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|Pegfilgrastim

PEGFILGRASTIM (Systemic)

Some commonly used brand names are:

In the U.S.—

• Neulasta

In Canada—

• Neulasta

Category

• Hematopoietic stimulant or
• antineutropenic

Description

Pegfilgrastim (peg-fil-GRA-stim) is a substance called a Colony Stimulating Factor. These substances, are synthetic (man-made) versions of substances naturally produced in your body which help the bone marrow to make new white blood cells.

Certain medicines affect those white blood cells in your body that fight infection. To help prevent infections when these medicines are used, colony stimulating factors may be given.

This medicine is available only with your doctor"s prescription, in the following dosage form:

• Parenteral
• Injection (U.S. and Canada)

Before Using This Medicine

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For pegfilgrastim, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to pegfilgrastim or Filgrastim. Also tell your doctor and pharmacist if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Pegfilgrastim has not been studied in pregnant women.

However, studies in animals have shown that pegfilgrastim causes a decrease in successful pregnancies. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding—It is not known whether pegfilgrastim passes into breast milk. Although most medicines pass into breast milk in small amounts, many of them may be used safely while breast-feeding. Mothers who are taking this medicine and who wish to breast-feed should discuss this with their doctor.

Children—Studies on this medicine have been done only in adult patients and there is no specific information comparing use of pegfilgrastim in children with use in other age groups. The 6-mg syringe should not be used in infants, children, and smaller adolescents weighing less than 45 kilograms (99 lbs) of body weight.

Older adults— This medicine has been tested in a limited number of patients 65 years of age or older and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your health care professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other medical problems—The presence of other medical problems may affect the use of pegfilgrastim. Make sure you tell your doctor if you have any other medical problems, especially:

• Bone marrow cancer or other bone marrow problems—Pegfilgrastim may make the cancer or other problems worse.

• Liver problems—Safety of this medicine in patients with liver problems has not been studied.

• Peripheral blood progenitor cell (PBPC) mobilization—Use of pegfilgrastim is not recommended for PBPC mobilization.

• Sepsis (serious infection)—There have been reports of adult respiratory distress syndrome (ARDS) in patients who had a serious infection and were receiving a similar medicine called filgrastim.

• Sickle cell disease—Pegfilgrastim may increase the risk of unwanted effects.

Proper Use of This Medicine

Dosing—The dose of pegfilgrastim may be different for different patients. Follow your doctor"s orders or the directions on the label . The following information includes only the average doses of pegfilgrastim. If your dose is different, do not change it unless your doctor tells you to do so.

• For injectable dosage form:
  • To increase white blood cell count:
    • Adults—6 mg as an injection one time every chemotherapy cycle
    • Children—Use and dose must be determined by your doctor.

Storage—To store this medicine:

• Keep out of the reach of children.
• Protect from light
• Store in the refrigerator. However, keep the medicine from freezing. If the medicine freezes, you may thaw it out one time in the refrigerator.
• Do not keep outdated medicine or medicine no longer needed. Ask your health care professional how you should dispose of any medicine you do not use. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

It is very important that your doctor check your progress at regular visits for any problems that may be caused by this medicine and to make sure that this medicine is working properly.

If you experience upper stomach pain or shoulder tip pain, contact your doctor right away.

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects. Not all of these side effects may occur, if they do occur they may need medical attention.

Some of the side effects listed below may be caused by your cancer or by the cancer medicines that you are also receiving.

Other side effect not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Developed: 04/29/2002
Revised: 11/02/2005

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