VEPPANU 100 mg/1
vepdegestrant · TABLET · Arvinas Operations, Inc.
Veppanu (vepdegestrant) is a prescription tablet taken by mouth that contains 100 mg of the active ingredient. Your doctor will determine if this medication is right for your condition and how to use it.
Key Facts
- Brand Name
- VEPPANU
- Generic Name
- vepdegestrant
- NDC Code (Product)
84043-100- Manufacturer
- Arvinas Operations, Inc.
- Strength
- 100 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- NDA219835
- Marketing Start
- 05/01/2026
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE 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. VEPPANU is a heterobifunctional protein degrader 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. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Select patients for treatment with VEPPANU based on the presence of ESR1 mutation. ( 2.1 ) Recommended Dosage: 200 mg orally once daily with food. ( 2.2 ) Interruption, dose reduction, or permanent discontinuation may be required due to adverse reactions. ( 2.3 ) 2.1 Patient Selection 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 )] . Information on FDA-authorized tests for detection of ESR1 mutations in breast cancer is available at: http://www.fda.gov/CompanionDiagnostics. 2.2 Recommended Dosage and Administration 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 reg…
Contraindications
4 CONTRAINDICATIONS None. None. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Strong CYP3A Inhibitors : Avoid concomitant use with strong CYP3A inhibitors. If concomitant use cannot be avoided, reduce VEPPANU dosage. ( 2.4 , 7.1 ) Strong CYP3A Inducers : Avoid concomitant use with strong CYP3A inducers. If concomitant use cannot be avoided, increase VEPPANU dosage. ( 2.4 , 7.1 ) Certain P-gp Substrates : Avoid concomitant use with certain P-gp substrates where minimal increases in concentration may lead to serious adverse reactions. ( 7.2 ) Certain UGT1A9 Substrates : Refer to the Prescribing Information for UGT1A9 substrates where minimal increases in concentration may lead to serious adverse reactions. ( 7.2 ) 7.1 Effect of Other Drugs on VEPPANU Table 5 describes drug interactions where concomitant use of another drug affects VEPPANU. Table 5: Drug Interactions that Affect VEPPANU Strong CYP3A Inhibitors Prevention or Management Strong CYP3A Inhibitors: Avoid concomitant use of VEPPANU with strong CYP3A inhibitors in patients receiving VEPPANU 200 mg once daily. If concomitant use cannot be avoided, reduce VEPPANU dosage [see Dosage and Administration ( 2.4 )] . Avoid concomitant use with strong CYP3A inhibitors in patients receiving V…
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reaction is described elsewhere in the labeling: QTc Interval Prolongation [see Warnings and Precautions ( 5.1 )] Most common ( > 10%) adverse reactions with VEPPANU, including laboratory abnormalities, were decreased white blood cells, increased AST, musculoskeletal pain, fatigue, decreased hemoglobin, decreased neutrophils, increased ALT, increased alkaline phosphatase, nausea, decreased blood potassium, increased bilirubin, decreased appetite, electrocardiogram QT prolonged, decreased platelets, and constipation. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Rigel Pharmaceuticals, Inc. at 1-800-983-1329 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of VEPPANU was evaluated in patients with ER-positive, HER2-negative, advanced or metastatic breast cancer following endocrine therapy in VERITAC-2 [see Cli…
Frequently Asked Questions
What is VEPPANU used for?
Veppanu (vepdegestrant) is a prescription tablet taken by mouth that contains 100 mg of the active ingredient. Your doctor will determine if this medication is right for your condition and how to use it.
Is VEPPANU a controlled substance?
VEPPANU is not classified as a controlled substance by the DEA.
What is the generic name for VEPPANU?
The generic name for VEPPANU is vepdegestrant. There are no other listed brand versions of vepdegestrant.
What is the NDC code for VEPPANU 100 mg/1?
The NDC (National Drug Code) for VEPPANU 100 mg/1 is 84043-100, listed by Arvinas Operations, Inc..
Other VEPPANU Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)