When This Medicine Should Not Be Used:
You should not receive this medicine if you have had an allergic reaction to sargramostim, yeast, or anything made from yeast. You should not receive this medicine at the same time that you receive chemotherapy or radiation treatments. You should not receive this medicine during the 24 hours (1 day) before and after certain chemotherapy treatments.

How to Use This Medicine:
Injectable

• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given as a shot under your skin or through a needle placed in one of your veins.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• A nurse or other health provider will give you this medicine.
• You may be taught how to give your medicine at home. Make sure you understand all instructions before giving yourself an injection. Do not use more medicine or use it more often than your doctor tells you to.
• If you will be giving this medicine to yourself as a shot under your skin (subcutaneous): You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas.
• Do not shake the medicine. Use a new needle and syringe each time you inject your medicine.
• This medicine is available in two different forms. These forms are either a pre-mixed liquid or a powder. You might be able to use the pre-mixed liquid directly from the vial, or you might have to mix it with another liquid before you use it. You must mix the powder with another liquid before you use it. Make sure you understand how to prepare the medicine before giving yourself an injection.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you are also using lithium or a corticosteroid (such as cortisone, prednisone, Flonase®, Advair®).
• Make sure your doctor knows about all other radiation and chemotherapy treatments you have received in the past.

Warnings While Using This Medicine:

• Make sure your doctor knows if you are pregnant or breast feeding, or if you have kidney disease or liver disease. Your doctor also needs to know if you have lung disease or other breathing problems. Make sure your doctor knows if you have heart disease, especially if you have heart rhythm problems or congestive heart failure (CHF). It is important for your doctor to know if you have problems with too much fluid in your body (sometimes called "edema"). Some examples of edema are pleural effusion (fluid around your lungs) or pericardial effusion (fluid around your heart).
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• If your cancer symptoms get worse, call your doctor.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blue lips or fingers.
• Chest pain or pressure.
• Dizziness or fainting, and warmth or redness in your face, neck, arms, or upper chest.
• Fast or uneven heartbeat.
• Sudden trouble breathing.
• Swelling in your hands, ankles, or feet, or rapid weight gain.

If you notice these less serious side effects, talk with your doctor:

• Bone, joint, or muscle pain.
• Headache.
• Low fever (under 100.5 degrees F), chills.
• Nausea, vomiting, diarrhea, stomach pain, weight loss, trouble swallowing.
• Redness, pain, or swelling where the injection was given.

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088