By Darcy Burbage, DNP, RN, AOCN®, CBCN®
On March 10, 2021, the U.S. Food and Drug Administration approved tivozanib (Fotivda®), an oral kinase inhibitor, for adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies.
Vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI)
Mechanism of Action
In vitro cellular kinase assays demonstrated that tivozanib inhibits VEGFR-1, 2, and 3 and other kinases, including c-kit and PDGFR β, at clinically relevant concentrations. In tumor xenograft models, it inhibited angiogenesis, vascular permeability, and tumor growth.
Adult patients with relapsed or refractory advanced RCC following two or more prior systemic therapies
One 1.34 mg capsule orally daily for 21 days followed by 7 days off treatment for a 28-day cycle
Give by mouth once daily, with or without food. Capsules should be taken whole with a glass of water; do not open the capsule.
Tivozanib can cause severe hypertension and hypertensive crisis. Hypertension occurred in 45% of patients, with 22% of the events at grade 3 or higher. Median time to onset of hypertension was two weeks.
The 0.89 mg capsules contain FD&C yellow no. 5 (tartrazine), which may cause allergic-type reactions, including bronchial asthma, in certain people, most often those who also have an allergy to aspirin.
Severe (grades 3 and 4) laboratory abnormalities, including decreased sodium, increased lipase, and decreased phosphate, were reported in more than 5% of patients. The most common adverse reactions in more than 20% of patients are fatigue, hypertension, diarrhea, decreased appetite, nausea, dysphonia, hypothyroidism, cough, and stomatitis.
Tivozanib is associated with embryo-fetal toxicity.
Take any missed doses at the next regularly scheduled time. Do not take two doses in the same day. Dose modifications or delays may be needed to manage adverse reactions.
VEGFR inhibitors may impair wound healing and temporary interruption is recommended prior to elective surgery. Advise patients to contact their healthcare provider before any planned surgeries, including dental surgery.
Because of the risk for hypertension or hypertensive crisis, advise patients to routinely monitor their blood pressure and to contact their healthcare provider if it elevates or if they experience signs or symptoms of hypertension.
Advise patients about the risk for embryo-fetal toxicity and to use effective contraception and avoid breastfeeding during treatment and for at least one month after the last dose.
Advise patients to routinely monitor their blood pressure and to contact their oncologist if it elevates or if they experience signs or symptoms of hypertension. Recommend use of effective contraception to avoid pregnancy or getting a partner pregnant during treatment and for at least one month after the final dose. Patients must inform their healthcare provider of a known or suspected pregnancy and avoid breastfeeding.
Tell patients to contact their healthcare provider before any planned surgeries, including dental surgery. Advise patients to inform their healthcare providers of all concomitant medications, including prescription medicines, over-the-counter drugs, vitamins, herbs, and other supplements.
No overall differences in effectiveness were observed in patients older or younger than 65.
Use hazardous drug precautions. Tivozanib can cause fetal harm and impair fertility in both sexes.
Call the AVEO ACE Patient Support Program at 833-FOTIVDA (833-368-4832).