This medication is given to those whose ability to make white blood cells has been reduced. This medication stimulates the blood system (bone marrow) to make white blood cells, which help your body fight infections. Sargramostim (also known as GM-CSF, or granulocyte-macrophage colony stimulating factor) is a man-made version of a certain natural substance found in the body that also stimulates the bone marrow to make white blood cells. It is produced using a certain yeast (Saccharomyces cerevisiae).

Do not shake this medication. Doing so may make the drug ineffective.

Follow your doctor's directions exactly. This medication is given by infusion into a vein (IV) or by injection under the skin by a health care professional, usually once a day until the proper blood counts are reached. Dosage is based on your medical condition, body size, lab results, and response to treatment. Use the exact amount of drug prescribed by your doctor. If you use less than the prescribed amount, your body may not produce enough white blood cells to protect your body against infections. If you use more than the prescribed amount, your body may produce too many white blood cells.

Remove the medication from the refrigerator 30 minutes before you inject it to allow it to reach room temperature. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid.

Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same time each day.

If you are giving yourself injections at home, make sure you learn how to prepare and inject this medication properly. Ask your doctor, pharmacist, or nurse any questions you may have about how to give yourself sargramostim. Learn how to store and discard needles, medical supplies, and any unused medication safely. Consult your pharmacist. Never reuse needles or syringes.

When injecting under the skin, choose a new injection site each time you give yourself a dose. This will help prevent soreness. Never inject sargramostim into skin that is tender, red, bruised, or hard or has scars or stretch marks.

If you are receiving chemotherapy for cancer, you should not be given sargramostim at the same time. You should receive sargramostim either before or after the chemotherapy, depending on your blood count results and your doctor's directions.

Aching in the bones and muscles, chills, or headache may occur. Taking a non-aspirin pain reliever such as acetaminophen may help. Ask your doctor or pharmacist for more details. Nausea, vomiting, or injection-site reactions such as redness, swelling, itching, lumps, or bruising may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: chest pain, sudden weight gain, swelling of the hands/feet, shortness of breath, black stools, persistent stomach/abdominal pain, vomit that looks like coffee grounds.

Tell your doctor immediately if any of these rare but very serious side effects occur: fast/irregular heartbeat, vision problems, a sudden reddening of the face/neck/chest, severe dizziness, fainting.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking sargramostim, tell your doctor or pharmacist if you are allergic to it; or to other medications made in a similar manner (man-made proteins using Saccharomyces cerevisiae); or to benzyl alcohol; or if you have any other allergies.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: fluid retention, lung problems, heart problems (e.g., congestive heart failure-CHF, rhythm problems), liver disease, kidney disease, other blood disorders (e.g., myeloid cancers), current chemotherapy.

If you are scheduled to have radiation therapy, tell your doctor you are taking sargramostim. This medication should not be given during the time you are receiving radiation therapy.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: corticosteroids (e.g., prednisone), lithium.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: shortness of breath, unusual weakness, fast heartbeat.

Do not share this medication with others.

This medication must be taken under close medical supervision so your blood counts can be monitored. Keep all medical appointments. Laboratory and/or medical tests (e.g., blood counts, platelet counts, liver function, kidney function, body weight, fluid status) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

It is important that each dose be used as scheduled. If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Refrigerate between 36-46 degrees F (2-8 degrees C). Do not freeze or leave out in direct sunlight. Do not shake this medication. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-800-854-1166 (USA) or 1-800-668-1507 (Canada).

Information last revised May 2009 Copyright(c) 2009 First DataBank, Inc.