VONOPRAZAN TAB
Clinical Criteria Summary
Document 608
Indication
- Erosive esophagitis
Exclusion Criteria
- Concomitant therapy with rilpivirine, atazanavir, nelfinavir, and other antiretrovirals dependent on gastric pH for absorption
- Concomitant therapy with other drugs dependent on gastric pH for absorption that should be avoided with acid inhibiting drugs
- Concomitant use with St. John’s Wort, rifampin, efavirenz or other strong or moderate CYP3A4 inducers
- Concomitant proton pump inhibitor (PPI) therapy
- Inability to swallow tablets whole
- Lactation; patients should not breastfeed/provide breastmilk during treatment
Inclusion Criteria
- Endoscopy-confirmed erosive esophagitis (all grades) despite treatment with ≥ 8 weeks of properly timed / administered double-dose or twice daily formulary PPI
- Prescribed and monitored by a VA / VA Community Care gastroenterologist or locally designated expert in erosive esophagitis
Additional Inclusion Criteria
- Endoscopy-confirmed erosive esophagitis (all grades) despite treatment with ≥ 8 weeks of properly timed / administered double-dose or twice daily esomeprazole or rabeprazole (PPIs less affected by CYP2C19 polymorphisms)
- Unmanageable intolerance to PPI therapy
Special Populations & Counseling
- For patients who can become pregnant: Counseling provided on potential risks vs benefits of treatment and the use of effective contraception.
Document 609
Indications
- • Healing of all grades of erosive esophagitis (EE) and relief of heartburn associated with EE in adults
- • Maintenance of healing of all grades of EE and relief of heartburn associated with EE in adults
Dosage & Administration
- • Healing Phase: 20 mg once daily for 8 weeks
- • Maintenance Phase: 10 mg once daily for up to 6 months
- • Renal Impairment (Healing): ≥30 mL/min: 20 mg once daily; <30 mL/min: 10 mg once daily. Maintenance phase follows normal renal function dosing.
- • Hepatic Impairment (Healing): Child-Pugh Class A: 20 mg once daily; Classes B and C: 10 mg once daily. Maintenance phase follows normal hepatic function dosing.
Patient Selection & Place in Therapy
- • Alternative treatment for healing and maintenance of healing in patients with EE confirmed by endoscopy and, if indicated, pH monitoring
- • Indicated for patients who are PPI-refractory or for whom PPIs are not tolerated
- • PPI refractoriness is defined as an inadequate endoscopic response or intolerance to ≥8-week trials of properly timed/administered double-dose or twice daily formulary PPI and properly timed/administered double-dose or twice daily esomeprazole or rabeprazole (PPIs less affected by CYP2C19 polymorphisms)
Contraindications
- • Hypersensitivity
- • Rilpivirine-containing products
Warnings & Precautions
- • Presence of gastric malignancy (despite symptomatic response to treatment)
- • Acute tubulointerstitial nephritis
- • Clostridioides difficile-associated diarrhea (CDAD)
- • Bone fracture
- • Severe cutaneous adverse reactions
- • Vitamin B12 / cobalamin deficiency
- • Hypomagnesemia and mineral metabolism
- • Interactions with diagnostic investigations for neuroendocrine tumors
- • Fundic gland polyps (particularly with therapy beyond 1 year); use the shortest duration of therapy clinically required
Document 705
Exclusion Criteria
- Concomitant therapy with rilpivirine, atazanavir, nelfinavir, and other antiretrovirals dependent on gastric pH for absorption
- Concomitant therapy with other drugs dependent on gastric pH for absorption that should be avoided with acid inhibiting drugs
- Concomitant use with St. John’s Wort, rifampin, efavirenz or other strong or moderate CYP3A4 inducers
- Concomitant proton pump inhibitor (PPI) therapy
- Inability to swallow tablets whole
- Lactation; patients should not provide breastmilk to infants during treatment
- Core Inclusion Criteria (All must be met)
- Acid reflux symptoms that started ≥ 6 months ago, are currently occurring (in the past 2 weeks), are bothersome to the patient, and frequent (occurring on ≥ 4 of 7 consecutive days) or nocturnal
- Acid reflux symptoms are related to gastroesophageal reflux disease (GERD)
- Prescribed and monitored by a VA / VA Community Care gastroenterologist or locally designated expert
- Confirmed abnormal esophageal acid exposure on 96-hour Bravo pH monitoring or 24-hour impedance pH monitoring OFF any acid suppression (i.e., symptoms not due to non-acid reflux)
- Failure of twice-daily PPI documented by acid reflux on 24-hour impedance pH monitoring ON twice-daily PPI therapy
- No esophageal erosions on endoscopy
- No spastic esophageal motility disease on esophageal manometry
- Patient has persistent, bothersome symptoms related to GERD despite ≥ 8 weeks of properly timed/administered double-dose or twice daily formulary PPI (omeprazole or pantoprazole per VA National Formulary)
- Additional Inclusion Criteria (One of the following must be selected)
- Patient has persistent, bothersome symptoms related to GERD despite ≥ 8 weeks of properly timed/administered double-dose or twice daily esomeprazole or rabeprazole (PPIs less affected by CYP2C19 polymorphisms)
- Unmanageable intolerance to PPI therapy
- Reproductive Safety & Counseling (Select if appropriate)
- For patients who can become pregnant: Counseling provided on potential risks vs benefits of treatment and the use of effective contraception.