Sargramostim

Sargramostim is a prescription medication used to to help your bone marrow make more white blood cells in certain situations such as after chemotherapy. 

Sargramostim belongs to a group of drugs called colony-stimulating factors. These work to increase the number and function of your white blood cells and in turn help increase the number and function of your white blood cells.

This medication is available in an injectable form to be given directly under the skin (subcutaneously) or given into a vein. 

Common side effects of sargramostim include mild bone pain and flu like syndrome. 

Sargramostim is a prescription medication used to help increase the number and function of white blood cells:

• after bone marrow transplantation
• bone marrow transplantation failure or engraftment delay
• before and after peripheral blood stem cell transplantation
• following induction chemotherapy in older patients with acute myelogenous leukemia.

Your doctor may also choose to treat other conditions with sargramostim.

Sargramostim may be found in some form under the following brand names:

• Leukine

Serious side effects have been reported with sargramostim. See the “Sargramostim Precautions” section.

The most common side effect during sargramostim therapy is:

• mild bone pain, usually in the lower back or pelvis and lasting only a few days.
• flu-like syndrome with fever, fatigue, chills, and muscle aches. Your doctor may recommend that you take acetaminophen or other painkillers.
• feeling tired or weak
• muscle aches
• diarrhea
• stomach upset
• low fever (less than 100.5° F or 38° C) about one to four hours after an injection
• swelling, redness, and/or discomfort where sargramostim is injected. Occasionally a skin reaction may occur at the injection site. This usually will not require you to stop taking sargramostim. The skin may become red, painful, or swollen. If a skin reaction occurs, contact your doctor. 

This is not a complete list of sargramostim side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Drug Interactions between Leukine and other drugs have not been fully evaluated. Drugs which may potentiate the myeloproliferative effects of sargramostim, such as lithium and corticosteroids, should be used with caution.

Serious side effects have been reported with sargramostim. These may be due to sargramostim, your illness, or other treatments you may have received. Call your doctor immediately if any of the following happen to 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).
• You have trouble breathing, or you develop wheezing, fainting, extensive skin rash, hives, or feel you are having an allergic reaction.
• 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.

A generalized allergy is an uncommon but potentially serious reaction to sargramostim. This may include a skin 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 sargramostim, stop taking sargramostim and notify your doctor immediately.

Occasionally a skin reaction may occur at the injection site. This usually will not require you to stop taking sargramostim. The skin may become red, painful, or swollen. If a skin reaction occurs, contact your doctor. The following steps may be taken to help prevent further skin reactions:

• At least 30 minutes before you plan to inject, remove your sargramostim from the refrigerator and allow it to come to room temperature before injecting.
• Rotate the injection sites from one injection to the next.
• Apply ice to the site for one minute immediately prior to injection.
• Inject sargramostim slowly.
• Avoid rubbing the skin before or after injecting.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of sargramostim, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking sargramostim, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to sargramostim or to any of its ingredients
• take the medication lithium
• take corticosteroids such as prednisone
• are pregnant or plan to become pregnant
• are breast-feeding or plan to breast feed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Sargramostim falls into category C. No well-controlled studies have been done in humans. It is not known whether sargramostim can cause fetal harm when administered to a pregnant woman or can affect reproductive capability. Sargramostim should be given to a pregnant woman only if clearly needed.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known whether sargramostim is excreted in human milk. Because many drugs are excreted in human milk, sargramostim should be administered to a nursing woman only if clearly needed.

Take sargramostim exactly as prescribed.

This medication is available in an injectable form to be given directly under the skin or a vein (IV)  by a healthcare professional.

If your doctor has recommended that you take sargramostim at home, your doctor, nurse, or pharmacist should have instructed you and/or your caregiver on how sargramostim should be prepared, how it should be injected, and how often it should be injected. Do not attempt to self-administer sargramostim until you are sure that you understand the instructions for giving an injection to yourself. 

Use the correct syringe and dose:

The dose will usually be measured in milliliters (mL) or cubic centimeters (cc). It is important that you use a syringe that is marked in tenths (1/10) of a milliliter or cubic centimeter so that you are able to measure the correct dose prescribed by your doctor. Your doctor will either supply you with the correct syringes and needles, or will write you a prescription so you can get the correct syringes and needles from your pharmacy.

It is very important that you use the correct needle and syringe. Failure to use the correct syringe could result in your receiving either too little or too much sargramostim. 

Choosing an Injection Site:

Sargramostim is available in an injectable form to be given directly under the skin. The best areas for self-injecting sargramostim are the thighs or stomach. The navel and waistline should be avoided. If a caregiver is helping with the injections, you may be instructed to inject on the back portion of the upper arms. It is important to use a different injection site each time to avoid soreness in any one area.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medications you are taking
• how you respond to this medication
• your body mass index
• your height
• your age

The recommended dose of Leukine (sargramostim) is 250 mcg/m2/day. Sargramostim will be administered on certain days and for a certain time frame depending on the condition being treated and how you respond to this medication.

If you take too much sargramostim, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

Since sargramostim is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Keep sargramostim in the refrigerator but not in the freezer compartment.
• Do not shake sargramostim.
• Do not use sargramostim that has been frozen.
• Keep sargramostim out of direct sunlight.
• Do not use sargramostim beyond the expiration date printed on the vial label. Once the vial has been used, any remaining sargramostim should be stored in the refrigerator and used within 20 days (be sure to mark down the date you first used the vial). Throw away any remaining sargramostim after 20 days.