ZEGFROVY Tablet Ref.[115731] Active ingredients: Sunvozertinib

Source: FDA, National Drug Code (US) Revision Year: 2025

Product description

ZEGFROVY (sunvozertinib) is a kinase inhibitor. The molecular formula for sunvozertinib is C₂₉H₃₅ClFN7O~3', and the molecular weight is 584.09 g/mol. The chemical name of sunvozertinib is N-{5-[(4-{[5-chloro-4-fluoro-2-(1-hydroxy-1-methylethyl)phenyl]amino}pyrimidin-2-yl)amino]-2-[(3R)-3-(dimethylamino)pyrrolidin-1-yl]-4-methoxyphenyl}prop-2-enamide. Sunvozertinib has one chiral carbon with R-configuration. The chemical structure of sunvozertinib is shown below:

ZEGFROVY tablets contain 150 mg or 200 mg of active ingredient sunvozertinib. Inactive ingredients in ZEGFROVY core tablets are colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The tablet coating consists of hypromellose 2910, iron oxide yellow, titanium dioxide, and triacetin.

Dosage Forms and Strengths
Strong CYP3A Inhibitors Avoid concomitant use of strong CYP3A inhibitors. If concomitant use cannot be avoided, reduce the ZEGFROVY dose from 200 mg to 150 mg [see Drug Interactions (7.1)]. After discontinuing a CYP3A inhibitor, resume the ZEGFROVY dose (after 3 to 5 half-lives of the CYP3A inhibitor) that was taken prior to initiating the CYP3A inhibitor. Strong and Moderate CYP3A Inducers Avoid concomitant use of strong and moderate CYP3A inducers. If concomitant use cannot be avoided, increase the ZEGFROVY dose from 200 mg to 400 mg [see Drug Interactions (7.1)]. After discontinuing a CYP3A inducer, resume the ZEGFROVY dose (7 to 14 days after discontinuing the CYP3A inducer) that was taken prior to initiating the CYP3A inducer.

Dosage Forms and Strengths

Strong CYP3A Inhibitors

Avoid concomitant use of strong CYP3A inhibitors. If concomitant use cannot be avoided, reduce the ZEGFROVY dose from 200 mg to 150 mg [see Drug Interactions (7.1)].

After discontinuing a CYP3A inhibitor, resume the ZEGFROVY dose (after 3 to 5 half-lives of the CYP3A inhibitor) that was taken prior to initiating the CYP3A inhibitor.

Strong and Moderate CYP3A Inducers

Avoid concomitant use of strong and moderate CYP3A inducers. If concomitant use cannot be avoided, increase the ZEGFROVY dose from 200 mg to 400 mg [see Drug Interactions (7.1)].

After discontinuing a CYP3A inducer, resume the ZEGFROVY dose (7 to 14 days after discontinuing the CYP3A inducer) that was taken prior to initiating the CYP3A inducer.

How Supplied

ZEGFROVY tablets are supplied in bottles with a child-resistant cap as follows:

Tablet Strength	Description	Quantity	NDC Code
150 mg	Yellow, biconvex film-coated tablets, debossed with "150" on one side and Dizal company logo on the other side.	30	24538-101-01
200 mg	Yellow, biconvex film-coated tablets, debossed with "200" on one side and Dizal company logo on the other side.	30	24538-102-01

Manufactured for: Dizal (Jiangsu) Pharmaceutical Co., Ltd., Shanghai, 201203, China

Drugs

Drug	Countries
ZEGFROVY	United States

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