Leukine 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.

Leukine 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.

Leukine 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.

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

Before you receive Leukine, tell your doctor if you have fluid retention (especially around your lungs), heart disease, high blood pressure, congestive heart failure, bone marrow cancer, a seizure disorder, liver or kidney disease, or a breathing disorder such as COPD or asthma.

Tell your caregiver right away if you feel dizzy, nauseated, light-headed, short of breath, or have a fast heartbeat, chest tightness, or trouble breathing when you inject Leukine.

Call your doctor at once if you have any other serious side effects such as fever, chills, sore throat, flu symptoms, mouth sores, easy bruising or bleeding, and swelling or rapid weight gain.

Using Leukine may increase your risk of developing other cancers. Ask your doctor about your individual risk.

Leukine 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.

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

Read and carefully follow any Instructions for Use provided with your medicine. Do not use Leukine 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 Leukine 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 Leukine.

Store this medicine 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.

Usual Adult Dose of Leukine for Neutropenia Associated with Chemotherapy:

250 mcg/m2/day IV over a 4 hour period beginning on or around day 11 or 4 days following the completion of induction chemotherapy, if the day 10 bone marrow is hypoplastic with less than 5% blasts. If a second cycle of induction chemotherapy is needed, administer approximately 4 days after the completion of chemotherapy if the bone marrow is hypoplastic with less than 5% blasts. Continue until absolute neutrophil count (ANC) is greater than 1500 cells/mm3 for 3 consecutive days or a maximum of 42 days.

Use: To shorten time to neutrophil recovery and to reduce the incidence of severe and life-threatening infections and infections resulting in death following induction chemotherapy in older adult patients with acute myelogenous leukemia (AML). Safety and efficacy have not been assessed in AML patients younger than 55 years.

Usual Adult Dose of Leukine for Bone Marrow Transplantation -- Myeloid Reconstruction:

250 mcg/m2/day IV over 2 hours beginning 2 to 4 hours after bone marrow infusion and at least 24 hours after the last dose of chemotherapy or radiotherapy when absolute neutrophil count (ANC) is less than 500 cells/mm3; continue until ANC is greater than 1500 cells/mm3 for 3 consecutive days.

Uses:
-To accelerate myeloid recovery in patients with non-Hodgkin's lymphoma (NHL), acute lymphoblastic leukemia (ALL), and Hodgkin's disease undergoing autologous bone marrow transplantation (BMT).
-To accelerate myeloid recovery in patients undergoing allogeneic BMT from human leukocyte antigen (HLA)-matched related donors.

Usual Adult Dose of Leukine for Bone Marrow Transplantation -- Failure or Engraftment Delay:

250 mcg/m2/day IV for 14 days as a 2 hour infusion. The dose can be repeated 7 days later if engraftment has not been achieved. If engraftment has not taken place after the second administration of this drug, a dose of 500 mcg/m2/day for 14 days may be administered beginning 7 days after the previous dose (14 days after the initial dose).

Use: To prolong survival of patients who are experiencing graft failure or engraftment delay, in the presence or absence of infection, following autologous or allogeneic bone marrow transplantation (BMT).

Usual Adult Dose of Leukine for Peripheral Progenitor Cell Transplantation:

MOBILIZATION:
250 mcg/m2/day IV over 24 hours or subcutaneously once a day. Continue at the same dose throughout peripheral blood progenitor cell (PBPC) collection.

Comments: Optimal PBPC collection times have not been established; in clinical studies, collection usually began by day 5 and was performed daily until protocol targets were achieved.

Use: Mobilization of hematopoietic progenitor cells into peripheral blood for collection by leukapheresis.

POST-TRANSPLANT:
250 mcg/m2/day IV over 24 hours or subcutaneously once a day immediately following progenitor cell infusion and continuing until absolute neutrophil count (ANC) is greater than 1500 cells/mm3 for 3 consecutive days.

Use: To further accelerate myeloid reconstitution following PBPC transplantation.

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

Leukine 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 Leukine 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.

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 to Leukine: 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.

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

Common Leukine side effects 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 Leukine within 24 hours before you receive chemotherapy or radiation, or within 24 hours after chemotherapy.

Other drugs may interact with 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.