Drug use surveillance of Takecab tablets "Supplement to Helicobacter pylori eradication"
Drug use surveillance of Takecab for "Supplement to Helicobacter pylori eradication"
version:
date:
Takeda Pharmaceutical Company Limited
https://www.takeda.co.jp/contact/form/jp/form/
500
Observational
Post-marketing surveillance
N/A
Participants who meet the following criteria will be included.
1. Participants receiving H. pylori eradication treatment for the first time
2. Participants for whom H. pylori eradication with Takecab tablets or proton pump inhibitor + amoxicillin + clarithromycin was found unsuccessful and who will receive eradication treatment with amoxicillin and metronidazole
Participants who meet any of the following criteria will not be included. Refer to the Contraindications and Precautions section of the package insert of antimicrobials used in triple therapy.
1. Participants with previous history of hypersensitivity to ingredients in Takecab tablets
2. Participants taking atazanavir sulfate or rilpivirine hydrochloride
No limit
No limit
Both
The following diseases in patients for whom H. pylori will be eradicated with triple therapy: Gastric ulcer, duodenal ulcer, gastric mucosa-associated lymphoid tissue (MALT) lymphoma, idiopathic thrombocytopenic purpura, stomach following endoscopic treatment of early gastric cancer, or H. pylori gastritis
investigational material(s)
Generic name etc : Takecab tablets + amoxicillin + clarithromycin (first-line eradication) Takecab tablets + amoxicillin + metronidazole (second-line eradication)
INN of investigational material :
Therapeutic category code : 232 Agents for peptic ulcer
Dosage and Administration for Investigational material : For adults, the following three-drug regimen will be administered orally at the same time twice daily for 7 days: 20 mg dose of vonoprazan, 750 mg (potency) dose of amoxicillin hydrate, and 200 mg (potency) dose of clarithromycin. The dose of clarithromycin may be increased as clinically warranted. However, dosage should not exceed 400 mg (potency)/dose twice daily. If H. pylori eradication with a three-drug regimen comprising vonoprazan or proton pump inhibitor + amoxicillin hydrate + clarithromycin has been unsuccessful, as an alternative treatment, the following three drugs will be administered orally twice daily for 7 days to adults: 20 mg dose of vonoprazan, 750 mg (potency) dose of amoxicillin hydrate, and 250 mg dose of metronidazole. Participants will receive interventions as part of routine medical care.
Percentage of participants who had one or more adverse drug reactions
Adverse drug reaction refers to adverse events related to administered drug. Timeframe is defined as duration of triple therapy (7 days) and up to the time of determination of H. pylori eradication after triple therapy (approximately 2 months as maximum duration).
Timeframe; Up to 7days and 2 months
H. pylori eradication rate
In patients who are determined as achieving H. pylori eradication, the proportion of patients negative for H. pylori (eradication rates) will be tabulated by first-line eradication and second-line eradication. Timeframe is defined as duration of triple therapy (7 days) and up to the time of determination of H. pylori eradication after triple therapy (approximately 2 months as maximum duration).
Timeframe; 7days + 2 months
