Sargramostim

Sargramostim is a man-made version of a protein that helps your body produce more white blood cells. White blood cells are important for fighting off infection.

Sargramostim is used in adults and children who are at least 2 years old to help prevent serious infections in conditions like leukemia, after a bone marrow transplant, and before collecting blood cells for chemotherapy.

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

Sargramostim may also be used for reasons not mentioned in this medication guide.

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

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.

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

Some side effects may occur during the injection. Tell your caregiver if you feel dizzy, nauseous, 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 stopped 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.

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.

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.

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

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.