Zubilin
Eribulin Mesylate Injection
Strength
✓0.88 mg✓2 ml
Pack Size
Vial
Drug Class
Microtubule Dynamics Inhibitors Chemotherapeutic Agent
Specification
USP/BP/IH Specs offered for exports
Storage
Store at 25°C to 30°C.
Eribulin is a microtubule inhibitor indicated for the treatment of patients with metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease.
Eribulin was isolated from the marine sponge Halichondria okadai.
Eribulin is also being investigated for use in the treatment of advanced solid tumors.
Zubilin injection is a microtubule inhibitor indicated for the treatment of patients with:
- Metastatic breast cancer who have previously received at least two chemotherapeutic regimens for treatment of metastatic disease.
- Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting.
- Unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen.
This postmarketing surveillance study utilized real-world clinical data to analyze neutropenic profiles in patients with recurrent or metastatic breast cancer treated with eribulin.
Data from 401 patients, including 5199 neutrophil count measurements, were analyzed using a mechanistic pharmacodynamic model to understand changes in neutrophil counts and investigate factors affecting neutropenia severity.
The analysis revealed that low serum albumin levels and low baseline neutrophil counts were linked to severe neutropenia.
Virtual simulations predicted the probability of Grade ≥3 neutropenia to be:
- 69% for standard treatment
- 27% for biweekly regimen
- 27% for triweekly regimen
The mean transit time was estimated at 104.5 hours, the neutrophil proliferation rate constant at 0.0377 h−1, the neutrophil elimination rate constant at 0.0295 h−1, and the linear coefficient of drug effect at 0.0413 mL/ng.
This study offers valuable insights into the safe use and potential risk factors of eribulin in real-world clinical settings.
Pregnancy
Eribulin mesylate is classified as a pregnancy category D drug and may cause fetal harm when administered during pregnancy.
Women of reproductive potential should use effective contraception during treatment.
The use of eribulin mesylate should be avoided during pregnancy, particularly during the first trimester.
Breastfeeding
It is not recommended to breastfeed during treatment with eribulin mesylate due to the potential for serious adverse reactions in nursing infants.
Fertility
Eribulin mesylate may impair fertility in both men and women.
Women should use effective contraception during treatment and for at least 2 weeks after the last dose.
Men should consider sperm preservation prior to treatment.
Teratogenicity
Similar to other cytotoxic agents, eribulin mesylate is potentially teratogenic.
Pregnancy testing and effective contraception are recommended during treatment to minimize fetal exposure risk.
- Administer 1.4 mg/m² intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle.
- Reduce dose in patients with hepatic impairment or with moderate or severe renal impairment.
- Do not mix with other drugs or administer with dextrose-containing solutions.