VEGF/VEGFR inhibitors
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Fotivda Dosage

Drug Detail:Fotivda (Tivozanib)

Generic Name: tivozanib hydrochloride 0.89mg

Dosage Form: capsule

Drug Class: VEGF/VEGFR inhibitors

Contents
Uses Warnings Before Taking Dosage Side effects Interactions

Recommended Dosing

The recommended dosage of FOTIVDA 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 FOTIVDA 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.

Dose Modifications for Adverse Reactions

Initiate medical management for diarrhea, nausea, or vomiting prior to dose interruption or reduction.

If dose modifications are required for adverse reactions, reduce the dosage of FOTIVDA to 0.89 mg for 21 days on treatment followed by 7 days off treatment for a 28-day cycle.

Recommendations for dosage modifications are provided in Table 1.

Table 1. Dosage Modifications for Adverse Reactions
Adverse Reaction Severity* Dosage Modifications for FOTIVDA
*
Grades are based on the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE).
Hypertension
[see Warnings and Precautions (5.1)]		 Grade 3
  • Withhold for Grade 3 that persists despite optimal anti-hypertensive therapy.
  • Resume at reduced dose when hypertension is controlled at less than or equal to Grade 2.
Grade 4
  • Permanently discontinue.
Cardiac Failure
[see Warnings and Precautions (5.2)]		 Grade 3
  • Withhold until improves to Grade 0 to 1 or baseline.
  • Resume at a reduced dose or discontinue depending on the severity and persistence of adverse reaction.
Grade 4
  • Permanently discontinue.
Arterial Thromboembolic Events
[see Warnings and Precautions (5.3)]		 Any Grade
  • Permanently discontinue.
Hemorrhagic Events
[see Warnings and Precautions (5.5)]		 Grade 3 or 4
  • Permanently discontinue.
Proteinuria
[see Warnings and Precautions (5.6)]		 2 grams or greater proteinuria in 24 hours
  • Withhold until less than or equal to 2 grams of proteinuria per 24 hours.
  • Resume at a reduced dose.
  • Permanently discontinue for nephrotic syndrome.
Reverse Posterior Leukoencephalopathy Syndrome
[see Warnings and Precautions (5.9)]		 Any Grade
  • Permanently discontinue.
Other Adverse Reactions Persistent or intolerable Grade 2 or 3 adverse reaction
Grade 4 laboratory abnormality
  • Withhold until improves to Grade 0 to 1 or baseline.
  • Resume at reduced dose.
Grade 4 adverse reaction
  • Permanently discontinue.

Dosage Modifications for Moderate Hepatic Impairment

Reduce the recommended dosage of FOTIVDA to 0.89 mg capsule taken orally once daily for 21 days on treatment followed by 7 days off treatment for a 28-day cycle for patients with moderate hepatic impairment [see Use in Specific Populations (8.7)].

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