FOTIVDA- tivozanib capsule

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

tivozanib hydrochloride (UNII: 8A9H4VK35Z) (tivozanib - UNII:172030934T)

Beschikbaar vanaf:

AVEO Pharmaceuticals, Inc.

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

FOTIVDA is indicated for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies. None. 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

Product samenvatting:

How Supplied FOTIVDA (tivozanib) capsules, for oral use are supplied as follows: Storage and Handling Store at 20° C to 25° C (68° F to 77° F); excursions permitted between 15°C to 30° C (59°F to 86° F) [see USP Controlled Room Temperature] . Keep out of reach of children.

Autorisatie-status:

New Drug Application

Productkenmerken

FOTIVDA- TIVOZANIB CAPSULE
AVEO PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FOTIVDA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR FOTIVDA.
FOTIVDA (TIVOZANIB) CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 2021
INDICATIONS AND USAGE
FOTIVDA is a kinase inhibitor indicated for the treatment of adult
patients with relapsed or refractory
advanced renal cell carcinoma (RCC) following two or more prior
systemic therapies. (1)
DOSAGE AND 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. (2.1)
Dose interruptions and/or dose reduction may be needed to manage
adverse reactions. (2.2)
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). (2.3)
DOSAGE FORMS AND STRENGTHS
Capsules: 1.34 mg and 0.89 mg (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
Hypertension and Hypertensive Crisis: Control blood pressure prior to
initiating FOTIVDA. Monitor for
hypertension and treat as needed. For persistent hypertension despite
use of anti-hypertensive
medications, reduce the FOTIVDA dose. (5.1)
Cardiac Failure: Monitor for signs or symptoms of cardiac failure
throughout treatment with FOTIVDA.
(5.2)
Cardiac Ischemia and Arterial Thromboembolic Events: Closely monitor
patients who are at increased
risk for these events. Permanently discontinue FOTIVDA for severe
arterial thromboembolic events,
such as myocardial infarction and stroke. (5.3)
Venous Thromboembolic Events: Closely monitor patients who are at
increased risk for these events.
Permanently discontinue FOTIVDA for severe venous thromboembolic
events. (5.4)
Hemorrhagic Events: Closely monitor patients who are at risk for or
who have a history of bleeding.
(5.5)
Proteinuria: Monitor throughout treatment with FOTIVDA. For modera