Beova Special Precautions

PRECAUTIONS CONCERNING INDICATIONS: Prior to use of this product, clinical symptoms of patients should be confirmed with an appropriate interview, and diagnosis by exclusion of some other diseases with similar symptoms, including urinary tract infection, urinary calculus, and lower urinary-tract neoplasm such as bladder cancer and prostate cancer, should be made by performing appropriate examinations such as urinalysis. In addition, special examinations should be considered to conduct, if necessary.
For patients with lower urinary-tract obstructive disease, including benign prostatic hyperplasia, treatment for these diseases should be prioritised.
PRECAUTIONS CONCERNING PATIENTS WITH SPECIFIC BACKGROUNDS: Patients with Complication or History of Diseases, etc: Patients with severe cardiac disease: Symptoms may be aggravated due to heart rate increased, etc.
Patients with Hepatic Impairment: No dosage adjustment for Vibegron is recommended for patients with mild to moderate hepatic impairment (Child-Pugh A and B). Vibegron has not been studied in patients with severe hepatic impairment (Child-Pugh C) and is not recommended in this patient population.
Urinary Retention: Urinary retention has been reported in patients taking Vibegron. Monitor patients for signs and symptoms of urinary retention, particularly in patients with bladder outlet obstruction and patients taking muscarinic antagonist medications for the treatment of overactive bladder as the risk of urinary retention may be increased. Discontinue Vibegron in patients who develop urinary retention.
Patient with renal impairment: No dosage adjustment for Vibegron is recommended for patients with mild (eGFR ≥60 - <90 mL/min/1.73 m²), moderate (eGFR ≥30 - <60 mL/min/1.73 m²), and severe (<30 mL/min/1.73 m², not on dialysis). Vibegron has not been studied in patient with eGFR <30 mL/min/1.73 m² on dialysis and eGFR <15 mL/min/1.73 m² (with or without hemodialysis) and is not recommended in these patients [see Pharmacology: Pharmacokinetics under Actions].
Precautions for Co-administration (This drug should be administered with caution when co-administered with the following.): See Table 10.

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PRECAUTIONS CONCERNING USE: Precautions Concerning the Dispensing of the Drug: Patients should be instructed to press the tablet out of a press-through package (PTP) before administration. The sharp corner of swallowed PTP sheet may puncture the esophageal mucosa, resulting in serious complications such as mediastinitis.
Effects on ability to drive and use machines: No data available.
Use in Children: No clinical studies in children have been conducted.
Use in the Elderly: Vibegron should be administered with care while monitoring the condition of the patient. The physiological functions are generally reduced in the elderly [see Pharmacology: Pharmacokinetics under Actions].