Special Warning : אזהרת שימוש

4.4   Special warnings and precautions for use

Hepatic enzymes elevations
Elevations in hepatic enzymes were observed in clinical studies (see section 4.8). Laboratory monitoring of hepatic enzymes prior to and during telotristat therapy is recommended as clinically indicated. In patients with hepatic impairment, continuous monitoring for adverse reactions and worsening of liver function is recommended.
Patients who develop symptoms suggestive of hepatic dysfunction should have liver enzymes tested and telotristat should be discontinued if liver injury is suspected. Therapy with telotristat should not be resumed unless the liver injury can be explained by another cause.

Constipation
Telotristat reduces bowel movement (BM) frequency. Constipation was reported in patients using a higher dose (500 mg). Patients should be monitored for signs and symptoms of constipation. If constipation develops, the use of telotristat and other concomitant therapies affecting bowel motility should be re-evaluated.

Depressive disorders
Depression, depressed mood and decreased interest have been reported in clinical studies and from post-marketing in some patients treated with telotristat (see section 4.8). Patients should be advised to report any symptoms of depression, depressed mood and decreased interest to their physicians.

Excipients

Lactose
Xermelo contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Sodium
This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially “sodium-free”.

Effects on Driving

4.7   Effects on ability to drive and use machines

Xermelo has minor influence on the ability to drive and use machines. Fatigue may occur following administration of telotristat, patients with fatigue should be advised to refrain from driving or using machines until symptoms have subsided. (see section 4.8).