Posted on December 29th, 2009 by
Class: Supportive care
Generic Name: Sargramostim (sar-gram-OH-stim), GM-CSF, granulocyte-macrophage colony stimulating factor
Trade Name: Leukine®
How is this drug used? Sargramostim is FDA approved for increasing the number and function of white blood cell levels following chemotherapy for acute myelogenous leukemia in older patients, and after bone marrow transplant and autologous stem cell transplants using peripheral blood. Sargramostim is also FDA approved to stimulate the production of white blood cells prior to collection in a stem cell transplant. It is important for patients to remember that physicians have the ability to prescribe medication for conditions other than those for which the drug has been approved by the FDA. Patients who have received a prescription of this drug for a condition other than which it is approved may wish to discuss this issue with their physician.
What is the mechanism of action? Sargramostim is classified as a biologic response modifier. It is a man-made form of a protein, called a growth factor, that helps to increase the number and function of white blood cells. Sargramostim stimulates the body to produce white blood cells.
How is sargramostim given (administered)? Sargramostim is administered either as an injection under the skin (subcutaneous), or into a vein (intravenous), and the dose depends on several factors, including the condition being treated, the size of the patient, the particular regimen being used, and the overall health of the patient.
How are patients monitored? Patients will usually have scheduled meetings with their healthcare provider while they are being treated with sargramostim. Typically, blood will be drawn to check levels of blood cells and to monitor functions of some organ systems, such as the kidneys or liver. Patients may also undergo physical examinations, scans or other measures to assess side effects and response to therapy. Levels of white blood cells are of particular importance in patients receiving sargramostim.
Patients will also be monitored for reactions that occur either during infusion or following infusion of sargramostim that include difficulty in breathing, wheezing, fainting, hives, increased heart rate, low blood pressure, and reddening of the face or neck. Patients experiencing these symptoms should tell their healthcare provider immediately.
Patients are also monitored for an uncommon (less than 1%) condition called capillary leak syndrome, in which fluid “leaks” from the veins and capillaries into surrounding tissues. This results in low fluid and blood volume to organs. Patients experiencing dizziness, sudden or extreme weight gain, difficulty breathing, little or no urine output or chest pain should notify their healthcare provider immediately.
In addition, patients may have their heart function monitored, as heart rhythm may be affected by sargramostim. Patients will also be monitored for blood clots. If patients experience redness, swelling or pain in one extremity and not the other, sudden difficulty or pain in breathing, a sudden and severe headache or visual changes should contact their healthcare provider immediately.
What are the most common side effects of treatment with sargramostim?
• A “first dose effect” may occur, which is characterized by an increased heart rate, feeling faint, low blood pressure and reddening of the face. This tends to only happen on the first dose of sargramostim
• Diarrhea or stomach upset
• Swelling, pain, redness, tenderness at the site of injection
• Flu-like symptoms that may include fever, headache, achiness or pain, weakness and fatigue
• Bone pain
• Swelling of feet or hands
This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.
Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.
What can patients do to help alleviate or prevent discomfort and side effects?
• Pay careful attention to the physician’s instructions and inform the physician of any side effects.
• Maintain adequate rest and nutrition.
• Wear sunscreen and protective clothing and try to minimize sun exposure.
• Drink plenty of fluids. (Patients should ask their physician about the amount of liquid to consume during a day.)
• Patients being treated with sargramostim are often at risk of developing an infection from low immune cell levels caused by their treatment. Staying away from large crowds or other people that are not feeling well will reduce the risk of infection.
• Wash hands well to reduce the risk of infection.
• Rotate sites on the body where sargramostim is injected.
• Do not rub skin before or after injection.
• Ice applied to the site of injection prior to administration may help alleviate pain.
Are there any special precautions patients should be aware of before starting treatment?
• Patients should inform their physician if they are pregnant, breastfeeding or planning a family in the near future. This drug may cause birth defects. It is important to use some kind of birth control while undergoing treatment. Also, patients may want to talk to their physician if they are considering having children in the future, since some drugs may cause fertility problems.
• It is important that patients inform their physician of any pre-existing conditions (chicken pox, heart disease, kidney disease, liver disease, lung disease, etc.) as they may worsen with this drug.
• Patients should inform their physician of any other medication they are taking (whether prescription or over-the-counter, including vitamins, herbs, etc.) as they may interfere with treatment.
• Patients should check with their physician before starting any new drug or nutritional supplement.
• Patients should inform their physician of any known drug or food allergies or any reactions to medications they have experienced in the past.
• Sargramostim may enhance complications associated with the following pre-existing conditions: edema, pleura or pericardial infusion or capillary leak syndrome
When should patients notify their physician?
• Signs of an allergic reaction – difficulty breathing, chest pain, hives, fainting, increased heart rate or reddening of the face or neck, skin rash, hives
• Signs of capillary leak syndrome - dizziness, sudden or extreme weight gain, difficulty breathing, chest pain, little or no urine output or chest pain
• Chest pain, rapid or irregular pulse
• Signs of infection – redness, swelling, pus
• Cold or flu-like symptoms – cough, sore throat, fever, chills, runny nose, achiness
• Signs of a blood clot – swelling, redness or pain of one extremity and not the other, sudden difficulty or pain in breathing, sudden and severe headache and/or visual disturbances
• Severe bone pain
What is a package insert?
A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.
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