Bladder, kidney, and other urologic cancers:

Recent Updates:

Monograph added.

Indications for FOTIVDA:

Relapsed or refractory advanced renal cell carcinoma (RCC) following 2 or more prior systemic therapies.

Adult Dosage:

Swallow whole. 1.34mg once daily for 21 days, followed by 7 days off treatment for a 28-day cycle. Continue until disease progression or unacceptable toxicity. Moderate hepatic impairment (total bilirubin >1.5–3×ULN with any AST): reduce dose to 0.89mg once daily. Dose modifications for adverse reactions: see full labeling.

Children Dosage:

Not established.

FOTIVDA Warnings/Precautions:

Withhold, reduce dose or discontinue therapy based on severity and type of adverse reaction; see full labeling. SBP >150mmHg or DBP >100mmHg: not studied. Control BP prior to initiation. Monitor BP after 2 weeks and at least monthly thereafter. Symptomatic cardiac failure, arterial thrombotic event, myocardial infarction, unstable angina, or significant bleeding within the preceding 6 months prior to Fotivda initiation: not studied. Monitor periodically for symptoms of cardiac failure. Monitor closely in patients who are risk for, or who have a history of cardiac ischemia, thromboembolic events, hemorrhagic events. Monitor proteinuria and thyroid function prior to initiation, then periodically during therapy. Impaired wound healing: withhold for ≥24 days prior to elective surgery; do not give for ≥2 weeks after major surgery and until adequate healing. Discontinue if reversible posterior leukoencephalopathy syndrome (RPLS) occurs. ESRD. Moderate hepatic impairment: see Adult dose. Severe hepatic impairment (total bilirubin >3–10×ULN with any AST). Embryo-fetal toxicity. Advise females of reproductive potential and males (w. female partners) to use effective contraception during and for 1 month after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 1 month after the last dose).

FOTIVDA Classification:

Tyrosine kinase inhibitor.

FOTIVDA Interactions:

Antagonized by strong CYP3A inducers (eg, rifampin); avoid.

Adverse Reactions:

Fatigue, hypertension, diarrhea, decreased appetite, nausea, dysphonia, hypothyroidism, cough, stomatitis; Grade 3 or 4 lab abnormalities (decreased sodium, increased lipase, decreased phosphate); cardiac failure, cardiac ischemia, thromboembolic and hemorrhagic events, acute kidney injury, hepatobiliary disorders.

Generic Drug Availability:

NO

How Supplied:

Caps—21