Sargramostim Solution for injection

What is this medicine?

SARGRAMOSTIM, GM-CSF (sar GRAM oh stim) helps the body make more blood cells. It is used to increase the number of blood cells after chemotherapy or with a blood or bone marrow transplant.

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

What should I tell my health care provider before I take this medicine?

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

• heart disease
• irregular heartbeat
• kidney disease
• liver disease
• lung or breathing disease, like asthma
• retaining water
• 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 medicine?

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. Do not shake the solution. 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. This medicine is not approved for use in newborns.

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?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

• lithium
• medicines for cancer chemotherapy
• steroid medicines 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 medicine?

Visit your doctor for regular check ups. You will need blood work done while you are taking this medicine.

This medicine may make you feel flushed, faint, dizzy, or weak on your first dose. Tell your doctor if your symptoms do not get better.

Do not become pregnant while taking this medicine. Talk to your doctor about birth control. Call your doctor right away if you think that you may be pregnant.

What side effects may I notice from receiving this medicine?

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
• chest pain
• fast, irregular heartbeat
• feeling faint or lightheaded, falls
• fever
• flu-like symptoms
• flushing
• sudden weight gain
• swelling of hands or feet

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

• bone pain
• diarrhea
• muscle aches
• pain, redness, or swelling at site where injected
• stomach upset

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 medicine?

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. Do not shake. If you are giving this medicine at home, you will be instructed on how to store this medicine. Throw away any unused medicine after the expiration date.

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.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.