Leukine

Generic Name: sargramostim (sar grah MOSS tim)Brand Names: Leukine

What is sargramostim?

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.

What is the most important information I should know about sargramostim?

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. Contact your doctor if you develop a fever, chills, sore throat, congestion, or other signs of infection or illness while using sargramostim.

What should I discuss with my healthcare provider before using sargramostim?

Do not use sargramostim without first talking to your doctor if you have an allergy to yeast. You may have an allergic reaction to this medication.

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.

How should I use sargramostim?

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.

What happens if I miss a dose?

Contact your doctor if you miss a dose of this medication by more than a few hours.

What happens if I overdose?

Seek emergency medical attention if an overdose is suspected.

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.

What should I avoid while using sargramostim?

There are no restrictions regarding foods, beverages, or activities during treatment with sargramostim unless your doctor directs otherwise.

Sargramostim side effects

If you experience any of the following serious side effects, stop using sargramostim and seek emergency medical treatment or contact your doctor immediately:

• 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:

• bone pain;

• "flu-like" feeling;

• chills;

• muscle aching or weakness;

• tiredness;

• headache;

• diarrhea;

• nausea, upset stomach, or loss of appetite;

• rash; or

• 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.

What other drugs will affect sargramostim?

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.

Where can I get more information?

• Your pharmacist has additional information about sargramostim written for health professionals that you may read.

• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 1.04. Revision Date: 4/12/2009 4:37:31 PM.