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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 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 medicine if you are allergic to sargramostim or to yeast.

Do not use sargramostim within 24 hours before or after you receive chemotherapy or radiation.

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

You should not use this medicine if you are allergic to sargramostim or to yeast.

Your doctor will perform blood tests to make sure you do not have conditions that would prevent you from safely using sargramostim.

To make sure sargramostim is safe for you, tell your doctor if you have:

  • 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), sleep apnea, or other breathing disorder.

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

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether sargramostim passes into breast milk or if it could affect a nursing baby. Tell your doctor if you are breast-feeding.

How should I use sargramostim?

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Do not use sargramostim within 24 hours before or after you receive chemotherapy or radiation.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

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

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

Your care provider will show you the best places on your body to inject sargramostim under the skin. Use a different place each time you give an injection. 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 medicine.

After mixing sargramostim powder with sterile water for injection, you must use the medicine within 6 hours. After mixing the powder with bacteriostatic water for injection, you must use the medicine within 20 hours. Store mixed medicine in a refrigerator until you are ready to use it. Do not freeze.

Sargramostim liquid does not need to be mixed with a diluent.

Do not shake the mixed medicine. Prepare your dose only when you are ready to give an injection. Do not use if the medicine has changed colors or has particles in it. Call your pharmacist for new medicine.

You may need frequent medical tests to help your doctor determine how long to treat you with sargramostim. Your liver function may also need to be checked.

Tell your doctor if you have any changes in height or weight. Sargramostim doses are based on body surface area (height and weight), and any changes may affect your dose.

Store unmixed sargramostim in the refrigerator. Do not freeze. Once you have punctured the vial with a needle, the medicine may be used for up to 20 days. Throw the vial away after 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?

Avoid combining sargramostim mixtures that have been prepared at different times or with different diluents.

Sargramostim side effects

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

Call your doctor at once if you have:

  • fever, chills, sore throat, weakness, general ill feeling;

  • swollen gums, painful mouth sores, pain when swallowing;

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

  • chest pain, fast heartbeats;

  • shortness of breath (even while lying down);

  • a light-headed feeling, like you might pass out;

  • eye redness;

  • low red blood cells (anemia)--pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating; or

  • signs of stomach bleeding--bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds.

Common side effects may include:

  • nausea, vomiting, stomach pain;

  • itching;

  • bone pain, muscle or joint pain;

  • headache, dizziness; or

  • pain, swelling, or irritation where the medicine was injected.

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.

Side Effects (complete list)

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 less than 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 less than 5% blasts. Continue until absolute neutrophil count (ANC) is greater than 1500 cells/mm3 for 3 consecutive days or a maximum of 42 days.

Use: To shorten time to neutrophil recovery and to reduce the incidence of severe and life-threatening infections and infections resulting in death following induction chemotherapy in older adult patients with acute myelogenous leukemia (AML). Safety and efficacy have not been assessed in AML patients younger than 55 years.

Usual Adult Dose for Bone Marrow Transplantation -- Myeloid Reconstruction:

250 mcg/m2/day IV over 2 hours beginning 2 to 4 hours after bone marrow infusion and at least 24 hours after the last dose of chemotherapy or radiotherapy when absolute neutrophil count (ANC) is less than 500 cells/mm3; continue until ANC is greater than 1500 cells/mm3 for 3 consecutive days.

Uses:
-To accelerate myeloid recovery in patients with non-Hodgkin's lymphoma (NHL), acute lymphoblastic leukemia (ALL), and Hodgkin's disease undergoing autologous bone marrow transplantation (BMT).
-To accelerate myeloid recovery in patients undergoing allogeneic BMT from human leukocyte antigen (HLA)-matched related donors.

Usual Adult Dose for Bone Marrow Transplantation -- Failure or Engraftment Delay:

250 mcg/m2/day IV for 14 days as a 2 hour 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 this drug, 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).

Use: To prolong survival of patients who are experiencing graft failure or engraftment delay, in the presence or absence of infection, following autologous or allogeneic bone marrow transplantation (BMT).

Usual Adult Dose for Peripheral Progenitor Cell Transplantation:

MOBILIZATION:
250 mcg/m2/day IV over 24 hours or subcutaneously once a day. Continue at the same dose throughout peripheral blood progenitor cell (PBPC) collection.

Comments: Optimal PBPC collection times have not been established; in clinical studies, collection usually began by day 5 and was performed daily until protocol targets were achieved.

Use: Mobilization of hematopoietic progenitor cells into peripheral blood for collection by leukapheresis.

POST-TRANSPLANT:
250 mcg/m2/day IV over 24 hours or subcutaneously once a day immediately following progenitor cell infusion and continuing until absolute neutrophil count (ANC) is greater than 1500 cells/mm3 for 3 consecutive days.

Use: To further accelerate myeloid reconstitution following PBPC transplantation.

What other drugs will affect sargramostim?

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

  • lithium; or

  • a steroid such as prednisone, methylprednisolone, dexamethasone, and others.

This list is not complete. Other drugs may interact with sargramostim, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

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: 4.02.

Date modified: December 03, 2017
Last reviewed: April 10, 2017

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