Source: FDA, National Drug Code (US) Revision Year: 2025
VEPPANU is indicated for the treatment of adults with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, estrogen receptor-1 (ESR1)-mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test, with disease progression following at least one line of endocrine therapy.
Select patients for treatment of ER-positive, HER2-negative advanced or metastatic breast cancer with VEPPANU based on the presence of ESR1 mutation(s) in plasma specimen using an FDA-authorized test [see Indications and Usage (1) and Clinical Studies (14)].
The recommended dosage of VEPPANU is 200 mg taken orally once daily with food [see Clinical Pharmacology (12.3)] until disease progression or unacceptable toxicity.
Swallow VEPPANU tablet(s) whole. Do not chew, crush, dissolve, or split prior to swallowing. Do not take VEPPANU tablets that are broken, cracked, or look damaged.
If a patient misses a dose or vomits after taking a dose, the patient should take the next dose at the regularly scheduled time.
The recommended dose reduction for adverse reactions is 100 mg orally once daily.
Permanently discontinue VEPPANU in patients who are unable to tolerate 100 mg orally once daily.
The recommended dosage modifications for VEPPANU for adverse reactions are provided in Table 1 and Table 2.
Table 1. Dosage Modifications for Adverse Reactions (Except QTc Prolongation):
| CTCAE Severity Grade | Dosage Modification |
| Grade 1 | No dose modification is required. |
| Grade 2 | Consider interruption of VEPPANU until recovery to Grade ≤1 or baseline. Then resume VEPPANU at the same dose. |
| Grade 3 | First occurrence: Interrupt VEPPANU until recovery to Grade ≤1 or baseline. Then resume VEPPANU at the same dose or at the reduced dose at the discretion of the physician. If the Grade 3 toxicity recurs, interrupt VEPPANU until recovery to Grade ≤1 or baseline. Then resume VEPPANU at the reduced dose or discontinue VEPPANU at the discretion of the physician. |
| Grade 4 | First occurrence: Interrupt VEPPANU until recovery to Grade ≤1 or baseline. Then resume VEPPANU at the reduced dose. If a Grade 4 or intolerable adverse reaction recurs, permanently discontinue VEPPANU. |
Abbreviations: CTCAE=National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events
Table 2. Dosage Modification and Management for QTc Prolongation:
| QTc Prolongation 1 [see Warnings and Precautions (5.1)] | Dosage Modification and Management |
| QTc >480 ms or >60 ms increase from baseline (and QTc ≤500 ms) | Withhold until QTc resolves to ≤480 ms and ≤60 ms above baseline, then resume VEPPANU at the same dose. Identify and treat reversible causes (e.g., hypokalemia and hypomagnesemia). Initiate more frequent ECG monitoring. |
| QTc >500 ms | Withhold until QTc resolves to ≤480 ms and ≤60 ms above baseline, then: • resume VEPPANU at the same dose if reversible cause is identified and corrected (e.g., hypokalemia and hypomagnesemia). • resume VEPPANU at the reduced dose if no reversible cause is identified. Initiate more frequent ECG monitoring. Permanently discontinue if QTc >500 ms recurs. |
| Torsade de Pointes, polymorphic ventricular tachycardia, or signs/symptoms of serious arrhythmia | Permanently discontinue VEPPANU. |
1 Heart-rate corrected QTc using Fridericia's method.
Avoid concomitant use with strong CYP3A inhibitors in patients receiving VEPPANU 200 mg once daily. If concomitant use cannot be avoided, reduce VEPPANU from 200 mg once daily to 100 mg once daily [see Drug Interactions (7.1)]. After a CYP3A inhibitor has been discontinued for 3 to 5 elimination half-lives, resume VEPPANU 200 mg once daily.
Avoid concomitant use with strong CYP3A inhibitors in patients receiving VEPPANU 100 mg once daily.
Avoid concomitant use with strong CYP3A inducers in patients receiving VEPPANU 200 mg once daily. If concomitant use cannot be avoided, increase VEPPANU from 200 mg once daily to 300 mg once daily [see Drug Interactions (7.1)]. After a CYP3A inducer has been discontinued for 7 to 14 days, resume VEPPANU 200 mg once daily.
Avoid concomitant use with strong CYP3A inducers in patients receiving VEPPANU 100 mg once daily.
Store at 20°C to 25°C (68°F to 77°F). Excursions permitted between 15°C and 30°C (between 59°F and 86°F) [see USP controlled room temperature].
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