| Important Precautions | Precaution on Special Populations | Precaution Concerning Dosage & Administration | Precaution Concerning Use |
Important Precautions
Effects on Ability to Drive, Operate Machinery
There is no evidence of drug effects on the ability to drive or operate machinery.
Drug Compatibility
Because there are no studies on drug compatibility, do not mix this drug with other drugs.
Precautions on Special Populations
Careful Administration (Elobixibat should be administered with care in the following patients.)
Patient with serious liver disorder
Elobixibat (GOOFICE®) may fail to achieve its expected efficacy in patients with biliary obstruction or reduced bile acid secretion, etc.]
Use in the Elderly
Since the elderly generally have reduced physiological functions, cautions should be exercised, such as reducing the dose.
Pediatric Use
Safety has not been established in low-birth-weight infants, neonates, nursing infants, infants, or pediatric patients (no clinical experience).
Precaution Concerning Indication
No clinical experience of use in drug-induced and disease-induced constipations.
Precaution Concerning Dosage & Administration
Elobixibat (GOOFICE®) may cause abdominal pain or diarrhea; dose reduction, drug withdrawal, or discontinuation should be considered depending on the patient’s symptoms, and the need for continuing treatment with Elobixibat (GOOFICE®) should be carefully evaluated on a regular basis to avoid continuing aimless administration.
Precaution Concerning Use
Precaution Concerning the Dispensing of Drug
Patients who are given drugs supplied in PTP package must be instructed to remove the drugs from the PTP sheet before taking drugs. [It has been reported that, if the PTP sheet is swallowed, the sharp corners of the sheet may puncture the esophageal mucosa causing perforation and resulting in serious complications, such as mediastinitis.]
