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Leukine SARGRAMOSTIM 250 ug/mL Injection, Powder, Lyophilized, For Solution, 5 vials — NDC 71837-5843-5 (Billing 71837-5843-05)

by Partner Therapeutics, Inc. · 5 VIAL, SINGLE-DOSE in 1 CARTON / 1 mL in 1 VIAL, SINGLE-DOSE

This is a package of 5 vials of Leukine SARGRAMOSTIM 250 ug/mL Injection, Powder, Lyophilized, For Solution from Partner Therapeutics, Inc., marketed since Sep 2023 and currently FDA-listed. It is this product's only package size.

NDC 71837-5843-05
🏷️ FDA NDC (as labeled) 71837-5843-5 billing pads the package segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

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Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 71837-5843-5 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
71837 labeler · 5843 product · 5 package
Package marketed since
Sep 1, 2023
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
5 EA per package
Barcode (UPC)
0371837584354
Medicaid fills, this package
866 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 71837-5843-5
Product NDC 71837-5843
11-digit billing NDC 71837584305
NCPDP billing unit EA — each (per item)
RxCUI 208083, 315199
UNII 5TAA004E22
UPC 0371837584354
Application # BLA103362
SPL Set ID bb9a3820-f31a-4dd9-bef4-97094c01a398
Established class (EPC) Leukocyte Growth Factor
Physiologic effect Increased Myeloid Cell Production
Chemical class Granulocyte Colony-Stimulating Factor; Granulocyte-Macrophage Colony-Stimulating Factor
DEA schedule Non-controlled
Marketing category BLA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-09-01
Route INTRAVENOUS, SUBCUTANEOUS
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Substance SARGRAMOSTIM
Biologic (Purple Book) 351(a)

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 82402050002120
GPI class Leukine
GCN Seq No 015927
GCN 26221
HICL code 006074
Ingredient (HICL) Sargramostim
HIC1 code N
Therapeutic class — broad (HIC1) Bone Marrow
HIC2 code N1
Therapeutic class — intermediate (HIC2) Affecting Blood, Non-Iron Hematinics And Others
HIC3 code N1C
Therapeutic class — specific (HIC3) Leukocyte (Wbc) Stimulants
AHFS code 20:16.00.00
AHFS class Hematopoietic Agents
FDB label name LEUKINE 250 MCG VIAL
FDB brand name Leukine
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 015927
  • GCN: 26221
  • GPI-14 (Medi-Span): 82402050002120
  • HICL (First Databank): 006074
  • AHFS class code: 20:16.00.00
  • RxCUI (RxNorm): 208083
Why two NDCs? The FDA registers this code as 71837-5843-5 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 71837-5843-05. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Leukocyte Growth Factor class.

Pharmacologic class Leukocyte Growth Factor
Drug family (ATC) Colony stimulating factors
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name LEUKINE 250 MCG VIAL Ingredient Sargramostim
📗 Our plain-language guide HelloPharmacist
  • Leukine helps your body rebuild its infection-fighting white blood cells — specifically a type called neutrophils — after they've been knocked down by chemotherapy, a bone marrow t...
  • Why was I prescribed Leukine? What does it actually do?
  • Leukine is not a pill — it's always given as an injection. Depending on what it's being used for, you'll either receive it as an IV infusion through a vein (usually in a clinic or...
  • How will I get this medication? Do I take it as a pill?
📖 Read our full Sargramostim guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo $298.79 $1,493.97 / 5 ml
Medicare drug plans payPart D · Q2 2026 $311.01 $1,555.04 / 5 ml
Medicare Part B allowsASP · J2820 $62.474 / J2820 unit —
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Billing & reimbursement

FDA NDC (as labeled)71837-5843-5
11-digit billing NDC71837-5843-05
Format5-4-1 as registered → padded to 5-4-2 for billing (zero added to the package segment)
HCPCS J-codeJ2820
DescriptorInjection, sargramostim (gm-csf), 50 mcg
Billing units / pkg25 units
How the units are derivedThis package is 1; the HCPCS unit is 50 MCG, so one package = 25 billing units.
Medicare Part B spend (2026 (Q1))$227,490 · 392 claims · $580.33 per claim (all NDCs under J2820)
Crosswalk sourceCMS ASP NDC-HCPCS Crosswalk
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
71837-5843-05 You're viewing this Main listing 5 VIAL, SINGLE-DOSE in 1 CARTON / 1 mL in 1 VIAL, SINGLE-DOSE 2023-09-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Leukine 250 ug/mLthis 71837-5843-05 Partner 5 vials — — FDA listed —
About this product: this is a biologic. Biologics don't have small-molecule generics — competition comes from FDA-licensed biosimilars (shown above), not generics.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & biosimilar status

🏛️
1991
First FDA approval
Mar 1991
📍
2026
Currently FDA-listed
35 years listed
🧬
·
Biosimilars
see Purple Book
🧬Biologic — competition comes from biosimilars

Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.

FDA Purple Book — biosimilars & interchangeables ⓘ
Reference product
Leukinesargramostim
🔒 No FDA-licensed biosimilars or interchangeable biosimilars are listed yet for this biologic. It currently has no biosimilar competition in the FDA Purple Book.
Source: FDA Purple Book (purplebooksearch.fda.gov), matched on the reference product’s active ingredient.
Where does this data come from?
Patents and exclusivity from the FDA Purple Book (biologics), refreshed from public FDA data. Biosimilar launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

🧪 Avoiding an ingredient? See Sargramostim inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII QTT17582CB
    A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
  • 40 mg / 1 mL UNII 3OWL53L36A
    A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
  • 10 mg / 1 mL UNII C151H8M554
    A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.
  • 1.2 mg / 1 mL UNII 023C2WHX2V
    Tromethamine is a chemical buffer that helps maintain the proper acidity level in liquid medicines. It neutralizes acids and stabilizes the solution so the medication remains effective and safe throughout its shelf life.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

5 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerPartner Therapeutics, Inc.
FDA applicationBLA103362 (BLA)
Labeler code71837
First marketedSep 2023
Product typeHuman Prescription Drug
Portfolio2 products on file

More NDCs from Partner Therapeutics, Inc. labeler code 71837

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📄 Package Label / Principal Display Panel
🎯 Indications and Usage ~2 min read ▾

1 INDICATIONS AND USAGE LEUKINE is a leukocyte growth factor indicated: 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 adult patients 55 years and older with acute myeloid leukemia (AML). ( 1.1 ) For the mobilization of hematopoietic progenitor cells into peripheral blood for collection by leukapheresis and autologous transplantation in adult patients. ( 1.2 ) For the acceleration of myeloid reconstitution following autologous bone marrow or peripheral blood progenitor cell transplantation in adult and pediatric patients 2 years of age and older.

( 1.3 ) For the acceleration of myeloid reconstitution following allogeneic bone marrow transplantation in adult and pediatric patients 2 years of age and older. ( 1.4 ) For treatment of delayed neutrophil recovery or graft failure after autologous or allogeneic bone marrow transplantation in adult and pediatric patients 2 years of age and older. ( 1.5 ) To increase survival in adult and pediatric patients from birth to 17 years of age acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome [H-ARS]).

( 1.6 )

1.1Acute Myeloid Leukemia Following Induction Chemotherapy LEUKINE is indicated to shorten time to neutrophil recovery and to reduce the incidence of severe, life-threatening, or fatal infections following induction chemotherapy in adult patients 55 years and older with acute myeloid leukemia (AML).

1.2Autologous Peripheral Blood Progenitor Cell Mobilization and Collection LEUKINE is indicated in adult patients with cancer undergoing autologous hematopoietic stem cell transplantation for the mobilization of hematopoietic progenitor cells into peripheral blood for collection by leukapheresis.

1.3Autologous Peripheral Blood Progenitor Cell and Bone Marrow Transplantation LEUKINE is indicated for the acceleration of myeloid reconstitution following autologous peripheral blood progenitor cell (PBPC) or bone marrow transplantation in adult and pediatric patients 2 years of age and older with non-Hodgkin's lymphoma (NHL), acute lymphoblastic leukemia (ALL) and Hodgkin's lymphoma (HL).

1.4Allogeneic Bone Marrow Transplantation LEUKINE is indicated for the acceleration of myeloid reconstitution in adult and pediatric patients 2 years of age and older undergoing allogeneic bone marrow transplantation from HLA-matched related donors.

1.5Allogeneic or Autologous Bone Marrow Transplantation: Treatment of Delayed Neutrophil Recovery or Graft Failure LEUKINE is indicated for the treatment of adult and pediatric patients 2 years and older who have undergone allogeneic or autologous bone marrow transplantation in whom neutrophil recovery is delayed or failed.

1.6Acute Exposure to Myelosuppressive Doses of Radiation (H-ARS) LEUKINE is indicated to increase survival in adult and pediatric patients from birth to 17 years of age acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome [H-ARS]).

⏱️ Dosage and Administration ~3 min read ▾

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 )

2.1Neutrophil 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 )] . Dose Modifications Obtain a CBC with differential twice per week during LEUKINE therapy and modify the dose for the following: Leukemic regrowth: Discontinue LEUKINE immediately Grade 3 or 4 adverse reactions: Reduce the dose of LEUKINE by 50% or interrupt dosing until the reaction abates ANC greater than 20,000 cells/mm 3 : Interrupt LEUKINE treatment or reduce the dose by 50%

2.2Autologous Peripheral Blood Progenitor Cell Mobilization and Collection The recommended dose is 250 mcg/m 2 /day administered intravenously over 24 hours or subcutaneously once daily. Continue at the same dose through the period of PBPC collection. The optimal schedule for PBPC collection has not been established.

In clinical studies, collection of PBPC was usually begun after 5 days of LEUKINE and performed daily until protocol specified targets were achieved [see Clinical Studies ( 14 )] . If WBC greater than 50,000 cells/mm 3 , reduce the LEUKINE dose by 50%. Consider other mobilization therapy if adequate numbers of progenitor cells are not collected.

2.3Autologous Peripheral Blood Progenitor Cell and Bone Marrow Transplantation Autologous Peripheral Blood Progenitor Cell Transplantation The recommended dose is 250 mcg/m 2 /day administered intravenously over 24 hours or subcutaneously once daily beginning immediately following infusion of progenitor cells and continuing until an ANC greater than 1500 cells/mm 3 for three consecutive days is attained. Do not administer LEUKINE within 24 hours preceding or following receipt of chemotherapy or radiotherapy. Autologous Bone Marrow Transplantation The recommended dose is 250 mcg/m 2 /day administered intravenously over a 2-hour period beginning two to four hours after bone marrow infusion, and not less than 24 hours after the last dose of chemotherapy or radiotherapy.

Do not administer LEUKINE until the post marrow infusion ANC is less than 500 cells/mm 3 . Continue LEUKINE until an ANC greater than 1500 cells/mm 3 for three consecutive days is attained. Do not administer LEUKINE within 24 hours preceding or following receipt of chemotherapy or radiothe… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 38 words ▾

3 DOSAGE FORMS AND STRENGTHS For injection: 250 mcg of sargramostim as a white lyophilized powder in a single-dose vial for reconstitution For injection (lyophilized powder): 250 mcg of sargramostim in single-dose vial for reconstitution ( 3 )

⛔ Contraindications 83 words ▾

4 CONTRAINDICATIONS Do not administer LEUKINE to patients with a history of serious allergic reactions, including anaphylaxis, to human granulocyte-macrophage colony-stimulating factor such as sargramostim, yeast-derived products, or any component of the product. Anaphylactic reactions have been reported with LEUKINE [see Warnings and Precautions ( 5.1 )] . Do not administer LEUKINE to patients with a history of serious allergic reactions, including anaphylaxis, to human granulocyte-macrophage colony stimulating factor such as sargramostim, yeast-derived products, or any component of the product.

( 4 )

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS Hypersensitivity Reactions: Permanently discontinue LEUKINE in patients with serious allergic reactions. ( 5.1 ) Infusion Related Reactions: Manage using infusion rate reductions or discontinuations. ( 5.2 ) Effusions and Capillary Leak Syndrome: Manage with dose-reduction, discontinuation, or diuretics.

Monitor body weight and hydration status during therapy. ( 5.4 ) Supraventricular Arrhythmias: Risk may be increased in patients with history of cardiac arrhythmias. Manage medically and discontinue LEUKINE.

( 5.5 )

5.1Hypersensitivity Reactions Serious hypersensitivity reactions, including anaphylactic reactions, have been reported with LEUKINE. Parenteral administration of LEUKINE should be attended by appropriate precautions in case an allergic or untoward reaction occurs. If any serious allergic or anaphylactic reaction occurs, immediately discontinue LEUKINE therapy and institute medical management.

Discontinue LEUKINE permanently for patients with serious allergic reactions.

5.2Infusion Related Reactions LEUKINE can cause infusion-related reactions. Infusion-related reactions may be characterized by respiratory distress, hypoxia, flushing, hypotension, syncope, and/or tachycardia following the first administration of LEUKINE in a particular cycle. These signs have resolved with symptomatic treatment and usually do not recur with subsequent doses in the same cycle of treatment.

Observe closely during infusion for symptoms, particularly in patients with pre-existing lung disease. If patients display dyspnea or other acute symptoms, reduce the rate of infusion by 50%. If symptoms persist or worsen despite rate reduction, discontinue the LEUKINE infusion.

If patient experiences infusion-related reaction, subsequent intravenous infusions may be administered following the standard dose schedule with careful monitoring.

5.3Risk of Severe Myelosuppression when LEUKINE Administered within 24 hours of Chemotherapy or Radiotherapy Due to the potential sensitivity of rapidly dividing hematopoietic progenitor cells, LEUKINE should not be administered simultaneously with or within 24 hours preceding cytotoxic chemotherapy or radiotherapy or within 24 hours following chemotherapy. In one controlled study, patients with small cell lung cancer received LEUKINE and concurrent thoracic radiotherapy and chemotherapy or the identical radiotherapy and chemotherapy without LEUKINE.

The patients randomized to LEUKINE had significantly higher incidence of adverse reactions, including higher mortality and a higher incidence of grade 3 and 4 infections and grade 3 and 4 thrombocytopenia.

5.4Effusions and Capillary Leak Syndrome Edema, capillary leak syndrome, and pleural and/or pericardial effusion, have been reported in patients after LEUKINE administration. In 156 patients enrolled in placebo-controlled studies using LEUKINE at a dose of 250 mcg/m 2 /day by 2-hour IV infusion, the reported incidences of fluid retention (LEUKINE vs. placebo) were as follows: peripheral edema, 11% vs. 7%; pleural effusion, 1% vs.

0%; and pericardial effusion, 4% vs. 1%. Capillary leak syndrome was not observed in this limited number of studies; based on other uncontrolled studies and reports from users of marketed LEUKINE, the incidence is estimated to be less than 1%.

In patients with preexisting pleural and pericardial effusions, administration of LEUKINE may aggravate fluid retention; however, fluid retention associated with or worsened by LEUKINE has been reversible after interruption or dose reduction of LEUKINE with or without diuretic therapy. LEUKINE should be used with caution in patients with preexisting fluid retention, pulmonary infiltrates, or congestive heart failure. Body weight and hydration status should be carefully monitored during LEUKINE administration.

5.5Supraventricular Arrhythmias Supraventricular arrhythmia has been reported in uncontrolled studies during LEUKINE administration, particularly in patients wit… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following serious adverse reactions are discussed in greater detail in other sections of the labeling: Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] Infusion Related Reactions [see Warnings and Precautions ( 5.2 )] Risk of Severe Myelosuppression when LEUKINE Administered within 24 Hours of Chemotherapy or Radiotherapy [see Warnings and Precautions ( 5.3 )] Effusions and Capillary Leak Syndrome [see Warnings and Precautions ( 5.4 )] Supraventricular Arrhythmias [see Warnings and Precautions ( 5.5 )] Leukocytosis [see Warnings and Precautions ( 5.6 )] Potential Effect on Malignant Cells [see Warnings and Precautions ( 5.7 )] Immunogenicity [see Warnings and Precautions ( 5.8 )] Risk of Serious Adverse Reactions in Infants Due to Benzyl Alcohol Preservative [see Warnings and Precautions ( 5.9 )] The most common adverse reactions (incidence >30%) were ( 6.1 ): In recipients of autologous BMT: fever, nausea, diarrhea, vomiting, mucous membrane disorder, alopecia, asthenia, malaise, anorexia, rash, gastrointestinal disorder and edema.

In recipients of allogeneic BMT: diarrhea, fever, nausea, rash, vomiting, stomatitis, anorexia, high glucose, alopecia, abdominal pain, low albumin, headache and hypertension. In patients with AML: fever, liver toxicity, skin reactions, infections, metabolic laboratory abnormalities, nausea, diarrhea, genitourinary abnormalities, pulmonary toxicity, vomiting, neurotoxicity, stomatitis, alopecia and weight loss. To report SUSPECTED ADVERSE REACTIONS, contact Partner Therapeutics, Inc., at 1-888-4RX-LEUKINE or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Autologous Peripheral Blood Progenitor Cell (PBPC) and Bone Marrow Transplantation Studies 301, 302 and 303 enrolled a total of 156 patients after autologous or allogeneic marrow or PBPC transplantation. In these placebo-controlled studies, pediatric and adult patients received once-daily intravenous infusions of LEUKINE 250 mcg/m 2 or placebo for 21 days.

In Studies 301, 302, and 303, there was no difference in relapse rate between the LEUKINE and placebo-treated patients. Adverse reactions reported in at least 10% of patients who received intravenous LEUKINE or at a rate that was at least 5% higher than the placebo arm are shown in Table 1 . Table 1: Adverse Reactions after Autologous Marrow or PBPC Transplantation in at Least 10% of Patients Receiving Intravenous LEUKINE or at Least 5% Higher than the Placebo Arm Adverse Reactions by Body System LEUKINE (n=79) % Placebo (n=77) % Adverse Reactions by Body System LEUKINE (n=79) % Placebo (n=77) % Body, General Metabolic, Nutritional Disorder Fever 95 96 Edema 34 35 Mucous membrane disorder 75 78 Peripheral edema 11 7 Asthenia 66 51 Respiratory System Malaise 57 51 Dyspnea 28 31 Sepsis 11 14 Lung disorder 20 23 Digestive System Blood and Lymphatic System Nausea 90 96 Blood dyscrasia 25 27 Diarrhea 89 82 Cardiovascular Vascular System Vomiting 85 90 Hemorrhage 23 30 Anorexia 54 58 Urogenital System GI disorder 37 47 Urinary tract disorder 14 13 GI hemorrhage 27 33 Nervous System Stomatitis 24 29 CNS disorder 11 16 Liver damage 13 14 Skin and Appendages Alopecia 73 74 Rash 44 38 Additional Clinically Significant Adverse Reactions Occurring in Less than 10% Incidence Investigations : Elevated creatinine, elevated bilirubin, elevate transaminases Allogeneic Bone Marrow Transplantation In the placebo-controlled trial of 109 patients after allogeneic BMT (Study 9002), acute graft-vs-host disease occurred in 55% on the LEUKINE arm and in 59% on the placebo arm.

Adverse reactions reported in at least 10% of patients who received IV LEUKINE or at a rate at least 5%… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions 77 words ▾

7 DRUG INTERACTIONS Use with caution in patients receiving drugs that may potentiate LEUKINE's myeloproliferative effects, such as lithium and corticosteroids. ( 7.1 )

7.1Concomitant 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.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Pregnancy: Benzyl alcohol–free formulation recommended. May cause fetal harm. ( 8.1 ) Pediatrics: In infants, avoid use of benzyl alcohol–containing solutions when feasible. ( 2.7 , 5.9 , 8.4 ) Lactation: Advise women not to breastfeed. ( 8.2 )

8.1Pregnancy Risk Summary LEUKINE for injection reconstituted with Bacteriostatic Water for Injection, USP contain 0.9% benzyl alcohol, which has been associated with gasping syndrome in neonates and infants. The preservative benzyl alcohol can cause serious adverse reactions and death when administered intravenously to neonates and infants. If LEUKINE is needed during pregnancy, reconstitute LEUKINE for injection only with Sterile Water for injection without preservatives [see Dosage and Administration ( 2.7 ) and Use in Specific Populations ( 8.4 )] .

The limited available data on LEUKINE use in pregnant women are insufficient to inform the drug-associated risk of adverse developmental outcomes. Based on animal studies LEUKINE may cause embryofetal harm. In animal reproduction studies, administration of LEUKINE to pregnant rabbits during organogenesis resulted in adverse developmental outcomes including increased spontaneous abortion at systemic exposures ≥1.3 times the human exposure expected at the recommended human dose [see Data ] .

Advise pregnant women of the potential risk to a fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies are 2%-4% and 15%-20%, respectively. Data Animal data In an embryofetal developmental study and a prenatal and postnatal study, pregnant rabbits were administered SC doses of LEUKINE during the period of gestation day (GD) 6 to GD19, GD19 to GD28, or GD19 to parturition at 25, 70, and 200 mcg/kg/day. An increase in spontaneous abortions, late resorptions, and post implantation loss, and a reduction in viable fetuses, mean live litter size, and offspring body weight were evident in rabbits treated with LEUKINE at 200 mcg/kg/day.

No adverse effects were observed at ≤70 mcg/kg/day. After the first administration in rabbits, the dose of 200 mcg/kg/day corresponds to a systemic exposure (AUC) of approximately 11-25.3 times the exposures observed in patients treated with the clinical LEUKINE dose of 250 mcg/m 2 ; however, due to the production of anti-LEUKINE antibodies with repeat administration, the AUC in rabbits was reduced to 1.3-5.5 times the clinical exposure by the end of the dosing periods. Similarly, after the first administration in rabbits, the dose of 70 mcg/kg/day corresponds to a systemic exposure (AUC) of approximately 7 to 11 times the exposures observed in patients treated with the clinical LEUKINE dose of 250 mcg/m 2 ; however, due to the production of anti-LEUKINE antibodies with repeat administration, the AUC in rabbits was reduced to 1.0-1.2 times the clinical exposure by the end of the dosing periods.

8.2Lactation Risk Summary There is no information regarding the presence of LEUKINE in human milk, the effects on the breastfed child, or the effects on milk production. Administration of LEUKINE to rabbits during lactation resulted in reduction in postnatal offspring survival [see Data ] . Because of the potential for serious adverse reactions advise a lactating woman not to breastfeed during treatment and for at least 2 weeks after the last dose.

Data There are no data regarding the presence of LEUKINE in rabbit milk. However, in the prenatal and postnatal study, lactating rabbits were administered SC doses of LEUKINE during the period of lactation day (LD) 1 to LD14 at 25, 70, and 200 mcg/kg/day. At doses ≥25 mcg/kg/day a reduction in postnatal offspring survival was observed.

Maternal toxicity was also observed at LE… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary LEUKINE for injection reconstituted with Bacteriostatic Water for Injection, USP contain 0.9% benzyl alcohol, which has been associated with gasping syndrome in neonates and infants. The preservative benzyl alcohol can cause serious adverse reactions and death when administered intravenously to neonates and infants. If LEUKINE is needed during pregnancy, reconstitute LEUKINE for injection only with Sterile Water for injection without preservatives [see Dosage and Administration ( 2.7 ) and Use in Specific Populations ( 8.4 )] .

The limited available data on LEUKINE use in pregnant women are insufficient to inform the drug-associated risk of adverse developmental outcomes. Based on animal studies LEUKINE may cause embryofetal harm. In animal reproduction studies, administration of LEUKINE to pregnant rabbits during organogenesis resulted in adverse developmental outcomes including increased spontaneous abortion at systemic exposures ≥1.3 times the human exposure expected at the recommended human dose [see Data ] .

Advise pregnant women of the potential risk to a fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies are 2%-4% and 15%-20%, respectively. Data Animal data In an embryofetal developmental study and a prenatal and postnatal study, pregnant rabbits were administered SC doses of LEUKINE during the period of gestation day (GD) 6 to GD19, GD19 to GD28, or GD19 to parturition at 25, 70, and 200 mcg/kg/day. An increase in spontaneous abortions, late resorptions, and post implantation loss, and a reduction in viable fetuses, mean live litter size, and offspring body weight were evident in rabbits treated with LEUKINE at 200 mcg/kg/day.

No adverse effects were observed at ≤70 mcg/kg/day. After the first administration in rabbits, the dose of 200 mcg/kg/day corresponds to a systemic exposure (AUC) of approximately 11-25.3 times the exposures observed in patients treated with the clinical LEUKINE dose of 250 mcg/m 2 ; however, due to the production of anti-LEUKINE antibodies with repeat administration, the AUC in rabbits was reduced to 1.3-5.5 times the clinical exposure by the end of the dosing periods. Similarly, after the first administration in rabbits, the dose of 70 mcg/kg/day corresponds to a systemic exposure (AUC) of approximately 7 to 11 times the exposures observed in patients treated with the clinical LEUKINE dose of 250 mcg/m 2 ; however, due to the production of anti-LEUKINE antibodies with repeat administration, the AUC in rabbits was reduced to 1.0-1.2 times the clinical exposure by the end of the dosing periods.

🧒 Pediatric Use ~2 min read ▾

8.4Pediatric Use The safety and effectiveness of LEUKINE have been established in pediatric patients 2 years of age and older for autologous peripheral blood progenitor cells and bone marrow transplantation, allogeneic bone marrow transplantation, and treatment of delayed neutrophil recovery or graft failure. Use of LEUKINE for these indications in this age group is based on adequate and well-controlled studies of LEUKINE in adults, in addition to clinical data in 12, 23, and 37 pediatric patients, respectively [See Clinical Studies ( 14.3 , 14.4 and 14.5 )] .

The pediatric adverse reactions were consistent with those reported in the adult population. The safety and effectiveness of LEUKINE for pediatric patients less than 2 years of age for autologous peripheral blood progenitor cells and bone marrow transplantation, allogeneic bone marrow transplantation, and treatment of delayed neutrophil recovery or graft failure have not been established. The use of LEUKINE to increase survival in pediatric patients acutely exposed to myelosuppressive doses of radiation (H-ARS) is based on efficacy studies conducted in animals and clinical data supporting the use of LEUKINE in patients undergoing autologous or allogeneic BMT following myelosuppressive chemotherapy with or without total body irradiation.

Efficacy studies of LEUKINE could not be conducted in humans with acute radiation syndrome for ethical and feasibility reasons. Modeling and simulation were used to derive dosing regimens that are predicted to provide pediatric patients with exposure comparable to the observed exposure in adults receiving 7 mcg/kg [see Clinical Pharmacology ( 12.3 )] . The dose for pediatric patients is based on weight [see Dosage and Administration ( 2.2 )] .

Safety and effectiveness in pediatric patients have not been established in: Acute Myeloid Leukemia: Neutrophil Recovery Following Induction Chemotherapy Autologous Peripheral Blood Progenitor Cell Mobilization and Collection Avoid administration of solutions containing benzyl alcohol [LEUKINE for injection reconstituted with Bacteriostatic Water for Injection, USP (0.9% benzyl alcohol)] to neonates and low birth weight infants. Instead, administer lyophilized LEUKINE reconstituted with Sterile Water for Injection, USP [see Dosage and Administration ( 2.7 )] .

Serious adverse reactions including fatal reactions and the “gasping syndrome” occurred in premature infants in the neonatal intensive care unit who received drugs containing benzyl alcohol as a preservative. In these cases, benzyl alcohol dosages of 99 to 234 mg/kg/day produced high levels of benzyl alcohol and its metabolites in the blood and urine (blood levels of benzyl alcohol were 0.61 to 1.38 mmol/L). Additional adverse reactions included gradual neurological deterioration, seizures, intracranial hemorrhage, hematologic abnormalities, skin breakdown, hepatic and renal failure, hypotension, bradycardia, and cardiovascular collapse.

Preterm, low birth weight infants may be more likely to develop these reactions because they may be less able to metabolize benzyl alcohol. If LEUKINE for injection reconstituted with Bacteriostatic Water for Injection, USP (0.9% benzyl alcohol) must be used in neonates and low birth weight infants, consider the combined daily metabolic load of benzyl alcohol from all sources including LEUKINE (LEUKINE for injection reconstituted with Bacteriostatic Water for Injection, USP [0.9% benzyl alcohol] contains 9 mg of benzyl alcohol per mL).

The minimum amount of benzyl alcohol at which serious adverse reactions may occur is not known [see Dosage and Administration ( 2.7 )] .

🧓 Geriatric Use 44 words ▾

8.5Geriatric Use Clinical studies of LEUKINE did not include a sufficient numbers of subject aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

🆘 Overdosage 88 words ▾

10 OVERDOSAGE Doses up to 100 mcg/kg/day (4,000 mcg/m 2 /day or 16 times the recommended dose) were administered to four patients in a Phase 1 uncontrolled clinical study by continuous IV infusion for 7 to 18 days. Increases in WBC up to 200,000 cells/mm 3 were observed. Adverse events reported were dyspnea, malaise, nausea, fever, rash, sinus tachycardia, headache, and chills.

All these events were reversible after discontinuation of LEUKINE. In case of overdosage, discontinue LEUKINE therapy and monitor the patient for WBC increase and respiratory symptoms.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Sargramostim (GM-CSF) belongs to a group of growth factors termed colony-stimulating factors which support survival, clonal expansion, and differentiation of hematopoietic progenitor cells. GM-CSF induces partially committed progenitor cells to divide and differentiate in the granulocyte-macrophage pathways which include neutrophils, monocytes/macrophages and myeloid-derived dendritic cells. GM-CSF is also capable of activating mature granulocytes and macrophages.

GM-CSF is a multilineage factor and, in addition to dose-dependent effects on the myelomonocytic lineage, can promote the proliferation of megakaryocytic and erythroid progenitors. However, other factors are required to induce complete maturation in these two lineages. The various cellular responses (i.e., division, maturation, activation) are induced through GM-CSF binding to specific receptors expressed on the cell surface of target cells.

The biological activity of GM-CSF is species-specific. Consequently, in vitro studies have been performed on human cells to characterize the pharmacological activity of GM-CSF. In vitro exposure of human bone marrow cells to GM-CSF at concentrations ranging from 1-100 ng/mL results in the proliferation of hematopoietic progenitors and in the formation of pure granulocyte, pure macrophage, and mixed granulocyte macrophage colonies.

Chemotactic, anti-fungal, and anti-parasitic activities of granulocytes and monocytes are increased by exposure to GM-CSF in vitro. GM-CSF increases the cytotoxicity of monocytes toward certain neoplastic cell lines and activates polymorphonuclear neutrophils to inhibit the growth of tumor cells.

12.2Pharmacodynamics LEUKINE stimulates hematopoietic precursor cells and increases neutrophil, eosinophil, megakaryocyte, macrophage, and dendritic cell production. In AML adult patients undergoing induction chemotherapy [see Clinical Studies (14.1)], LEUKINE at daily doses of 250 mcg/m 2 significantly shortened the median duration of ANC <500/mm 3 by 4 days and <1000/mm 3 by 7 days following induction; 75% of patients receiving sargramostim achieved ANC greater than 500/mm 3 by day 16 compared to day 25 for patients receiving placebo.

Animal data and clinical data in humans suggest a correlation between sargramostim exposure and the duration of severe neutropenia as a predictor of efficacy. At doses of 250 mcg/m 2 (approximately 7 mcg/kg in a 70 kg human with a body surface area of 1.96), daily LEUKINE treatment reduced the duration of severe neutropenia.

12.3Pharmacokinetics Intravenous Administration (IV) Peak concentrations of sargramostim were observed in blood samples obtained during or immediately after completion of LEUKINE infusion. Subcutaneous Administration (SC) Based on a population pharmacokinetics analysis of lyophilized LEUKINE data, the mean C max after a 7 mcg/kg SC dose (equivalent to a 250 mcg/m 2 dose in a 70 kg human with a body surface area of 1.96) was 3.03 ng/mL and mean AUC 0-24 was 21.3 ng•h/mL ( Table 4 ). There is no accumulation of GM-CSF after repeat SC dosing and steady state conditions are met after a single SC dose.

Table 4: Sargramostim serum C max and AUC Exposure (CV%) in Humans after Subcutaneous Administration Data type Sargramostim dose Formulation Number of healthy subjects AUC (CV%) (ng·h/mL ) C max (CV%) (ng/mL) Observed 6.5 mcg/kg Lyophilized LEUKINE 39 20.4 (28.7%) 3.15 (35.2%) Population PK model simulation 7 mcg/kg Lyophilized LEUKINE 500 21.3 (32.6) 3.03 (31.0) Absorption After SC administration GM-CSF was detected in the serum early (15 min) and reached maximum serum concentrations between 2.5 and 4 h. The absolute bioavailability with the SC route, when compared to the IV route, was 75%.

Distribution The observed volume of distribution after IV (Vz) administration was 96.8. Elimination LEUKINE administered SC to healthy adult volunteers, GM-CSF had a terminal elimination half-life of 1.4 h. The observed total… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 220 words ▾

12.1Mechanism of Action Sargramostim (GM-CSF) belongs to a group of growth factors termed colony-stimulating factors which support survival, clonal expansion, and differentiation of hematopoietic progenitor cells. GM-CSF induces partially committed progenitor cells to divide and differentiate in the granulocyte-macrophage pathways which include neutrophils, monocytes/macrophages and myeloid-derived dendritic cells. GM-CSF is also capable of activating mature granulocytes and macrophages.

GM-CSF is a multilineage factor and, in addition to dose-dependent effects on the myelomonocytic lineage, can promote the proliferation of megakaryocytic and erythroid progenitors. However, other factors are required to induce complete maturation in these two lineages. The various cellular responses (i.e., division, maturation, activation) are induced through GM-CSF binding to specific receptors expressed on the cell surface of target cells.

The biological activity of GM-CSF is species-specific. Consequently, in vitro studies have been performed on human cells to characterize the pharmacological activity of GM-CSF. In vitro exposure of human bone marrow cells to GM-CSF at concentrations ranging from 1-100 ng/mL results in the proliferation of hematopoietic progenitors and in the formation of pure granulocyte, pure macrophage, and mixed granulocyte macrophage colonies.

Chemotactic, anti-fungal, and anti-parasitic activities of granulocytes and monocytes are increased by exposure to GM-CSF in vitro. GM-CSF increases the cytotoxicity of monocytes toward certain neoplastic cell lines and activates polymorphonuclear neutrophils to inhibit the growth of tumor cells.

📦 How Supplied / Storage and Handling 68 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied LEUKINE (sargramostim) for injection is a sterile, preservative-free, white lyophilized powder supplied in a carton containing five 250 mcg single-dose vials. (NDC 71837-5843-5). Storage and Handling 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. Do not use beyond the expiration date printed on the vial.

📋 Description 182 words ▾

11 DESCRIPTION Sargramostim is a glycosylated recombinant human granulocyte-macrophage colony-stimulating factor (rhu GM-CSF) produced by recombinant DNA technology in a yeast ( S. cerevisiae ) expression system. Sargramostim is a glycoprotein of 127 amino acids characterized by three primary molecular species having molecular masses of 19,500, 16,800 and 15,500 Daltons. The amino acid sequence of sargramostim differs from the natural human GM-CSF by a substitution of leucine at position 23, and the carbohydrate moiety may be different from the native protein.

Sargramostim differs from human GM-CSF by one amino acid at position 23, where leucine is substituted for arginine. LEUKINE (sargramostim) for injection is supplied as a sterile, preservative-free, white lyophilized powder in a single-dose vial for subcutaneous or intravenous use. Reconstitute each single-dose vial with 1 mL of diluent (i.e., sterile water for injection or bacteriostatic water for injection).

After reconstitution each single-dose vial contains 250 mcg/mL sargramostim and the inactive ingredients mannitol (40 mg), sucrose (10 mg), and tromethamine (1.21 mg) per mL with a pH range of 7.1 - 7.7 with a deliverable volume of 1 mL (250 mcg).

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling ( Patient Information ). LEUKINE should be used under the guidance and supervision of a health care professional. However, if the physician determines that LEUKINE may be used outside of the hospital or office setting, persons who will be administering LEUKINE should be instructed as to the proper dose, and the method of reconstituting and administering LEUKINE [see Dosage and Administration ( 2.7 )] .

If home use is prescribed, patients should be instructed in the importance of proper disposal and cautioned against the reuse of needles, syringes, drug product, and diluent. A puncture resistant container should be used by the patient for the disposal of used needles. Advise patients of the following risks and potential risks with LEUKINE: Serious allergic reactions [see Warnings and Precautions ( 5.1 )] Infusion related reactions [see Warnings and Precautions ( 5.2 )] Risk of severe myelosuppression when LEUKINE administered within 24 hours of chemotherapy or radiotherapy [see Warnings and Precautions ( 5.3 )] Effusions and capillary leak syndrome [see Warnings and Precautions ( 5.4 )] Supraventricular arrhythmias [see Warnings and Precautions ( 5.5 )] Leukocytosis including eosinophilia [see Warnings and Precautions ( 5.6 )] Potential effect on malignant cells [see Warnings and Precautions ( 5.7 )] Pain including chest, abdominal, back, and joint pain [see Adverse Reactions ( 6.1 )] Thromboembolic events [see Adverse Reactions ( 6.3 )] Embryofetal Toxicity: Advise females of reproductive potential that LEUKINE may cause fetal harm and to inform their prescriber of a known or suspected pregnancy [see Use in Specific Populations ( 8.1 )] Lactation: Advise lactating woman not to breastfeed during treatment and for at least 2 weeks after the last dose [see Use in Specific Populations ( 8.2 )] Advise patients acutely exposed to myelosuppressive doses of radiation (H-ARS) that efficacy studies of LEUKINE for this indication could not be conducted in humans for ethical and feasibility reasons and that, therefore, approval of this use was based on efficacy studies conducted in animals [see Clinical Studies ( 14.6 )] Instruct patients who self-administer LEUKINE: Do not reuse needles, syringes, or unused portions of vials Follow local requirements for proper disposal of used syringes, needles, and unused vials LEUKINE ® is a registered trademark licensed to Partner Therapeutics, Inc.

Partner Therapeutics is a registered trademark of Partner Therapeutics, Inc. Manufactured by: Partner Therapeutics, Inc., Lexington, MA 02421 US License No. 2087 ©2023 Partner Therapeutics, Inc.

All rights reserved. (VER-AW009-02) Phone: 1-888-4RX-LEUKINE

🧬 Pharmacokinetics ~2 min read ▾

12.3Pharmacokinetics Intravenous Administration (IV) Peak concentrations of sargramostim were observed in blood samples obtained during or immediately after completion of LEUKINE infusion. Subcutaneous Administration (SC) Based on a population pharmacokinetics analysis of lyophilized LEUKINE data, the mean C max after a 7 mcg/kg SC dose (equivalent to a 250 mcg/m 2 dose in a 70 kg human with a body surface area of 1.96) was 3.03 ng/mL and mean AUC 0-24 was 21.3 ng•h/mL ( Table 4 ). There is no accumulation of GM-CSF after repeat SC dosing and steady state conditions are met after a single SC dose.

Table 4: Sargramostim serum C max and AUC Exposure (CV%) in Humans after Subcutaneous Administration Data type Sargramostim dose Formulation Number of healthy subjects AUC (CV%) (ng·h/mL ) C max (CV%) (ng/mL) Observed 6.5 mcg/kg Lyophilized LEUKINE 39 20.4 (28.7%) 3.15 (35.2%) Population PK model simulation 7 mcg/kg Lyophilized LEUKINE 500 21.3 (32.6) 3.03 (31.0) Absorption After SC administration GM-CSF was detected in the serum early (15 min) and reached maximum serum concentrations between 2.5 and 4 h. The absolute bioavailability with the SC route, when compared to the IV route, was 75%.

Distribution The observed volume of distribution after IV (Vz) administration was 96.8. Elimination LEUKINE administered SC to healthy adult volunteers, GM-CSF had a terminal elimination half-life of 1.4 h. The observed total body clearance/subcutaneous bioavailability (CL/F) was 23 L/h.

Specific metabolism studies were not conducted, because LEUKINE is a protein and is expected to degrade to small peptides and individual amino acids. Special Populations Adult patients acutely exposed to myelosuppressive doses of radiation (H-ARS) The pharmacokinetics of sargramostim are not available in adult patients acutely exposed to myelosuppressive doses of radiation. Pharmacokinetic data in irradiated and non-irradiated non-human primates and in healthy human adults were used to derive human doses for patients acutely exposed to myelosuppressive doses of radiation.

Modeling and simulation of the healthy human adult pharmacokinetic data indicate that sargramostim C max and AUC exposures at a LEUKINE dose of 7 mcg/kg in patients acutely exposed to myelosuppressive doses of radiation are expected to exceed sargramostim C max (97.6% of patients) and AUC (100% of patients) exposures at a LEUKINE dose of 7 mcg/kg in non-human primates. Pediatric patients acutely exposed to myelosuppressive doses of radiation (H-ARS) The pharmacokinetics of sargramostim was not available in pediatric patients acutely exposed to myelosuppressive doses of radiation.

The pharmacokinetics of sargramostim in pediatric patients after being exposed to myelosuppressive doses of radiation were estimated by scaling the adult population pharmacokinetic model to the pediatric population. The model-predicted mean AUC 0-24 values at 7, 10, and 12 mcg/kg doses of LEUKINE in pediatric patients weighing greater than 40 kg (~adolescents), 15 to 40 kg (~young children), and 0 to less than 15 kg (~newborns to toddlers), respectively, were similar to AUC values in adults after a 7 mcg/kg dose.

🧬 Pharmacodynamics 132 words ▾

12.2Pharmacodynamics LEUKINE stimulates hematopoietic precursor cells and increases neutrophil, eosinophil, megakaryocyte, macrophage, and dendritic cell production. In AML adult patients undergoing induction chemotherapy [see Clinical Studies (14.1)], LEUKINE at daily doses of 250 mcg/m 2 significantly shortened the median duration of ANC <500/mm 3 by 4 days and <1000/mm 3 by 7 days following induction; 75% of patients receiving sargramostim achieved ANC greater than 500/mm 3 by day 16 compared to day 25 for patients receiving placebo.

Animal data and clinical data in humans suggest a correlation between sargramostim exposure and the duration of severe neutropenia as a predictor of efficacy. At doses of 250 mcg/m 2 (approximately 7 mcg/kg in a 70 kg human with a body surface area of 1.96), daily LEUKINE treatment reduced the duration of severe neutropenia.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Following Induction Chemotherapy for Acute Myelogenous Leukemia The efficacy of LEUKINE in the treatment of AML was evaluated in a multicenter, randomized, double-blind placebo-controlled trial (study 305) of 99 newly-diagnosed adult patients, 55-70 years of age, receiving induction with or without consolidation. A combination of standard doses of daunorubicin (days 1-3) and ara-C (days 1-7) was administered during induction and high dose ara-C was administered days 1-6 as a single course of consolidation, if given.

Bone marrow evaluation was performed on day 10 following induction chemotherapy. If hypoplasia with <5% blasts was not achieved, patients immediately received a second cycle of induction chemotherapy. If the bone marrow was hypoplastic with <5% blasts on day 10 or four days following the second cycle of induction chemotherapy, LEUKINE (250 mcg/m 2 /day) or placebo was given intravenously over four hours each day, starting four days after the completion of chemotherapy.

Study drug was continued until an ANC ≥1500 cells/mm 3 for three consecutive days was attained or a maximum of 42 days. LEUKINE or placebo was also administered after the single course of consolidation chemotherapy if delivered (ara-C 3-6 weeks after induction following neutrophil recovery). Study drug was discontinued immediately if leukemic regrowth occurred.

LEUKINE significantly shortened the median duration of ANC <500 cells/mm3 by 4 days and <1000 cells/mm 3 by 7 days following induction (see Table 5 ). Of patients receiving LEUKINE, 75% achieved ANC >500 cells/mm 3 by day 16, compared to day 25 for patients receiving placebo. The proportion of patients receiving one cycle (70%) or two cycles (30%) of induction was similar in both treatment groups.

LEUKINE significantly shortened the median times to neutrophil recovery whether one cycle (12 vs. 15 days) or two cycles (14 vs. 23 days) of induction chemotherapy was administered.

Median times to platelet (>20,000 cells/mm 3 ) and RBC transfusion independence were not significantly different between treatment groups. Table 5: Hematological Recovery (in Days) in Patients with AML: Induction a Patients with missing data censored b p = Generalized Wilcoxon c 2 patients on LEUKINE and 4 patients on placebo had missing values d 2 patients on LEUKINE and 3 patients on placebo had missing values e 4 patients on placebo had missing values f 3 patients on LEUKINE and 4 patients on placebo had missing values Dataset LEUKINE n=52 a Median (25%, 75%) Placebo n=47 Median (25%, 75%) p-value b ANC >500/mm 3 c 13 (11, 16) 17 (13, 25) 0.009 ANC >1000/mm 3 d 14 (12, 18) 21 (13, 34) 0.003 PLT >20,000/mm 3 e 11 (7, 14) 12 (9, >42)

0.10 RBC f 12 (9, 24) 14 (9, 42)

0.53During the consolidation phase of treatment, LEUKINE did not shorten the median time to recovery of ANC to 500 cells/mm 3 (13 days) or 1000 cells/mm 3 (14.5 days) compared to placebo. There were no significant differences in time to platelet and RBC transfusion independence. The incidence of severe infections and deaths associated with infections was significantly reduced in patients who received LEUKINE.

During induction or consolidation, 27 of 52 patients receiving LEUKINE and 35 of 47 patients receiving placebo had at least one grade 3, 4 or 5 infection (p=0.02). Twenty-five patients receiving LEUKINE and 30 patients receiving placebo experienced severe and fatal infections during induction only. There were significantly fewer deaths from infectious causes in the LEUKINE arm (3 vs.

11, p=0.02). The majority of deaths in the placebo group were associated with fungal infections with pneumonia as the primary infection.

14.2Autologous Peripheral Blood Progenitor Cell Mobilization and Collection A retrospective review was conducted of data from adult patients with cancer undergoing collection of peripheral blood progenitor cells (PBPC) at a single transplant center. Mobilization of PBPC and myeloid reconstitution post transplant w… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 187 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis and Mutagenesis Carcinogenicity and genetic toxicology studies have not been conducted with LEUKINE. Impairment of Fertility LEUKINE had no effect on fertility of female rabbits up to a dose of 200 mcg/kg/day. The toxicology studies with up to 6 weeks of exposure to LEUKINE in sexually mature female and male cynomolgus monkeys did not reveal findings in male or female reproductive organs that would suggest impairment of fertility up to a dose of 200 mcg/kg/day.

At 200 mcg/kg, the AUC exposure of LEUKINE was 8.8 to 11.4 times (monkeys) and 2.0 to 25.3 times (rabbits) the exposure in humans at the recommended clinical dose of 250 mcg/m 2 . After the first administration, a dose of 200 mcg/kg/day corresponds to an AUC of approximately 11.4 (monkeys) and 25.3 (rabbits) times the exposures observed in patients treated with the clinical LEUKINE dose of 250 mcg/m 2 ; however, due to the production of anti-LEUKINE antibodies with repeat administration, the AUC decreased to 8.8 (monkeys) and 2.0 (rabbits) times the clinical exposure by the end of the dosing periods.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 184 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis and Mutagenesis Carcinogenicity and genetic toxicology studies have not been conducted with LEUKINE. Impairment of Fertility LEUKINE had no effect on fertility of female rabbits up to a dose of 200 mcg/kg/day. The toxicology studies with up to 6 weeks of exposure to LEUKINE in sexually mature female and male cynomolgus monkeys did not reveal findings in male or female reproductive organs that would suggest impairment of fertility up to a dose of 200 mcg/kg/day.

At 200 mcg/kg, the AUC exposure of LEUKINE was 8.8 to 11.4 times (monkeys) and 2.0 to 25.3 times (rabbits) the exposure in humans at the recommended clinical dose of 250 mcg/m 2 . After the first administration, a dose of 200 mcg/kg/day corresponds to an AUC of approximately 11.4 (monkeys) and 25.3 (rabbits) times the exposures observed in patients treated with the clinical LEUKINE dose of 250 mcg/m 2 ; however, due to the production of anti-LEUKINE antibodies with repeat administration, the AUC decreased to 8.8 (monkeys) and 2.0 (rabbits) times the clinical exposure by the end of the dosing periods.

📄 Patient Package Insert ~3 min read ▾

This Patient Information has been approved by the U.S. Food and Drug Administration Revised: 05/2018 Patient Information LEUKINE ® (loo-kine) (sargramostim) injection LEUKINE ® (loo-kine) (sargramostim) for injection What is LEUKINE? LEUKINE is a man-made form of granulocyte-macrophage colony-stimulating factor (GM-CSF).

GM-CSF is a substance produced by the body. It stimulates the growth of certain white blood cells that are important in the body’s fight against infection. Acute Radiation Syndrome: The effectiveness of LEUKINE for this use was only studied in animals because it could not be studied in people.

Do not take LEUKINE if you have had a serious allergic reaction to human GM-CSF, such as sargramostim, products that are made from yeast, or any of the ingredients in LEUKINE. See the end of this leaflet for a complete list of ingredients in LEUKINE. Before receiving LEUKINE, tell your healthcare provider about all your medical conditions, including if you: have heart or lung disease are allergic to benzyl alcohol are pregnant or plan to become pregnant.

It is not known if LEUKINE will harm your unborn baby. See “What are the possible side effects of LEUKINE?” Talk to your healthcare provider about the type of LEUKINE that is right for you. are breastfeeding or plan to breastfeed. It is not known if LEUKINE passes into your breast milk.

Do not breast feed during treatment and for at least 2 weeks after your last dose of LEUKINE. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. How will I receive LEUKINE?

LEUKINE comes in two ways: as a solution or as a powder to be mixed for injection. LEUKINE is given as an injection under your skin (subcutaneous injection) by a healthcare provider. If your healthcare provider decides that the subcutaneous injections can be given at home by you or your caregiver, see the detailed “Instructions for Use” that comes with your LEUKINE for information on how to draw up and inject a dose of LEUKINE.

If your healthcare provider gives you LEUKINE for injection (powder) to be mixed, carefully follow your healthcare provider’s instructions on how to store, mix, draw up and inject the medicine. You and your caregiver should be shown how to prepare and inject LEUKINE before you use it, by your healthcare provider. Your healthcare provider will tell you how much LEUKINE to inject and when to inject it.

Do not change your dose or stop LEUKINE unless your healthcare provider tells you to. If you are also receiving chemotherapy or radiation therapy, your dose of LEUKINE should be injected at least 24 hours before or 24 hours after your dose of chemotherapy and at least 24 hours before your dose of radiation therapy. Your healthcare provider will do blood tests to monitor your white blood cell count and, if necessary, adjust your LEUKINE dose.

If you are receiving LEUKINE because you have been suddenly (acutely) exposed to an amount of radiation that can affect your bone marrow (Acute Radiation Syndrome), you will need to have blood tests about every 3 days during treatment with LEUKINE to check your white blood cell count until it returns to normal. If your child needs to receive LEUKINE for Acute Radiation Syndrome, follow your healthcare provider’s instructions. LEUKINE injection contains the preservative benzyl alcohol.

If you miss a dose of LEUKINE, talk to your healthcare provider about when you should give your next dose. What are the possible side effects of LEUKINE? LEUKINE may cause serious side effects, including: Serious allergic reactions.

LEUKINE can cause serious allergic reactions that can be severe. Get medical help right away if you get any of the following signs or symptoms of a serious allergic reaction with LEUKINE, including: skin rash over your entire body, hives, trouble breathing, wheezing, swelling around your mouth or eyes, a fast heartbeat, sweating, and dizziness or feelin… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 48 words ▾

PRINCIPAL DISPLAY PANEL - NDC: 71837-5843-1 - 250 mcg Lyophilized Powder for Injection Vial Label 250 mcg Lyophilized Powder for Injection Vial Label

PRINCIPAL DISPLAY PANEL - NDC: 71837-5843-5 - 250 mcg Lyophilized Powder for Injection 5-count Carton Label 250 mcg Lyophilized Powder for Injection 5-count Carton Label

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
866
Units reimbursed last 4 qtrs
6.9K
Gross reimbursed last 4 qtrs
$2.06M
Avg / prescription
$2,382.07
Avg / unit
$298.81
Latest quarter Q1 2026
203Rx
Fee-for-service vs managed care ⓘ
47% FFS 53% MCO
Fee-for-service · 411 Rx Managed care · 455 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: 180 units · 1.8 per 100k residents MI New York: 1,669 units · 8.5 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 448 units · 3.6 per 100k residents IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: 2,075 units · 5.3 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: 726 units · 11.7 per 100k residents MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: 127 units · 1.7 per 100k residents AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: 192 units · 1.8 per 100k residents NC South Carolina: 105 units · 2.0 per 100k residents SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: 36 units · 1.2 per 100k residents MS Alabama: no data reported AL Georgia: 227 units · 2.1 per 100k residents GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 118 units · 0.4 per 100k residents TX Florida: 1,001 units · 4.4 per 100k residents FL
Units reimbursed · per 100k residents
0.411.7
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Missouri 11.7 /100k
2 New York 8.5 /100k
3 California 5.3 /100k
4 Florida 4.4 /100k
5 Illinois 3.6 /100k
6 Georgia 2.1 /100k
7 South Carolina 2.0 /100k
8 Michigan 1.8 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Leukine — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Leukine. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$973.2K
Claims incl. refills
108
Beneficiaries
52
Spend / beneficiary
$18,715.79
Spend / claim
$9,011.31
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Leukine (this brand).

Top reported reactions

Pyrexia157
Nausea123
Pain113
Hypotension112
Dyspnoea111
Fatigue94
Diarrhoea87

Reporter sex

1,703 reports
Male · 56%
Female · 43%
Unknown · 1%

Serious outcomes

Hospitalization568
Death250
Life-threatening72
Disabling22
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 62 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk ✓ Available
Medicaid utilization (CMS SDUD) ✓ Available
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Partner Therapeutics, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Partner Therapeutics, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code J2820 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 71837-1000-02 · Partner 71839-0104-01 · BE →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.