Pazopanib is a kinase inhibitor sold in the U.S. under 2 brand and generic names, for renal cell carcinoma and soft tissue neoplasms. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Votrient (application NDA022465). Other pazopanib products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Recommended Dosage : 800 mg orally once daily without food (at least 1 hour before or 2 hours after a meal). ( 2.1 ) Moderate Hepatic Impairment : 200 mg orally once daily. ( 2.2 ) 2.1 Recommended Dosage The recommended dosage of VOTRIENT is 800 mg (four 200 mg tablets) orally once daily without food (at least 1 hour before or 2 hours after a meal) until disease progression or unacceptable toxicity [see Clinical Pharmacology (12.3)] . The dosage should be modified for hepatic impairment and in patients taking certain concomitant drugs [see Dosage and Administration (2.3, 2.4)] . Swallow tablets whole. Do not crush tablets due to the potential for increased rate of absorption, which may affect systemic exposure [see Clinical Pharmacology (12.3)] . If a dose is missed, it should not be taken if it is < 12 hours until the next dose. 2.2 Dosage Modifications for Adverse Reactions Table 1 summarizes the recommended dose reductions. Table 1. Recommended Dose Reductions of VOTRIENT for Adverse Reactions Dose reduction For renal cell carcinoma For soft tissue sarcoma First 400 mg orally once daily 600 mg orally once daily Second 200 mg orally once daily 400 mg orally once daily Permanently discontinue VOTRIENT in patients unable to tolerate the second dose reduction. Table 2 summarizes the recommended dosage modifications for adverse reactions. Table 2. Recommended Dosage…
The following clinically significant adverse reactions are elsewhere in the labeling: Hepatic Toxicity [see Warnings and Precautions (5.1)] QT Prolongation and Torsades de Pointes [see Warnings and Precautions (5.2)] Cardiac Dysfunction [see Warnings and Precautions (5.3)] Hemorrhagic Events [see Warnings and Precautions (5.4)] Arterial Thromboembolic Events [see Warnings and Precautions (5.5)] Venous Thromboembolic Events [see Warnings and Precautions (5.6)] Thrombotic Microangiopathy (TMA) [see Warnings and Precautions (5.7)] Gastrointestinal Perforation and Fistula [see Warnings and Precautions (5.8)] Interstitial Lung Disease (ILD)/Pneumonitis [see Warnings and Precautions (5.9)] Posterior Reversible Encephalopathy Syndrome (PRES) [see Warnings and Precautions (5.10)] Hypertension [see Warnings and Precautions (5.11)] Hypothyroidism [see Warnings and Precautions (5.13)] Proteinuria [see Warnings and Precautions (5.14)] Tumor Lysis Syndrome [see Warnings and Precautions (5.15)] Infection [see Warnings and Precautions (5.16)] The most common adverse reactions in patients with RCC (≥ 20%) are diarrhea, hypertension, hair color changes (depigmentation), nausea, anorexia, and vomiting. ( 6.1 ) The most common adverse reactions in patients with STS (≥ 20%) are fatigue, diarrhea, nausea, decreased weight, hypertension, decreased appetite, vomiting, tumor pain, hair color changes,…
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Typical price | |
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| 1 | 68/100 | Prescription | Tablet | — | — | View → | |
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Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
| Imprint | Strength | Colour | Shape | Maker |
|---|---|---|---|---|
| A77 | 400 mg | white | capsule | — |
| GS;JT | 200 mg | pink | freeform | — |
| P200 | 200 mg | gray | capsule | — |
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
None. None. ( 4 )
Strong CYP3A4 Inhibitors : Avoid coadministration of VOTRIENT with strong CYP3A4 inhibitors. If coadministration cannot be avoided, reduce the dose of VOTRIENT. ( 2.4 , 7.1 ) Strong CYP3A4 Inducers : Consider an alternate concomitant medication with no or minimal enzyme induction potential. VOTRIENT is not recommended if chronic use of strong CYP3A4 inducers cannot be avoided. ( 2.4 , 7.1 ) CYP Substrates : Coadministration of VOTRIENT with agents with narrow therapeutic windows that are metabolized by CYP3A4, CYP2D6, or CYP2C8 is not recommended. ( 7.2 ) Concomitant Use With Simvastatin : Concomitant use of VOTRIENT with simvastatin increases the risk of alanine aminotransferase (ALT) elevations. Increase to weekly monitoring of liver function as recommended. Withhold VOTRIENT and resume at reduced dose, or permanently discontinue based on severity of hepatotoxicity. ( 7.3 ) Concomitant Use With Gastric Acid-Reducing Agents : Avoid concomitant use of VOTRIENT with gastric acid-reducing agents. Consider short-acting antacids in place of proton pump inhibitors (PPIs) and H2-receptor antagonists. Separate antacid and pazopanib dosing by several hours. ( 2.4 , 7.4 ) 7.1 Effect of Other Drugs on VOTRIENT Strong CYP3A4 Inhibitors Coadministration of pazopanib with strong inhibitors of CYP3A4 increases pazopanib concentrations [see Clinical Pharmacology (12.3)] . Avoid…
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