; a stroke; or high blood fats (triglycerides). If you experience any of the following symptoms, call your doctor immediately: chest pain or irregular heartbeat.

Ropeginterferon alfa-2b may cause or worsen infections, which may be serious or life-threatening. Tell your doctor if you have an infection or if you have or ever have had HIV (human immunodeficiency virus) or hepatitis B infection. If you experience any of the following symptoms, call your doctor immediately: fever, chills, cough, sore throat, burning and painful urination, or other signs of infection.

Ropeginterferon alfa-2b may cause or worsen autoimmune disorders (conditions in which the immune system attacks one or more parts of the body), which may be serious or life-threatening. Tell your doctor if you have or have ever had an autoimmune disease. Your doctor may tell you not to use ropeginterferon alfa-2b injection. Also, tell your doctor if you have or have ever had diabetes or thyroid problems. If you experience any of the following symptoms, call your doctor immediately: tiredness, urinating more frequently, increased thirst (drinking more than normal), or worsening of an autoimmune disease.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain tests to check your body's response to ropeginterferon alfa-2b- injection.

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

WHY is this medicine prescribed?

Ropeginterferon alfa-2b injection is used to treat polycythemia vera (PV; a slow growing cancer of the blood in which the bone marrow makes too many red blood cells). Ropeginterferon alfa-2b injection is in a class of medications called interferons. It works by blocking the signals that cause cancer cells to multiply.

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?

Ropeginterferon alfa-2b comes as a solution (liquid) in a prefilled syringe to inject subcutaneously (under the skin). It is usually injected once every 2 weeks for at least one year and after that, it may be injected once every 4 weeks. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use ropeginterferon alfa-2b injection exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Your doctor will probably start you on a low dose of ropeginterferon alfa-2b and may gradually increase your dose, not more than once every 2 weeks.

You may receive your first dose of ropeginterferon alfa-2b injection in your doctor's office. After your first dose, your doctor may allow you or a friend or relative to perform the injections at home. Carefully read the manufacturer's instructions for use that comes with the medication. These instructions describe how to inject a dose of ropeginterferon alfa-2b. Be sure to ask your doctor or pharmacist if you have any questions about how to inject the medication.

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

Use a new prefilled syringe each time you inject your medication. Do not reuse or share syringes and needles. Dispose of used syringes and needles 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 ropeginterferon alfa-2b, you will need to remove the medication from the refrigerator, and allow it to rest for around 15 to 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 ropeginterferon alfa-2b solution before injecting it. Check that the expiration date has not passed and that the liquid is clear and colorless to slightly yellow. The liquid should not contain visible particles. Do not use a syringe if it is damaged or broken, expired, or if the liquid is cloudy, discolored, or contains particles.

You can inject ropeginterferon alfa-2b anywhere on the front of your thighs (upper leg) or your lower part of your stomach except your navel (belly button) and the area 2 inches (5 centimeters) around it. 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.

What SPECIAL PRECAUTIONS should I follow?

Before using ropeginterferon alfa-2b injection,

• tell your doctor and pharmacist if you are allergic to ropeginterferon alfa-2b, interferon alfa-2b (Intron A), other alpha interferons, any other medications, polyethylene glycol (PEG), or any of the ingredients in ropeginterferon alfa-2b injecton. Ask your pharmacist or check the Medication Guide for a list of the ingredients.

• tell your doctor and pharmacist what other 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: narcotic medications for pain, sedatives, sleeping pills, and tranquilizers. Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with ropeginterferon alfa-2b, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.

• tell your doctor if you have ever had an organ transplant (surgery to replace a part of the body) or liver disease. Your doctor may tell you not to use ropeginterferon alfa-2b injection.

• tell your doctor if you have or have ever had any of the conditions mentioned in the IMPORTANT WARNING section or any of the following: cancer, anemia (red blood cells do not bring enough oxygen to other parts of the body), bleeding problems, blood clots, colitis or problems with your kidneys, lungs, eyes, or pancreas.

• tell your doctor if you are pregnant or plan to become pregnant. Ropeginterferon alfa-2b may harm the fetus or cause you to miscarry (lose your baby). You will have to take a pregnancy test before starting treatment and use birth control to prevent pregnancy during your treatment with ropeginterferon alfa-2b and for at least 8 weeks after your final dose. Talk to your doctor about using birth control while you are taking this medication.

• tell your doctor if you are breastfeeding. Do not breastfeed during your treatment with ropeginterferon alfa-2b and for 8 weeks after your final dose.

• you should know that ropeginterferon alfa-2b may make you drowsy, dizzy, or confused. Do not drive a car or operate machinery until you know how this medication affects you.

• you should know that ropeginterferon alfa-2b may cause vision problems including vision loss or blindness. Your doctor may tell you to have an eye exam before starting your treatment and during your treatment with ropeginterferon alfa-2b. Call your doctor if your eyes become dry, sensitive to light, if you see halos, or have blurred vision or any other problems with your vision.

• you should know that ropeginterferon alfa-2b may cause tooth and gum problems including loss of teeth. Be sure to brush your teeth and clean your mouth properly while you are receiving ropeginterferon alfa-2b injection. Also, have regular dental exams during your treatment. Tell you doctor if you develop dry mouth during your treatment with ropeginterferon alfa-2b injection.

• you should know that you may have flu-like symptoms such as headache, fever, chills, muscle aches, tiredness, and joint pain during your treatment with ropeginterferon alfa-2b injection. Talk to your doctor if these symptoms are difficult to manage or become severe.

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?

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

• bruising, pain, redness, swelling, itching, or irritation in a place where you injected ropeginterferon alfa-2b.
• hair loss
• rash
• acne
• sweating
• skin redness or thickening
• joint pain
• headache
• diarrhea
• nausea
• difficulty falling asleep or staying asleep
• dizziness
• muscle spasms
• irregular or absent menstrual periods

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

• hives; rash; itching; difficulty breathing or swallowing; swelling of the eyes, face, mouth, lips, tongue or throat; hoarseness; lightheadedness; fainting; or chest pain
• decreased urination; swelling of the feet, ankles, or lower legs; blood in urine
• lower back pain
• fast heartbeat
• shortness of breath
• ongoing pain that begins in the stomach area but may spread to the back nausea, vomiting, or loss of appetite
• yellowing of the skin or eyes, light-colored bowel movements, dark-colored urine, or pain in the upper right part of stomach
• pale skin, weakness, or excessive tiredness
• unusual bleeding or bruising
• bloody diarrhea or bowel movements; stomach pain, tenderness or swelling

Ropeginterferon alfa-2b 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 carton it came in, tightly closed, and out of reach of children. Store it in a refrigerator, but do not freeze it. Keep ropeginterferon alfa-2b injection away from light. 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.

Symptoms of overdose may include:

• flu-like symptoms

What OTHER INFORMATION should I know?

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.