Tivozanib Dosage

Medically reviewed by Drugs.com. Last updated on Apr 10, 2023.

Usual Adult Dose for Renal Cell Carcinoma

1.34 mg orally once a day for 21 days followed by 7 days off (28-day cycle) until disease progression or unacceptable toxicity

Use: For adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following 2 or more prior systemic therapies

Renal Dose Adjustments

Mild/moderate/severe renal impairment (CrCl 15 to 89 mL/min): No adjustment recommended.
End-stage renal disease: Data not available

Liver Dose Adjustments

Mild (total bilirubin less than or equal to upper limit of normal [ULN] with AST greater than ULN or total bilirubin greater than 1 to 1.5 x ULN with any AST) hepatic impairment: No adjustment recommended.
Moderate (total bilirubin greater than 1.5 to 3 x ULN with any AST) hepatic impairment: Reduce dose to 0.89 mg orally once a day for 21 days followed by 7 days off (28-day cycle)
Severe (total bilirubin greater than 3 to 10 x ULN with any AST) hepatic impairment: Data not available

Dose Adjustments

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

Recommended dose modifications:

• Reduce the dose to 0.89 mg orally once a day for 21 days followed by 7 days off for a 28-day cycle.

Dose Modifications for Adverse Reactions:
HYPERTENSION:

• Grade 3: Withhold therapy for Grade 3 that persists despite antihypertensive therapy; resume at reduced dose when hypertension is controlled at less than or equal to Grade 2.
• Grade 4: Permanently discontinue therapy.

CARDIAC FAILURE:

• Grade 3: Withhold until improvement to Grade 0, 1, or baseline; resume at reduced dose or discontinue therapy based on severity and persistence of adverse reaction.
• Grade 4: Permanently discontinue therapy.

ARTERIAL THROMBOEMBOLIC EVENTS:

• Any Grade: Permanently discontinue therapy.

HEMORRHAGIC EVENTS:

• Grade 3 or 4: Permanently discontinue therapy.

PROTEINURIA:

• Two grams or greater proteinuria in 24 hours: Withhold therapy until less than or equal to 2 grams of proteinuria in 24 hours; resume at a reduced dose; permanently discontinue for nephrotic syndrome.

REVERSE POSTERIOR LEUKOENCEPHALOPATHY SYNDROME:

• Any Grade: Permanently discontinue therapy.

OTHER ADVERSE REACTIONS:

• Persistent or intolerable Grade 2 or 3 adverse reaction:
• Grade 4 laboratory abnormality: Withhold therapy until improvement to Grade 0, 1, or baseline; resume at reduced dose.
• Grade 4 adverse reaction: Permanently discontinue therapy.

Precautions

CONTRAINDICATIONS:

• None

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• This drug can be taken with or without food.
• Swallow the capsule whole with a glass of water.
• Swallow capsule whole; do not open, crush, or chew 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.
• In the case of vomiting a replacement dose should not be taken; the next dose should be taken at the next scheduled time.

Storage requirements:

• Store at 20C to 25C (68F to 77F); excursions permitted between 15C to 30C (59F to 86F).

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer