Methoxy Polyethylene Glycol-Epoetin Beta Injection

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.

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.

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

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.

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.

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.

• 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).

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.

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

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.