Generic Name: Sargramostim Brand Name(s): Generics only. No brands available.

Uses

What is Sargramostim used for?

Sargramostim is a man-made version of a certain natural substance made in your body. It is used to help your body make more white blood cells. White blood cells are important to help you fight off infections. Sargramostim is given to people whose ability to make white blood cells is reduced (for instance, due to chemotherapy). It is also used in certain treatment procedures (such as bone marrow/stem cell transplant).

How should I take Sargramostim?

This medication is given by injection under the skin or into a vein as directed by your doctor, usually once a day. The dosage is based on your medical condition, body size, lab tests, and response to treatment.

If you are using this medication at home, learn all preparation and usage instructions from your health care professional and the product package. Take the medication out of the refrigerator at least 30 minutes before you inject it to allow it to reach room temperature. Do not shake the medication. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid.

If you are injecting this drug under the skin, first clean the injection site with rubbing alcohol. Change the injection site each time to lessen injury under the skin. Do not inject sargramostim into skin that is bruised, tender, red, hard, or that has scars or stretch marks.

Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same time each day.

This medication may cause a reaction after the first dose of each treatment period. Tell your doctor or nurse right away if you have any signs of a serious reaction, including: flushing, shortness of breath, dizziness, fainting, or fast heartbeat.

Learn how to store and discard medical supplies safely.

If you are receiving cancer chemotherapy or radiation treatment, you should not use this medication within 24 hours before or 24 hours after chemotherapy or radiation treatment. Ask your doctor for specific directions about when to use this medication.

How do I store Sargramostim?

Sargramostim is best stored in the refrigerator. To prevent drug damage, do not freeze. There may be different brands of Sargramostim that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Sargramostim down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using Sargramostim?

Before using sargramostim, tell your doctor or pharmacist if you are allergic to it; or to yeast; or if you have any other allergies. This product may contain inactive ingredients (such as benzyl alcohol), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: lung disease, heart problems (such as heart failure, irregular heartbeat), liver disease, kidney disease, swelling (edema).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

Is it safe during pregnancy or breast-feeding?

There are no adequate studies in women for determining risk when using this Sargramostim during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Sargramostim. Sargramostim is pregnancy risk category C according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

  • A=No risk,
  • B=No risk in some studies,
  • C=There may be some risk,
  • D=Positive evidence of risk,
  • X=Contraindicated,
  • N=Unknown

Side effects

What side effects can occur from Sargramostim?

Aching or pain in the bones and muscles or headache may occur. Taking a non-aspirin pain reliever such as acetaminophen may help relieve pain. Ask your doctor or pharmacist for more details. Redness, swelling, itching, or bruising at the injection site may also occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: fast/irregular heartbeat, chest pain, sudden weight gain, swelling ankles/feet/hands, shortness of breath, black/bloody stools, stomach/abdominal pain, vomit that is bloody or looks like coffee grounds, vision problems.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Sargramostim?

Sargramostim may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Does food or alcohol interact with Sargramostim?

Sargramostim may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Sargramostim?

Sargramostim may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using this Sargramostim.

What is the dose of Sargramostim for an adult?

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.

Renal Dose Adjustments

No adjustment recommended

Liver Dose Adjustments

No adjustment recommended

Dose Adjustments

If dyspnea occurs during administration: Reduce the infusion rate by half; if respiratory symptoms worsen despite infusion rate reduction: Discontinue this drug; subsequent IV infusions may be administered following the standard dose schedule with careful monitoring.

Neutrophil recovery following chemotherapy in acute myelogenous leukemia (AML):

-If leukemic regrowth occurs: Discontinue this drug immediately.

-If a severe adverse reaction occurs: May reduce dose by 50% or temporarily discontinue until the reaction subsides.

Mobilization of peripheral blood progenitor cells (PBPCs):

-If WBC is greater than 50,000 cells/mm3: Reduce dose by 50%.

-If inadequate progenitor cells are collected: Consider other mobilization therapy.

Myeloid reconstitution after bone marrow transplantation (BMT):

-If a severe adverse reaction occurs: May reduce dose by 50% or temporarily discontinue until the reaction subsides.

-If blast cells appear or disease progression occurs: Discontinue this drug immediately.

BMT failure or engraftment delay:

-If a severe adverse reaction occurs: May reduce dose by 50% or temporarily discontinue until the reaction subsides.

-If blast cells appear or disease progression occurs: Discontinue this drug immediately.

Other Comments

Administration advice: This drug should be used under the guidance and supervision of a health care professional unless determined otherwise by the physician.

Storage requirements: The manufacturer product information should be consulted.

Reconstitution/preparation techniques: The manufacturer product information should be consulted.

IV compatibility: No other medication should be added to infusion solutions containing this drug.

Monitoring:

-Hematologic: Complete blood count (CBC) with differential and examination for blast cells twice a week.

-Hepatic: Hepatic function in patients displaying liver dysfunction prior to initiation of treatment and at least every other week during treatment.

-Metabolic: Body weight and hydration status.

-Renal: Renal function in patients displaying kidney dysfunction prior to initiation of treatment and at least every other week during treatment.

-Respiratory: Respiratory symptoms during and immediately after infusion of this drug, especially in patients with preexisting lung disease.

Patient advice:

-If the physician determines that this drug may be used outside of the hospital or office setting, the people who will be administering this drug should be instructed regarding proper reconstitution, administration, and disposal of this drug.

-Female patients of childbearing potential should be apprised of the potential harm to the fetus.

What is the dose of Sargramostim for a child?

The dosage has not been established in pediatric patients. It may be unsafe for your child. It is always important to fully understand the safety of the drug before using. Please consult with your doctor or pharmacist for more information.

How is Sargramostim available?

Sargramostim is available in the following dosage forms and strengths:

  • Injectable powder for injection,
  • Injectable solution.

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Sargramostim, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

 

Hello Health Group does not provide medical advice, diagnosis or treatment.

Sources

Review Date: April 26, 2018 | Last Modified: April 26, 2018

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