Sargramostim is a drug approved by the Food and Drug Administration (FDA) to decrease the time it takes for the bone marrow blood counts to recover after a bone marrow transplant. This decreases the risk of infection, the amount of time patients are treated with antibiotics, and the amount of time patients are in the hospital
Sargramostim is approved for use after chemotherapy to increase the recovery of the white cell counts and decrease the length of time a patient may have a fever and infection due to a low white count.
Sargramostim can be used after bone marrow transplantation. Once the new healthy bone marrow has been given back to a patient, sargramostim can be administered to help increase the blood cell counts and decrease the risk of fever and infection. Sargramostim can be used in patients when bone marrow is not recovering after a bone marrow transplant.
Sargramostim can be used for patients who will undergo a peripheral blood stem cell transplant. Patients will receive the sargramostim before the transplant. The sargramostim in these patients causes young, non-developed blood cells, known as stem or progenitor cells, to move from the bone marrow to the blood where they will then be removed from a patient by the process of apheresis. These blood cells are stored until after the patient receives larges doses of chemotherapy that destroy the bone marrow and the cancer. The patient then receives these stored cells back by an intravenous infusion. The stored cells repopulate the bone marrow and develop into the many types of functioning blood cells.
Description
Sargramostim is known as the brand name Leukine or Prokine. It has been available for use in bone marrow transplant patients for almost a decade. In cancer patients, chemotherapy destroys white blood cells temporarily. These white blood cells will grow again, but during the time that the levels are low patients are at an increased risk of developing fevers and infection. Sargramostim acts to stimulate the bone marrow to make more white blood cells which can either prevent the white count from dropping below normal or decrease the time that the level is low. This helps the patient avoid fevers and infections and allows them to receive their next doses of chemotherapy without delay.
Recommended dosage
Sargramostim is a clear colorless liquid that is dosed based on a mathematical calculation that measures a person's body surface area (BSA). This number is dependent on a patient's height and weight. The larger the person the greater the body surface area. Body surface area is measured in the units known as square meter (m
2). The body surface area is calculated and then multiplied by the drug dosage in milligrams per square meter (mg/m
2). This calculates the actual dose a patient is to receive.
It is kept refrigerated until ready to use and it is administered to patients as an injection directly underneath the skin, subcutaneously. Subcutaneous is the preferred way to give the drug; it can be given in the back of the arms, upper legs, or stomach area. Sargramostim can also be administered to patients as a short intravenous infusion into a vein over 15 to 30 minutes.
To treat chemotherapy caused neutropenia in AML patients
The starting dose for AML patients that have just finished induction chemotherapy is 250 micrograms per square meter per day. This is given beginning four days after the chemotherapy has ended or approximately day number eleven of therapy. The dose is administered as intravenous infusion over a period of four hours. The doctor will inform the patient when it is time to stop the sargramostim based on blood count monitoring.
For patients receiving bone marrow transplant
The recommended dose is 250 micrograms per square meter per day administered as a two-hour infusion intravenously. This medication should begin within two to four hours of the patient receiving the bone marrow infusion.
If the patient's counts are not returning after the bone marrow has been received, sargramostim can be administered at a dose of 250 micrograms per square meter per day intravenously over a two hour time period for 14 consecutive days. This can be repeated after a
seven-day rest for two more cycles. The doctor may increase the dose to 500 micrograms per square meter per day if the white count does not rise.
For patients prior to receiving a peripheral blood stem cell transplant
The recommended dose is 250 micrograms per square meter per day. This can be given either as a once daily dose administered under the skin, or intravenously administered as a continuous infusion over 24 hours. This dosing should continue until the last day of collection.
For patients after receiving a peripheral blood stem cell transplant
The recommended dose is 250 micrograms per square meter per day. This can be given either as a once daily dose administered under the skin, or intravenously administered as a continuous infusion over 24 hours. This dosing should begin right after the patient receives the stem cell infusion and continue until the white count rises to acceptable levels.
Precautions
Sargramostim should not be received by a patient in the 24-hour time frame before or after receiving chemo-therapy.
Blood counts will be monitored frequently while on sargramostim. This allows the doctor to determine if the drug is working and when to stop treatment.
Sargramostim can affect patients who have kidney or liver problems before beginning treatment. These patients will be monitored by the doctor for any changes in kidney or liver function.
It is not recommended to give sargramostim to patients who have certain types of leukemias.
Sargramostim should be used with caution in patients who have fluid problems, including heart and lung problems.
Patients with a known previous allergic reaction to sargramostim or yeast-derived substances should tell their doctor before receiving this drug.
Patients who may be pregnant or trying to become pregnant should tell their doctor before receiving sargramostim.
Side effects
One of the most common side effects of sargramostim is bone pain. The sargramostim causes bone marrow to produce more white blood cells, and the process causes the patient to experience pain in their bones.
Other common side effects due to sargramostim administration are fever, muscle aches, chills, and weakness.
An uncommon, but serious side effect of sargramostim is increased fluid in patients. This swelling with fluid can occur in the body as a whole, legs, arms, around the heart, and in the lungs.
Patients who have received sargramostim treatment have reported: nausea and vomiting, muscle pain, abdominal pain, rash, diarrhea, hair loss (alopecia), mouth sores, fatigue, allergic reactions and itching, shortness of breath, weakness, dizziness, heart problems, pain at the injection site, blood clots, headache, cough, rash, constipation, and change in kidney and/or liver function.
These side effects may be due to the chemotherapy administration patients have received prior to the sargramostim.
Interactions
Sargramostim should not be given at the same time as chemotherapy or radiation therapy. Dosing should begin at least 24 hours after the last dose of treatment.
Patients on lithium or steroids should tell their doctor before starting sargramostim therapy, as these drugs can affect the white blood cell count.
—The process of removing and collecting specific cells from the blood through a machine.
Bone marrow transplant
—A procedure that destroys all of a patient's diseased bone marrow and replaces it with healthy bone marrow.
Chemotherapy
—Specific drugs used to treat cancer.
Intravenous
—Entering the body directly through a vein.
Food and Drug Administration (FDA)
—A government agency that oversees public safety in relation to drugs and medical devices. The FDA gives the approval to pharmaceutical companies for commercial marketing of their products.
Neutropenia
—A condition involving low levels of the white blood cells responsible for fighting infections.
Peripheral blood stem cell transplant
—A procedure that collects and stores healthy young and non-developed blood stem cells. These are then given back to a patient to help them recover from high doses of chemotherapy.
Reinfusion
—The transfer through a vein of healthy stem cells or bone marrow to a patient that has received large doses of chemotherapy.
