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Voquezna Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Tabs—30
Manufacturer
Generic Availability
Mechanism of Action
Vonoprazan suppresses basal and stimulated gastric acid secretion at the secretory surface of the gastric parietal cell through inhibition of the H+, K+-ATPase enzyme system in a potassium competitive manner. Because this enzyme is regarded as the acid (proton) pump within the parietal cell, vonoprazan has been characterized as a type of gastric proton-pump inhibitor, in that it blocks the final step of acid production. Vonoprazan does not require activation by acid. Vonoprazan may selectively concentrate in the parietal cells in both the resting and stimulated states. Vonoprazan binds to the active proton pumps in a noncovalent and reversible manner.
Voquezna Indications
Indications
For healing and maintenance of healing of all grades of erosive esophagitis (EE), and relief of heartburn associated with erosive esophagitis in adults. In combination with amoxicillin, with or without clarithromycin, for the treatment of H. pylori infection in adults.
Voquezna Dosage and Administration
Adult
Swallow whole. Healingof EE/relief of heartburn: 20mg once daily for 8 weeks. Maintenanceof EE/relief of heartburn: 10mg once daily for up to 6 months. Renal impairment (eGFR <30mL/min), hepatic impairment (Child-Pugh B or C) in healing of EE/relief of heartburn: 10mg once daily. Treatment of H. pylori infection: for triple or dual therapy, see full labeling.
Children
Voquezna Contraindications
Contraindications
Voquezna Boxed Warnings
Not Applicable
Voquezna Warnings/Precautions
Warnings/Precautions
Symptomatic response does not preclude gastric malignancy. Discontinue and evaluate if acute tubulointerstitial nephritis is suspected. Evaluate if diarrhea occurs. Discontinue at the first signs/symptoms of severe cutaneous reactions or other hypersensitivity. Long-term therapy may lead to malabsorption/deficiency of Vit. B12. Consider monitoring magnesium levels during prolonged therapy. Consider monitoring magnesium, calcium levels in those with preexisting risk of hypocalcemia (eg, hypoparathyroidism). Increased risk of fundic gland polyps with long-term use (esp. >1yr) or osteoporosis-related fractures (hip, wrist or spine) with long-term (>1yr) and multiple daily dose PPI therapy. Use the shortest duration appropriate to the condition. Reevaluate periodically. Severe renal impairment (healing of EE): reduce dose; (treatment of H. pylori): not recommended. Moderate to severe hepatic impairment (healing of EE): reduce dose; (treatment of H. pylori): not recommended. Pregnancy. Nursing mothers: not recommended.
Voquezna Pharmacokinetics
Absorption
Steady state concentrations are achieved by Day 3–4.
Distribution
Plasma protein bound: 85–88%.
Elimination
Renal (67%), fecal (31%); Half-life: 6.8–7.9 hours.
Voquezna Interactions
Interactions
May be antagonized by strong or moderate CYP3A inducers; avoid. Vonoprazan reduces intragastric acidity which may alter the absorption of antiretrovirals and other drugs (eg, iron salts, erlotinib, dasatinib, nilotinib, mycophenolate mofetil, ketoconazole/itraconazole); avoid concomitant with atazanavir, nelfinavir. May potentiate CYP3A4 substrates (eg, midazolam); dose reduction of substrate drugs may be needed. May potentiate CYP2C19 substrates (eg, citalopram, cilostazol); monitor closely. May antagonize clopidogrel; monitor and consider alternative therapy. Concomitant drugs that may have increased toxicity in the presence of hypomagnesemia (eg, digoxin), or drugs that may cause hypomagnesemia (eg, diuretics). May cause false (+) results in diagnostic tests for neuroendocrine tumors; assess CgA levels at least 14 days after treatment; repeat if initial levels are high. May cause false (+) results with secretin stimulation test; interrupt therapy at least 14 days before assessing to allow gastrin levels to return to baseline.
Voquezna Adverse Reactions
Adverse Reactions
Erosive esophagitis: gastritis, diarrhea, abdominal distension, abdominal pain, nausea, dyspepsia, hypertension, urinary tract infection; also for H. pylori infection: dysgeusia, vulvovaginal candidiasis, headache, nasopharyngitis; possible C. difficile-associated diarrhea, severe cutaneous reactions (eg, SJS, TEN), hypomagnesium.
Voquezna Clinical Trials
See Literature
Voquezna Note
Not Applicable
Voquezna Patient Counseling
See Literature
