Adult Dosing
Advanced renal cell carcinoma, Advanced soft tissue sarcoma
- Adults: 800 mg PO qd; administer 1 hr before or 2 hrs after a meal
- Max: 800 mg
- If toxicity occurs: Reduce dose by 400 mg, then decrease/increase in 200 mg steps depending on individual tolerability
- Concurrent CYP3A4 inhibitors: Reduce dosage to 400 mg/day
Pediatric Dosing
- Safety and effectiveness in pediatric patients have not been established
[Outline]
See Supplemental Patient Information
- Severe fatal hepatotoxicity has been observed in clinical trials. Monitor hepatic function (LFTs at baseline, then at least q 4wk x 4 month, then periodically) and adjust/discontinue therapy accordingly [FDA Black Box Warnings]
- Pazopanib can cause increases in serum transaminase and bilirubin levels, severe fatal hepatotoxicity has occurred. Measure liver function tests before initiating treatment and periodically thereafter
- It can cause prolonged QT intervals and torsades de pointes. Use with caution in patients at high risk of developing QT interval prolongation, patients taking antiarrhythmics or other medications that may prolong QT interval. Monitor electrocardiograms and electrolytes
- Fatal hemorrhagic events have been reported. Do not use in patients with history of hemoptysis, cerebral, or clinically significant gastrointestinal hemorrhage in the past 6 months
- Use with caution in patients who are at increased risk for arterial thrombotic events or who have had a history of these events
- Gastrointestinal perforation or fistula has been reported. Monitor for symptoms of gastrointestinal perforation or fistula
- Hypertension may occur early in the course of treatment. Hypertension (systolic blood pressure =150 or diastolic blood pressure =100 mm Hg) has been observed. Maintain BP prior to initiating therapy. Monitor for hypertension and treat as needed with anti-hypertensive therapy. Discontinue if hypertension is severe and persistent
- Pazopanib may impair wound healing. Stop treatment at least 7 days prior to scheduled surgery
- Events of hypothyroidism have been reported with the therapy. Monitor thyroid function tests proactively
- Perform baseline and periodic urinalysis during treatment as proteinuria has been reported. Discontinue therapy if patient develops Grade 4 proteinuria
- Concomitant use of pazopanib with agents with narrow therapeutic windows that are metabolized by CYP3A4, CYP2D6, or CYP2C8 is not recommended
- The therapy is not indicated for use in combination with other agents since thrombotic microangiopathy (TMA), including thrombotic thrombocytopenic purpura (TTP) and hemolytic uremic syndrome (HUS) have been observed in randomized clinical trials
- Based on mechanism of action the drug may cause severe effects on organ growth and maturation during early postnatal development, particularly in children younger than 2 years
Cautions: Use cautiously in
- Hepatic impairment (refer dose adjustment section)
- Congenital long QT syndrome
- CV disease
- Hypertension
- Hx of arterial thrombotic events
- Risk factors for GI fistula
- Hypothyroidism
- Pregnancy
Supplemental Patient Information
- Women of childbearing age should be advised of the potential hazard to the fetus and to avoid becoming pregnant while using the drug
Pregnancy Category:D
Breastfeeding: Safety unknown; due to the potential for possible serious adverse reactions in nursing infants, 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.
Drug Name: Votrient 200 MG Oral Tablet
Ingredient(s): Pazopanib
Imprint: GS;JT
Color(s): Gray
Shape: Freeform
Size (mm): 14.00
Score: 1
Inactive Ingredient(s): magnesium stearate / cellulose, microcrystalline / povidone / sodium starch glycolate type a potato / hypromellose / ferric oxide black / polyethylene glycol 400 / polysorbate 80 / titanium dioxide
Drug Label Author:
GlaxoSmithKline LLC
DEA Schedule:
Non-Scheduled
