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Rolvedon eflapegrastim-xnst 13.2 mg/.6mL Injection, Solution, 6 mL — NDC 76961-0101-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Rolvedon eflapegrastim-xnst 13.2 mg/.6mL Injection, Solution, 6 mL — NDC 76961-101-01 (Billing 76961-0101-01)

by Spectrum Pharmaceuticals, Inc. · .6 mL in 1 SYRINGE, GLASS

This is a package of 6 mL of Rolvedon eflapegrastim-xnst 13.2 mg/.6mL Injection, Solution from Spectrum Pharmaceuticals, Inc., marketed since Oct 2022 and currently FDA-listed, this package's marketing is listed to end Aug 2027. It is this product's only package size.

NDC 76961-0101-01
🏷️ FDA NDC (as labeled) 76961-101-01 billing pads the product 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 →

This page is curated, coded, and maintained by

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 76961-101-01 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
76961 labeler · 101 product · 01 package
Package marketed since
Oct 18, 2022
Package marketing ended
Aug 31, 2027
Sample package
No — commercial package
Billing quantity
6 mL per package
Barcode (UPC-A, from the NDC)
3 7696110101 9
Medicaid fills, this package
2,042 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) 76961-101-01
Product NDC 76961-101
11-digit billing NDC 76961010101
NCPDP billing unit ML — per mL (volume)
RxCUI 2612541, 2612547
UNII UT99UG9QJX
Application # BLA761148
SPL Set ID 6e436115-62e7-4729-aeb0-ff78ea685206
Established class (EPC) Leukocyte Growth Factor
Physiologic effect Increased Myeloid Cell Production
Chemical class Granulocyte Colony-Stimulating Factor
DEA schedule Non-controlled
Marketing category BLA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-10-18
Marketing end 2027-08-31
Route SUBCUTANEOUS
Dosage form INJECTION, SOLUTION
Substance EFLAPEGRASTIM
Biologic (Purple Book) 351(a)

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

GPI-14 8240151880E520
GCN Seq No 083823
GCN 52886
HICL code 048301
Ingredient (HICL) Eflapegrastim-Xnst
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 ROLVEDON 13.2 MG/0.6 ML SYRING
FDB brand name Rolvedon
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 083823
  • GCN: 52886
  • GPI-14 (Medi-Span): 8240151880E520
  • HICL (First Databank): 048301
  • AHFS class code: 20:16.00.00
  • RxCUI (RxNorm): 2612541
Why two NDCs? The FDA registers this code as 76961-101-01 — a 5-3-2 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 product segment → 76961-0101-01. 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 ROLVEDON 13.2 MG/0.6 ML SYRING Ingredient Eflapegrastim-Xnst

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 $4,612.32 $2,767.39 / 0.6 ml
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · J1449 $38.562 / J1449 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)76961-101-01
11-digit billing NDC76961-0101-01
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ1449
DescriptorINJECTION, EFLAPEGRASTIM-XNST, 0.1 MG
Billing units / pkg220 units
How the units are derivedThis package is 0.6 ML; the HCPCS unit is 0.1 MG, so one package = 220 billing units.
Medicare Part B spend (2026 (Q1))$20,720,853 · 6,822 claims · $3,037.36 per claim (all NDCs under J1449)
Crosswalk sourcePDAC NDC-HCPCS crosswalk (DME MAC / DMEPOS)
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
76961-0101-01 You're viewing this Main listing .6 mL in 1 SYRINGE, GLASS 2022-10-18 Aug 31, 2027 Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Rolvedon 13.2 mg/.6mLthis 76961-0101-01 Spectrum 6 ml — — FDA listed —
Rolvedon 13.2 mg/.6mL 82497-0132-01 Assertio 6 ml — — 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

🏛️
2022
First FDA approval
Sep 2022
📍
2026
Currently FDA-listed
4 years listed
🛡️
2034
Latest patent/protection listed
not a guaranteed launch date
🧬Biologic — competition comes from biosimilars

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

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Sep 2034. This may affect when biosimilars become widely available, but it is not a guaranteed launch date.
📅 FDA approved Sep 9, 2022 ⏳ ~7.9 yr to latest listed protection

Why the date isn’t exact: Biosimilar timing can change because patents may be challenged, settled, licensed, added or removed, and litigation can move the real date earlier or later.

FDA Purple Book — biosimilars & interchangeables ⓘ
Reference product
Rolvedoneflapegrastim-xnst
🔒 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.
Patents & exclusivity — FDA Purple Book
Exclusivity RefProduct
2022 2024 2026 2028 2030 2032 2034
Today
LOE
Biologic patent Exclusivity
🏛️Reference-product exclusivity
A flat 12 years of FDA market protection from first licensure. No biosimilar can be licensed before it ends — regardless of patents.
🧪Listed biologic patents
Patents the reference maker lists covering the molecule, formulation, or manufacturing. A biosimilar generally can’t launch until these resolve.
🔁Interchangeability
An interchangeable biosimilar may be substituted at the pharmacy (state laws vary). The first one can earn its own exclusivity period.
🛈 What do these terms mean?
Biologic patent
A patent the reference product’s maker has publicly listed. A biosimilar generally can’t launch until these expire — unless they’re invalidated or resolved in a settlement.
Reference-product exclusivity
A flat 12 years of FDA market protection from the biologic’s first licensure (the BPCIA). No biosimilar can be licensed before it ends, regardless of patents.
Interchangeable exclusivity
The first interchangeable biosimilar can earn a period as the only interchangeable version (pharmacists can substitute it without the prescriber).
Earliest biosimilar (LOE)
The latest of all the dates above — the soonest a biosimilar can realistically reach the market. Litigation and settlements can move it earlier.

Biologics have no small-molecule “generics” — competition comes from FDA-licensed biosimilars, tracked in the FDA Purple Book.

FDA exclusivity
CodeWhat it grantsExpires
RefProductReference-product exclusivity (12-year, BPCIA) — no biosimilar can be licensed before this dateSep 9, 2034
Common questions
Is there a biosimilar for ROLVEDON 13.2 MG/0.6 ML SYRING?
No FDA-licensed biosimilar is currently listed for this biologic in the FDA Purple Book.
Why do different websites show different biosimilar dates?
Biosimilar availability isn’t based on one single date. Some sources use the reference-product exclusivity, some use the last listed patent, and patent litigation, settlements, and licenses can all change the real-world launch date. This page shows the underlying Purple Book dates so you can see why estimates differ.
Can a biosimilar launch before the last patent expires?
Sometimes. A biosimilar maker may settle with the reference manufacturer or receive a license to launch earlier. In other cases, the last listed protection delays competition.
What does “current Purple Book estimate” mean?
It means we’re using the latest patent and exclusivity dates currently listed in the FDA Purple Book. It is not a guaranteed launch date.
What does “FDA listed” mean?
It means the product appears in the FDA’s official directory. That’s a good sign a product exists for the U.S. market, but on its own it does not confirm a pharmacy can get it today. Where we have recent retail pricing data, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Purple Book for a patent or exclusivity on the reference biologic. It can affect when a biosimilar becomes widely available — but it is not a guaranteed launch date. Settlements and licenses can move the real date earlier or later.
Built from the FDA Purple Book Patent List (patents the reference-product sponsor has publicly listed under the BPCIA) plus reference-product exclusivity. Biosimilars cannot launch until these clear; patent litigation and settlements can shift the real date. Biologics have no small-molecule generics — competition comes from FDA-licensed biosimilars, not the Orange Book.
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.

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

  • 2.52 mg / 0.6 mL UNII 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • 30 mg / 0.6 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.
  • 0.72 mg / 0.6 mL UNII 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • 5.26 mg / 0.6 mL UNII 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • 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

LabelerSpectrum Pharmaceuticals, Inc.
FDA applicationBLA761148 (BLA)
Labeler code76961
First marketedOct 2022
Product typeHuman Prescription Drug
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 👥 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 📖 Instructions for Use 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 118 words ▾

1 INDICATIONS AND USAGE Rolvedon is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia. Limitations of Use Rolvedon is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. Rolvedon is a leukocyte growth factor indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia.

( 1 ) Limitations of Use Rolvedon is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. ( 1 )

⏱️ Dosage and Administration ~1 min read ▾

2 DOSAGE AND ADMINISTRATION • Recommended Dose: 13.2 mg administered subcutaneously once per chemotherapy cycle. ( 2.1 ) • Administer approximately 24 hours after cytotoxic chemotherapy. Do not administer within the period from 14 days before to 24 hours after administration of cytotoxic chemotherapy. ( 2.1 )

2.1Recommended Dosage The recommended dosage of Rolvedon is a single subcutaneous injection of 13.2 mg administered once per chemotherapy cycle. Administer approximately 24 hours after cytotoxic chemotherapy. Do not administer within the period from 14 days before to 24 hours after administration of cytotoxic chemotherapy.

2.2Administration Rolvedon is administered subcutaneously via a single-dose prefilled syringe. Prior to use‚ take the carton out of the refrigerator and place the sealed blister tray on a clean flat surface for a minimum of 30 minutes to allow the product to reach room temperature. Do not warm up the prefilled syringe in any other way.

Discard any prefilled syringe left at room temperature for greater than 72 hours. Do not shake. If Rolvedon is accidentally frozen, do not use.

Remove the tray from box and carefully remove the prefilled syringe from the tray. If you drop the prefilled syringe onto a hard surface, do not use it. Use a new syringe for the injection.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not administer Rolvedon if discoloration or particulates are observed. Administer the entire contents of the prefilled syringe.

If the patient or caregiver misses a dose of Rolvedon, instruct them to contact their healthcare provider. The Rolvedon prefilled syringe does not bear graduation marks and is intended only to deliver the entire contents of the syringe (13.2 mg/0.6 mL) for direct administration. Not made with natural rubber latex.

💊 Dosage Forms and Strengths 33 words ▾

3 DOSAGE FORMS AND STRENGTHS Injection: 13.2 mg/0.6 mL as a clear, colorless, preservative-free solution in a single-dose prefilled syringe. Injection: 13.2 mg/0.6 mL solution in a single-dose prefilled syringe. ( 3 )

⛔ Contraindications 55 words ▾

4 CONTRAINDICATIONS Rolvedon is contraindicated in patients with a history of serious allergic reactions to eflapegrastim, pegfilgrastim, or filgrastim products. Reactions may include anaphylaxis [see Warnings and Precautions ( 5.3 )] . Patients with a history of serious allergic reactions to human granulocyte colony-stimulating factors such as eflapegrastim, pegfilgrastim or filgrastim products. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS • Fatal splenic rupture: Evaluate patients who report left upper abdominal or shoulder pain for an enlarged spleen or splenic rupture. ( 5.1 ) • Acute respiratory distress syndrome (ARDS): Evaluate patients who develop fever, lung infiltrates, or respiratory distress. Discontinue Rolvedon in patients with ARDS.

( 5.2 ) • Serious allergic reactions, including anaphylaxis: Permanently discontinue Rolvedon in patients with serious allergic reactions. ( 5.3 ) • Sickle Cell Crisis in Patients with Sickle Cell Disorders: Discontinue Rolvedon if sickle cell crisis occurs. ( 5.4 ) • Glomerulonephritis: Evaluate and consider dose-reduction or interruption of Rolvedon if causality is likely.

( 5.5 ) • Leukocytosis: Monitor complete blood count (CBC) during Rolvedon therapy. ( 5.6 ) • Thrombocytopenia: Monitor platelet counts. ( 5.7 ) • Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML): Monitor patients with breast and lung cancer using Rolvedon in conjunction with chemotherapy and/or radiotherapy for signs and symptoms of MDS/AML.

( 5.10 )

5.1Splenic Rupture Splenic rupture, including fatal cases, can occur following the administration of recombinant human granulocyte colony-stimulating factor (rhG-CSF) products, such as Rolvedon. Evaluate for an enlarged spleen or splenic rupture in patients who report left upper abdominal or shoulder pain after receiving Rolvedon.

5.2Acute Respiratory Distress Syndrome Acute respiratory distress syndrome (ARDS) can occur in patients receiving rhG-CSF products, such as Rolvedon. Evaluate patients who develop fever and lung infiltrates or respiratory distress after receiving Rolvedon for ARDS. Discontinue Rolvedon in patients with ARDS.

5.3Serious Allergic Reactions Serious allergic reactions, including anaphylaxis, can occur in patients receiving rhG-CSF products, such as Rolvedon. Permanently discontinue Rolvedon in patients with serious allergic reactions. Rolvedon is contraindicated in patients with a history of serious allergic reactions to eflapegrastim, pegfilgrastim, or filgrastim products [see Contraindications ( 4 )].

5.4Sickle Cell Crisis in Patients with Sickle Cell Disorders Severe and sometimes fatal sickle cell crises can occur in patients with sickle cell disorders receiving rhG-CSF products, such as Rolvedon. Discontinue Rolvedon if sickle cell crisis occurs.

5.5Glomerulonephritis Glomerulonephritis has occurred in patients receiving rhG-CSF products. The diagnoses were based upon azotemia, hematuria (microscopic and macroscopic), proteinuria, and renal biopsy. Generally, events of glomerulonephritis resolved after dose-reduction or discontinuation of rhG-CSF. If glomerulonephritis is suspected, evaluate for cause. If causality is likely, consider dose-reduction or interruption of Rolvedon.

5.6Leukocytosis White blood cell (WBC) counts of 100 x 10 9 /L or greater have been observed in patients receiving rhG-CSF products. Monitor complete blood count (CBC) during Rolvedon therapy. Discontinue Rolvedon treatment if WBC count of 100 x 10 9 /L or greater occurs.

5.7Thrombocytopenia Thrombocytopenia has been reported in patients receiving rhG-CSF products. Monitor platelet counts.

5.8Capillary Leak Syndrome Capillary leak syndrome has been reported after administration of rhG-CSF products and is characterized by hypotension, hypoalbuminemia, edema and hemoconcentration. Episodes vary in frequency and severity, and may be life-threatening if treatment is delayed. Patients who develop symptoms of capillary leak syndrome should be closely monitored and receive standard symptomatic treatment, which may include a need for intensive care.

5.9Potential for Tumor Growth Stimulatory Effects on Malignant Cells The granulocyte colony-stimulating factor (G-CSF) receptor through which Rolvedon acts has been found on tumor cell lines. The possibility that Rolvedon acts as a growth factor for any tumor type, including myeloid malignancies and myelodysplasia… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: • Splenic rupture [see Warnings and Precautions ( 5.1 )] • Acute respiratory distress syndrome [see Warnings and Precautions ( 5.2 )] • Serious allergic reactions [see Warnings and Precautions ( 5.3 )] • Sickle cell crisis in patients with sickle cell disorders [see Warnings and Precautions ( 5.4 )] • Glomerulonephritis [see Warnings and Precautions ( 5.5 )] • Leukocytosis [see Warnings and Precautions ( 5.6 )] • Thrombocytopenia [see Warnings and Precautions ( 5.7 )] • Capillary leak syndrome [see Warnings and Precautions ( 5.8 )] • Potential for tumor growth stimulatory effects on malignant cells [see Warnings and Precautions ( 5.9 )] • Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML) in Patients with Breast and Lung Cancer [see Warnings and Precautions ( 5.10 )] • Aortitis [see Warnings and Precautions ( 5.11 )] • Nuclear Imaging [see Warnings and Precautions ( 5.12 )] The most common adverse reactions (≥20%) are fatigue, nausea, diarrhea, bone pain, headache, pyrexia, anemia, rash, myalgia, arthralgia, and back pain.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Spectrum Pharmaceuticals, Inc. at 1-888-713-0688 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 to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The safety of Rolvedon was evaluated in Study 1 and Study 2 [see Clinical Studies ( 14 )]. Patients with early-stage breast cancer received Rolvedon 13.2 mg by subcutaneous injection (n=314) or pegfilgrastim 6 mg by subcutaneous injection (n=326) on Day 2 of each cycle after docetaxel 75 mg/m 2 and cyclophosphamide 600 mg/m 2 (TC) chemotherapy.

Among patients receiving Rolvedon, a total of 272 patients received four 21-day treatment cycles. The most common adverse reactions (≥20%) were fatigue, nausea, diarrhea, bone pain, headache, pyrexia, anemia, rash, myalgia, arthralgia, and back pain. Table 1 summarizes the adverse reactions that occurred in Studies 1 and 2.

Table 1. Common Adverse Reactions with a Frequency of ≥10% Through Week 14 in Patients with Early-Stage Breast Cancer in Study 1 and Study 2 Adverse Reaction Rolvedon (N = 314) % Pegfilgrastim** (N=326) % *Grouped Terms **Study 1 and Study 2 were not designed to evaluate meaningful comparisons of the incidence of adverse reactions in the Rolvedon and the pegfilgrastim treatment groups. Fatigue * 181 (58%) 192 (59%) Nausea 162 (52%) 166 (51%) Diarrhea 125 (40%) 126 (39%) Bone pain 119 (38%) 121 (37%) Headache * 92 (29%) 90 (28%) Pyrexia * 87 (28%) 84 (26%) Anemia * 77 (25%) 52 (16%) Rash * 77 (25%) 99 (30%) Myalgia 69 (22%) 49 (15%) Arthralgia 66 (21%) 48 (15%) Back pain * 63 (20%) 55 (17%) Decreased appetite 61 (19%) 50 (15%) Peripheral edema * 57 (18%) 53 (16%) Abdominal pain * 53 (17%) 67 (21%) Dizziness * 50 (16%) 38 (12%) Dyspnea * 49 (16%) 44 (13%) Cough * 48 (15%) 51 (16%) Thrombocytopenia * 44 (14%) 17 (5%) Pain 37 (12%) 42 (13%) Pain in extremity 36 (11%) 42 (13%) Local administration reactions * 34 (11%) 27 (8%) Flushing 32 (10%) 27 (8%) Permanent discontinuation due to an adverse reaction occurred in 4% of patients who received Rolvedon.

The adverse reaction requiring permanent discontinuation in 3 patients who received Rolvedon was rash.

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary There are no available data on Rolvedon use in pregnant women; however, data from published studies with use of other recombinant human granulocyte colony-stimulating factor (rhG-CSF) products in pregnant women have not identified any drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Animal reproduction studies were conducted in rats and rabbits. In rats, eflapegrastim-xnst did not adversely affect embryofetal and/or postnatal development when administered from organogenesis throughout lactation at doses that produced maternal exposures up to 7 times the exposure at the recommended clinical dose.

In rabbits, eflapegrastim-xnst caused embryofetal lethality and reduced fetal weight when administered during the organogenesis period at approximately 6 times the exposure at the clinical dose (see Data) . 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 is 2-4% and 15-20%, respectively. Data Animal Data In an embryofetal developmental study in rabbits, eflapegrastim-xnst was administered subcutaneously every other day during the period of organogenesis at doses up to 10 times the clinical exposure at the maximum recommended dose of 13.2 mg. Increased post-implantation loss, reduced number of live fetuses, and reduced fetal body weights were observed at 6 times the clinical exposure, based on AUC.

No malformations were observed up to 10 times the clinical exposure, based on AUC. In an embryofetal developmental study in rats, eflapegrastim-xnst administered subcutaneously every other day during the period of organogenesis did not adversely affect embryofetal development at doses up to 7 times clinical exposure, based on AUC. In a pre- and post-natal development study in rats, eflapegrastim-xnst administered subcutaneously once weekly from organogenesis through lactation did not adversely affect behavioral, developmental, or reproductive parameters at doses up to 7 times the clinical exposure, based on AUC.

8.2Lactation Risk Summary There are no data on the presence of eflapegrastim-xnst in human milk, the effects on the breastfed child, or the effects on milk production. Endogenous granulocyte colony-stimulating factor (G-CSF) is present in human milk. Other recombinant human granulocyte colony-stimulating factor (rhG-CSF) products are present in human milk at low levels and are not orally absorbed by infants.

The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Rolvedon and any potential adverse effects on the breastfed child from Rolvedon or from the underlying maternal condition.

8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established.

8.5Geriatric Use Of the 314 patients in clinical studies of Rolvedon, 39% were 65 and over, while 6% were 75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects.

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Risk Summary There are no available data on Rolvedon use in pregnant women; however, data from published studies with use of other recombinant human granulocyte colony-stimulating factor (rhG-CSF) products in pregnant women have not identified any drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Animal reproduction studies were conducted in rats and rabbits. In rats, eflapegrastim-xnst did not adversely affect embryofetal and/or postnatal development when administered from organogenesis throughout lactation at doses that produced maternal exposures up to 7 times the exposure at the recommended clinical dose.

In rabbits, eflapegrastim-xnst caused embryofetal lethality and reduced fetal weight when administered during the organogenesis period at approximately 6 times the exposure at the clinical dose (see Data) . 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 is 2-4% and 15-20%, respectively. Data Animal Data In an embryofetal developmental study in rabbits, eflapegrastim-xnst was administered subcutaneously every other day during the period of organogenesis at doses up to 10 times the clinical exposure at the maximum recommended dose of 13.2 mg. Increased post-implantation loss, reduced number of live fetuses, and reduced fetal body weights were observed at 6 times the clinical exposure, based on AUC.

No malformations were observed up to 10 times the clinical exposure, based on AUC. In an embryofetal developmental study in rats, eflapegrastim-xnst administered subcutaneously every other day during the period of organogenesis did not adversely affect embryofetal development at doses up to 7 times clinical exposure, based on AUC. In a pre- and post-natal development study in rats, eflapegrastim-xnst administered subcutaneously once weekly from organogenesis through lactation did not adversely affect behavioral, developmental, or reproductive parameters at doses up to 7 times the clinical exposure, based on AUC.

🧒 Pediatric Use 13 words ▾

8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established.

🧓 Geriatric Use 38 words ▾

8.5Geriatric Use Of the 314 patients in clinical studies of Rolvedon, 39% were 65 and over, while 6% were 75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects.

🆘 Overdosage 38 words ▾

10 OVERDOSAGE Overdose of Rolvedon may result in leukocytosis and bone pain. In the event of overdose, general supportive measures should be instituted as necessary. Monitor the patient for adverse reactions [see Adverse Reactions ( 6 )] .

🧬 Clinical Pharmacology ~2 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Eflapegrastim-xnst is a recombinant human granulocyte growth factor that binds to G-CSF receptors on myeloid progenitor cells and neutrophils, triggering signaling pathways that control cell differentiation, proliferation, migration and survival.

12.2Pharmacodynamics Eflapegrastim-xnst has been shown to elevate neutrophil counts in healthy subjects and in cancer patients. Absolute neutrophil count (ANC), C max and area under the effect curve (AUEC last ) increased with increasing doses of eflapegrastim-xnst in a linear, but less than dose-proportional, manner over a dose range of 45 to 350 mcg/kg.

12.3Pharmacokinetics The pharmacokinetics of eflapegrastim-xnst was studied in healthy subjects and patients with breast cancer. After subcutaneous (SC) dosing, the pharmacokinetics of eflapegrastim-xnst was nonlinear and exposure increases were not dose-proportional over the dose range of 45 to 350 mcg/kg. Absorption The median T max of eflapegrastim-xnst is 25 hours (6 to 144 hours) in patients with breast cancer following administration of the recommended dosage.

Distribution The volume of distribution of eflapegrastim-xnst is

1.44L. Elimination The geometric mean half-life of eflapegrastim-xnst in patients with breast cancer is 36.4 hours (Range: 16.1 to 115 hours) during Cycle 1. Eflapegrastim-xnst clearance decreased with increasing doses following single dose administration, suggesting target-mediated clearance of eflapegrastim-xnst by neutrophils.

Following repeat administration, clearance increased in Cycle 3 as compared to Cycle 1, potentially due to the subsequent increase in neutrophils. In in vitro studies, the IgG4 Fc fragment in eflapegrastim-xnst binds to the neonatal Fc receptor (FcRn), facilitating the FcRn-mediated transcytosis of eflapegrastim-xnst. Metabolism Eflapegrastim-xnst is expected to be metabolized by endogenous degradation following receptor-mediated internalization by cells bearing the G-CSF receptor.

Excretion Eflapegrastim-xnst was not detected in urine. Drug Interaction Studies No studies evaluating the drug interaction potential of eflapegrastim-xnst have been conducted.

12.6Immunogenicity The observed incidence of anti-drug antibodies is highly dependent on the sensitivity and specificity of the assay. Differences in assay methods preclude meaningful comparisons of the incidence of anti-drug antibodies in the studies described below with the incidence of anti-drug antibodies in other studies, including those of eflapegrastim-xnst or of other eflapegrastim products. Antibodies to eflapegrastim-xnst were detected using bridging enzyme-linked immunosorbent assay (ELISA) with a sensitivity of 65 ng/mL.

During the 12-week treatment period in the two randomized studies, twenty-one of 297 (7.1%) patients treated with eflapegrastim-xnst developed antibodies. At the 12-month follow-up visit after the last dose of treatment in the two randomized studies, 28 of 297 (9.4%) patients treated with eflapegrastim-xnst developed antibodies. Neutralizing antibodies were detected by a cell-based assay with a sensitivity of 1.95 mcg/mL.

One patient out of 297 (0.3%) in the eflapegrastim-xnst arm tested positive for neutralizing antibodies post-treatment. Treatment-emergent anti-PEG antibodies were detected by a direct binding ELISA in 126 out of 268 patients (47%) treated with eflapegrastim-xnst. There was no identified clinically significant effect of anti-drug antibodies on pharmacokinetics, pharmacodynamics, safety or effectiveness of Rolvedon over the treatment duration of 12 weeks.

There was no identified clinically significant effect of anti-drug antibodies on the safety profile of Rolvedon during the 12-month follow-up period after the last dose.

🧬 Mechanism of Action 34 words ▾

12.1Mechanism of Action Eflapegrastim-xnst is a recombinant human granulocyte growth factor that binds to G-CSF receptors on myeloid progenitor cells and neutrophils, triggering signaling pathways that control cell differentiation, proliferation, migration and survival.

📦 How Supplied / Storage and Handling 95 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Rolvedon (eflapegrastim-xnst) injection is a clear, colorless solution supplied in a single-dose prefilled syringe containing 13.2 mg of eflapegrastim-xnst in 0.6 mL solution, with 29-gauge 1/2 inch pre-attached (staked) needle with a needle guard. Rolvedon is provided in a dispensing pack containing one sterile 13.2 mg/0.6 mL prefilled syringe (NDC 76961‑101-01). Store refrigerated at 36°F to 46°F (2°C to 8°C) in the carton to protect from light.

Do not shake. Discard any prefilled syringe left at room temperature for greater than 72 hours. Do not freeze; discard syringe if frozen.

📋 Description 144 words ▾

11 DESCRIPTION Eflapegrastim-xnst is a granulocyte colony-stimulating factor (G‑CSF) produced by covalent coupling of a human G-CSF analog (18.6 kDa) and an Fc fragment of human immunoglobulin G4 (IgG4) (49.8 kDa), both derived from recombinant E. coli , via a single 3.4 kDa polyethylene glycol linker. The recombinant G-CSF domain in eflapegrastim-xnst is a variant of human G-CSF with two serine substitutions at positions 17 and 65, and no additional N-terminal methionine. Eflapegrastim-xnst has a molecular weight of approximately 72 kDa.

Rolvedon (eflapegrastim-xnst) injection is a sterile, preservative-free, clear, colorless solution supplied in a single-dose prefilled syringe for subcutaneous use. Each 0.6 mL single-dose prefilled syringe contains 13.2 mg of eflapegrastim-xnst, citric acid monohydrate (2.52 mg), mannitol (30 mg), polysorbate 80 (0.72 mg) and sodium chloride (5.26 mg) in Water for Injection. Sodium hydroxide may be used to adjust pH to 5.5 during manufacturing.

💬 Information for Patients 220 words ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use). Inform patients to contact their healthcare provider with any questions. Advise patients of the following risks and potential risks with Rolvedon: •Splenic rupture and splenomegaly [see Warnings and Precautions ( 5.1 )] •Acute respiratory distress syndrome [see Warnings and Precautions ( 5.2 )] •Serious allergic reactions [see Warnings and Precautions ( 5.3 )] •Sickle cell crisis [see Warnings and Precautions ( 5.4 )] •Glomerulonephritis [see Warnings and Precautions ( 5.5 )] •Leukocytosis [see Warnings and Precautions ( 5.6 )] •Thrombocytopenia [see Warnings and Precautions ( 5.7 )] •Capillary leak syndrome [see Warnings and Precautions ( 5.8 )] •Potential for tumor growth stimulatory effects on malignant cells [see Warnings and Precautions ( 5.9 )] •Increased risk of myelodysplastic syndrome and/or acute myeloid leukemia in patients with breast and lung cancer who receive Rolvedon in conjunction with chemotherapy and/or radiation therapy [see Warnings and Precautions ( 5.10 )] •Aortitis [see Warnings and Precautions ( 5.11 )] Instruct patients who self-administer Rolvedon using the single-dose prefilled syringe of the: •Importance of following the Instructions for Use •Dangers of reusing syringes •Importance of following local requirements for proper disposal of used syringes.

Manufactured by: Spectrum Pharmaceuticals, Inc. Lake Forest, IL 60045 U.S. License No.

2312

🧬 Pharmacokinetics 201 words ▾

12.3Pharmacokinetics The pharmacokinetics of eflapegrastim-xnst was studied in healthy subjects and patients with breast cancer. After subcutaneous (SC) dosing, the pharmacokinetics of eflapegrastim-xnst was nonlinear and exposure increases were not dose-proportional over the dose range of 45 to 350 mcg/kg. Absorption The median T max of eflapegrastim-xnst is 25 hours (6 to 144 hours) in patients with breast cancer following administration of the recommended dosage.

Distribution The volume of distribution of eflapegrastim-xnst is

1.44L. Elimination The geometric mean half-life of eflapegrastim-xnst in patients with breast cancer is 36.4 hours (Range: 16.1 to 115 hours) during Cycle 1. Eflapegrastim-xnst clearance decreased with increasing doses following single dose administration, suggesting target-mediated clearance of eflapegrastim-xnst by neutrophils.

Following repeat administration, clearance increased in Cycle 3 as compared to Cycle 1, potentially due to the subsequent increase in neutrophils. In in vitro studies, the IgG4 Fc fragment in eflapegrastim-xnst binds to the neonatal Fc receptor (FcRn), facilitating the FcRn-mediated transcytosis of eflapegrastim-xnst. Metabolism Eflapegrastim-xnst is expected to be metabolized by endogenous degradation following receptor-mediated internalization by cells bearing the G-CSF receptor.

Excretion Eflapegrastim-xnst was not detected in urine. Drug Interaction Studies No studies evaluating the drug interaction potential of eflapegrastim-xnst have been conducted.

🧬 Pharmacodynamics 55 words ▾

12.2Pharmacodynamics Eflapegrastim-xnst has been shown to elevate neutrophil counts in healthy subjects and in cancer patients. Absolute neutrophil count (ANC), C max and area under the effect curve (AUEC last ) increased with increasing doses of eflapegrastim-xnst in a linear, but less than dose-proportional, manner over a dose range of 45 to 350 mcg/kg.

🔬 Clinical Studies ~2 min read ▾

14 CLINICAL STUDIES Patients with Cancer Receiving Myelosuppressive Chemotherapy The efficacy of Rolvedon to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs was evaluated in two 1:1 randomized, open-label, active-controlled non-inferiority studies of similar design (Study 1 [NCT02643420] and Study 2 [NCT02953340]) that enrolled a total of 643 patients with early-stage breast cancer. Docetaxel 75 mg/m 2 and cyclophosphamide 600 mg/m 2 (TC) were administered intravenously every 21 days (on Day 1 of each cycle) for up to 4 cycles.

A fixed dose of Rolvedon 13.2 mg/0.6 mL or pegfilgrastim (6 mg/0.6 mL) was administered subcutaneously on Day 2 of each cycle after TC chemotherapy. The median age of patients enrolled in the two randomized studies was 60 years (Range: 24 to 88), the majority of patients were female (>99%), 77% were White and 12% were Black or African American. Study 1 enrolled 406 patients; 196 patients to the Rolvedon arm and 210 patients to the pegfilgrastim arm.

Study 2 enrolled 237 patients; 118 patients to the Rolvedon arm and 119 patients to the pegfilgrastim arm. Efficacy for both trials was based on the duration of severe neutropenia (DSN) in Cycle 1. Efficacy results are shown in Table 2 .

In both studies, Rolvedon was non-inferior to pegfilgrastim. The distributions of the severe neutropenia events in percentage from Cycle 1 for Study 1 and Study 2 are presented in Figure 1. Table 2.

Duration of Severe Neutropenia (DSN) in Cycle 1 (Study 1 and Study 2) a Confidence intervals were obtained using 2.5 percentile and 97.5 percentile of the 100,000 bootstrap samples with treatment as stratification factor. *The non-inferiority of Rolvedon to pegfilgrastim was to be declared if the upper bound of 95% CI of the difference in mean DSN between the treatment arms was <0.62 days. Study 1 Study 2 Rolvedon (n=196) Pegfilgrastim (n=210) Rolvedon (n=118) Pegfilgrastim (n=119) Mean DSN (SD) (Days) 0.20 (0.503) 0.35 (0.683) 0.31 (0.688) 0.39 (0.949) Median DSN (Range) (Days) 0 (0, 3) 0 (0, 3) 0 (0, 3) 0 (0, 7) Difference in DSN (Days) -0.148 -0.073 *95% Confidence Interval a -0.265, -0.033 -0.292, 0.129 Figure 1.

Duration of Severe Neutropenia (DSN) by Day in Cycle 1 (Study 1 and Study 2) Duration of Severe Neutropenia (DSN) Graphs

🧪 Nonclinical Toxicology 75 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility No long-term carcinogenicity studies have been performed with eflapegrastim-xnst. Eflapegrastim-xnst was not mutagenic or clastogenic in a standard battery of genotoxicity tests (bacterial mutagenicity (Ames), Chinese hamster ovary cells chromosomal aberration, rat bone marrow micronucleus). Eflapegrastim-xnst did not affect reproductive performance or fertility in male or female rats at weekly doses up to 7 times the clinical exposure at the maximum recommended dose of 13.2 mg.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 72 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility No long-term carcinogenicity studies have been performed with eflapegrastim-xnst. Eflapegrastim-xnst was not mutagenic or clastogenic in a standard battery of genotoxicity tests (bacterial mutagenicity (Ames), Chinese hamster ovary cells chromosomal aberration, rat bone marrow micronucleus). Eflapegrastim-xnst did not affect reproductive performance or fertility in male or female rats at weekly doses up to 7 times the clinical exposure at the maximum recommended dose of 13.2 mg.

📄 Patient Package Insert ~3 min read ▾

PATIENT INFORMATION ROLVEDON ® (roll veh don) (eflapegrastim-xnst) injection What is Rolvedon? Rolvedon is a man-made form of granulocyte colony-stimulating factor (G-CSF). G-CSF is a substance produced by the body.

It stimulates the growth of neutrophils, a type of white blood cell important in the body’s fight against infection. It is not known if Rolvedon is safe and effective in children. Do not take Rolvedon if you have had a serious allergic reaction to eflapegrastim, pegfilgrastim or filgrastim products.

Before receiving Rolvedon, tell your healthcare provider about all of your medical conditions, including if you: • have a sickle cell disorder • have kidney problems • are pregnant or plan to become pregnant. It is not known if Rolvedon can harm your unborn baby. Tell your healthcare provider right away if you become pregnant during treatment with Rolvedon. • are breastfeeding or plan to breastfeed.

It is not known if Rolvedon passes into your breast milk. 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 Rolvedon? • Rolvedon 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, follow the detailed “Instructions for Use” that comes with your Rolvedon for information on how to prepare and inject a dose of Rolvedon. • You and your caregiver will be shown how to prepare and inject Rolvedon before you use it. • You will receive 1 injection of Rolvedon for each cycle of chemotherapy. • You will receive your injection of Rolvedon about 24 hours after you finish receiving your chemotherapy . • You should not receive Rolvedon for 14 days before or within 24 hours after your dose of chemotherapy. • If you miss a dose of Rolvedon, talk to your healthcare provider about when you should receive your next dose.

What are the possible side effects of Rolvedon? Rolvedon may cause serious side effects, including: • Spleen rupture. Your spleen may become enlarged and can rupture.

A ruptured spleen can cause death. Call your healthcare provider right away if you have pain in the left upper stomach-area or your left shoulder. • A serious lung problem called Acute Respiratory Distress Syndrome (ARDS). Call your healthcare provider or get emergency help right away if you have shortness of breath with or without a fever, trouble breathing, or a fast rate of breathing. • Serious allergic reactions.

Rolvedon can cause serious allergic reactions. These reactions can cause a rash all over your whole body, shortness of breath, wheezing, dizziness, swelling around your mouth or eyes, fast heart rate, and sweating. If you have any of these symptoms, stop using Rolvedon and call your healthcare provider or get emergency medical help right away. • Sickle cell crises.

You may have a serious sickle cell crisis, which could lead to death, if you have a sickle cell disorder and receive Rolvedon. Call your healthcare provider right away if you develop symptoms of sickle cell crisis such as pain or difficulty breathing. • Kidney injury (glomerulonephritis) . Rolvedon can cause kidney injury.

Call your healthcare provider right away if you develop any of the following symptoms: o swelling of your face or ankles o blood in your urine or dark colored urine o you urinate less than usual • Increased white blood cell count (leukocytosis). Your healthcare provider will check your blood count during treatment with Rolvedon. • Decreased platelet count (thrombocytopenia). Your healthcare provider will check your blood during treatment with Rolvedon.

Tell your healthcare provider if you have unusual bleeding or bruising during treatment with Rolvedon. This could be a sign of decreased platelet counts, which may reduce the ability of your blood to clot. • Capillary Leak Syndrome. Rolvedon can caus… [Excerpted — this section continues on DailyMed.]

📖 Instructions for Use ~3 min read ▾

INSTRUCTIONS FOR USE ROLVEDON ® [roll veh don] (eflapegrastim-xnst) injection, for subcutaneous use Single-Dose Prefilled Syringe This Instructions for Use contains information on how to inject Rolvedon. Read this Instructions for Use before using Rolvedon and each time you get a refill. There may be new information.

This information does not take the place of talking to your healthcare provider about your medical condition or treatment. Important Information You Need To Know Before Injecting Rolvedon • It is important that you do not try to give the injection unless you or your caregiver have received training from your healthcare provider. • Rolvedon is for use under the skin (subcutaneous injection) only. • To help reduce needle stick injuries, each prefilled syringe has a needle guard that is automatically activated to cover the needle after the injection is complete. • Make sure the name Rolvedon appears on the carton and prefilled syringe label. • Do not use a Rolvedon prefilled syringe after the expiration date on the label. • Do not use the Rolvedon prefilled syringe if it has been dropped on a hard surface.

The prefilled syringe may be broken even if you cannot see the break. Use a new prefilled syringe. • Do not use the Rolvedon prefilled syringe if the seal on the carton or the seal on the blister tray is broken. • Do not shake the Rolvedon prefilled syringe. • Do not touch the needle guard clips before use. Touching them may cause the needle guard to be activated too early. • Do not remove the needle cap until just before you give the injection.

Rolvedon prefilled syringe parts Figure A Storing the Rolvedon prefilled syringe • Store Rolvedon in the refrigerator between 36°F to 46°F (2°C to 8°C). • Do not freeze Rolvedon. Throw away (dispose of) any Rolvedon that has been frozen. • Store Rolvedon in the original carton to protect from light. • Take the carton out of the refrigerator and place the sealed blister tray on a clean flat surface for at least 30 minutes to allow it to reach room temperature before use. • Throw away (dispose of) any prefilled syringe of Rolvedon that has been left at room temperature, 68ºF to 77ºF (20ºC to 25ºC), for more than 72 hours.

Keep Rolvedon and all medicines out of the reach of children. Preparing to inject Rolvedon Step 1. Remove the carton from refrigerator • Remove the carton from the refrigerator (see Figure B). • Check the expiration date on the carton (see Figure C).

Do not use the prefilled syringe if it is expired or if the carton has been previously opened. • Open the carton and remove the blister tray. Figure B Figure C Step 2. Allow Rolvedon to reach room temperature Place the sealed blister tray on a clean flat surface and wait 30 minutes to reach room temperature (see Figure D).

Do not warm up the prefilled syringe in any other way. Figure D Step 3. Gather the supplies needed for your injection Gather the following supplies for the injection (see Figure E): • 1 sterile cotton ball or gauze pad • 1 alcohol wipe • 1 sharps disposal container.

See “Disposing of used Rolvedon prefilled syringes” at the end of this Instructions for Use. Figure E Step 4. Wash your hands Wash your hands with soap and water.

Step 5. Remove the prefilled syringe from the blister tray • Open the tray by peeling away the tray cover. • To remove the prefilled syringe, grip the prefilled syringe by the center of the viewing window as shown in Figure F. • Do not remove the prefilled syringe by the plunger rod, plunger head, or the needle cap. • Do not touch the needle guard clips, as it could activate the needle guard. • Do not remove the needle cap until you are ready to inject. Figure F Step 6.

Inspect the prefilled syringe and medicine • Visually inspect the prefilled syringe. Do not use the prefilled syringe if it appears damaged (for example, if the syringe is cracked or broken, or if the plunger rod is detached or broken) or if the needle cap is missing. • Check the expiration date on the prefi… [Excerpted — this section continues on DailyMed.]

📄 Recent Major Changes 8 words ▾

Dosage and Administration, Administration ( 2.2 ) 07/2025

📄 Package Label / Principal Display Panel 61 words ▾

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL Rolvedon (eflapegrastim-xnst) injection 13.2 mg/0.6 mL Rolvedon (eflapegrastim-xnst) injection 13.2 mg/0.6 mL For subcutaneous injection Sterile Solution – No Preservative One 0.6 mL Single-dose Pre-filled Syringe Rolvedon (eflapegrastim-xnst) injection 13.2 mg/0.6 mL NDC 76961-101-01 Rx only For subcutaneous injection Sterile Solution – No Preservative One 0.6 mL Single-dose Pre-filled Syringe Syringe Label Blister Tray Label Carton Labeling

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
2K
Units reimbursed last 4 qtrs
1.2K
Gross reimbursed last 4 qtrs
$5.57M
Avg / prescription
$2,728.54
Avg / unit
$4,613.54
Latest quarter Q1 2026
520Rx
Fee-for-service vs managed care ⓘ
51% FFS 49% MCO
Fee-for-service · 1,045 Rx Managed care · 997 Rx
State Medicaid map
Alaska: 7 units · 1.0 per 100k residents AK Maine: 82 units · 5.9 per 100k residents 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: 116 units · 1.2 per 100k residents MI New York: 189 units · 1.0 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: 39 units · 1.2 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 57 units · 0.5 per 100k residents IL Indiana: 7 units · 0.1 per 100k residents IN Ohio: 32 units · 0.3 per 100k residents OH Pennsylvania: 39 units · 0.3 per 100k residents PA New Jersey: 56 units · 0.6 per 100k residents NJ Massachusetts: no data reported MA California: 323 units · 0.8 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: 18 units · 0.9 per 100k residents NE Missouri: 7 units · 0.1 per 100k residents MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: 11 units · 0.2 per 100k residents MD Connecticut: 34 units · 0.9 per 100k residents CT Rhode Island: no data reported RI Arizona: 14 units · 0.2 per 100k residents AZ New Mexico: 66 units · 3.1 per 100k residents NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: 8 units · 0.1 per 100k residents NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: 40 units · 1.4 per 100k residents MS Alabama: 33 units · 0.6 per 100k residents AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 31 units · 0.1 per 100k residents TX Florida: no data reported FL
Units reimbursed · per 100k residents
0.15.9
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 Maine 5.9 /100k
2 New Mexico 3.1 /100k
3 Mississippi 1.4 /100k
4 Nevada 1.2 /100k
5 Michigan 1.2 /100k
6 New York 1.0 /100k
7 Alaska 1.0 /100k
8 Connecticut 0.9 /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 Rolvedon — 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 Rolvedon. 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
$519.4K
Claims incl. refills
117
Beneficiaries
64
Spend / beneficiary
$8,115.77
Spend / claim
$4,439.40
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 Rolvedon (this brand).

Top reported reactions

White Blood Cell Count Increased4
Asthenia3
Diarrhoea3
Leukocytosis3
Abdominal Pain2
Bone Pain2
Constipation2

Age at onset

Adult2

Reporter sex

29 reports
Male · 32%
Female · 68%

Serious outcomes

Hospitalization10
Death4
Life-threatening2
Reports over time (by year) — tap or hover for the count & year
2022 2023 2024 2026 13 2
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 ✓ Available
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 ✓ Available
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 it is currently marketed — but Spectrum Pharmaceuticals, Inc. has reported a marketing end date of 2027-08-31, after which this package is expected to stop being marketed. The directory data on this page refreshes weekly.
Who lists this product with the FDA?
Spectrum Pharmaceuticals, 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 J1449 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.
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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.