Eflapegrastim

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.

• 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 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 )] .contraindicated

• 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 ) 2.1 Recommended 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. 2.2 Administration 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.

• 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 ) 5.1 Splenic 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. 5.2 Acute Respiratory Distress Syndrome Acute respiratory distress syndrome (ARDS) can occur in patients receiving rhG-CSF products, such as Rolvedon.

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 1-800-518-1084 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical 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.

8.1 Pregnancy 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.

Metabolism

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.

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 )] .

• Sep 9, 2022BLABLA761148Spectrum Pharms

1. 1White Blood Cell Count Increased414%
2. 2Asthenia311%
3. 3Diarrhoea311%
4. 4Leukocytosis311%
5. 5Abdominal Pain27.1%
6. 6Accidental Exposure To Product27.1%
7. 7Bone Pain27.1%
8. 8Constipation27.1%
9. 9Fatigue27.1%
10. 10Febrile Neutropenia27.1%
11. 11Nausea27.1%
12. 12Off Label Use27.1%
13. 13Pancytopenia27.1%
14. 14Thrombocytopenia27.1%
15. 15Vomiting27.1%

The 9 most recently updated of 9 ClinicalTrials.gov registrations naming Eflapegrastim as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• A Study to Evaluate the Safety and Pharmacokinetics of Eflapegrastim in Pediatric Participants With Solid Tumors or Lymphomas and Treated With Myelosuppressive Chemotherapy
  Recruiting · Phase 2 · Interventional · 40 enrolled · Spectrum Pharmaceuticals, Inc
  NCT04570423updated 2026-05-22
• Open-Label, Phase 1 Study to Evaluate Duration of Severe Neutropenia After Same-Day Dosing of Eflapegrastim in Patients With Breast-Cancer
  Completed · Phase 1 · Interventional · 59 enrolled · Spectrum Pharmaceuticals, Inc
  NCT04187898updated 2024-09-19
• Reducing Neutropenia Incidence With Pegfilgrastim Administration on Day 3 After Chemotherapy
  Unknown · Phase 4 · Interventional · 100 enrolled · Eunseong Medical Foundation Good GANG-AN HOSPITAL
  NCT05949333updated 2024-02-23
• Phase 2 Study of SPI-2012 or Pegfilgrastim for the Management of Neutropenia in Participants With Breast Cancer
  Completed · Phase 2 · Interventional · 148 enrolled · Spectrum Pharmaceuticals, Inc
  NCT01724866updated 2022-04-15
• SPI-2012 vs Pegfilgrastim in the Management of Neutropenia in Participants With Breast Cancer With Docetaxel and Cyclophosphamide (ADVANCE)
  Completed · Phase 3 · Interventional · 406 enrolled · Spectrum Pharmaceuticals, Inc
  NCT02643420updated 2022-03-02
• SPI-2012 vs Pegfilgrastim in Management of Neutropenia in Breast Cancer Participants With Docetaxel and Cyclophosphamide
  Completed · Phase 3 · Interventional · 237 enrolled · Spectrum Pharmaceuticals, Inc
  NCT02953340updated 2022-03-02
• Pharmacokinetics of SPI-2012 (Eflapegrastim) in Breast Cancer Patients Receiving Docetaxel and Cyclophosphamide (TC) Chemotherapy
  Completed · Phase 1 · Interventional · 26 enrolled · Spectrum Pharmaceuticals, Inc
  NCT03135951updated 2020-11-13
• Safety and PK of HM10460A (HNK460) in Healthy Adult Japanese and Caucasian Subjects
  Completed · Phase 1 · Interventional · 84 enrolled · Hanmi Pharmaceutical Company Limited
  NCT01037543updated 2014-02-07
• Assess the Safety, Tolerability, and Pharmacokinetic (PK) Characteristics of HM10460A (HNK460) in Healthy Adult Korean Subjects
  Completed · Phase 1 · Interventional · 40 enrolled · Hanmi Pharmaceutical Company Limited
  NCT00998283updated 2014-02-07

Frequently asked questions

How does Eflapegrastim work?

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.

What is Eflapegrastim used for?

According to FDA labeling, Eflapegrastim carries indications including: 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Eflapegrastim?

Eflapegrastim is classified as Colony stimulating factors, Leukocyte Growth Factor, Cellular Proliferation Alteration, Increased Myeloid Cell Production.

What are the brand names for Eflapegrastim?

Eflapegrastim is marketed under brand names including Rolvedon.

What are the contraindications for Eflapegrastim?

Eflapegrastim labeling lists contraindications including: 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 )] .. Always consult the full prescribing information and a clinician.