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|Granulocyte colony stimulating factor

COLONY STIMULATING FACTORS (Systemic)

Some commonly used brand names are:

In the U.S.—

• Neupogen ¹
• Leukine ²

In Canada—

• Neupogen ¹

Other commonly used names are:

• Granulocyte colony stimulating factor (G-CSF)
• Granulocyte-macrophage colony stimulating factor (GM-CSF)

Category

• Antineutropenic—Filgrastim; Sargramostim
• Hematopoietic stimulant—Filgrastim; Sargramostim

Description

Filgrastim and sargramostim are synthetic (man-made) versions of substances naturally produced in your body. These substances, called colony stimulating factors, help the bone marrow to make new white blood cells.

When certain cancer medicines fight your cancer cells, they also affect those white blood cells that fight infection. To help prevent infections when these cancer medicines are used, colony stimulating factors may be given. Colony stimulating factors also may be used to help the bone marrow recover after bone marrow transplantation and stem cell transplantation.

Colony stimulating factors are available only with your doctor"s prescription, in the following dosage form:

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

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 colony stimulating factors, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to the colony stimulating factor. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Colony stimulating factors have not been studied in pregnant women. Before you take a colony stimulating factor, make sure your doctor knows if you are pregnant of if you may become pregnant.

• Filgrastim— In studies in rabbits, filgrastim did not cause birth defects but did cause internal defects, a decrease in average weight, and death of the fetus at high doses.
• Sargramostim— Studies on birth defects have not been done in animals.

Breast-feeding—It is not known whether colony stimulating factors pass into human breast milk. However, these medicines have not been reported to cause problems in nursing babies. Mothers who are taking a colony stimulating factor and who wish to breast-feed should discuss this with their doctor.

Children—Although there is no specific information comparing use of colony stimulating factors in children with use in other age groups, this medicine is not expected to cause different side effects or problems in children than it does in adults. In Canada, data from clinical trials in children indicate that the safety of filgrastim is similar in both adults and children receiving certain cancer medicines. Sargramostim may contain benzyl alcohol and should not be given to infants because it could cause serious adverse effects.

Older adults—Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of colony stimulating factors in the elderly with use in other age groups, this medicine has been used in many elderly patients and is not expected 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. When you are taking a colony stimulating factor, it is especially important that your health care professional knows if you are taking any of the following:

• Chemotherapy or
• Radiation therapy—You should not use filgrastim close to the time you are undergoing chemotherapy or radiation therapy for cancer treatment.

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

• Conditions caused by inflammation or immune system problems—There is a chance these may be worsened by colony stimulating factor

• Heart disease—Risk of some unwanted effects (heart rhythm problems, retaining water) may be increased

• Kidney disease or
• Liver disease—May sometimes be worsened by colony stimulating factor

• Leukemia (cancer of the blood-forming organs)—May make condition worse

• Lung disease—Colony stimulating factor may cause shortness of breath

• Sickle cell disease (condition that affects the cells in your blood)—May make condition worse

Proper Use of This Medicine

If you are injecting this medicine yourself, use it exactly as directed by your doctor . Do not use more or less of it, and do not use it more often than your doctor ordered. The exact amount of medicine you need has been carefully worked out. Using too much will increase the risk of side effects, while using too little may not improve your condition.

If you are injecting this medicine yourself, each package of colony stimulating factor will contain a patient instruction sheet. Read this sheet carefully and make sure you understand:

• How to prepare the injection.
• Proper use of disposable syringes.
• How to give the injection.
• How long the injection is stable.

If you have any questions about any of this, check with your health care professional.

Dosing—The dose of colony stimulating factors will be different for different patients. The dose that is used may depend on a number of things, including what the medicine is being used for, the patient"s body weight or size, and whether or not other medicines are also being taken. If you are receiving colony stimulating factors at home, follow your doctor"s orders or the directions on the label . If you have any questions about the proper dose of colony stimulating factors, ask your doctor.

Missed dose—If you miss a dose of this medicine, check with your doctor.

Storage—To store this medicine:

• Keep out of the reach of children.
• Store in the refrigerator.
• Keep the medicine from freezing.
• 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 to make sure that this medicine is working properly and to check for unwanted effects.

Colony stimulating factors are used to prevent or reduce the risk of infection while you are being treated with cancer medicines. Because your body"s ability to fight infection is reduced, it is very important that you call your doctor at the first sign of any infection (for example, if you get a fever or chills) so you can start antibiotic treatment right away.

Contact your doctor if you develop shortness of breath, tightness in chest. troubled breathing, or wheezing. These could be symptoms of a serious lung condition called adult respiratory distress syndrome (ARDS).

If you experience left upper abdominal or shoulder tip pain, contact your doctor right away. These could be symptoms of an enlarged or ruptured spleen.

Colony stimulating factors commonly cause mild bone pain, usually in the lower back or pelvis, about the time the white blood cells start to come back in your bone marrow. The pain is usually mild and lasts only a few days. Your doctor will probably prescribe a mild analgesic (painkiller) for you to take during that time. If you find that the analgesic is not strong enough, talk with your doctor about using something that will make you more comfortable.

Side Effects of This Medicine

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

The side effects listed below include only those that might be caused by colony stimulating factors. To find out about other side effects that may be caused by the cancer medicines you are also receiving, look under the information about those specific medicines.

Check with your doctor as soon as possible if any of the following side effects occur:

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

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

Additional Information

Once a medicine has been approved for marketing for a certain use, experience may show that it also is useful for other medical problems. Although not specifically included in the product labeling, colony stimulating factors are used in certain patients with the following medical conditions:

• Failure or delay of myeloid engraftment after hemapoietic stem cell transplantation
• Myelodysplastic syndromes
• Neutropenia, AIDS-associated
• Neutropenia, drug-induced

Other than the above information, there is no additional information relating to proper use, precautions, or side effects for these uses.

Revised: 03/25/2005

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