Instructions for Tivozanib

1. Name: tivozanib hydrochloride, tivozanib capsules, Fotivda capsules

2. Indications:

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

3. Usage and dosage:

1. Recommended dose: The recommended dose of tivozanib is 1.34 mg orally once daily, requiring treatment for 21 days, and then stopping treatment for 7 days in a 28-day cycle, and continuing treatment until disease progression or unacceptable toxicity occurs.

2. Dose adjustment: If adverse reactions require dose adjustment, during the 28-day treatment cycle, reduce the dose of tivozanib to 0.89 mg, treat for 21 days, and then discontinue treatment for 7 days. Medical treatment of adverse events such as diarrhea, nausea, or vomiting is required before dose interruption or reduction.

(1) Patients with moderate hepatic impairment: For patients with moderate hepatic impairment, reduce the recommended dose of tivozanib to 0.89 mg orally once daily for 21 days, followed by 7 days of discontinuation for a 28-day treatment cycle.

4. Adverse reactions:

In clinical studies of tivozanib in patients with advanced renal cancer who have relapsed or been refractory after two or more systemic therapies, the most common (≥20%) adverse reactions were fatigue, hypertension, diarrhea, decreased appetite, nausea, dysphonia, hypothyroidism, cough, and stomatitis, and the most common grade 3 or 4 laboratory abnormalities (≥5%) were decreased sodium, increased lipase, and decreased phosphate.

5. Storage:

Tivozanib will be store at 20°C to 25°C (68°F to 77°F); tolerances are allowed between 15°C and 30°C (59°F to 86°F), out of the reach of children.

6. Special groups:

(1) Women: Based on the results of animal studies and its mechanism of action, pregnant women should take itTivozanib may cause fetal harm, so lactating women are advised not to breastfeed during treatment with tivozanib and for one month after the last dose; advise females of reproductive potential to use effective contraception during treatment with tivozanib and for one month after the last dose.

(2) Men: Advise men who are partners of a female of reproductive potential to use effective contraception during treatment with tivozanib and for one month after the last dose.

7. Mechanism of action:

Tivozanib is a tyrosine kinase inhibitor. In vitro cellular kinase assays demonstrated that tivozanib inhibits the phosphorylation of vascular endothelial growth factor receptor (VEGFR)-1, VEGFR-2, and VEGFR-3 at clinically relevant concentrations, and inhibits other kinases, including c-kit and PDGFR beta. Tivozanib inhibited angiogenesis, vascular permeability and tumor growth in various tumor cell types, including human renal cell carcinoma, in tumor xenograft models in mice and rats.

The original drug Tivozanib has not yet been marketed in the country, so it has not been included in medical insurance. The European version of tivozanib Original drug, specifications1340mcg*21 pills sold overseas may cost around 30,000 yuan per box (the price may fluctuate due to exchange rates), which is relatively expensive. There is currently no generic version of Tivozanib on the market. For more drug information and specific prices, please consult Yaode Medical Consultant.