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Hepatotoxicity: Hepatic function abnormalities including liver injury have been reported in clinical studies (see Adverse Reactions). 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.
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 associated diarrhea, including pseudomembranous colitis: Drugs that elevate intragastric pH may be associated with an increased risk of Clostridium difficile gastrointestinal infection. Pseudomembranous colitis may be due to antibiotics used for Helicobacter pylori eradication in combination with vonoprazan. If abdominal pain and frequent diarrhea occur, appropriate measures, including discontinuation of the treatment, should be taken.
Bone Fracture: 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 with the use of proton pump inhibitors, especially with use of high doses over a long-term period (>1 year). The mechanism is not clear and is likely to be multifactorial.
Renal Impairment: 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 Pharmacology: Pharmacokinetics under Actions.)
Hepatic Impairment: 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 Pharmacology: Pharmacokinetics under Actions.)
Use in Children: Vonoprazan has not been studied in patients under 18 years of age.
Use in the Elderly: Since the physiological functions such as hepatic or renal function are decreased in elderly patients in general, vonoprazan should be carefully administered. (See Renal Impairment and Hepatic Impairment as previously mentioned).
