VOQUEZNA

Steady state pharmacokinetic (PK) parameters for vonoprazan 10 mg or 20 mg following once daily administration and vonoprazan 20 mg following twice daily administration from data collected across multiple studies are summarized in Table 12 .

Table 12Mean (%CV) Steady State Pharmacokinetic Parameters For Vonoprazan Following Once or Twice Daily Dosing PK Parameter Vonoprazan 10 mg Vonoprazan 20 mg Once Daily (N=30) Once Daily (N=68) Twice Daily (N=32) T max (h) median (min, max) 1.5 (0.75, 3.0)...

14.1 Healing of Erosive Esophagitis and Relief of Heartburn The effectiveness and safety of VOQUEZNA was evaluated in a randomized, active-controlled, double-blind, eight-week study conducted in the United States and Europe in 1024 adult patients with endoscopically confirmed erosive esophagitis (NCT04124926). Severity of the disease was classified based on the Los Angeles (LA) Classification Grading System (Grades A through D). Patients were randomized to one of the following treatment groups: VOQUEZNA 20 mg once daily or lansoprazole 30 mg once daily for 2 to 8 weeks. Patients who were posit...

The following serious adverse reactions are described elsewhere in labeling: Acute Tubulointerstitial Nephritis [see Warnings and Precautions (5.2) ] Clostridioides difficile -Associated Diarrhea [see Warnings and Precautions (5.3) ] Bone Fracture [see Warnings and Precautions (5.4) ] Severe Cutaneous Adverse Reactions [see Warnings and Precautions (5.5) ] Vitamin B12 (Cobalamin) Deficiency [see Warnings and Precautions (5.6) ] Hypomagnesemia and Mineral Metabolism [see Warnings and Precautions ...

VOQUEZNA is contraindicated in patients with a known hypersensitivity to vonoprazan or any component of VOQUEZNA. Reactions have included anaphylactic shock [see Adverse Reactions (6.2) and Description (11) ] . VOQUEZNA is contraindicated with rilpivirine-containing products [see Drug Interactions (7) ] . For information about contraindications of antibacterial agents (clarithromycin and amoxicill...

Gastric Malignancy : Symptomatic response to treatment does not preclude the presence of gastric malignancy; consider additional follow-up and diagnostic testing. ( 5.1 ) Acute Tubulointerstitial Nephritis : Discontinue treatment and evaluate patients. ( 5.2 ) Clostridioides difficile -Associated Diarrhea (CDAD) : May be associated with an increased risk; use the shortest duration of treatment appropriate to the condition. ( 5.3 ) Bone Fracture, including Osteoporosis-related Fracture : Use the ...

7 DRUG INTERACTIONS Table 9 and Table 10 include drugs with clinically important drug interactions and interaction with diagnostics when administered concomitantly with VOQUEZNA and instructions for preventing or managing them. These recommendations are based on either drug interaction trials or predicted interactions due to the expected magnitude of interaction and potential for serious adverse r...