Vibegron

A single dose of 100 mg vibegron increased C_max and AUC by 21% and 11%, respectively, of the P-gp substrate digoxin in healthy volunteers. Serum digoxin concentrations should be monitored and used for titration of the digoxin dose to obtain the desired clinical effect.

The potential for interaction with P-gp by vibegron should be considered when combined with sensitive P-gp substrates with narrow therapeutic index e.g. dabigatran etexilate, apixaban or rivaroxaban.

Vibegron has not been studied in patients with end-stage renal disease (GFR <15 mL/min with or without haemodialysis) and is therefore not recommended in these patients.

Vibegron has not been studied in patients with severe hepatic impairment (Child-Pugh C) and is therefore not recommended in this patient population.

Urinary retention has been reported in patients taking vibegron. The risk of urinary retention may be increased in patients with bladder outlet obstruction and also in patients taking muscarinic antagonist medicinal product concomitantly with vibegron treatment. Signs and symptoms of urinary retention should be monitored before and during the treatment with vibegron, particularly in patients with clinically significant bladder outlet obstruction, in patients with conditions predisposing for bladder outlet obstruction, and in patients taking muscarinic antagonist medicinal product concomitantly with vibegron.

There are no or limited amount of data from the use of vibegron in pregnant women. Studies in animals have shown reproductive toxicity.

Vibegron is not recommended during pregnancy. When pregnancy is planned or diagnosed, treatment with vibegron should be stopped and, if appropriate, alternative therapy should be started.

It is unknown whether vibegron/metabolites are excreted in human milk.

Available non-clinical data in animals have shown excretion of vibegron/metabolites in milk.

A risk to the newborns/infants cannot be excluded.

Vibegron should not be used during breast-feeding.

Women of childbearing potential

Vibegron is not recommended in women of childbearing potential not using contraception.

Fertility

The effect of vibegron on human fertility has not been established. Studies in animals have not shown effects on female or male rat fertility.

Vibegron has no or negligible influence on the ability to drive and use machines.

Summary of the safety profile

The most frequently reported adverse reactions include urinary tract infection (6.6%), headache (5.0%), diarrhoea (3.1%) and nausea (3.0%).

The frequency of adverse drug reactions that led to treatment discontinuation is 0.9%. The most common adverse reactions leading to treatment discontinuation are: headache (0.5%), constipation, diarrhoea, nausea and rash (0.2% each).

Tabulated list of adverse reactions

The table below reflects the adverse reactions observed with vibegron obtained from the phase 3 12-week study, phase 3 long-term extension study and post-marketing data.

The frequency of adverse reactions is defined as follows: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1 000 to <1/100); rare (≥1/10 000 to <1/1 000); very rare (<1/10 000) and not known (cannot be established from the available data).

Adverse reactions reported for vibegron 75 mg:

^a includes rash pruritic and rash erythematous
^b includes urinary straining