Medications
Sargramostim (Leukine)
Sargramostim is a man-made colony-stimulating factor (GM-CSF) that helps the bone marrow make neutrophils and other white blood cells. It is used to shorten recovery and cut serious infections after induction chemotherapy in adults 55 and older with acute myeloid leukemia, around stem cell and bone marrow transplants, for graft failure or delayed neutrophil recovery, and to raise survival after exposure to radiation doses that suppress the marrow. Medicare Part B covers it as an injection (HCPCS J2820) in the clinician setting, and it also appears in Part D formularies.
How Medicare covers it
Part B can apply for the clinician-administered injection (the CMS Part B file carries HCPCS J2820), and Part D formularies also list it (the packaged aggregation). Part A during a covered inpatient stay.
| Coverage details | |
|---|---|
| Part B status | CMS Part B Spending by Drug HCPCS file carries J2820 (injection, sargramostim (GM-CSF), 50 mcg) — a Part B path exists for the clinician-administered setting; the at-home / formulary path is packaged from the Part D aggregation. |
| Medicare Advantage | Most Medicare Advantage plans that include drug coverage (MAPD plans) use the same formulary-and-tier system; the plan's own drug list decides coverage and copay — check the plan's formulary. |
| Medicare Supplement (Medigap) | Medicare Supplement (Medigap) plans sold today do not include prescription drug coverage; drug coverage comes from Part D or an MAPD plan. |
What it treats
Leukine is a leukocyte growth factor used: (1) to shorten time to neutrophil recovery and reduce severe, life-threatening, or fatal infections after induction chemotherapy in adults 55 and older with acute myeloid leukemia (AML); (2) to mobilize blood-forming progenitor cells for collection by leukapheresis in adults having autologous stem cell transplantation; (3) to speed myeloid recovery after autologous stem cell or bone marrow transplantation in adults and children 2 and older with non-Hodgkin lymphoma, acute lymphoblastic leukemia, or Hodgkin lymphoma; (4) to speed myeloid recovery after allogeneic bone marrow transplantation from HLA-matched related donors, in patients 2 and older; (5) to treat delayed neutrophil recovery or graft failure after allogeneic or autologous bone marrow transplantation, in patients 2 and older; and (6) to increase survival in patients from birth to 17 years acutely exposed to marrow-suppressing radiation doses (the hematopoietic syndrome of acute radiation syndrome).
What it is for, in depth
Sargramostim fits around chemotherapy and transplantation, where the marrow's neutrophil production is the problem: after AML induction chemotherapy in adults 55 and older, it is started about 4 days after induction ends and continued until neutrophil counts recover; around autologous and allogeneic stem cell and bone marrow transplants, it mobilizes progenitor cells for collection and speeds myeloid recovery afterward; for delayed recovery or graft failure it is given in 14-day courses; and after marrow-suppressing radiation exposure it is a weight-based daily under-skin injection started as soon as possible. The current label carries only one form: a 250 mcg single-dose vial of powder for reconstitution. It is never given within 24 hours of chemotherapy or radiotherapy.
How it works
Sargramostim is recombinant human GM-CSF, a colony-stimulating factor. It supports the survival, growth, and maturation of blood-forming progenitor cells, pushing them to divide and develop along the granulocyte-macrophage pathways — into neutrophils, monocytes and macrophages, and myeloid dendritic cells — and it can activate mature granulocytes and macrophages. It also increases production of eosinophils, megakaryocytes, macrophages, and dendritic cells.
How it is taken
It comes as a 250 mcg vial of powder that is mixed with 1 mL of sterile water (or bacteriostatic water) before use, and is given under the skin or into a vein. The dose for most uses is 250 mcg per square meter of body size per day: as a 4-hour IV infusion after AML induction chemotherapy (started about day 11 or 4 days after induction ends; continued until neutrophils stay above 1,500 for 3 days in a row, up to 42 days); as a 24-hour IV infusion or a daily under-skin injection for cell mobilization and after autologous transplantation; as a 2-hour IV infusion after allogeneic transplantation; and as a 2-hour IV infusion once a day for 14 days for delayed recovery or graft failure (courses may be repeated). For radiation exposure, it is a once-daily under-skin injection dosed by weight, started as soon as possible after exposure. It must never be given at the same time as, or within 24 hours before or after, chemotherapy or radiotherapy. Blood counts are checked twice a week during therapy. The label's patient information states no self catch-up rule for a missed dose: if you miss a dose of Leukine, talk to your health care provider about when you should give your next dose.
Common side effects
Common side effects depend on the setting. In autologous transplant patients: fever, nausea, diarrhea, vomiting, mouth sores, weakness, generally feeling unwell, decreased appetite, rash, stomach and bowel problems, and fluid buildup (edema). In allogeneic transplant patients: diarrhea, fever, nausea, rash, vomiting, mouth sores, decreased appetite, hair loss, abdominal pain, headache, and high blood pressure. In AML patients: fever, liver problems, skin reactions, infections, metabolic lab changes, nausea, diarrhea, urinary problems, lung problems, vomiting, nervous-system problems, mouth sores, hair loss, and weight loss.
Serious warnings
Serious allergic reactions, including anaphylaxis, can occur — stop the drug permanently if one occurs. Infusion reactions (trouble breathing, low oxygen, flushing, low blood pressure, fainting, fast heartbeat) can happen during or soon after an infusion. Giving Leukine within 24 hours of chemotherapy or radiotherapy risks severe marrow suppression — in one study with chest radiotherapy and chemotherapy, the Leukine arm had more deaths and more severe infections and low platelets. Fluid buildup and capillary leak syndrome (swelling, fluid around the lungs or heart) can occur and usually reverse when the drug is paused or the dose lowered, sometimes with water pills. Heart rhythm problems (supraventricular arrhythmias) have occurred, especially in people with prior rhythm problems. White counts can overshoot (50,000 or more) — counts are checked twice a week and return to normal within 3 to 7 days of stopping. Because GM-CSF could act as a growth factor for tumors, especially myeloid cancers, the drug is stopped if the disease progresses. Antibodies against the drug can develop with longer use. Reconstituted with bacteriostatic water, the benzyl alcohol preservative caused serious and fatal 'gasping syndrome' in newborns and low-birth-weight infants — sterile water is used for newborns and infants.
Who should be careful
Leukine is contraindicated in patients with a history of serious allergic reactions, including anaphylaxis, to human GM-CSF products such as sargramostim, to yeast-derived products, or to any component of the product (sargramostim is produced in yeast). Use with caution in people with fluid retention, fluid in the lungs, heart failure, or prior heart disease. Animal studies suggest it may cause fetal harm; if it is used in pregnancy, only the preservative-free sterile-water form should be used. Do not breastfeed during treatment and for at least 2 weeks after the last dose.
Major interactions
Avoid using Leukine together with products that themselves induce blood-cell proliferation, such as lithium and corticosteroids, because they may add to Leukine's marrow-stimulating effects; if they are used together, watch frequently for signs of excess blood-cell production.
Why it is in its tier
The most common Part D tier for this drug in the CMS data is Tier 5, the specialty tier — the highest cost share, usually a percentage of the drug's cost. This is a brand-name drug (Leukine) with no generic version in the CMS-matched products. It is listed by 4,479 of 5,495 Part D plans (81.51%), and 96.2% of listing plans place it on Tier 5. In the CMS Part D Drug Spending Dashboard data through 2024, the Leukine row averaged $37,090.71 in total spending per beneficiary — a program average across Part D (before rebates), not a reader's copay. The tier shown is the most common one across plans. Individual plans vary, so check your own plan's drug list for your exact cost.
What official patient guides say
MedlinePlus says sargramostim is used to decrease the chance of infection in people with acute myelogenous leukemia receiving chemotherapy that lowers neutrophils, in people having blood stem cell or bone marrow transplants, to prepare blood for leukapheresis, and in people whose bone marrow transplant did not respond. It comes as a solution or a powder to be mixed, injected under the skin or into a vein, infused over 2 to 24 hours once a day or injected under the skin once a day; it may be given by a nurse or health care provider, or injected at home at about the same time every day after you are shown how. Keep it in the container it came in, away from sunlight, closed and out of reach of children, stored in the refrigerator — do not freeze or shake it; opened vials may be refrigerated for up to 20 days. The MedlinePlus page states no missed-dose rule.
Part D formulary coverage
| Formulary summary | |
|---|---|
| Most common tier | 5 |
| Plans listing this drug | 4479 |
| Total Part D plans | 5495 |
| Share of plans listing it | 81.51 |
| Formularies listing it | 276 |
| Tier | Plans |
|---|---|
| Tier 1 | 123 plans |
| Tier 2 | 1 plans |
| Tier 4 | 46 plans |
| Tier 5 | 4309 plans |
Source: CMS Prescription Drug Plan Formulary, Pharmacy Network, and Pricing Information Files — Monthly file 2026-10-15 (plan year 2027), file 2027_20261008.zip (data.cms.gov dataset ed1496ea-23e7-41f1-9292-172fa842ccfb): basic drugs formulary file + plan information file, both dated 20261031 inside the zip; downloaded and aggregated 2026-10-30. Medication RxCUI sets for the expansion queue resolved from the CMS file itself and name-verified via the NLM RxNav (RxNorm) API (ops/medications/data/expansion_uncovered_names.json).
What you pay
| With Medicare Part D | |
|---|---|
| Most common tier | Tier 5 |
| Typical copay | $0 — half of plans charge between $0 and $0 |
| Typical coinsurance | 26.0% of the price |
| Based on | 4231 plans that cover this drug · 2027 plan year |
A tier is not a price; what you pay depends on your plan, pharmacy, and benefit stage; Extra Help or Medicaid can lower it further.
Sources: CMS Plan Benefit Package + formulary data; CMS NADAC · Checked 2026-11-08
Similar medications
Other medications in the same FDA pharmacologic class (Leukocyte Growth Factor):
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Part D spending averages (2024)
| Brand name | Generic name | Total claims 2024 | Total spending 2024 | Total beneficiaries 2024 | Rank by beneficiaries 2024 |
|---|---|---|---|---|---|
| Leukine | Sargramostim | 456 | 3.30107e+06 | 89 | 2769 |
Source: CMS Medicare Part D Spending by Drug (Drug Spending Dashboard), release RY26 P04 V10, data through 2024 (DSD_PTD_RY26_P04_V10_DY24_BGM.csv), downloaded 2026-10-30
Companies covering this drug
4,479 plans from 472 companies list this drug on a formulary for 2027. Search by company or plan name, or filter by tier. Cost sharing is the plan's published amount for this drug's tier in the initial coverage stage (1-month retail supply), where the plan publishes it; a blank means the plan does not publish it.
| Company | Plan | Tier | Copay | Coinsurance |
|---|
A tier is not a price; what you pay depends on your plan, pharmacy, and benefit stage; Extra Help or Medicaid can lower it further.
Coverage and costs change. Drug lists (formularies), tiers, and copays can change during the year and differ by plan. Always check with your insurance company or plan directly to confirm what is covered and what you will pay.
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