Tivozanib

Tivozanib was first launched in the European market in 2017 and received approval from the US Food and Drug Administration on March 10, 2021. 

The Lucius version of Tivozanig has two drug specifications, 1.34mg and 0.89mg. Tivozanig with a drug specification of 1.34mg, priced at approximately 1000 yuan.

As a targeted therapy for advanced renal cell carcinoma (RCC), Tivozanib precisely acts on VEGFR, inhibiting its phosphorylation, blocking the VEGF signaling pathway, reducing tumor angiogenesis, and thus preventing cancer cell spread.

1.Main components

Tivozanib

2.Adapt to the population

Tivozanib is indicated for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies.

3.Medication for special populations

3.1Pregnancy

There are no available data on Tivozanib use in pregnant woman to inform the drug-associated risk.

3.2Lactation

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

3.3Females and Males of Reproductive Potential

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

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

3.4Pediatric Use

The safety and effectiveness of Tivozanib in pediatric patients have not been established.

3.5Geriatric Use

No overall differences in effectiveness were observed between patients ≥ 65 versus < 65 years of age.

3.6Renal Impairment

No dosage modification is recommended for patients with mild to severe renal impairment.The recommended dosage for patients with end-stage renal disease has not been established. 

3.7Hepatic Impairment

Reduce the dosage when administering Tivozanib in patients with moderate hepatic impairment No dosage modification is recommended for patients with mild hepatic impairment. The recommended dosage of Tivozanib in patients with severe hepatic impairment has not been established.

4.Drug overdose

There is no specific treatment or antidote for Tivozanib overdose.

In cases of suspected overdose, withhold Tivozanib, closely monitor patients for hypertension and hypertensive crisis and other potential adverse reactions.Immediately manage signs or symptoms of hypertension and provide other supportive care as clinically indicated.

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

The median Tmax of Tivozanib is 10 hours with a range of 3 to 24 hours.

from FDA，2021.03