sargramostim

Generic Name: sargramostim (sar GRA moe stim)
Brand Name: Leukine

What is sargramostim?

Sargramostim 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.

Sargramostim is used to increase white blood cells and help prevent serious infection in conditions such as leukemia, bone marrow transplant, and pre-chemotherapy blood cell collection. Sargramostim is for use in adults who are at least 55 years old.

Sargramostim may also be used for purposes not listed in this medication guide.

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

You should not use this medication if you are allergic to sargramostim or to yeast. Sargramostim should not be used within 24 hours before or after you receive chemotherapy or radiation.

Before you receive sargramostim, 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.

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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 this medication.

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

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

You should not use this medication if you are allergic to sargramostim or to yeast. Sargramostim should not be used within 24 hours before or after you receive chemotherapy or radiation.

To make sure you can safely use sargramostim, tell your doctor if you have any of these other conditions:

  • fluid retention;

  • a buildup of fluid around your lungs (also called pleural effusion);

  • bone marrow cancer;

  • heart disease, high blood pressure; congestive heart failure;

  • epilepsy or other seizure disorder;

  • liver or kidney disease; or

  • asthma, chronic obstructive pulmonary disease (COPD), or other breathing problems.

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

FDA pregnancy category C. It is not known whether sargramostim will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether sargramostim passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I use sargramostim?

Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Sargramostim should not be used within 24 hours before or after you receive chemotherapy or radiation.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Sargramostim is injected into a vein or under the skin. You may be shown how to use injections at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles, syringes, IV tubing, and other items used to inject the medicine.

When injected into a vein, sargramostim must be given slowly. The IV infusion can take up to 24 hours to complete.

Use a different place on your stomach, thigh, or upper arm each time you give the injection under the skin. Just before you give the injection, apply an ice pack to the skin for one minute. Your care provider will show you the best places on your body to inject the medication. Do not inject into the same place two times in a row.

Sargramostim powder must be mixed with a liquid (diluent) before using it. If you are using the injections at home, be sure you understand how to properly mix and store the medication.

Do not shake the mixed medicine or it may foam. Do not use the medication if it has changed colors or has particles in it. Call your doctor for a new prescription.

To be sure this medication is helping your condition, your blood may need to be tested often. This will help your doctor determine how long to treat you with sargramostim. Your liver function will also need to be tested. Visit your doctor regularly.

Store the liquid medicine in the refrigerator, do not freeze. Protect from light. You may take the medicine out and allow it to reach room temperature before measuring your dose in a syringe. Then return the medicine to the refrigerator. Throw away any unused liquid after 20 days.

After mixing sargramostim powder with a diluent, store in the refrigerator and use it within 6 hours. Do not freeze. Protect from light. If you have mixed the powder with bacteriostatic water, you may store this mixture in the refrigerator for up to 20 days.

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose of sargramostim.

What happens if I overdose?

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.

What should I avoid while using sargramostim?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Sargramostim side effects

Some people receiving a sargramostim injection have had a reaction to the infusion (when the medicine is injected into the vein). 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 during the injection.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • high fever, chills, sore throat, stuffy nose, flu symptoms;

  • white patches or sores inside your mouth or on your lips;

  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

  • swelling, rapid weight gain;

  • chest pain, fast or uneven heart rate;

  • weakness or fainting;

  • black, bloody, or tarry stools;

  • coughing up blood or vomit that looks like coffee grounds;

  • painful or difficult urination;

  • dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

  • breathing problems; or

  • problems with vision, speech, balance, or memory.

Less serious side effects may include:

  • nausea, stomach pain, vomiting, diarrhea, loss of appetite;

  • tired feeling;

  • hair loss;

  • weight loss;

  • headache;

  • mild skin rash or itching;

  • bone pain;

  • joint or muscle pain; or

  • redness, swelling, or irritation where the injection was given.

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.

See also: Side effects (in more detail)

Sargramostim dosing information

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:

Sargramostim has not been FDA approved for use in pediatric patients (less than 18 years of age).

8 to 32 mcg/kg/day IV or subcutaneously, administered once a day.

Usual Pediatric Dose for Bone Marrow Transplantation:

Sargramostim has not been FDA approved for use in pediatric patients (less than 18 years of age).

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:

Sargramostim has not been FDA approved for use in pediatric patients (less than 18 years of age).

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.

What other drugs will affect sargramostim?

Tell your doctor about all other medicines you use, especially:

  • lithium (Eskalith, Lithobid); or

  • a steroid such as prednisone (Meticorten, Sterapred), methylprednisolone (Medrol), dexamethasone (Decadron), and others.

This list is not complete and other drugs may interact with sargramostim. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

  • Your doctor or pharmacist can provide more information about sargramostim.
  • 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.
  • Disclaimer: 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 1996-2012 Cerner Multum, Inc. Version: 3.02. Revision Date: 2010-12-15, 5:01:39 PM.

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