VOTRIENT pazopanib hydrochloride tablet film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PAZOPANIB HYDROCHLORIDE (UNII: 33Y9ANM545) (PAZOPANIB - UNII:7RN5DR86CK)

Available from:

GlaxoSmithKline LLC

INN (International Name):

PAZOPANIB HYDROCHLORIDE

Composition:

PAZOPANIB 200 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

New Drug Application

Summary of Product characteristics

VOTRIENT- PAZOPANIB HYDROCHLORIDE TABLET, FILM COATED
GLAXOSMITHKLINE LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VOTRIENT SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR VOTRIENT.
VOTRIENT (PAZOPANIB) TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2009
WARNING: HEPATOTOXICITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
SEVERE AND FATAL HEPATOTOXICITY HAS BEEN OBSERVED IN CLINICAL TRIALS.
MONITOR HEPATIC FUNCTION AND
INTERRUPT, REDUCE, OR DISCONTINUE DOSING AS RECOMMENDED _[SEE WARNINGS
AND PRECAUTIONS (5.1)]_.
RECENT MAJOR CHANGES
Warnings and Precautions, Hepatic Toxicity and Hepatic
Impairment (5.1)
04/2015
Warnings and Precautions, Interstitial Lung Disease
(ILD)/Pneumonitis (5.9)
9/2015
INDICATIONS AND USAGE
VOTRIENT is a kinase inhibitor indicated for the treatment of patients
with:
•
•
Limitation of Use: The efficacy of VOTRIENT for the treatment of
patients with adipocytic soft tissue sarcoma or
gastrointestinal stromal tumors has not been demonstrated.
DOSAGE AND ADMINISTRATION
•
•
DOSAGE FORMS AND STRENGTHS
200 mg tablets (3)
CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
•
•
•
•
•
•
•
advanced renal cell carcinoma. (1)
advanced soft tissue sarcoma who have received prior chemotherapy. (1)
800 mg orally once daily without food (at least 1 hour before or 2
hours after a meal). (2.1)
Baseline moderate hepatic impairment – 200 mg orally once daily. Not
recommended in patients with severe hepatic
impairment. (2.2)
Increases in serum transaminase levels and bilirubin were observed.
Severe and fatal hepatotoxicity has occurred.
Measure liver chemistries before the initiation of treatment and
regularly during treatment. (5.1)
Prolonged QT intervals and torsades de pointes have been observed. Use
with caution in patients at higher risk of
developing QT interval prolongation. Monitoring electrocardiograms and
electrolytes should be considered. (5.2)
Cardiac dysfunction such as con