Sargramostim is a man-made form of a protein that stimulates the growth of white blood cells in your body. White blood cells help your body fight against infection.

Sargramostim is used in adults and children who are at least 2 years old, to help prevent serious infection in conditions such as leukemia, bone marrow transplant, and pre-chemotherapy blood cell collection.

Sargramostim is also used to lower the risk of death from bone marrow suppression after exposure to radiation in adults and children as young as newborns.

Sargramostim may also be used for purposes not listed in this medication guide.

Do not use sargramostim within 24 hours before you receive chemotherapy or radiation, or within 24 hours after chemotherapy.

Sargramostim comes as a solution (liquid) or a powder to be mixed with liquid to inject subcutaneously (under the skin) or intravenously (into a vein). It is infused (injected slowly) over a period of 2 to 24 hours once daily. It also may be injected subcutaneously once daily. The length of your treatment depends on the condition that you have and how well your body responds to the medication.

If you are using sargramostim to decrease the risk of infection during chemotherapy, you will receive the medication at least 4 days after you receive your last dose of each chemotherapy cycle. You will continue to receive the medication every day until your blood cell counts return to normal or for up to 6 weeks. If you are using sargramostim to prepare your blood for leukapheresis, you will receive the medication once daily until the last leukapheresis. If you are using sargramostim because you are undergoing blood stem cell transplant, you will receive the medication beginning on the day of the blood cell transplant and continue for at least 3 days. If you are using sargramostim to decrease the risk of infection during a bone marrow transplant, you will receive the medication at least 24 hours after you receive chemotherapy and again 2 to 4 hours after the bone marrow is infused. If you are using sargramostim because you are not responding to a bone marrow transplant, you will receive the medication once a day for 14 days. Do not stop using sargramostim without talking to your doctor.

Sargramostim may be given to you by a nurse or other healthcare provider, or you may be told to inject the medication at home. If you will be injecting sargramostim, inject the medication at about the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use sargramostim exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

If you will be injecting sargramostim yourself, a healthcare provider will show you how to inject the medication. Be sure that you understand these directions. Ask your healthcare provider if you have any questions about where on your body you should inject sargramostim, how to give the injection, what type of syringe to use, or how to dispose of used needles and syringes after you inject the medication.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

Your doctor will perform blood tests to make sure you do not have conditions that would prevent you from safely using sargramostim.

Sargramostim is injected under the skin, or given as an infusion into a vein. A healthcare provider will give your first dose and may teach you how to properly use the medication by yourself.

When injected into a vein, the infusion may take up to 24 hours to complete.

Read and carefully follow any Instructions for Use provided with your medicine. Do not use sargramostim if you don't understand all instructions for proper use. Ask your doctor or pharmacist if you have questions.

Do not shake this medicine. Prepare your injection only when you are ready to give it. Do not use if the medicine has changed colors or has particles in it. Call your pharmacist for new medicine.

Your care provider will show you the best places on your body to inject sargramostim under the skin. Use a different place each time you give an injection. Do not inject into the same place two times in a row.

Sargramostim doses are based on body surface area (height and weight). Your dose needs may change if you gain or lose weight or if you are still growing.

You may need frequent medical tests to help your doctor determine how long to treat you with sargramostim.

Store sargramostim in its original carton in the refrigerator. Do not freeze and do not shake. Throw the vial (bottle) away after 20 days of use, even if there is still medicine left inside.

You should not use sargramostim if you are allergic to sargramostim, filgrastim, or yeast.

Sargramostim may contain an ingredient that can cause serious side effects or death in very young or low birth-weight babies. Do not give this medicine to a child without medical advice.

Tell your doctor if you have ever had:

• heart disease;

• lung disease;

• an allergy to benzyl alcohol; or

• a buildup of fluid around your lungs (also called pleural effusion).

Using sargramostim may increase your risk of tumor growth or blood cancers. Ask your doctor about these risks.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

You should not breast-feed while using sargramostim and for at least 2 weeks after your last dose.

Call your doctor for instructions if you miss a dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include nausea, weakness, headache, fever, chills, skin rash, fast heart rate, or trouble breathing.

Keep this medication in the container it came in, away from sunlight, closed, and out of reach of children. Store sargramostim in the refrigerator. Do not freeze or shake sargramostim. Opened sargramostim vials may be refrigerated for up to 20 days. Dispose of opened vials after 20 days.

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unless your doctor tells you otherwise, continue your normal diet.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some side effects may occur during the injection. Tell your caregiver if you feel dizzy, nauseated, sweaty, light-headed, short of breath, or have chest tightness or fast heartbeats.

Capillary leak syndrome is a rare but serious side effect of sargramostim. Call your doctor right away if you have signs of this condition: stuffy or runny nose followed by tiredness, thirst, decreased urination, trouble breathing, and sudden swelling or weight gain.

Sargramostim may cause serious side effects. Call your doctor at once if you have:

• pain when you breathe, feeling short of breath while lying down;

• chest pain or pressure;

• fast or slow heartbeats;

• pain or burning when you urinate;

• easy bruising, unusual bleeding, purple or red spots under your skin;

• increased blood pressure--severe headache, blurred vision, pounding in your neck or ears, anxiety, nosebleed; or

• liver problems--loss of appetite, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Your sargramostim doses may be delayed or permanently discontinued if you have certain side effects.

Common side effects of sargramostim may include:

• swelling, breathing problems;

• stomach pain, nausea, vomiting, diarrhea;

• loss of appetite, weight loss;

• urination problems;

• fever, weakness, not feeling well;

• mouth sores;

• headache, high blood pressure;

• numbness, tingling, rash, itching;

• hair loss; or

• abnormal blood tests.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

If you also receive chemotherapy or radiation: Do not use sargramostim within 24 hours before you receive chemotherapy or radiation, or within 24 hours after chemotherapy.

Other drugs may affect sargramostim, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to sargramostim.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.