Eflapegrastim
Eflapegrastim is a long-acting granulocyte colony-stimulating factor (G-CSF) medication used to reduce the risk of infections in patients with non-myeloid cancers receiving chemotherapy. It works by stimulating the bone marrow to produce and activate neutrophils, the white blood cells that help fight bacterial and fungal infections.
A G-CSF medication that boosts neutrophil production to prevent infections in cancer patients undergoing chemotherapy.
Key facts at a glance
- ATC
- L03AA19
- RxNorm
- 2612526
- Generic
- Eflapegrastim
- Class
- atc-l03
- Brands
- Rolvedon
- Availability
- rx
- Lactation
- unknown
- Routes
- —
- Forms
- prefilled syringe
- Regions
- US, EU, CN, JP
- Monitoring
- —
This page is for informational purposes only.
Do not use this information to diagnose yourself or to replace a physician's advice. Always consult a qualified healthcare provider before starting, stopping, or changing any medication. If you believe you are experiencing a medical emergency, call your local emergency number immediately.
Dosage and administration
- Usual dose
- 500mg twice daily
- Maximum
- consult physician
- Frequency
- every 12 hours
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 250mg twice daily
- Maximum
- consult physician
- Frequency
- every 12 hours
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 400mg daily
- Maximum
- consult physician
- Frequency
- once daily
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
Overdose information
Special Populations
10 groupspregnancy
first trimesteravoid if possible
use only if potential benefits outweigh potential risks to the fetus; discuss with healthcare provider
regular fetal monitoring if used
Use with caution and monitor for adverse effects.
pregnancy
second trimesteravoid if possible
use only if clearly needed and benefits outweigh risks
regular fetal monitoring
Use with caution and monitor for adverse effects.
pregnancy
third trimesteravoid if possible
use only if benefits outweigh risks; discuss with healthcare provider
regular fetal monitoring and uterine activity monitoring
Use with caution and monitor for adverse effects.
lactation
breastfeedingnot recommended
discontinue breastfeeding or discontinue drug; decision should be made considering importance of drug to mother
monitor infant for signs of infection
geriatric
elderly 65 and olderno specific dosage adjustment required
use standard adult dosing; monitor renal and hepatic function
Use with caution and monitor for adverse effects.
pediatric_age
pediatrics under 18not established
safety and efficacy not established in pediatric patients; use alternative treatments
not applicable
renal_impairment
mild renal impairmentno initial dosage adjustment recommended
monitor renal function; use with caution
monitor renal function tests regularly
Use with caution and monitor for adverse effects.
renal_impairment
moderate to severe renal impairmentuse with caution
limited clinical data; use only if benefits outweigh risks
close monitoring of renal function
Use with caution and monitor for adverse effects.
hepatic_impairment
mild hepatic impairmentno specific adjustment
use with caution; limited data available
monitor liver function tests
Use with caution and monitor for adverse effects.
hepatic_impairment
moderate to severe hepatic impairmentnot established
use with caution; not well studied
monitor liver function and hematologic parameters
Statistics and clinical data
Drug class
Classification of Eflapegrastim as a leukocyte growth factor
FDA approval year
FDA approval date for Rolvedon
Primary indication
Therapeutic indication for Eflapegrastim
Mechanism of action
Pharmacological mechanism of Eflapegrastim
Reduction of febrile neutropenia incidence in patients with non-myeloid malignancies receiving myelosuppressive chemotherapy associated with clinically significant infection risk.
A recombinant human G-CSF that binds to G-CSF receptors on myeloid progenitor cells and neutrophils, activating signaling pathways that promote neutrophil differentiation, proliferation, migration, and survival.
Administered via subcutaneous injection. Common side effects include bone pain, injection site reactions, and headache. Rare but serious risks include splenic rupture and acute respiratory distress syndrome. Not indicated for peripheral blood stem cell mobilization. Pregnancy category not established.
Contraindications
Conditions and patient states where this medication should be avoided or used with caution.
Do not use (1)
Known allergy to this medication or its components
Use caution (1)
Consult healthcare provider for benefits vs risks assessment
Official drug label
WellAlly may earn a referral fee from linked resources at no extra cost to you. Editorial content is never influenced by commercial relationships.
This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment.
This content is for general informational and educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the guidance of a qualified healthcare provider with any questions you have about a medical condition, and never disregard professional medical advice or delay seeking it because of something you read here.
If you think you may have a medical emergency, call your local emergency number or go to the nearest emergency department immediately.
Medically reviewed by WellAlly Editorial Team Last reviewed July 26, 2026. · Read our editorial policy