Generic Name: sargramostim (sar grah MOSS tim)Brand Names: Leukine
Sargramostim is a protein that stimulates the production of white blood cells. Sargramostim is similar a substance in the body called granulocyte-macrophage colony stimulating factor (GM-CSF).
Sargramostim is used to increase white blood cells and decrease the risk of infection in conditions such as cancer, bone marrow transplant, and pre-chemotherapy blood cell collection.
Sargramostim may also be used for purposes other than those listed in this medication guide.
Before using sargramostim, tell your doctor if you
are undergoing radiation or chemotherapy;
have asthma or another lung disease;
have heart disease, especially an irregular heartbeat or congestive heart failure;
have fluid retention;
have myeloid (bone marrow) cancer;
have kidney disease; or
have liver disease.
You may not be able to use sargramostim or you may require a dosage adjustment or special monitoring if you have any of the conditions listed above.Sargramostim is in the FDA pregnancy category C. This means that it is not known whether sargramostim will be harmful to an unborn baby. Do not use sargramostim without first talking to your doctor if you are pregnant or could become pregnant during treatment. It is not known whether sargramostim passes into breast milk. Do not use this medication without first talking to your doctor if you are breast-feeding a baby.
Use sargramostim exactly as directed by your doctor. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.
Sargramostim can be used subcutaneously (SC) or intravenously (IV). Your doctor, nurse, or pharmacist will give you specific instructions on how and where to inject the medication.Do not administer an injection if you are unsure how it should be injected, how much to inject, or how often to inject the medication. Call your doctor, nurse, or pharmacist to go over the instructions with you.
Rotate injection sites as directed and inject the medication slowly.
Do not shake any vial of sargramostim. It can be gently swirled if mixing is needed.
The powdered form of Leukine must be reconstituted (mixed) with sterile water, or bacteriostatic water to form a solution for injection. Solutions made with sterile water (no preservative) must be used within 6 hours of mixing, then thrown away. Leukine Liquid and solutions mixed with bacteriostatic water can be kept for up to 20 days under refrigeration.The vial of medication can be allowed to reach room temperature by leaving it out of the refrigerator for about 30 minutes before injecting a dose. Do not leave the vial in direct sunlight.
Properly store and discard all syringes and needles.
It is important to use sargramostim regularly to get the most benefit.
Your doctor may want you to have blood tests or other medical evaluations during treatment with sargramostim to monitor progress and side effects.Store this medication in the refrigerator between 2 and 8 degrees Celsius (36 to 46 degrees Fahrenheit) away from light, moisture, and the reach of children. Discard all medication on the expiration date.
Contact your doctor if you miss a dose of this medication by more than a few hours.
Symptoms of a sargramostim overdose include shortness of breath, a feeling of discomfort or illness (malaise), nausea, fever, a rash, a fast heartbeat, headache, and chills.
There are no restrictions regarding foods, beverages, or activities during treatment with sargramostim unless your doctor directs otherwise.
an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
dizziness or fainting;
a fever (over 100.5 degrees Fahrenheit or 38 degrees Celsius);
signs of infection including chills, sore throat, or congestion or redness, pain, or swelling around a wound or sore;
swelling of the feet or lower legs;
sudden weight gain (5 pounds or more); or
chest pain, chest discomfort, or a fast, irregular pulse.
Other, less serious side effects may be more likely to occur. Continue to use sargramostim and talk to your doctor if you experience:
muscle aching or weakness;
nausea, upset stomach, or loss of appetite;
swelling, redness, or pain at the injection site.
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.
Usual Adult Dose 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 < 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 < 5% blasts. Continue sargramostim until absolute neutrophil count (ANC) is greater than 1500 cells/mm3. For 3 consecutive days, or a maximum of 42 days.
Usual Adult Dose for Bone Marrow Transplantation -- Myeloid Reconstruction:
250 mcg/m2/day for 21 days as a 2 hour IV infusion beginning 2 to 4 hours after the autologous bone marrow infusion, at least 24 hours after the last dose of chemotherapy and 12 hours after the last dose of radiotherapy.
Usual Adult Dose for Bone Marrow Transplantation -- Failure or Engraftment Delay:
250 mcg/m2/day for 14 days as a 2 hour IV 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 sargramostim, 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).
Usual Pediatric Dose for Aplastic Anemia:
8 to 32 mcg/kg/day IV or subcutaneously, administered once a day.
Usual Pediatric Dose for Bone Marrow Transplantation:
250 mcg/m2/day IV or subcutaneously, once a day for 21 days beginning 2 to 4 hours after the marrow infusion on day 0.
Usual Pediatric Dose for Neutropenia Associated with Chemotherapy:
3 to 15 mcg/kg/day IV or subcutaneously, each day for 14 to 21 days. Maximum dose: 30 mcg/kg/day or 1500 mcg/m2/day.
Before using this medication, tell your doctor if you
are taking lithium (Eskalith, Lithobid, Lithane, others);
are taking a steroid such as prednisone (Deltasone, others), methylprednisolone (Medrol, others), prednisolone (Prelone, others), dexamethasone (Decadron, others), and others; or
are undergoing radiation or chemotherapy.
You may not be able to use sargramostim or you may require special monitoring if you are taking any of the medications listed above.
Drugs other than those listed here may also interact with sargramostim. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.