Brand Names:

• Leukine
• Neulasta
• Neupogen

Dosage Forms:

• Solution
• Powder for Solution
• Injectable

Uses of This Medicine:

Filgrastim, pegfilgrastim, 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.

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

Before Using This Medicine:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

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. The pegfilgrastim 6-mg syringe should not be used in infants, children, and small teenagers who weigh less than 45 kg (99.2 lbs) .

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.

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.

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.

Other medicines

Using medicines in this class with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Topotecan
• Vincristine
• Vincristine Liposome

Other interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems

The presence of other medical problems may affect the use of medicines in this class. Make sure you tell your doctor if you have any other medical problems, especially:

• Conditions caused by inflammation or immune system problems or
• Kidney disease or
• Leukemia (type of blood cancer) or
• Liver disease or
• Sickle cell disease (red blood cell disease) May make these conditions worse.

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

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

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

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 medicines in this class will 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 these medicines. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

Missed dose

Call your doctor or pharmacist for instructions.

Storage

Store in the refrigerator. Do not freeze.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

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 the chest, troubled breathing, or wheezing. These could be symptoms of a serious lung condition called adult respiratory distress syndrome (ARDS).

This medicine may also cause bleeding in your lungs. Check with your doctor right away if you cough up blood or if you have blood in your sputum .

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 immediately if any of the following side effects occur:

For filgrastim: Less common

Redness or pain at the site of subcutaneous (under the skin) injection

For filgrastim: Rare

Fever

rapid or irregular heartbeat

sores on skin

wheezing

For sargramostim: Less common

Fever

redness or pain at the site of subcutaneous (under the skin) injection

shortness of breath

swelling of feet or lower legs

weight gain (sudden)

For sargramostim: Rare

Chest pain

rapid or irregular heartbeat

sores on skin

wheezing

Some 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. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

For filgrastim, pegfilgrastim, and sargramostim: More common

Headache

pain in arms or legs

pain in joints or muscles

pain in lower back or pelvis

skin rash or itching

For sargramostim only (in addition to the above): Less common or rare

Dizziness or faintness after first dose of medicine

flushing of face after first dose of medicine

weakness

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