Vonoprazan
VOQUEZNA
What it isA potassium-competitive acid blocker (P-CAB) for erosive esophagitis and H. pylori combination therapy.
Why this oneUnlike covalent PPIs, it suppresses acid rapidly, needs no meal timing or acid activation, and holds intragastric pH higher and steadier.
What limits itSustained acid suppression can cause diarrhea, infection and nutrient depletion; review drugs needing gastric acidity for absorption.
FDA label
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| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Healing of erosive esophagitis (and relief of associated heartburn) | Adults | 20 mg QD | 20 mg QD x 8 weeks | 20 mg QD |
| Maintenance of healed erosive esophagitis (and relief of associated heartburn) | Adults | 10 mg QD | 10 mg QD up to 6 months | 10 mg QD |
| Heartburn of non-erosive GERD | Adults | 10 mg QD | 10 mg QD x 4 weeks | 10 mg QD |
| H. pylori infection - triple therapy (with amoxicillin 1,000 mg BID + clarithromycin 500 mg BID) | Adults | 20 mg BID (12 h apart) | 20 mg BID x 14 days | 20 mg BID |
| H. pylori infection - dual therapy (with amoxicillin 1,000 mg TID) | Adults | 20 mg BID | 20 mg BID x 14 days | 20 mg BID |
Renal eGFR <30 mL/min: EE healing 10 mg QD; H. pylori regimens not recommended. eGFR >=30 and all maintenance-of-EE/NERD dosing: no adjustment
Hepatic Child-Pugh B/C: EE healing 10 mg QD; H. pylori regimens not recommended. Child-Pugh A and all maintenance-of-EE/NERD dosing: no adjustment
Instructions
- With or without food; swallow tablets whole - do not chew or crush
- Missed dose (EE/NERD): take within 12 h, otherwise skip. Missed dose (H. pylori): take within 4 h, otherwise skip; continue schedule until course completed
- For H. pylori regimens also refer to amoxicillin and clarithromycin prescribing information
- Use the shortest duration appropriate to the condition
Contraindications
- Rilpivirine-containing products
- For H. pylori combination regimens, contraindications of amoxicillin and clarithromycin also apply
Cautions
- Symptomatic response does not exclude gastric malignancy; consider follow-up/diagnostics (endoscopy in older patients) if suboptimal response or early relapse
- Acute tubulointerstitial nephritis: discontinue and evaluate if suspected
- C. difficile-associated diarrhea risk (acid suppression); use shortest duration
- Bone fracture incl. osteoporosis-related with high-dose/long-term acid suppression
- Severe cutaneous adverse reactions (SJS, TEN): discontinue at first signs
- Vitamin B12 deficiency with long-term use
- Hypomagnesemia (may cause hypocalcemia/hypokalemia); consider Mg/Ca monitoring esp. with digoxin, diuretics, or hypocalcemia risk
- Falsely elevated chromogranin A: stop vonoprazan at least 4 weeks before neuroendocrine-tumor testing
- Fundic gland polyps with long-term use (especially beyond 1 year)
Adverse reactions
- EE healing (>=2%): gastritis, diarrhea, abdominal distension, abdominal pain, nausea
- EE maintenance (>=3%): gastritis, abdominal pain, dyspepsia, hypertension, UTI
- NERD (>=2%): abdominal pain, constipation, diarrhea, nausea, UTI
- H. pylori (>=2%): diarrhea, dysgeusia, vulvovaginal candidiasis, abdominal pain, headache, hypertension, nasopharyngitis
Pregnancy No adequate human data; rat fetal abnormalities only at ~130x human exposure; offspring liver injury in rats attributed to lactation exposure; pregnancy registry 1-866-609-1612
Lactation Present in human milk (<0.3% of maternal weight-adjusted dose); infant liver injury seen in rat studies at clinically relevant exposures - weigh benefits against risk
NO BOXED WARNINGS
Classes and tags
Clinical profile
Mechanism of action: Vonoprazan ballicule
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