What is the dosage of Fotivda?

Fotivda is available in 2 dosages, including 0.89 mg Cap and 1.34 mg Cap

What does Fotivda treat?

Fotivda treats Carcinoma, Renal Cell

What is Fotivda made of?

Fotivda contains tivozanib which is a Kinase Inhibitor

How is Fotivda administered?

Fotivda is administered as a Oral Pill

What is Fotivda mechanism of action?

Fotivda mechanism of action is Tyrosine Kinase Inhibitors

Fotivda

(tivozanib)

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Dosage & Administration

* Recommended Dose: 1.34 mg once daily with or without food for 21 days on treatment followed by 7 days off treatment (28-day cycle) until disease progression or unacceptable toxicity.
* Dose interruptions and/or dose reduction may be needed to manage adverse reactions.
* For patients with moderate hepatic impairment, reduce the dose to 0.89 mg for 21 days on treatment followed by 7 days off treatment (28-day cycle).

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Fotivda Prescribing Information

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.
Reversible Posterior Leukoencephalopathy Syndrome [see Warnings and Precautions (5.10)]	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)].

Pregnancy

Risk Summary

Based on findings in animal studies and its mechanism of action, FOTIVDA can cause fetal harm when administered to a pregnant woman [see CLINICAL PHARMACOLOGY (12.1)]. There are no available data on FOTIVDA use in pregnant woman to inform the drug-associated risk. In embryo-fetal developmental studies, oral administration of tivozanib to pregnant animals during the period of organogenesis caused maternal toxicity, fetal malformations and embryo- fetal death at doses below the maximum recommended clinical dose on a mg/m2 basis [see DATA] . Advise pregnant woman of the potential risk to a fetus.

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically-recognized pregnancies is 2% to 4% and 15% to 20% respectively.

Data

Animal Data

In an embryo-fetal developmental study in pregnant rats, daily oral administration of tivozanib at doses ≥ 0.03 mg/kg/day (0.2 times the maximum recommended clinical dose on a mg/m2 basis) during the period of organogenesis resulted in maternal toxicity, increases in early and late resorptions, and an increase in fetal external malformations (body edema, short/kinked tail), and skeletal developmental delays.

In an embryo-fetal developmental study in pregnant rabbits, daily oral administration of tivozanib at 1 mg/kg/day (14.5 times the maximum recommended clinical dose on a mg/m2 basis) during the period of organogenesis resulted in fetal malformations including ventricular septal defects and major vessel anomalies. No maternal toxicity was reported at doses up to 1 mg/kg/day.

Lactation

Risk Summary

There are no data on the presence of tivozanib in human milk, or the effects of tivozanib on the breastfed child, or on milk production. Because of the potential for serious adverse reactions in a breastfed child, advise a lactating woman not to breastfeed during treatment with FOTIVDA and for one month after the last dose.

Females and Males of Reproductive Potential

FOTIVDA can cause fetal harm when administered to a pregnant woman [see USE IN SPECIFIC POPULATIONS (8.1)].

Pregnancy Testing

Verify pregnancy status of females of reproductive potential prior to starting treatment with FOTIVDA.

Contraception

Females

Advise females of reproductive potential to use effective contraception during treatment with FOTIVDA and for one month after the last dose [see USE IN SPECIFIC POPULATIONS (8.1)].

Males

Advise males with female partners of reproductive potential to use effective contraception during treatment with FOTIVDA and for one month after the last dose [see NONCLINICAL TOXICOLOGY (13.1)].

Infertility

Females and Males

Based on findings in animal studies, FOTIVDA can impair fertility in females and males of reproductive potential [see NONCLINICAL TOXICOLOGY (13.1)].

Pediatric Use

The safety and effectiveness of FOTIVDA in pediatric patients have not been established.

Animal Data

Juvenile animal studies have not been conducted with tivozanib.

In a 13-week repeat-dose study, oral administration of tivozanib to young and growing cynomolgus monkeys resulted in growth plate hypertrophy, absence of active corpora lutea, and no maturing follicles at doses ≥ 0.3 mg/kg/day (4.4 times the maximum recommended clinical dose on a mg/m2 basis). In a 13-week repeat-dose study in rats, teeth abnormalities (thin, brittle teeth, tooth loss, malocclusions) and growth plate hypertrophy were observed following oral administration of tivozanib at doses ≥ 0.1 mg/kg/day (0.7 times the maximum recommended clinical dose on a mg/m2 basis).

Geriatric Use

Of the 1008 patients with advanced RCC treated with FOTIVDA, 29% were ≥ 65 years of age and 4% were ≥ 75 of age. No overall differences in safety were observed between patients ≥ 65 versus < 65 years of age.

Of the 175 patients with advanced RCC following two or more prior systemic therapies randomized to FOTIVDA, 44% were ≥ 65 years of age and 9% were ≥ 75 of age. No overall differences in effectiveness were observed between patients ≥ 65 versus < 65 years of age.

Renal Impairment

No dosage modification is recommended for patients with mild to severe renal impairment (creatinine clearance [CLcr] 15-89 mL/min, estimated by Cockcroft-Gault). The recommended dosage for patients with end-stage renal disease has not been established [see CLINICAL PHARMACOLOGY (12.3)].

Hepatic Impairment

Reduce the dosage when administering FOTIVDA in patients with moderate (total bilirubin greater than 1.5 to 3 times ULN with any AST) hepatic impairment [see DOSAGE AND ADMINSITARTION (2.3)]. No dosage modification is recommended for patients with mild (total bilirubin less than or equal to ULN with AST greater than ULN or total bilirubin greater than 1 to 1.5 times ULN with any AST) hepatic impairment. The recommended dosage of FOTIVDA in patients with severe (total bilirubin greater than 3 to 10 times ULN with any AST) hepatic impairment has not been established [see CLINICAL PHARMACOLOGY (12.3)].

Hypertension and Hypertensive Crisis

FOTIVDA can cause severe hypertension and hypertensive crisis. Hypertension occurred in 45% of patients treated with FOTIVDA, with 22% of the events ≥ Grade 3. Median time to onset of hypertension was 2 weeks (range: 0 – 192 weeks).

Hypertensive crisis occurred in 0.8% of patients. One patient (0.1%) died due to hypertensive emergency after FOTIVDA overdose [see OVERDOSAGE (10)].

FOTIVDA has not been studied in patients with systolic blood pressure > 150 mmHg or diastolic blood pressure > 100 mmHg.

Control blood pressure prior to treatment with FOTIVDA. Monitor blood pressure after 2 weeks and at least monthly thereafter during treatment with FOTIVDA. Treat patients with anti- hypertensive therapy when hypertension occurs during treatment with FOTIVDA.

Withhold FOTIVDA for severe hypertension despite optimal anti-hypertensive therapy. For persistent hypertension despite use of anti-hypertensive medications, reduce the FOTIVDA dose [see DOSAGE AND ADMINISTRATION (2.2)].

Discontinue FOTIVDA if hypertension is severe and persistent despite anti-hypertensive therapy and dose reduction of FOTIVDA, or in patients who experience hypertensive crisis.

If FOTIVDA is interrupted, monitor patients receiving anti-hypertensive medications for hypotension.

Cardiac Failure

FOTIVDA can cause serious, sometimes fatal, cardiac failure. Cardiac failure in FOTIVDA- treated patients occurred in 1.6%, with 1% of events ≥ Grade 3, and 0.6% events were fatal.

FOTIVDA has not been studied in patients with symptomatic cardiac failure within the preceding 6 months before FOTIVDA treatment initiation.

Periodically monitor patients for symptoms of cardiac failure throughout treatment with FOTIVDA.

Management of cardiac failure events may require interruption, dose reduction, or permanent discontinuation of FOTIVDA therapy [see DOSAGE AND ADMINISTRATION (2.2)].

Cardiac Ischemia and Arterial Thromboembolic Events

FOTIVDA can cause serious, sometimes fatal, cardiac ischemia and arterial thromboembolic events. Cardiac ischemia in FOTIVDA-treated patients occurred in 3.2%, with 1.5% of events ≥ Grade 3, and 0.4% events were fatal. Arterial thromboembolic events were reported in 2% of FOTIVDA-treated patients, including death due to ischemic stroke (0.1%).

FOTIVDA has not been studied in patients who had an arterial thrombotic event, myocardial infarction, or unstable angina within the preceding 6 months before FOTIVDA treatment initiation.

Closely monitor patients who are at risk for, or who have a history of these events (such as myocardial infarction and stroke), during treatment with FOTIVDA.

Discontinue FOTIVDA in patients who develop any severe or life-threatening arterial thromboembolic event [see DOSAGE AND ADMINISTRATION (2.2)].

Venous Thromboembolic Events

FOTIVDA can cause serious, sometimes fatal, venous thromboembolic events. Venous thromboembolic events occurred in 2.4% of patients treated with FOTIVDA, including death (0.3%).

Closely monitor patients who are at risk for, or who have a history of these events during treatment with FOTIVDA.

Discontinue FOTIVDA in patients who develop any severe or life-threatening venous thromboembolic event [see DOSAGE AND ADMINISTRATION (2.2)].

Hemorrhagic Events

FOTIVDA can cause serious, sometimes fatal, hemorrhagic events. Hemorrhagic events occurred in 11% of patients treated with FOTIVDA, including death (0.2%).

FOTIVDA has not been studied in patients with significant bleeding within the preceding 6 months before FOTIVDA treatment initiation.

Closely monitor patients who are at risk for or who have a history of bleeding during treatment with FOTIVDA.

Discontinue FOTIVDA in patients who develop severe or life-threatening hemorrhagic events [see DOSAGE AND ADMINISTRATION (2.2)].

Proteinuria

FOTIVDA can cause proteinuria. Proteinuria occurred in 8% of FOTIVDA-treated patients with 2% of events Grade 3. Of the patients who developed proteinuria, 3/81 (3.7%) had acute kidney injury either concurrently or later during treatment.

Monitor patients for proteinuria before initiation of, and periodically throughout, treatment with FOTIVDA.

For patients who develop moderate to severe proteinuria, reduce the dose or interrupt FOTIVDA treatment.

Discontinue FOTIVDA in patients who develop nephrotic syndrome [see DOSAGE AND ADMINISTRATION (2.2)].

Gastrointestinal Perforation and Fistula Formation

Gastrointestinal perforation including fatal cases, has been reported in patients receiving FOTIVDA. Monitor for symptoms of gastrointestinal perforation or fistula periodically throughout treatment with FOTIVDA. Permanently discontinue FOTIVDA in patients who develop severe or life-threatening gastrointestinal perforation.

Thyroid Dysfunction

FOTIVDA can cause thyroid dysfunction. Thyroid dysfunction events in FOTIVDA-treated patients occurred in 11%, with 0.3% Grade 3 or 4 events. Hypothyroidism was reported in 8% of patients and hyperthyroidism was reported in 1% of patients.

Monitor thyroid function before initiation of, and periodically throughout, treatment with FOTIVDA.

Treat hypothyroidism and hyperthyroidism to maintain euthyroid state before and during treatment with FOTIVDA.

Risk of Impaired Wound Healing

Impaired wound healing can occur in patients who receive drugs that inhibit the vascular endothelial growth factor (VEGF) signaling pathway, such as FOTIVDA. Therefore, FOTIVDA has the potential to adversely affect wound healing.

Withhold FOTIVDA for at least 24 days prior to elective surgery. Do not administer for at least 2 weeks following major surgery and until adequate wound healing. The safety of resumption of FOTIVDA after resolution of wound healing complications has not been established.

Reversible Posterior Leukoencephalopathy Syndrome

Reversible posterior leukoencephalopathy syndrome (RPLS), a syndrome of subcortical vasogenic edema diagnosed by MRI, can occur with FOTIVDA. Perform an evaluation for RPLS in any patient presenting with seizures, headaches, visual disturbances, confusion, or altered mental function.

Discontinue FOTIVDA in patients who develop RPLS [see DOSAGE AND ADMINISTRATION (2.2)].

Embryo-Fetal Toxicity

Based on findings from animal studies and its mechanism of action, FOTIVDA can cause fetal harm when administered to a pregnant woman. In embryo-fetal developmental studies, oral administration of tivozanib to pregnant animals during the period of organogenesis caused maternal toxicity, fetal malformations and embryo-fetal death at doses below the maximum recommended clinical dose on a mg/m2 basis.

Advise pregnant woman of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment with FOTIVDA and for one month after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with FOTIVDA and for one month after the last dose [see USE IN SPECIFIC POPULATIONS (8.1), (8.3) and CLINICAL PHARMACOLOGY (12.1)].

Allergic Reactions to Tartrazine (FD&C Yellow No.5)

FOTIVDA 0.89 mg capsule contains FD&C Yellow No.5 (tartrazine) as an imprint ink which may cause allergic-type reactions (including bronchial asthma) in certain susceptible patients. Although the overall incidence of FD&C Yellow No.5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.