FOTIVDA® (tivozanib) is an oral, once-daily, differentiated vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI). It is a potent, selective inhibitor of VEGFRs 1, 2, and 3 with a long half-life designed to improve efficacy and tolerability.1,2
AVEO received U.S. Food and Drug Administration (FDA) approval in March 2021 for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies.
Approved in August 2017 in the European Union and other countries in the territory of its partner EUSA Pharma for the treatment of adult patients with advanced RCC. Tivozanib has been shown to significantly reduce regulatory T-cell production in preclinical models.3
Tivozanib was discovered by Kyowa Kirin (KKC) and is also being studied as a new formulation by KKC in wet acute macular degeneration. Visit Fotivda.com for additional information.
1Fotivda (Tivozanib) SmPC August 2017
2Motzer RJ, Nosov D, Eisen T, et al. J Clin Oncol 2013; 31(30): 3791-9.
3Pawlowski N et al. AACR 2013. Poster 3971
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FOTIVDA® is a limited distribution oral cancer medication just approved by the F.D.A. for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies.
|APPROVED INDICATION1||RECOMMENDED DOSAGE1|
FOTIVDA is indicated for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies.
The recommended dosage is 1.34 mg taken orally once daily for 21 days on treatment followed by 7 days off treatment for a 28-day cycle.
Continue treatment until disease progression or until unacceptable toxicity occurs. Take FOTIVDA with or without food.
Swallow the capsule whole with a glass of water. Do not open the capsule. If a dose is missed, the next dose should be taken at the next scheduled time.
Do not take two doses at the same time.
DOSAGE FORMS AND STRENGTHS
• 1.34 mg: bright yellow opaque cap imprinted with “TIVZ” in dark blue ink and a bright yellow opaque body imprinted with “SD” in dark blue ink.
• 0.89 mg: dark blue opaque cap imprinted with “TIVZ” in yellow ink and a bright yellow opaque body imprinted with “LD” in dark blue ink.
Mechanism of Action
Tivozanib is a tyrosine kinase inhibitor. In vitro cellular kinase assays demonstrated that tivozanib inhibits phosphorylation of vascular endothelial growth factor receptor (VEGFR)-1, VEGFR-2 and VEGFR-3 and inhibits other kinases including c-kit and PDGFR β at clinically relevant concentrations.
In tumor xenograft models in mice and rats, tivozanib inhibited angiogenesis, vascular permeability, and tumor growth of various tumor cell types including human renal cell carcinoma.