VOCINTI FILM-COATED TABLET 20MG

4.1 Therapeutic Indications

Treatment of gastric ulcer (GU)

Treatment of duodenal ulcer (DU)

Treatment of reflux esophagitis (RE) (erosive esophagitis EE)

Maintenance treatment of reflux esophagitis (erosive esophagitis)

Prevention of recurrence of gastric ulcer or duodenal ulcer during NSAIDs administration

Adjunct to Helicobacter pylori eradication

4.3 Contraindications

Hypersensitivity to the active ingredients or to any of the excipients.

4.2 Posology and Method of Administration

Dosage

Adults

Gastric ulcer

The usual dose is 20 mg of vonoprazan once a day. Administration should be limited to 8 weeks.

Duodenal ulcer

The usual dose is 20 mg of vonoprazan once a day. Administration should be limited to 6 weeks.

Reflux esophagitis (erosive esophagitis)

The usual dose is 20 mg of vonoprazan once a day. Administration should be limited to 4 weeks. However, when the effect is insufficient, treatment may be continued for up to 8 weeks. In addition, for the maintenance of healing of reflux esophagitis in patients with repeat recurrence and relapse of the condition, a dose of 10 mg is administered once a day; however, when the efficacy is inadequate, a dose of 20 mg may be administered once a day.

Prevention of recurrence of gastric ulcer or duodenal ulcer during NSAIDs administration

The usual dose is 10 mg of vonoprazan once a day.

Adjunct to Helicobacter pylori eradication

When selecting antibacterial agents to be used in combination therapy, consideration should be given to official national, regional and local guidance regarding bacterial resistance, duration of treatment and appropriate use of the antibacterial agents.

In a Phase III clinical study, the following 3 drugs were orally administered at the same time twice daily for 7 days: 20 mg vonoprazan, with amoxicillin and clarithromycin. When Helicobacter pylori eradication treatment with 3 drugs consisting of a proton pump inhibitor, amoxicillin, and clarithromycin fails, alternative treatment with the following 3 drugs is recommended; 20 mg vonoprazan, with amoxicillin and metronidazole, orally administered at the same time twice daily for 7 days. The doses of antibiotic should follow the respective label recommendations for H pylori eradication.

Method of Administration

Vonoprazan can be taken without regard to food or timing of food.

Special Patient Populations

Elderly Patients

Since the physiological functions such as hepatic or renal function are decreased in elderly patients in general, vonoprazan should be carefully administered. (See Impaired Renal Function and Impaired Hepatic Function sections below.)

Pediatric Patients

Vonoprazan has not been studied in patients under 18 years of age.

Impaired Renal Function

Vonoprazan should be administered with care in patients with renal disorders as a delay in the excretion of vonoprazan may occur, which may result in an increase in the concentration of vonoprazan in the blood. (See Section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)

Impaired Hepatic Function

Vonoprazan should be administered with care in patients with hepatic disorders as a delay in the metabolism and excretion of vonoprazan may occur, which may result in an increase in the concentration of vonoprazan in the blood. (See Section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)