Sargramostim
Sargramostim is a man-made growth factor that helps the body rebuild white blood cells, used after certain chemotherapy, bone marrow transplants, and radiation exposure.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Sargramostim (Leukine) is a lab-made copy of GM-CSF, a natural protein that signals the bone marrow to make infection-fighting white blood cells. It is a specialist drug, on the market since about 1991, used after certain leukemia chemotherapy, bone marrow transplants and dangerous radiation exposure. Fever, tiredness, nausea, diarrhea and mild swelling are what people notice most, and these are usually manageable. The thing to watch for is an allergic reaction or fluid buildup, so report trouble breathing, faintness, hives or sudden swelling right away, and expect regular blood counts so your white cells recover without climbing too high.
Clinical pearls
- Leukine is never given within 24 hours before or after chemotherapy or radiation, since that timing can damage blood cells.
- Tell your prescribers if you take lithium or a steroid such as prednisone, as both can push white counts too high.
- For newborns and low-birth-weight babies, confirm the preservative-free form is used, because benzyl alcohol in one form can be fatal.
- Do not breastfeed during treatment or for at least 2 weeks after the last dose.
Patient information guide A plain-language walkthrough of Sargramostim, written from its FDA label.
What Sargramostim is used for
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Sargramostim (brand name Leukine) is approved to help the body rebuild white blood cells in several serious situations:
- Leukine speeds neutrophil recovery and reduces severe infections after induction chemotherapy in adults 55 and older with acute myeloid leukemia (AML).
- Leukine is used to move blood stem cells from the bone marrow into the bloodstream for collection before an autologous transplant (stem cell mobilization) in adults with cancer.
- Leukine accelerates bone marrow recovery after autologous peripheral blood or bone marrow transplantation in adults and children aged 2 and older with non-Hodgkin's lymphoma, acute lymphoblastic leukemia, or Hodgkin's lymphoma.
- Leukine accelerates bone marrow recovery after allogeneic (donor) bone marrow transplantation in adults and children aged 2 and older.
- Leukine treats delayed neutrophil recovery or graft failure after autologous or allogeneic bone marrow transplantation in adults and children aged 2 and older.
- Leukine increases survival in adults and children from birth through age 17 who have been acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome, or H-ARS).
How Sargramostim works
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Sargramostim is a laboratory-made version of a protein your body naturally produces called GM-CSF (granulocyte-macrophage colony-stimulating factor). It works by binding to receptors on immature blood-forming cells in the bone marrow, telling them to multiply and mature into neutrophils, monocytes, macrophages, and other infection-fighting cells. This speeds up immune recovery when the bone marrow has been damaged by chemotherapy, radiation, or transplant conditioning.
Beyond just stimulating new cell production, sargramostim also activates mature white blood cells, making them better at fighting bacteria, fungi, and parasites. It primarily acts on the myeloid cell line — the branch of blood cell production responsible for most white blood cells — but can also support platelet and red blood cell precursors to some extent.
Sargramostim dosage
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Leukine is given only by injection — either as an intravenous (IV) infusion into a vein or as a subcutaneous (SC) injection under the skin. The route and duration of the infusion vary by indication: for AML the IV infusion runs over 4 hours; for bone marrow reconstitution it runs over 2 hours; for stem cell mobilization it may run over 24 hours or be given as a once-daily SC injection. For radiation exposure (H-ARS), it is given as a once-daily subcutaneous injection, with the dose based on body weight.
- It is not taken by mouth, so there are no food restrictions.
- Your care team will set the schedule and monitor your blood counts twice weekly during treatment.
- Always follow your prescriber's exact instructions — do not adjust the dose or timing on your own.
Dosing details from the FDA-approved label
From the Sargramostim prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- AML, Neutrophil recovery following chemotherapy
- 250 mcg/m2/day administered intravenously over a 4-hour period
- Mobilization of peripheral blood progenitor cells
- 250 mcg/m2/day administered intravenously over 24 hours or subcutaneous injection once daily
- Post peripheral blood progenitor cell transplantation
- 250 mcg/m2/day administered intravenously over 24 hours or subcutaneous injection once daily
- Myeloid reconstitution after autologous or allogeneic BMT
- 250 mcg/m2/day administered intravenously over a 2-hour period
- BMT failure or engraftment delayed
- 250 mcg/m2/day for 14 days as a 2-hour intravenous infusion
- Patients acutely exposed to myelosuppressive doses of radiation: adults and pediatric patients weighing >40 kg
- 7 mcg/kg once daily as subcutaneous injection
- Weight-based dose for patients >40 kg
- Patients acutely exposed to myelosuppressive doses of radiation: pediatric patients 15 kg to 40 kg
- 10 mcg/kg once daily as subcutaneous injection
- Weight-based dose for 15 kg to 40 kg
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION See Full Prescribing Information for dosage adjustments and timing of administration ( 2.1 - 2.6 ). AML, Neutrophil recovery following chemotherapy: 250 mcg/m 2 /day administered intravenously over a 4-hour period. ( 2.1 ) Mobilization of peripheral blood progenitor cells: 250 mcg/m 2 /day administered intravenously over 24 hours or subcutaneous injection once daily. ( 2.2 ) Post peripheral blood progenitor cell transplantation: 250 mcg/m 2 /day administered intravenously over 24 hours or subcutaneous injection once daily. ( 2.3 ) Myeloid reconstitution after autologous or allogeneic BMT: 250 mcg/m 2 /day administered intravenously over a 2-hour period. ( 2.4 ) BMT failure or engraftment delayed: 250 mcg/m 2 /day for 14 days as a 2-hour intravenous infusion. ( 2.5 ) Patients acutely exposed to myelosuppressive doses of radiation, administer once daily as subcutaneous injection: Adults and pediatric patients weighing >40 kg: 7 mcg/kg Pediatric patients 15 kg to 40 kg: 10 mcg/kg Pediatric patients <15 kg: 12 mcg/kg ( 2.6 ) 2.1 Neutrophil Recovery Following Induction Chemotherapy for Acute Myeloid Leukemia The recommended dose is 250 mcg/m 2 /day administered intravenously over a 4-hour period starting approximately on day 11 or four 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 necessary, administer LEUKINE approximately four days after the completion of chemotherapy if the bone marrow is hypoplastic with less than 5% blasts. Continue LEUKINE until an absolute neutrophil count (ANC) greater than 1500 cells/mm 3 for 3 consecutive days or a maximum of 42 days. Do not administer LEUKINE within 24 hours preceding or following receipt of chemotherapy or radiotherapy [see Warnings and Precautions ( 5.3 )] .
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Sargramostim side effects
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The most common side effects of Leukine include:
Common side effects
- Fever
- Nausea and vomiting
- Diarrhea
- Fatigue or weakness
- Rash or skin reactions
- Swelling (edema)
- Loss of appetite
- Hair loss (alopecia)
- Mouth sores (stomatitis)
When to get medical help
- Call your doctor right away if you have trouble breathing, feel faint, or develop hives or swelling — these may be signs of a serious allergic reaction or anaphylaxis.
- Tell your care team immediately if you notice your face or limbs swelling significantly, or feel short of breath — this could be fluid buildup or capillary leak syndrome.
- Seek help if you experience a rapid or irregular heartbeat (supraventricular arrhythmia), especially if you have a history of heart rhythm problems.
- Contact your doctor if you develop signs of infection or if your condition seems to be getting worse during treatment.
- Neonates and low-birth-weight infants given Leukine reconstituted with bacteriostatic water (containing benzyl alcohol) may develop a life-threatening 'gasping syndrome' — always confirm the correct formulation is used.
Sargramostim warnings and precautions
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- Serious allergic reactions: Anaphylaxis has been reported. If you have a severe allergic reaction, Leukine must be stopped immediately and permanently.
- Infusion-related reactions: During IV infusions, some patients experience breathing difficulty, low blood pressure, flushing, or a racing heart — particularly with the first dose. The infusion can be slowed or stopped if this happens.
- Fluid buildup and capillary leak: Leukine can cause fluid to collect around the lungs or heart, or cause widespread fluid leakage from blood vessels. Monitor for unusual weight gain or swelling.
- Heart rhythm problems: Supraventricular arrhythmia (irregular fast heartbeat) has occurred, especially in patients with a prior history of arrhythmia.
- Do not give with chemotherapy or radiation: Leukine must not be given within 24 hours of chemotherapy or radiotherapy — doing so can cause severe and potentially fatal blood toxicity.
- High white blood cell count (leukocytosis): Blood counts must be checked twice weekly. If white counts become dangerously high, the dose may be reduced or stopped.
- Benzyl alcohol danger in infants: The lyophilized (powder) form of Leukine reconstituted with bacteriostatic water contains benzyl alcohol, which can be fatal in newborns and low-birth-weight infants. The preservative-free formulation must be used in these patients.
- Potential tumor growth: As a growth factor, Leukine may theoretically stimulate certain myeloid cancers. If disease progression is detected, treatment should be stopped.
Sargramostim interactions
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Sargramostim has a limited number of known drug interactions, but they matter:
- Lithium (used for bipolar disorder): May amplify sargramostim's white blood cell-stimulating effect, risking dangerously high counts. Avoid combining when possible; monitor closely if used together.
- Corticosteroids (such as prednisone or dexamethasone): Can also enhance the myeloproliferative (white blood cell-boosting) effect of sargramostim, increasing the risk of leukocytosis. Use together with caution and close monitoring.
- Chemotherapy and radiation therapy: Leukine must not be given within 24 hours before or after these treatments. Concurrent use caused significantly higher rates of serious infections, low platelets, and deaths in clinical studies.
Interactions listed in the FDA-approved label
From the Sargramostim prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Lithium: May increase the myeloproliferative effects of LEUKINE. Avoid concomitant use; if both are given, monitor frequently for clinical and laboratory signs of excess myeloproliferative effects.
- Corticosteroids: May increase the myeloproliferative effects of LEUKINE. Avoid concomitant use; if both are given, monitor frequently for clinical and laboratory signs of excess myeloproliferative effects.
Read the label’s full interactions text
7 DRUG INTERACTIONS Use with caution in patients receiving drugs that may potentiate LEUKINE's myeloproliferative effects, such as lithium and corticosteroids. ( 7.1 ) 7.1 Concomitant Use with Products that Induce Myeloproliferation Avoid the concomitant use of LEUKINE and products that induce myeloproliferation (such as lithium and corticosteroids). Such products may increase the myeloproliferative effects of LEUKINE. Monitor patients receiving both LEUKINE and products that induce myeloproliferation frequently for clinical and laboratory signs of excess myeloproliferative effects.
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Sargramostim
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- Do not use Leukine if you have ever had a serious allergic reaction (including anaphylaxis) to sargramostim, yeast-derived products, or any ingredient in Leukine.
- Tell your doctor if you have a history of heart arrhythmia (irregular heartbeat) or heart disease — Leukine may worsen heart rhythm problems.
- Tell your doctor if you have pre-existing fluid retention, lung problems, or pulmonary infiltrates (fluid in lung tissue) — Leukine can make these worse.
- Tell your doctor if you have a cancer with myeloid (blood-forming cell) characteristics — Leukine could theoretically stimulate tumor growth.
- If you are pregnant or trying to become pregnant, tell your doctor — animal studies show Leukine may harm the developing baby. If Leukine must be used during pregnancy, avoid the benzyl alcohol–containing formulation.
- Do not breastfeed during Leukine treatment or for at least 2 weeks after the last dose.
- For infants and young children: Leukine is established as safe and effective in children 2 years and older for most transplant-related uses. In newborns and low-birth-weight infants, the preservative-free formulation must be used to avoid potentially fatal benzyl alcohol toxicity.
- Older adults: Clinical studies had limited numbers of patients over 65, so differences in response compared to younger patients are not fully characterized — follow your prescriber's guidance closely.
Sargramostim overdose
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Taking too much sargramostim can cause a very high white blood cell count (up to 200,000 cells/mm³ in reported cases), along with breathing difficulty, nausea, fever, rash, rapid heartbeat, headache, and chills. In clinical experience, these effects reversed after the drug was stopped. If an overdose is suspected, Leukine should be discontinued immediately and the patient monitored for rising white blood cell counts and respiratory symptoms.
What Sargramostim does in the body
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Sargramostim directly stimulates bone marrow precursor cells to produce more neutrophils, eosinophils, monocytes/macrophages, megakaryocytes (which make platelets), and dendritic cells (which help coordinate immune responses). In patients with AML undergoing chemotherapy, Leukine significantly shortened the time until neutrophil counts recovered to safe levels. It also enhances the ability of mature white blood cells to fight bacteria, fungi, and parasites, and can activate monocytes to attack certain cancer cells.
How your body processes Sargramostim
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When given intravenously, sargramostim reaches peak blood levels during or right after the infusion ends. When given as a subcutaneous (under-the-skin) injection, the drug is detectable in the blood within 15 minutes and reaches its peak concentration in about 2.5 to 4 hours, with an absolute bioavailability of 75% compared to IV administration. The drug is cleared quickly — its elimination half-life (the time it takes for the body to clear half the drug) is about 1.4 hours after subcutaneous dosing. Because sargramostim is a protein, the body breaks it down into small peptides and amino acids rather than processing it through the liver like most small-molecule drugs; no accumulation occurs with repeated once-daily dosing.
How to store Sargramostim
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Store LEUKINE vials refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze or shake.
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Sargramostim: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Sargramostim — the kind of thing our pharmacy team would talk through with you at the counter.
Why was I prescribed Leukine? What does it actually do?
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How will I get this medication? Do I take it as a pill?
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What side effects should I actually expect?
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Are there any medications I should avoid while taking Leukine?
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Is this safe if I'm pregnant or breastfeeding?
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Will my blood be monitored while I'm on this?
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Is Sargramostim available over the counter?
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When was Sargramostim first available?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Sargramostim on HelloPharmacist
Sargramostim forms and strengths (how it comes)
Sargramostim is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Injection
How this form is used
- Leukine intravenous infusion is used to speed neutrophil recovery after induction chemotherapy in adults 55 and older with acute myeloid leukemia (AML).
- Leukine given intravenously or by subcutaneous injection is used to mobilize stem cells into the bloodstream before collection for autologous transplant.
- Leukine given intravenously or by subcutaneous injection is used to accelerate bone marrow recovery after autologous or allogeneic bone marrow or blood cell transplantation.
- Leukine given by subcutaneous injection is used to improve survival in patients exposed to myelosuppressive doses of radiation (H-ARS).
- Leukine for AML neutrophil recovery is given as an intravenous infusion over 4 hours, once daily.
- Leukine for stem cell mobilization and post-transplant recovery may be given as an intravenous infusion over 24 hours or as a once-daily subcutaneous injection, depending on the specific use.
- Leukine for bone marrow transplant reconstitution (autologous or allogeneic) is given as an intravenous infusion over 2 hours, once daily.
- For radiation exposure (H-ARS), Leukine is given as a once-daily subcutaneous injection; the dose is based on body weight, especially in children.
Sargramostim on the U.S. market: products, makers and brands
How Sargramostim appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
1 company lists 1 Sargramostim product record with the FDA, mostly as injection; the earliest marketing or approval year on record is 2023. Brand names on the directory include Leukine; the rest are generics.
How widely Sargramostim is used (Medicaid data)
A general measure of how commonly Sargramostim is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Sargramostim is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Sargramostim prescribed? Of the 1,601 medications we measure, Sargramostim ranks #1,280 by Medicaid prescriptions — more than 20% of them.
Utilization by Sargramostim product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
sargramostim 0.25 MG/ML Injectable Solution
Summed across the 1 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 315199
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Sargramostim, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 1 of 4 listed Sargramostim NDCs with Medicaid activity.
Compare Sargramostim products
A representative set of FDA-listed product records for Sargramostim — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Injection | ||||
| 250 mcg/mL | Intravenous, Subcutaneous | Partner Therapeutics, Inc. | BLA | View NDC → |
Showing 1 of 1 products — FDA National Drug Code Directory. See every product, package size and price: browse all 1 Sargramostim NDCs →
Sargramostim side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Sargramostim — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Sargramostim in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Sargramostim FDA approval history
How Sargramostim went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Sargramostim recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list no Sargramostim recalls since July 2021.
✅No Sargramostim recalls on record since July 2021Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 69634 1 dose form · 1 strength
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Dose form (SCDF) Injectable Solution RxCUI 375626In current FDA listingsClinical drug / strength (SCD) 0.25 MG/MLRxCUI 315199
Look up RxCUI 69634 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Sargramostim supply and shortage status
Whether Sargramostim is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
Sargramostim brand names
Sargramostim is sold under one brand name in the FDA directory — Leukine. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Sargramostim: manufacturers and labelers
One company lists Sargramostim products with the FDA. By number of product records, the largest are Partner Therapeutics, Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Sargramostim drug class (RxNorm)
Sargramostim belongs to the Leukocyte Growth Factor class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Sargramostim page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Partner Therapeutics, Inc is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →