Important Safety Considerations

Leukine^® (sargramostim) is contraindicated in patients with excessive leukemic myeloid blasts in bone marrow or peripheral blood (≥ 10%), in patients with known hypersensitivity to GM-CSF, yeast derived products or any component of Leukine, and for concomitant use with chemotherapy and radiotherapy.
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Side Effects

There are drug interactions and side effects that should be considered before taking Leukine^® (sargramostim).

Drug Interactions

Drugs that can increase white blood cells (WBCs), such as lithium and corticosteroids, should be used with caution while receiving Leukine. Also, Leukine should not be used 24 hours before through 24 hours after any chemotherapy or radiation therapy. Interactions between Leukine and other drugs have not been fully evaluated.

Common Side Effects

Some patients who take Leukine may experience side effects, most of which are mild to moderate. Some common side effects include bone pain; a low fever elevation (usually less than 100.5°F or 38°C) for one to four hours after your injection; and swelling, redness, and/or discomfort at the injection site. You may also feel weak or tired, experience muscle aches, have diarrhea, experience stomach upset, or feel like you have the flu.

More About Bone Pain

Bone pain generally occurs in the areas of large marrow reserves, such as the sternum, pelvis, or long bones, and may be a result of expansion of the myeloid cell mass.

More About Low Fever

A low fever is caused by natural pyrogen stimulation in the body brought on by Leukine and can often be managed with acetaminophen administration.

More About Skin Reactions

Skin reactions may occur because cells of the immune system, such as macrophages, are drawn to the injection site.

Managing Side Effects

The following techniques may be used by the person administering your injection to help prevent, relieve, or manage some of the common side effects of Leukine treatment. Please consult with your healthcare team before taking any medications for fever or pain while you are receiving Leukine therapy.

For fever and/or bone pain, your healthcare provider may recommend pain relievers such as acetaminophen.

To minimize injection site discomfort, the person administering the injection should:

Allow Leukine to come to room temperature before injecting
Rotate injection sites from one injection to the next
Avoid rubbing the skin before or after injecting
Apply ice to the site for 1 minute before injecting
Inject Leukine slowly (over thirty to sixty seconds)

Serious Side Effects

During your treatment, some serious but rare side effects or symptoms may occur that might be due to Leukine, your illness, or other treatments you may be receiving. Call your doctor immediately if you:

You develop a high fever (over 100.5°F or 38°C)
You notice any signs of infection including chills, sore throat, or congestion (such as a stuffy nose).
Have trouble breathing; or experience wheezing, fainting, skin rash, or hives; or feel you are having an allergic reaction (see ALLERGY TO LEUKINE section below)
You experience sudden weight gain or other signs of fluid build-up such as swollen legs or feet.
You develop chest pain, chest discomfort, or a rapid or irregular pulse.
You are concerned about any other side effects or symptoms you may be having, contact your doctor, nurse, or pharmacist.

Leukine Resources

What to Expect from Leukine

Indication

Leukine^® (sargramostim) is used to help increase the number and function of white blood cells after bone marrow transplantation, in cases of bone marrow transplantation failure or engraftment delay, before and after peripheral blood stem cell transplantation, and following induction chemotherapy in older patients with acute myelogenous leukemia. Your doctor may also choose to treat other conditions with Leukine.

Important Safety Information for Leukine^® (sargramostim)

You should not use Leukine if you have high levels of abnormal white blood cells, called leukemic blasts, in the bone marrow or blood. You should not use Leukine® if you have had an allergic reaction to GM-CSF, other products made from yeast, or any ingredient used to make Leukine. If you are also receiving chemotherapy or radiation therapy, do not take your Leukine in the period 24 hours before through 24 hours after the administration of your chemotherapy or radiation therapy.
A generalized allergy is an uncommon but potentially serious reaction to Leukine. This may include askin rash over your entire body, hives, trouble breathing, a fast pulse, sweating, and feeling faint. In severe cases a generalized allergy may be life-threatening. If you think you are having a generalized allergy to Leukine, stop taking Leukine and notify your doctor immediately.
Liquid solutions containing benzyl alcohol, including Leukine liquid or lyophilized Leukine reconstituted with Bacteriostatic Water For Injection, USP should not be administered to newborns.
Leukine should be used with caution, and your doctor should monitor you if you have preexisting fluid buildup, heart or lung conditions, or kidney or liver disease.
Some patients taking Leukine may experience unwanted side effects, most of which are mild to moderate and not serious. Some of the more common side effects include bone pain, feeling like you have the flu, feeling tired or weak, muscle aches, diarrhea, stomach upset, weight loss, or loss of appetite. You may also get a low-grade fever (less than 100.5°F or 38°C) about 1 to 4 hours after an injection, or you may have swelling, redness, and/or discomfort where Leukine was injected.
Some side effects or symptoms may be serious. These include developing a high fever (over 100.5°F or 38°C), signs of infection including chills, sore throat, or congestion (such as stuffy nose), having trouble breathing, wheezing, or fainting, or developing extensive skin rash, hives, or other signs of an allergic reaction, experiencing sudden weight gain or other signs of fluid buildup, such as swollen legs or feet, having chest pain, chest discomfort, or a rapid or irregular pulse. These may be due to Leukine, your illness, or other treatments that you may have received. Many of these side effects can be reduced or eliminated. These or other side effects you may be concerned about should be reported promptly to your doctor, nurse, or pharmacist.
Your doctor will monitor your white blood cell and platelet counts with blood tests during Leukine treatment. If your white blood cell or platelet counts rise above certain levels, your doctor may stop your Leukine treatment, or may reduce the dose. If your doctor detects progression of your disease, he/she may stop your Leukine therapy.
Drugs that can increase WBCs, such as lithium and corticosteroids, should be used with caution while receiving Leukine Interactions between Leukine and other drugs have not been fully evaluated.

Please see full Prescribing Information.