Pegfilgrastim

Pegfilgrastim is used for:

Decreasing the incidence of infection in certain cancer patients undergoing myelosuppressive cancer treatments.

Pegfilgrastim is an amino acid. It works by stimulating bone marrow to produce white blood cells, which fight infection.

Do NOT use Pegfilgrastim if:

• you are allergic to any ingredient in Pegfilgrastim , filgrastim, or Escherichia coli (E. coli)-derived proteins

Contact your doctor or health care provider right away if any of these apply to you.

Before using Pegfilgrastim :

Some medical conditions may interact with Pegfilgrastim . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have other blood problems (eg, sickle cell anemia), bone marrow leukemia, spleen problems, lung problems, or a blood or tissue infection
• if you are or will be undergoing chemotherapy or radiation therapy

Some MEDICINES MAY INTERACT with Pegfilgrastim . Tell your health care provider if you are taking any other medicines, especially any of the following:

• Lithium because it may increase the risk of Pegfilgrastim 's side effects

This may not be a complete list of all interactions that may occur. Ask your health care provider if Pegfilgrastim may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Pegfilgrastim :

Use Pegfilgrastim as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Pegfilgrastim . Talk to your pharmacist if you have questions about this information.
• Pegfilgrastim is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Pegfilgrastim at home, a health care provider will teach you how to use it. Be sure you understand how to use Pegfilgrastim . Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
• Do not shake Pegfilgrastim .
• Do not use Pegfilgrastim if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
• Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
• If you miss a dose of Pegfilgrastim , contact your doctor right away.

Ask your health care provider any questions you may have about how to use Pegfilgrastim .

Important safety information:

• Serious and sometimes fatal spleen problems (including spleen rupture) have been reported in patients using Pegfilgrastim . Notify your doctor immediately if you experience left-sided upper stomach pain and/or shoulder tip pain.
• Pegfilgrastim may reduce the chance of infection, but it does not prevent all infection. Tell your doctor right away if you notice symptoms of infection (eg, fever; chills; sore throat; diarrhea; redness, swelling, or pain around a cut or sore) while you take Pegfilgrastim .
• Tell your doctor if you develop a lump, swelling, or bruising at the injection site that does not go away.
• Lab tests, including blood cell counts, may be performed while you use Pegfilgrastim . These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Pegfilgrastim is not recommended for use in INFANTS or in CHILDREN weighing less than 100 pounds (45 kilograms); safety and effectiveness have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Pegfilgrastim while you are pregnant. It is not known if Pegfilgrastim is found in breast milk. If you are or will be breast-feeding while you use Pegfilgrastim , check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Pegfilgrastim :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Bone or joint pain; constipation; muscle pain.

Severe allergic reactions (rash; hives; itching; difficulty breathing; dizziness; fast heartbeat; increased sweating; tightness in the chest; swelling of the mouth, face, lips, or tongue); fast breathing; fever; left-sided shoulder tip pain; left-sided upper stomach pain; shortness of breath; swelling of the hands, feet, arms, or legs.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center ( http: / / www.aapcc.org / dnn / Resources / FindLocalPoisonCenters / tabid / 130 / Default.aspx), or emergency room immediately.

Store Pegfilgrastim in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C), in the original carton. Do not freeze. If accidentally frozen, allow the medicine to thaw in the refrigerator. If frozen more than once, the medicine should be thrown away. If Pegfilgrastim is left at room temperature for more than 48 hours, it should be discarded. Protect from light. Keep Pegfilgrastim , as well as needles and syringes, out of the reach of children and away from pets.

General information:

• If you have any questions about Pegfilgrastim , please talk with your doctor, pharmacist, or other health care provider.
• Pegfilgrastim is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Pegfilgrastim . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

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