Vonoprazan
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vonoprazan FDA prescribing information approved indications United States
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https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/21…
Vonoprazan is an oral potassium-competitive acid blocker (PCAB) that suppresses gastric acid secretion. Brand name in the United States: Voquezna.
- How it works: reversibly blocks the gastric parietal-cell H+/K+-ATPase at the potassium-binding site. Unlike proton-pump inhibitors (PPIs), it does not require acid activation, works from the first dose, and can be taken with or without food. [Sleisenger and Fordtran's Gastrointestinal and Liver Disease, p. 892]
- Compared with PPIs: generally produces faster, more sustained acid suppression. It is metabolized mainly via CYP3A4/5, rather than CYP2C19. [Goodman & Gilman’s The Pharmacological Basis of Therapeutics, p. 1097]
- US adult indications: healing and maintenance of erosive esophagitis, relief of heartburn in erosive and non-erosive GERD, and, with antibiotics, eradication of H. pylori. See the current FDA prescribing information.
- Common adverse effects: diarrhea, abdominal pain or distension, nausea, dyspepsia, headache, and nasopharyngitis. [Goodman & Gilman’s The Pharmacological Basis of Therapeutics, p. 1097]
- Important cautions: it can mask symptoms of gastric malignancy; marked acid suppression can increase risk of enteric infections and may contribute to low magnesium or vitamin B12 with prolonged use. It is contraindicated with rilpivirine-containing products. Drug interaction review is needed, especially with medicines affected by gastric pH or CYP3A modulation.
- Evidence update: recent systematic reviews suggest benefit in non-erosive and PPI-resistant GERD, but the specific indication and regimen should follow local approval and the current product label (PMIDs: 38719148, 38263507).
Do not self-start it for persistent reflux, unexplained weight loss, vomiting, bleeding, anemia, or swallowing difficulty.
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