Vocinti Special Precautions

Important Precautions: At the treatment, the course of the disease should closely be observed and the minimum therapeutic necessity should be used according to the disease condition.
In the long-term treatment with VOCINTI Tablets, close observation by such means as endoscopy should be made.
In the maintenance of healing of reflux esophagitis, VOCINTI Tablets 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.
Hepatotoxicity: Hepatic function abnormalities including liver injury have been reported in clinical studies. Post marketing reports have also been received in patients treated with vonoprazan, many of which occurred shortly after initiation of treatment. Discontinuation of vonoprazan is recommended in patients who have evidence of liver function abnormalities or if they develop signs or symptoms suggestive of liver dysfunction.
Elevation of intragastric pH: Administration of vonoprazan results in elevation of intragastric pH and is therefore not recommended to be taken with drugs for which absorption is dependent on acidic intragastric pH (see Interactions).
Masking of Symptoms Associated with Gastric Malignancy: Gastric malignancy may present with symptoms associated with acid-related disorders which initially respond to drugs that elevate intragastric pH. A symptomatic response to vonoprazan does not exclude the presence of gastric malignancy.
Clostridium difficile Serious colitis, including pseudomembranous colitis: There is an increased risk of gastrointestinal infection caused by Clostridium difficile as was reported in patients that received proton pump inhibitors. Drugs that elevate intragastric pH may be associated with an increased risk of Clostridium difficile gastrointestinal infection. Serious colitis accompanied with bloody stools, such as Pseudomembranous colitis, may occur due to amoxicillin hydrate or clarithromycin being used for Helicobacter pylori eradication, in combination with vonoprazan. If abdominal pain and frequent diarrhea occur, appropriate measures, such as immediate discontinuation of the treatment, should be taken.
Benign gastric polyps: Benign gastric polyps has been observed in patient on long-term administration of PPIs.
Bone Fractures: An increased risk for osteoporosis-related fractures of the hip, wrist or spine, predominantly in the elderly or in presence of other recognized risk factors, has been reported in patients under treatment with proton pump inhibitors. The risk of fracture was especially increased in the patients receiving high dose or long term (a year or longer) treatment.
Precautions concerning Use: When dispensing the drug: The patient must be instructed to remove the tablets from the press-through package (PTP) before they are ingested. [It has been reported that, if the PTP sheet is swallowed, the sharp corners of the sheet may puncture the esophageal mucosa, and this could result in serious complications such as mediastinitis.]
Other Precautions: (1) 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.
Drug abuse and dependence: Vonoprazan has no known potential for abuse or dependence.
Effects on ability to drive and use machines: The influence of vonoprazan on the ability to drive or use machines is unknown.