Balversa

Edatinib is available in three different specifications: 3mg 28 tablets, 4mg 28 tablets, and 5mg 28 tablets. 

Among them, the price of 3mg 28 tablets is about 800 yuan, the price of 4mg 28 tablets is about 1000 yuan, and the price of 5mg 28 tablets is about 1300 yuan.

As a pan FGFR inhibitor, Balversa can effectively inhibit the activity of FGFR1, FGFR2, FGFR3, and FGFR4, thereby blocking the growth and diffusion pathways of tumor cells.

1.Main components

Balversa

2.Adapt to the population

Balversa is suitable for treating adult patients with locally advanced or metastatic urothelial carcinoma.

3.Medication for special populations

3.1Pregnancy

Based on the mechanism of action and findings in animal reproduction studies, Balversa can cause  fetal harm when administered to a pregnant woman. There are no  available data on Balversa use in pregnant women to inform a drug-associated risk. Oral  administration of erdafitinib to pregnant rats during organogenesis caused malformations and embryo-fetal death at maternal exposures that were less than the human exposures at the maximum  recommended human dose based on AUC. Advise pregnant women and females of  reproductive potential of the potential risk to the fetus.

3.2Lactation

There are no data on the presence of erdafitinib in human milk, or the effects of erdafitinib on the  breastfed child, or on milk production. Because of the potential for serious adverse reactions from erdafitinib in a breastfed child, advise lactating women not to breastfeed during treatment with Balversa and for one month following the last dose.

3.3Females and Males of Reproductive Potential

Balversa can cause fetal harm when administered to a pregnant woman.

Pregnancy Testing

Verify pregnancy status in females of reproductive potential prior to initiating treatment with Balversa.

Contraception

Females

Advise females of reproductive potential to use effective contraception during treatment with Balversa and for one month after the last dose.

Males

Advise male patients with female partners of reproductive potential to use effective contraception during  treatment with Balversa and for one month after the last dose.

Infertility

Females

Based on findings from animal studies, Balversa may impair fertility in females of reproductive  potential.

3.4Pediatric Use

Safety and effectiveness of Balversa in pediatric patients have not been established.

3.5Geriatric Use

Patients 65 years of age and older treated with Balversa experienced a higher incidence of adverse  reactions requiring treatment discontinuation than younger patients.

3.6CYP2C9 Poor Metabolizers

CYP2C9*3/*3 Genotype: Erdafitinib plasma concentrations are predicted to be higher in patients with  the CYP2C9*3/*3 genotype. Monitor for increased adverse reactions in patients who are known or  suspected to have CYP2C9*3/*3 genotype.

4.Drug overdose

Drug overdose is not yet clear.

5.Drug storage

Store at 20 °C to 25 °C (68 °F to 77 °F); excursions permitted between 15 °C to 30 °C (59 °F to 86 °F).

6.Pharmacokinetics

Median time to achieve peak plasma concentration (tmax) was 2.5 hours (range: 2 to 6 hours).

from FDA,2024.01