Vocinti Special Precautions

Important Precautions: All indications: In the long-term treatment with this drug, close observation by such means as endoscopy should be made.
Reflux esophagitis: In the maintenance of healing, this drug should be administered only to the patients who repeat recurrence and recrudescence of the condition. Administration to the patients who do not necessitate maintenance of healing should be avoided. When the healing is maintained over a long period, and when there is no risk of recurrence, the dose reduction to a dose of 10 mg from a dose of 20 mg, or suspension of administration should be considered.
Other Precautions: In 2-year carcinogenicity studies in mice and rats, following observations were made: neuroendocrine tumors in the stomach with the similar exposure (AUC) at the clinical dose (20 mg/day) of vonoprazan, adenoma in the stomach (mouse) at the exposure approximately 300 times of the clinical exposure, and hepatic tumor at approximately more than 13 times (mouse) and approximately more than 58 times (rat) of the clinical exposure.
It has been reported that benign gastric polyp was observed in long-term administration of this drug.
The administration of Vonoprazan (Vocinti) tablets may mask the symptoms of gastric cancer. It is, therefore, necessary to ascertain the ulcer is not of a malignant nature before initiating the administration of this drug.
In several observational studies in overseas, an increased risk for osteoporosis-related fractures of the hip, wrist or spine under the treatment with proton pump inhibitors has been reported. The risk of fracture was especially increased in the patients receiving high dose or long term (a year or longer) treatment.
In several overseas observational studies, mainly in hospitalized patients, increased risk of gastrointestinal infection caused by Clostridium difficile was reported in patients who receive proton pump inhibitors.
Precautions Concerning Patients with Specific Backgrounds: Patients with Renal Impairment: A delay in the excretion of this drug may occur, which may result in an increase in the concentration of vonoprazan in blood.
Patients with Hepatic Impairment: A delay in the metabolism and excretion of this drug may occur, which may result in an increase in the concentration of vonoprazan in blood.
Use in Pregnancy & Lactation: See USE IN PREGNANCY & LACTATION section for further information.
Use in Children: No clinical study has been conducted in pediatric patients.
Use in the Elderly: The physiological functions such as hepatic or renal function are decreased in elderly patients in general.