Yakira
Fludarabine Phosphate Injection
Strength
✓50 mg
Pack Size
Vial
Drug Class
Purine Analogs Antineoplastic Agent
Specification
USP/BP/IH Specs offered for exports
Storage
Store at 25°C to 30°C.
Fludarabine is a chemotherapy drug used in the treatment of chronic lymphocytic leukemia.
It acts at DNA polymerase alpha, ribonucleotide reductase and DNA primase, resulting in the inhibition of DNA synthesis and destruction of cancer cells.
Fludarabine Phosphate Injection is a nucleotide metabolic inhibitor indicated for:
- Treatment of adult patients with B-cell chronic lymphocytic leukemia (CLL) who have not responded to or whose disease has progressed during treatment with at least one standard alkylating-agent containing regimen.
- Benefit in treatment-naïve or non-refractory CLL patients is not established.
This prospective, multicenter, open-label phase II clinical trial evaluated the safety, efficacy, and quality of life of oral fludarabine phosphate in patients with previously untreated B-cell chronic lymphocytic leukemia, comparing it to historical data from the intravenous formulation.
Eighty-one patients received 40 mg/m²/d of oral fludarabine phosphate for 5 days every 4 weeks for six to eight cycles.
The overall response rate was
- 71.6% by International Workshop criteria
- Complete remission: 37.0%
- Partial remission: 34.6%
- 80.2% by National Cancer Institute criteria
- Complete remission: 12.3%
- Partial remission: 67.9%
Median time to progression was 841 days.
Grade 3/4 myelosuppression was the most frequent toxicity
- Granulocytopenia: 32.1%
- Anemia: 9.9%
- Thrombocytopenia: 4.9%
Gastrointestinal toxicity was more common with the oral formulation but was generally mild to moderate.
Statistically significant improvements in emotional and insomnia quality-of-life scores were observed.
The study concluded that oral fludarabine phosphate is clinically effective, well tolerated, and has a similar efficacy and safety profile to the IV formulation with potential quality-of-life benefits.
Pregnancy
Fludarabine phosphate is classified as a pregnancy category D drug and can cause fetal harm when administered during pregnancy.
Women of childbearing potential should avoid becoming pregnant during treatment.
Breastfeeding
Breastfeeding should be discontinued during treatment due to the potential for serious adverse reactions in nursing infants.
Fertility
Fludarabine phosphate may cause infertility in both men and women.
Women should use effective contraception during treatment and for at least 6 months after the last dose.
Men should consider sperm preservation prior to treatment.
Teratogenicity
Fludarabine phosphate is potentially teratogenic and can cause fetal harm if used during pregnancy.
Effective contraception should be used during treatment and for a recommended period after therapy.
- 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.