Eflapegrastim

Eflapegrastim
Names
Trade namesRolvedon
Other namesEflapegrastim-xnst, HM-10460A, SPI-2012
Clinical data
Drug classGranulocyte colony-stimulating factor (G-CSF)[1]
Main usesReduce the risk of febrile neutropenia with chemotherapy[1]
Side effectsTiredness, nausea, diarrhea, pain, fever, rash, low red blood cells[1]
Routes of
use		Subcutaneous
Typical dose13.2 mg[1]
External links
AHFS/Drugs.comMonograph
US NLMEflapegrastim
Legal
License data
Legal status

Eflapegrastim, sold under the brand names Rolvedon, is a medication used to reduce the risk of febrile neutropenia in non-myeloid cancers receiving chemotherapy that results in bone marrow suppression.[1] It is given by injection under the skin.[1] It is given about 24 hours after chemotherapy.[1]

Common side effects include tiredness, nausea, diarrhea, pain, fever, rash, and low red cells.[1] Other side effects may include spleen rupture, ARDS, anaphylaxis, low platelets, glomerulonephritis, and myelodysplastic syndrome.[1] It is a granulocyte colony-stimulating factor (G-CSF), specifically a leukocyte growth factor.[1]

Eflapegrastim was approved for medical use in the United States in 2022.[1] It is not approved in Europe or the United Kingdom as of 2022.[2] It costs about 4,700 USD per dose in the United States as of 2022.[3]

Medical uses

Eflapegrastim is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in adults with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia.[1]

Its efficacy has been shown to be non-inferior to pegfilgrastim.[1]

Dosage

It is generally given at a dose of 13.2 mg once per chemotherapy cycle.[1]

References

  1. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 "Rolvedon- eflapegrastim-xnst injection, solution". DailyMed. 23 September 2022. Archived from the original on 16 October 2022. Retrieved 16 October 2022.
  2. ↑ "Eflapegrastim". SPS - Specialist Pharmacy Service. 16 March 2018. Archived from the original on 25 June 2022. Retrieved 13 December 2022.
  3. ↑ "Rolvedon Prices, Coupons, Copay & Patient Assistance". Drugs.com. Retrieved 13 December 2022.
External sites:
Identifiers:
  • Clinical trial number NCT02643420 for "SPI-2012 vs Pegfilgrastim in the Management of Neutropenia in Participants With Breast Cancer With Docetaxel and Cyclophosphamide (ADVANCE) (ADVANCE)" at ClinicalTrials.gov
  • Clinical trial number NCT02953340 for "SPI-2012 vs Pegfilgrastim in Management of Neutropenia in Breast Cancer Participants With Docetaxel and Cyclophosphamide" at ClinicalTrials.gov
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