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Sargramostim

(sar-gram-o-stim)

Trade/other name(s): Leukine, granulocyte macrophage-colony stimulating factor (GM-CSF)

Why would this drug be used?

Sargramostim can be used at a number of different times when the body needs to make more white blood cells.

It is sometimes used to prevent or treat leukopenia (having a lower than normal number of white blood cells), which in turn lowers a person's risk of serious infections. Leukopenia can sometimes result from cancer chemotherapy or other treatments. Sargramostim is especially useful in people with acute myeloid leukemia (AML) after their first (induction) course of chemotherapy.

Sargramostim can be used to cause the bone marrow to make more young white blood cells (stem cells) and release them into the bloodstream, where they can be collected for use in a peripheral blood stem cell transplant (PBSCT).

It is also used after high-dose chemotherapy and either a PBSCT or bone marrow transplant (BMT), to help the body start to make white blood cells again more quickly.

How does this drug work?

Sargramostim is a man-made version of a protein called granulocyte macrophage-colony stimulating factor (GM-CSF). This protein is normally made by some cells in the body to stimulate the bone marrow to make more infection-fighting white blood cells. The man-made version has the same effect when injected into the body.

Before taking this medicine

Tell your doctor…

  • If you are allergic to any medicines, dyes, additives, or foods, especially yeast products.
  • If you have ever had heart disease, especially any type of abnormal heart rhythm. In rare cases this drug has caused the heart to beat abnormally.
  • If you have ever had lung disease or congestive heart failure. In rare cases this drug could make this worse.
  • If you have ever had kidney disease or liver disease (including hepatitis). This drug may affect the kidneys or liver.
  • If you have any other medical conditions such as diabetes, gout, or infections. You may need closer monitoring of these conditions while being treated, or the drug dose, regimen, or timing may need to be changed.
  • If you are pregnant, trying to get pregnant, or if there is any chance of pregnancy. It is not known if this drug might cause problems if either the male or female is taking it at the time of conception or during pregnancy. Check with your doctor about what kinds of birth control can be used with this medicine. This drug should be used during pregnancy only if the expected benefit is thought to justify the potential risk to the fetus.
  • If you are breast-feeding. While no studies have been done, this drug may pass into breast milk and affect the baby. Talk with your doctor about the possible risks of breast-feeding while taking this drug.
  • About any other prescription or over-the-counter medicines you are taking, including vitamins and herbs. In fact, keeping a written list of each of these medicines (including the doses of each and when you take them) with you in case of emergency may help prevent complications if you get sick.

Interactions with other drugs

Sargramostim should be used with caution in people taking lithium, as lithium may cause more white blood cells than normal to enter the bloodstream. Prednisone and dexamethasone may also increase the effects of sargramostim.

Check with your doctor, nurse, or pharmacist about all of your medicines, herbs, and supplements, and whether alcohol can cause problems with this medicine.

Interactions with foods

No serious interactions with food are known at this time. Check with your doctor, nurse, or pharmacist about whether some foods may be a problem.

Tell all the doctors, dentists, nurses, and pharmacists you visit that you are taking this drug.

How is this drug taken or given?

Sargramostim may be given either as an infusion into a vein (intravenously, or IV) or as a shot under the skin (subcutaneously, or SubQ). It may be given in a hospital or doctor's office, or you or a family member can learn how to give the shot under the skin at home.

The dose and treatment schedule will depend on your weight, general health, and the reason you are being treated. The dose and/or schedule may need to be adjusted based on how your body responds to treatment.

If you are taking it at home, make sure to keep the medicine in its original container in the refrigerator. Take this drug exactly as directed by your doctor. If you are not sure of the instructions, ask your doctor or nurse to explain them to you. Keep the needles and other equipment in a safe place out of reach of children and pets. Keep used needles in a closed needle bucket and bring them back to your doctor or nurse.

Precautions

This drug should not be given within 24 hours of radiation or chemotherapy treatments.

Your doctor will obtain blood tests as often as twice a week at first, to find out how you respond to the drug. Your doctor will adjust your dose or your medicines based on your test results. Keep all your appointments for doctor visits and blood tests.

Some people have a reaction to the first dose of sargramostim that may include low blood pressure, fast heart rate, trouble breathing, flushing, or feeling dizzy or faint. Tell your doctor or nurse right away if you notice these symptoms so that they can be treated. Most often, a reaction to the first dose in a cycle is not a true allergic reaction and tends not to happen with future doses.

This drug may affect the function of your liver and kidneys. These organs normally help filter the blood and help the body get rid of certain chemicals. Changes in these organs can change the blood levels of any other drugs you are taking. Your doctor will likely check the function of these organs with blood tests on a regular basis. The drug may need to be stopped or the dose reduced if the changes are severe. If you have kidney disease, liver metastasis, or other liver problems before starting treatment, the doctor may need to watch you more closely.

In rare cases, some people who were given sargramostim reported shortness of breath, which is thought to be due to white blood cells building up in the blood vessels of the lungs. Tell your doctor or nurse right away if you begin to notice shortness of breath, cough, or fever.

A rare but serious side effect is capillary leak syndrome, in which the small blood vessels in the body become leaky. This can allow fluid to leave the bloodstream and collect in other parts of the body. This could result in low blood pressure, fluid buildup, and poor blood flow to the internal organs. Tell your doctor right away if you feel dizzy or notice sudden swelling or rapid weight gain, trouble breathing, abnormal heart beats, chest pain, or little or no urine output.

In rare cases, this drug can cause allergic reactions when the drug is given. Mild reactions may consist of fever, chills, skin itching, or feeling flushed. More serious reactions happen rarely, but can be dangerous. Symptoms can include feeling lightheaded or dizzy (due to low blood pressure), chest tightness, shortness of breath, back pain, or swelling of the face, tongue, or throat. Tell your doctor or nurse right away if you notice any of these symptoms during or after being given the drug.

Possible side effects

You will probably not have most of the following side effects, but if you have any talk to your doctor or nurse. They can help you understand the side effects and cope with them.

Common

  • reaction to first infusion (may include face flushing, trouble breathing, dizziness)*
  • fever or chills
  • headache

Less common

  • feeling tired or weak
  • bone or muscle pain
  • skin rash or itching
  • diarrhea
  • abnormal blood tests which suggest that the drug is affecting the liver or kidneys (Your doctor will discuss the importance of this finding, if any.)*
  • injection site reaction (redness, pain, or swelling)

Rare

  • shortness of breath*
  • allergic reaction*
  • capillary leak syndrome*
  • abnormal heart rhythm

*See the "Precautions" section for more detailed information.

There are other side effects not listed above that can also occur in some patients. Tell your doctor or nurse if you develop these or any other problems.

FDA approval

Yes – first approved in 1991

Disclaimer: This information does not cover all possible uses, actions, precautions, side effects, or interactions. It is not intended as medical advice, and should not be relied upon as a substitute for talking with your doctor, who is familiar with your medical needs.


Last Medical Review: 11/19/2009
Last Revised: 11/19/2009