Pazopanib Dosage

The information at Drugs.com is not a substitute for medical advice. ALWAYS consult your doctor or pharmacist.

Usual Adult Dose for:

Additional dosage information:

Usual Adult Dose for Renal Cell Carcinoma

800 mg orally once a day without food, at least 1 hour before or 2 hours after a meal

Comments:
-Limitation of Use: The efficacy of the drug for adipocytic soft tissue sarcoma or gastrointestinal stromal tumors has not been demonstrated.
-Dose should not exceed 800 mg.
-Swallow tablets whole with water; do not break or crush due to potential for increased rate of absorption which may affect systemic exposure.
-Do not take missed dose if less than 12 hours until the next dose.
-Avoid grapefruit or grapefruit juice as it may increase plasma concentration of the drug.
-There is no specific antidote for overdosage of the drug. Treatment should consist of general supportive measures.

Uses: Advanced renal cell carcinoma (RCC), advanced soft tissue sarcoma (STS) with prior chemotherapy

Usual Adult Dose for Soft Tissue Sarcoma

800 mg orally once a day without food, at least 1 hour before or 2 hours after a meal

Comments:
-Limitation of Use: The efficacy of the drug for adipocytic soft tissue sarcoma or gastrointestinal stromal tumors has not been demonstrated.
-Dose should not exceed 800 mg.
-Swallow tablets whole with water; do not break or crush due to potential for increased rate of absorption which may affect systemic exposure.
-Do not take missed dose if less than 12 hours until the next dose.
-Avoid grapefruit or grapefruit juice as it may increase plasma concentration of the drug.
-There is no specific antidote for overdosage of the drug. Treatment should consist of general supportive measures.

Uses: Advanced renal cell carcinoma (RCC), advanced soft tissue sarcoma (STS) with prior chemotherapy

Renal Dose Adjustments

No adjustment recommended, but caution is recommended in patients with creatinine clearance below 30 mL/min.

Liver Dose Adjustments

-Mild hepatic impairment (either total bilirubin within normal limit with ALT greater than upper limit of normal [ULN] or bilirubin greater than 1 to 1.5 x ULN regardless of the ALT value): No adjustment required, but caution and close monitoring recommended.
-Moderate hepatic impairment (total bilirubin greater than 1.5 to 3 x ULN regardless of the ALT value): Consider alternative therapy or reduce dose to 200 mg orally once daily.
-Severe hepatic impairment (total bilirubin greater than 3 x ULN regardless of the ALT value): Not recommended.

Dose Adjustments

RCC:
-Initial dose reductions of 400 mg and additional dose adjustments of 200 mg increments based on individual tolerability

STS:
-Dose adjustments of 200 mg increments based on individual tolerability

Strong CYP450 3A4 inhibitors:
-Avoid concomitant use of a strong CYP450 3A4 inhibitor, consider an alternative medication, or reduce dose to 400 mg orally once a day.

ALT elevation between 3 and 8 x ULN:
-Continue drug therapy and monitor liver function weekly until ALT returns to Grade 1 or baseline.

ALT elevation greater than 8 x ULN:
-Interrupt drug therapy until ALT returns to Grade 1 or baseline. If the potential benefit outweighs the risk for hepatotoxicity, reduce dose to no more than 400 mg orally once daily and measure serum liver tests weekly for 8 weeks. If transaminase elevations greater than 3 x ULN recur, permanently discontinue drug therapy.

ALT elevation greater than 3 x ULN concurrently with bilirubin elevations greater than 2 x ULN:
-Permanently discontinue drug therapy. Monitor patient until return to Grade 1 or baseline.

Precautions

US BOXED WARNING: Severe and fatal hepatotoxicity has been observed in clinical trials. Monitor hepatic function and interrupt, reduce, or discontinue dosing as recommended.

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:
-Preparation, handling, and disposal of this drug should be performed in a manner consistent with safe procedures for cytotoxic agents.

Monitoring:
-Monitor serum liver function tests (ALT, AST, bilirubin) before initiation of drug therapy, and at weeks 3, 5, 7, and 9. Thereafter, monitor at months 3 and 4, and periodically as clinically indicated.
-Blood pressure should be well-controlled before treatment, and should be monitored within the first week after starting drug therapy and frequently thereafter.
-Monitor thyroid function prior to initiating therapy and periodically thereafter.
-Baseline and periodic monitoring of ECGs and maintenance of electrolytes should be performed.
-Baseline and periodic monitoring of left ventricular ejection fraction and congestive heart failure is recommended in patients at risk of cardiac dysfunction including previous anthracycline exposure.
-Baseline and periodic urinalysis during treatment is recommended with follow up measurement of 24-hour urine protein as clinically indicated.

Patient advice:
-This drug can cause serious liver problems including death. Your doctor will do blood tests to check your liver before and during drug therapy. Tell your doctor right away if you get any of these signs of liver problems during treatment such as yellowing of your skin/whites of eyes (jaundice), dark urine, tiredness, nausea or vomiting, loss of appetite, pain on the right side of your stomach, and unusual bruising.
-This drug can harm your unborn baby; avoid pregnancy during treatment. If pregnancy occurs, contact your doctor immediately.
-This drug may cause high blood pressure. Monitor your blood pressure within the first week of treatment and often during treatment to make sure your blood pressure is well controlled. Tell your doctor if you have increases of blood pressure or symptoms such as blurred vision, confusion, nausea and vomiting, shortness of breath, severe headache, severe anxiety, severe chest pain, or seizures.
-This drug may impair wound healing. Stop this drug at least 7 days prior to surgery and consult your doctor before restarting drug therapy after surgery.
-Swallow drug tablets whole with water on an empty stomach, at least 1 hour before or 2 hours after a meal. Do not crush or break the tablets and avoid grapefruit and grapefruit juice.
-This drug can interact with several medications. Tell your doctor about all the medications you take, including prescription and over-the-counter drugs, vitamins, dietary and herbal supplements.
-This drug may cause side effects including but not limited to diarrhea, hair color changes, nausea, vomiting, and loss of appetite. Tell your doctor if you have any side effect that bothers you or does not go away.

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