Vonoprazan

VOQUEZNA is indicated: for healing of all grades of erosive esophagitis and relief of heartburn associated with erosive esophagitis in adults. to maintain healing of all grades of erosive esophagitis and relief of heartburn associated with erosive esophagitis in adults. for the relief of heartburn associated with non-erosive gastroesophageal reflux disease in adults. in combination with amoxicillin and clarithromycin for the treatment of Helicobacter pylori ( H. pylori ) infection in adults. in combination with amoxicillin for the treatment of H. pylori infection in adults.

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 pumps in a noncovalent and reversible manner.

Recommended Dosage: Healing of Erosive Esophagitis: 20 mg once daily for 8 weeks. Maintenance of Healed Erosive Esophagitis: 10 mg once daily for up to 6 months. Relief of Heartburn Associated with Non-Erosive Gastroesophageal Reflux Disease: 10 mg once daily for 4 weeks. Treatment of H. pylori Infection: see full prescribing information. See also full prescribing information for the recommended dosage by indication for patients with renal or hepatic impairment. Administration Instructions: Take with or without food. Swallow whole, do not chew or crush.

VOQUEZNA is contraindicated in patients with a known hypersensitivity to vonoprazan or any component of VOQUEZNA. Reactions have included anaphylactic shock. VOQUEZNA is contraindicated with rilpivirine-containing products. For information about contraindications of antibacterial agents (clarithromycin and amoxicillin) indicated in combination with VOQUEZNA, refer to the Contraindications section of the corresponding prescribing information. Known hypersensitivity to vonoprazan or any component of VOQUEZNA. Rilpivirine-containing products.

Gastric Malignancy: Symptomatic response to treatment does not preclude the presence of gastric malignancy, consider additional follow-up and diagnostic testing. Acute Tubulointerstitial Nephritis: Discontinue treatment and evaluate patients. Clostridioides difficile -Associated Diarrhea (CDAD): May be associated with an increased risk, use the shortest duration of treatment appropriate to the condition. Bone Fracture, including Osteoporosis-related Fracture: Use the shortest duration of treatment appropriate to the condition. Severe Cutaneous Adverse Reactions: Discontinue at the first signs or symptoms of severe cutaneous adverse reactions or other signs of hypersensitivity and consider further evaluation. Vitamin B12 (Cobalamin) Deficiency: Long-term use may lead to malabsorption or deficiency, consider further workup if clinical symptoms are present.

The following serious adverse reactions are described elsewhere in labeling: Acute Tubulointerstitial Nephritis Clostridioides difficile -Associated Diarrhea Bone Fracture Severe Cutaneous Adverse Reactions Vitamin B12 (Cobalamin) Deficiency Hypomagnesemia and Mineral Metabolism Fundic Gland Polyps Most common adverse reactions in VOQUEZNA-treated patients are: Healing of Erosive Esophagitis (≥2%): gastritis, diarrhea, abdominal distension, abdominal pain, and nausea. Maintenance of Healed Erosive Esophagitis (≥3%): gastritis, abdominal pain, dyspepsia, hypertension, and urinary tract infection. Relief of Heartburn Associated with Non-Erosive Gastroesophageal Reflux Disease (≥2%): abdominal pain, constipation, diarrhea, nausea, and urinary tract infection.

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 reactions or loss of efficacy. Consult the labeling of concomitantly used drugs to obtain further information about interactions with vonoprazan. Table 9: Drug Interactions Affecting Drugs Co-Administered with VOQUEZNA and Interactions with Diagnostics Drugs Dependent on Gastric pH for Absorption Antiretrovirals Clinical Effect Vonoprazan reduces intragastric acidity, which may alter the absorption of antiretroviral drugs, leading to changes in the safety and/or effectiveness.

Store between 20°C and 25°C (68°F and 77°F), excursions permitted between 15°C and 30°C (59°F and 86°F).