Select therapeutic use:

Bladder, kidney, and other urologic cancers:

Indications for VOTRIENT:

Advanced renal cell carcinoma.

Adult:

Take on an empty stomach. Swallow whole. 800mg once daily until disease progression or unacceptable toxicity. Dose modifications for adverse reactions: see full labeling. Hepatic impairment (moderate): 200mg once daily; (severe): not recommended. Concomitant strong CYP3A4 inhibitors: avoid and use alternate drug; if warranted, reduce dose of pazopanib to 400mg. Concomitant strong CYP3A4 inducers: avoid and use alternate drug.

Children:

Not established.

Boxed Warning:

Hepatotoxicity.

Warnings/Precautions:

Not indicated for use in combination with other cancer agents. Risk of severe and fatal hepatotoxicity (esp. ≥65yrs old). Monitor liver tests at baseline, and at Weeks 3, 5, 7, and 9, thereafter at Months 3 and 4, then periodically. Increase to weekly monitoring for those with elevated ALT until ALT returns to Grade 1 or baseline. Withhold therapy and resume at reduced dose with continued weekly monitoring for 8 weeks, or permanently discontinue with weekly monitoring until resolution based on severity of hepatotoxicity. Gilbert's syndrome (see full labeling). History of QT prolongation. Cardiac dysfunction risk (including previous anthracycline exposure): evaluate LVEF at baseline and periodically; monitor for CHF. Monitor ECG, electrolytes (eg, calcium, magnesium, potassium), thyroid function. Correct hypokalemia, hypomagnesemia, hypocalcemia prior to initiation and during treatment. Hemorrhagic events. Arterial thrombotic events. Monitor for VTE, PE, infection, proteinuria (reduce dose if 24-hour urine protein ≥3g), thrombotic microangiopathy, interstitial lung disease (ILD)/pneumonitis, GI perforation or fistula. Monitor BP and manage hypertension promptly. Closely monitor those at risk for tumor lysis syndrome (eg, rapidly growing tumors, a high tumor burden, renal dysfunction, dehydration). Impaired wound healing: withhold for ≥1 week prior to elective surgery; do not give for ≥2 weeks after major surgery and until adequate healing. Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception and males (use condoms) during and for ≥2 weeks after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 2 weeks after final dose).

Pharmacologic Class:

Tyrosine kinase inhibitor.

Interactions:

See Adult dose. Potentiated by strong CYP3A4 inhibitors (eg, ketoconazole), grapefruit juice. Avoid concomitant strong Pgp or BCRP inhibitors. Antagonized by strong CYP3A4 inducers. Concomitant drugs with narrow therapeutic windows metabolized by CYP3A4, CYP2D6, or CYP2C8: not recommended. Increased risk of ALT elevations with concomitant simvastatin; increase to weekly liver function monitoring if occurs. Avoid concomitant with gastric acid-reducing agents (eg, PPIs, H2-blockers); if unavoidable, consider short-acting antacids. Separate dosing of short-acting antacids by several hours. Avoid concomitant drugs that prolong QT interval (eg, antiarrhythmics, others).

Adverse Reactions:

Diarrhea, hypertension, hair color changes, nausea, anorexia, vomiting, fatigue, decreased weight, decreased appetite, tumor pain, musculoskeletal pain, headache, dysgeusia, dyspnea, skin hypopigmentation; QT prolongation, hypothyroidism, posterior reversible encephalopathy syndrome (discontinue if occurs).

Generic Availability:

NO

How Supplied:

Tabs—120

Pricing for VOTRIENT

200mg tablet (Qty: 120)
Appx. price $14083
GoodRx

Bone and connective tissue cancer:

Indications for VOTRIENT:

Advanced soft tissue sarcoma in adults who have received prior chemotherapy.

Limitations of Use:

The efficacy for treating adipocytic soft tissue sarcoma or GI stromal tumors has not been demonstrated.

Adult:

Take on an empty stomach. Swallow whole. 800mg once daily until disease progression or unacceptable toxicity. Dose modifications for adverse reactions: see full labeling. Hepatic impairment (moderate): 200mg once daily; (severe): not recommended. Concomitant strong CYP3A4 inhibitors: avoid and use alternate drug; if warranted, reduce dose of pazopanib to 400mg. Concomitant strong CYP3A4 inducers: avoid and use alternate drug.

Children:

Not established.

Boxed Warning:

Hepatotoxicity.

Warnings/Precautions:

Not indicated for use in combination with other cancer agents. Risk of severe and fatal hepatotoxicity (esp. ≥65yrs old). Monitor liver tests at baseline, and at Weeks 3, 5, 7, and 9, thereafter at Months 3 and 4, then periodically. Increase to weekly monitoring for those with elevated ALT until ALT returns to Grade 1 or baseline. Withhold therapy and resume at reduced dose with continued weekly monitoring for 8 weeks, or permanently discontinue with weekly monitoring until resolution based on severity of hepatotoxicity. Gilbert's syndrome (see full labeling). History of QT prolongation. Cardiac dysfunction risk (including previous anthracycline exposure): evaluate LVEF at baseline and periodically; monitor for CHF. Monitor ECG, electrolytes (eg, calcium, magnesium, potassium), thyroid function. Correct hypokalemia, hypomagnesemia, hypocalcemia prior to initiation and during treatment. Hemorrhagic events. Arterial thrombotic events. Monitor for VTE, PE, infection, proteinuria (reduce dose if 24-hour urine protein ≥3g), thrombotic microangiopathy, interstitial lung disease (ILD)/pneumonitis, GI perforation or fistula. Monitor BP and manage hypertension promptly. Closely monitor those at risk for tumor lysis syndrome (eg, rapidly growing tumors, a high tumor burden, renal dysfunction, dehydration). Impaired wound healing: withhold for ≥1 week prior to elective surgery; do not give for ≥2 weeks after major surgery and until adequate healing. Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception and males (use condoms) during and for ≥2 weeks after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 2 weeks after final dose).

Pharmacologic Class:

Tyrosine kinase inhibitor.

Interactions:

See Adult dose. Potentiated by strong CYP3A4 inhibitors (eg, ketoconazole), grapefruit juice. Avoid concomitant strong Pgp or BCRP inhibitors. Antagonized by strong CYP3A4 inducers. Concomitant drugs with narrow therapeutic windows metabolized by CYP3A4, CYP2D6, or CYP2C8: not recommended. Increased risk of ALT elevations with concomitant simvastatin; increase to weekly liver function monitoring if occurs. Avoid concomitant with gastric acid-reducing agents (eg, PPIs, H2-blockers); if unavoidable, consider short-acting antacids. Separate dosing of short-acting antacids by several hours. Avoid concomitant drugs that prolong QT interval (eg, antiarrhythmics, others).

Adverse Reactions:

Diarrhea, hypertension, hair color changes, nausea, anorexia, vomiting, fatigue, decreased weight, decreased appetite, tumor pain, musculoskeletal pain, headache, dysgeusia, dyspnea, skin hypopigmentation; QT prolongation, hypothyroidism, posterior reversible encephalopathy syndrome (discontinue if occurs).

Generic Availability:

NO

How Supplied:

Tabs—120

Pricing for VOTRIENT

200mg tablet (Qty: 120)
Appx. price $14083
GoodRx