Special Warning : אזהרת שימוש

4.4   Special warnings and precautions for use
Renal impairment

The available data in patients with severe renal impairment are limited.
As exposure might be increased those patients should be closely monitored for adverse reactions (see sections 4.2 and 5.2).

Hepatic impairment

The available data in patients with moderate hepatic impairment are limited, and darolutamide has not been studied in patients with severe hepatic impairment.
As exposure might be increased those patients should be closely monitored for adverse reactions (see sections 4.2 and 5.2).

Recent cardiovascular disease

Patients with clinically significant cardiovascular disease in the past 6 months including stroke, myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, and symptomatic congestive heart failure were excluded from the clinical studies. Therefore, the safety of darolutamide in these patients has not been established.
If NUBEQA is prescribed, patients with clinically significant cardiovascular disease should be treated for these conditions according to established guidelines.

Hepatotoxicity

In case of liver function test abnormalities suggestive of idiosyncratic drug-induced liver injury, permanently discontinue treatment with darolutamide (see section 4.8).

Concomitant use with other medicinal products

Use of strong CYP3A4 and P-gp inducers during treatment with darolutamide may decrease the plasma concentration of darolutamide and is not recommended, unless there is no therapeutic alternative. Selection of an alternate concomitant medicinal product with less potential to induce CYP3A4 or P-gp should be considered (see section 4.5).

Patients should be monitored for adverse reactions of BCRP, OATP1B1 and OATP1B3 substrates as co-administration with darolutamide may increase the plasma concentrations of these substrates.
Co-administration with rosuvastatin should be avoided unless there is no therapeutic alternative (see section 4.5).

Androgen deprivation therapy may prolong the QT interval

In patients with a history of risk factors for QT prolongation and in patients receiving concomitant medicinal products that might prolong the QT interval (see section 4.5), physicians should assess the benefit-risk ratio including the potential for Torsade de pointes prior to initiating NUBEQA.

Information about excipients

NUBEQA contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.




Effects on Driving

4.7     Effects on ability to drive and use machines

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