EFLAPEGRASTIM-XNST INJ,SOLN
Clinical Criteria Summary
Indications & Target Population
- Decrease the incidence of infection (febrile neutropenia) in patients with non-myeloid malignancies receiving myelosuppressive cancer drugs.
- Not for mobilization for peripheral progenitor cells for stem cell transplantation.
- Clinical trial data supports use in early-stage breast cancer receiving adjuvant chemotherapy (docetaxel and cyclophosphamide).
Contraindications
- Serious allergic reaction to human G-CSF.
Warnings & Precautions
- Splenic rupture
- ARDS
- Serious allergic reactions
- Sickle Cell crisis
- Glomerulonephritis
- Leukocytosis
- Thrombocytopenia
- Capillary leak syndrome
- Stimulation of tumor growth
- MDS/AML in breast and lung cancer patients
Dosing & Administration
- 13.2 ng/0.6mL pre-filled syringe for subcutaneous injection once each chemotherapy cycle.
Safety Profile
- Adverse reactions ≥20%: fatigue, nausea, diarrhea, bone pain, headache, pyrexia, anemia, rash, myalgia, arthralgia, back pain.
- Safety during clinical trials was comparable to pegfilgrastim despite a lower G-CSF dose.
Formulary & Place in Therapy Considerations
- No clear place in therapy for eflapegrastim instead of pegfilgrastim.
- Application withdrawn in 2019 due to manufacturing issues.