Methoxy Polyethylene Glycol-Epoetin Beta Injection

IMPORTANT WARNING:

Chronic kidney disease patients:

Using methoxy polyethylene glycol-epoetin beta injection may increase the risk that blood clots will form in or move to the legs and lungs. Tell your doctor if you have or have ever had heart disease, a stroke, a deep venous thrombosis (DVT; blood clot in your leg), a pulmonary embolus (PE; blood clot in your lungs), or if you are going to have surgery. Before having any surgery, even dental surgery, tell your doctor or dentist that you are being treated with methoxy polyethylene glycol-epoetin beta injection, especially if you are having coronary artery bypass graft (CABG) surgery or surgery to treat a bone problem. Your doctor may prescribe an anticoagulant ('blood thinner') to prevent clots from forming during surgery. If you are being treated with hemodialysis (treatment to remove waste from the blood when the kidneys are not working), a blood clot may form in your vascular access (place where the hemodialysis tubing connects to your body). Tell your doctor if your vascular access stops working as usual. If you experience any of the following symptoms, call your doctor immediately or get medical help right away: chest pain; difficulty breathing or shortness of breath; pain in your legs with or without swelling; a cool or pale arm or leg; confusion; trouble speaking; sudden weakness or numbness of an arm or leg (especially on one side of the body) or of the face; vision problems; difficulty walking; dizziness; loss of balance or coordination; or fainting.

Your doctor will adjust your dose of methoxy polyethylene glycol-epoetin beta injection so that your hemoglobin level (amount of a protein found in red blood cells) is just high enough that you do not need a red blood cell transfusion (transfer of one person's red blood cells to another person's body to treat severe anemia). If you receive enough methoxy polyethylene glycol-epoetin beta injection to increase your hemoglobin to a normal or near normal level, there is a greater risk that you will have a stroke or develop serious or life-threatening heart problems including heart attack, and heart failure. Call your doctor immediately or get emergency medical help if you experience any of the following symptoms: chest pain, squeezing pressure, or tightness; shortness of breath; nausea; lightheadedness; sweating; discomfort or pain in the arms, shoulder, neck, jaw, or back; or swelling of the hands, feet, or ankles.

Keep all appointments with your doctor and the laboratory. Your doctor will monitor your blood pressure often during your treatment with methoxy polyethylene glycol-epoetin beta injection. Your doctor will also order certain tests to check your body's response to methoxy polyethylene glycol-epoetin beta injection. Your doctor may decrease your dose or tell you to stop using methoxy polyethylene glycol-epoetin beta injection for a period of time if the tests show that you are at high risk of experiencing serious side effects. Follow your doctor's directions carefully.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with methoxy polyethylene glycol-epoetin beta 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 methoxy polyethylene glycol-epoetin beta injection.

Cancer patients:

Methoxy polyethylene glycol-epoetin beta injection should not be used to treat anemia caused by cancer chemotherapy.

WHY is this medicine prescribed?

Methoxy polyethylene glycol-epoetin beta injection is used to treat anemia (a lower than normal number of red blood cells) in people with chronic kidney failure (condition in which the kidneys slowly and permanently stop working over a period of time) in adults on and not on dialysis and in children 5 years of age and older on dialysis who have already received another treatment for anemia. Methoxy polyethylene glycol-epoetin beta injection should not be used to treat anemia caused by cancer chemotherapy and should not be used in place of a red blood cell transfusion to treat severe anemia. Methoxy polyethylene glycol-epoetin beta injection is in a class of medications called erythropoiesis-stimulating agents (ESAs). It works by causing the bone marrow (soft tissue inside the bones where blood is made) to make more red blood cells.

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?

Methoxy polyethylene glycol-epoetin beta injection comes as a solution (liquid) to inject subcutaneously (just under the skin) or intravenously (into a vein) in adults and intravenously in children. It is usually injected once every 2 or 4 weeks as directed by your doctor. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use methoxy polyethylene glycol-epoetin beta injection exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

Your doctor will start you on a low dose of methoxy polyethylene glycol-epoetin beta injection and adjust your dose depending on your lab results and how you are feeling, usually not more than once every month. Your doctor may also tell you to stop using methoxy polyethylene glycol-epoetin beta injection for a time. Follow these instructions carefully.

Do not shake methoxy polyethylene glycol-epoetin beta injection.

Always inject methoxy polyethylene glycol-epoetin beta injection in its own syringe. Do not dilute it with any liquid and do not mix it with any other medications.

Methoxy polyethylene glycol-epoetin beta injections may be given by a doctor or nurse, or your doctor may decide that you can inject it yourself or that you may have a friend or relative give the injections. You and the person who will be giving the injections should read the manufacturer's information for the patient that comes with methoxy polyethylene glycol-epoetin beta injection before you use it for the first time at home. Ask your doctor to show you or the person who will be injecting the medication how to inject it.

You can inject methoxy polyethylene glycol-epoetin beta injection just under the skin anywhere on the outer area of your upper arms, middle of the front thighs, or stomach.

Always look at methoxy polyethylene glycol-epoetin beta solution before injecting it. Be sure that the prefilled syringe is labeled with the correct name and strength of medication and an expiration date that has not passed. Also check that the solution is clear and colorless to slightly yellowish and does not contain lumps, flakes, or particles. If there are any problems with your medication, call your pharmacist and do not inject it.

Do not use prefilled syringes more than once. Dispose of used syringes in a puncture-resistant container. Ask your doctor or pharmacist how to dispose of the puncture-resistant container.

What SPECIAL PRECAUTIONS should I follow?

Before using methoxy polyethylene glycol-epoetin beta injection,

• tell your doctor and pharmacist if you are allergic to methoxy polyethylene glycol-epoetin beta, any other medications, or any of the ingredients in methoxy polyethylene glycol-epoetin beta 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, 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 had high blood pressure and if you have ever had pure red cell aplasia (PRCA; a type of severe anemia that may develop after treatment with an ESA such as darbepoetin alfa injection, epoetin alfa injection, or methoxy polyethylene glycol-epoetin beta. Your doctor may tell you not to use methoxy polyethylene glycol-epoetin beta injection.

• tell your doctor if you have or have ever had seizures or cancer.

• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using methoxy polyethylene glycol-epoetin beta injection, call your doctor.

What SPECIAL DIETARY instructions should I follow?

Your doctor may prescribe a special diet to help control your blood pressure and to help increase your iron levels so that methoxy polyethylene glycol-epoetin beta injection can work as well as possible. Follow these directions carefully and ask your doctor or dietician if you have any questions.

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

Call your doctor to ask what to do if you miss a dose of methoxy polyethylene glycol-epoetin beta injection. Do not use a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Methoxy polyethylene glycol-epoetin beta injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• diarrhea
• vomiting
• constipation
• runny nose, sneezing, and congestion
• headache
• muscle spasms
• back pain
• stomach pain
• fever, cough, or chills
• pain in legs or hands

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:

• rash
• hives
• itching
• skin blisters or peeling skin
• swelling of the face, throat, tongue, lips, or eyes
• wheezing
• difficulty breathing or swallowing
• seizures

Methoxy polyethylene glycol-epoetin beta 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 and away from light. It also may be stored at room temperature for up to 30 days; do not freeze it. Discard any medication that has been frozen or if it has been stored at room temperature for more than 30 days.

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:

• fast or racing heart beat

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.