Sargramostim, GM-CSF injection

What is this medication?

SARGRAMOSTIM, GM-CSF (sar GRAM oh stim) is a granulocyte-macrophage colony-stimulating factor that stimulates the growth of certain blood cells including neutrophils, a type of white blood cell (WBC) important in the body's fight against infection. It is used to help increase WBC production after bone marrow transplantation (BMT), after BMT failure or engraftment delay, before and after stem-cell transplant, and after induction chemotherapy in older patients with acute myelogenous leukemia and to improve survival outcomes following high-dose radiation exposure that is toxic to the bone marrow.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Leukine

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• heart disease
• lung or breathing disease, like asthma
• an unusual or allergic reaction to sargramostim, yeast products, benzyl alcohol, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

This medicine is for injection under the skin or into a vein. It is usually given by a health care professional in a hospital or clinic setting. If you get this medicine at home, you will be taught how to prepare and give this medicine. Refer to the patient Instructions for Use for detailed instructions. Use exactly as directed. Take your medicine at regular intervals. Do not take your medicine more often than directed. It is important that you put your used needles and syringes in a special sharps container. Do not put them in a trash can. If you do not have a sharps container, call your pharmacist or healthcare provider to get one.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 2 years of age for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

It is important not to miss your dose. Call your doctor or health care professional if you miss a dose.

What may interact with this medication?

• medicines that may cause a release of neutrophils, such as lithium or steroid medications like prednisone or cortisone

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Tell your health care professional if your symptoms do not start to get better or if they get worse.

You may need blood work done while you are taking this medicine.

Do not breast-feed an infant while taking this medicine or for 2 weeks after stopping it.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• breathing problems
• fast, irregular heartbeat
• feeling faint or lightheaded, falls
• sudden weight gain
• swelling of the legs, ankles, feet, or hands

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• decreased appetite
• diarrhea
• headache
• mouth sores
• pain, redness, or swelling at site where injected
• nausea, vomiting
• stomach upset
• tiredness

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children.

Store in a refrigerator between 2 and 8 degrees C (36 and 46 degrees F). Do not freeze. Throw away any unused medicine after 20 days.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.