Brand Information

Strength	Rate	Packing Style
mg	0.00	unit

Drug Interaction:

CYP3A4 Inhibitors: Avoid use of strong inhibitors.

Consider dose reduction of VOTRIENT when administered with strong CYP3A4 inhibitors.

CYP3A4 Inducers: Consider an alternate concomitant medication with

no or minimal enzyme induction potential or avoid VOTRIENT.

CYP Substrates: Concomitant use of VOTRIENT with agents with narrow

therapeutic windows that are metabolized by CYP3A4, CYP2D6, or CYP2C8

is not recommended.

Concomitant use of VOTRIENT and simvastatin increases the risk of

ALT elevations and should be undertaken with caution and close monitoring.

Indication:

Proprietary Name- Votrient Tablets

Established Name - Pazopanib - A kinase inhibitor

Applicant- GlAXOSMITHKLINE

Indication-

Advanced renal cell carcinoma

Dosage-

800mg once intially without food at least 1 hour before or 2 hour (after meal)

Approved by FDA on 19-10-2010 (Ref- FDA approved List- 2010)

New Drugs Approved by (DCI) Drug Controller GENERAL - India For Marketing

(Ref- IDMA Publication)

Name of Drug Indication Date of Approval

Pazopanib (as Hcl 16-10-2010

Film Coated Tablets

200mg/400mg

For the treatment of Patients with advanced renal cell carcinoma

Adverse Reaction:

The most common adverse reactions (20%) are diarrhea, hypertension,

hair color changes (depigmentation), nausea, anorexia, and vomiting.

Contra-Indications:

CONTRAINDICATIONS

None.

WARNINGS AND PRECAUTIONS

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.

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.

Fatal hemorrhagic events have been reported

VOTRIENT has not been studied in patients who have a history of hemoptysis,

cerebral, or clinically significant gastrointestinal hemorrhage in the past 6 months

and should not be used in those patients.

Arterial thrombotic events have been observed and can be fatal.

Use with caution in patients who are at increased risk for these events.

Gastrointestinal perforation or fistula has occurred.

Fatal perforation events have occurred. Use with caution in patients at risk for

gastrointestinal perforation or fistula.

Hypertension including hypertensive crisis has been observed.

Blood pressure should be well-controlled prior to initiating VOTRIENT.

Monitor for hypertension and treat as needed.

Interruption of therapy with VOTRIENT is recommended in patients

undergoing surgical procedures.

Hypothyroidism may occur. Monitoring of thyroid function tests is recommended.

Proteinuria: Monitor urine protein. Discontinue for Grade 4 proteinuria.

VOTRIENT can cause fetal harm when administered to a pregnant woman.

Women of childbearing potential should be advised of the potential hazard to the

fetus and to avoid becoming pregnant while taking VOTRIENT.

Dosages/ Overdosage Etc:

For the treatment of Patients with advanced renal cell carcinoma

INDICATIONS AND USAGE

VOTRIENT is a kinase inhibitor indicated for the treatment of patients

with advanced renal cell carcinoma.

DOSAGE AND ADMINISTRATION

800 mg orally once daily without food (at least 1 hour before or 2 hours after a meal).

Baseline moderate hepatic impairment 200 mg orally once daily.

Not recommended in patients with severe hepatic impairment.

DOSAGE FORMS AND STRENGTHS

200 mg tablets.

Patient Information:

1.Therapy with VOTRIENT may result in hepatobiliary laboratory abnormalities.

2.Monitor serum liver tests (ALT, AST, and bilirubin) prior to initiation of VOTRIENT

and at least once every 4 weeks for the first 4 months of treatment or as

clinically indicated.

3 Inform patients that they should report any of the following signs and symptoms

of liver problems to their healthcare provider right away.

4.Yellowing of the skin or the whites of the eyes (jaundice),

5.Unusual darkening of the urine,

6.Unusual tiredness, in right upper stomach area pain.

7.Gastrointestinal adverse reactions such as diarrhea, nausea, and vomiting

have been reported with VOTRIENT.

8. Patients should be advised how to manage diarrhea and to notify their

healthcare provider if moderate to severe diarrhea occurs.

8.Women of childbearing potential should be advised of the potential hazard

to the fetus and to avoid becoming pregnant.

9.Patients should be advised to inform their healthcare providers of all

concomitant medications, vitamins, or dietary and herbal supplements.

10. Patients should be advised that depigmentation of the hair or skin may

occur during treatment with VOTRIENT.

11.Patients should be advised to take VOTRIENT without food (at least 1 hour

before or 2 hours after a meal).

Pharmacology/ Pharmacokinetics:

Mechanism of Action

Pazopanib is a multi-tyrosine kinase inhibitor of vascular endothelial growth factor

receptor (VEGFR)-1, VEGFR-2, VEGFR-3, platelet-derived growth factor receptor (PDGFR)-á and -a, fibroblast growth factor receptor (FGFR) -1 and -3, cytokine receptor (Kit), interleukin-2 receptor inducible T-cell kinase (Itk), leukocyte-specific protein tyrosine kinase (Lck), and transmembrane glycoprotein receptor tyrosine kinase

Pharmacokinetics

Absorption: Pazopanib is absorbed orally with median time to achieve peak

concentrations of 2 to 4 hours after the dose. Daily dosing at 800 mg results

in geometric mean

Pregnancy and lactation:

USE IN SPECIFIC POPULATIONS

1 Pregnancy

Pregnancy Category D

VOTRIENT can cause fetal harm when administered to a pregnant woman.

There are no adequate and well-controlled studies of VOTRIENT in pregnant women.

In pre-clinical studies in rats and rabbits, pazopanib was teratogenic, embryotoxic

2 Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs

are excreted in human milk and because of the potential for serious adverse

reactions in nursing infants from VOTRIENT,a decision should be made whether

to discontinue nursing or to discontinue the drug, taking into account the

importance of the drug to the mother

3 Pediatric Use

The safety and effectiveness of VOTRIENT in pediatric patients have not been

established.

4 Geriatric Use

In clinical trials with VOTRIENT for the treatment of RCC,

196 subjects (33%) were aged 65 years, and 34 subjects (6%) were

aged >75 years.

No overall differences in safety or effectiveness of VOTRIENT

were observed between these subjects and younger subjects.

However, patients >60 years of age may be at greater risk.

VOTRIENT TABLETS*

Drug Interaction

Indication

Adverse Reaction

Contra-Indications

Dosages/ Overdosage Etc

Patient Information

Pharmacology/ Pharmacokinetics

Pregnancy and lactation