Nubeqa

Treatment should be initiated and supervised by a specialist physician experienced in treatment of prostate cancer. 2). Darolutamide should be continued until disease progression or unacceptable toxicity. Medical castration with a luteinising hormone-releasing hormone (LHRH) agonist or antagonist (GnRH analogue) should be continued during treatment of patients not surgically castrated.

1). The first of 6 cycles of docetaxel should be administered within 6 weeks after the start of darolutamide treatment. The recommendation in the product information of docetaxel should be followed. Treatment with darolutamide should be continued until disease progression or unacceptable toxicity even if a cycle of docetaxel is delayed, interrupted, or discontinued.

Missed dose If a dose is missed, the dose should be taken as soon as the patient remembers prior to the next scheduled dose. The patient should not take two doses together to make up for a missed dose. 8), dosing should be withheld or reduced to 300 mg twice daily until symptoms improve.

Treatment may then be resumed at a dose of 600 mg twice daily. Dose reduction below 300 mg twice daily is not recommended, because efficacy has not been established. 2). Renal impairment No dose adjustment is necessary for patients with mild or moderate renal impairment.

2). Hepatic impairment No dose adjustment is necessary for patients with mild hepatic impairment. The available data on darolutamide pharmacokinetics in moderate hepatic impairment is limited. Darolutamide has not been studied in patients with severe hepatic impairment.

). Paediatric population There is no relevant use of darolutamide in the paediatric population. Method of administration NUBEQA is for oral use. 2).

8%). For additional safety information when darolutamide is administered in combination, refer to the product information of the individual medicinal products. Tabulated list of adverse reactions The adverse reactions observed in patients with nmCRPC or mHSPC treated with darolutamide are listed in Table 1.

The adverse reactions observed in patients with mHSPC treated with darolutamide in combination with docetaxel are listed in Table 2. Adverse reactions are classified according to System Organ Class. They are grouped according to their frequencies.

Frequency groups are defined by the following convention: 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); not known (cannot be estimated from the available data).

Within each frequency group, adverse reactions are presented in order of decreasing seriousness. 5 months) in patients treated with placebo. b Includes arteriosclerosis coronary artery, coronary artery disease, coronary artery occlusion, coronary artery stenosis, acute coronary syndrome, acute myocardial infarction, angina pectoris, angina unstable, myocardial infarction, myocardial ischaemia.

c Includes cardiac failure, cardiac failure acute, cardiac failure chronic, cardiac failure congestive, cardiogenic shock, heart failure with preserved ejection fraction. d Includes rash, rash macular, rash maculo-papular, rash papular, rash pustular, erythema, dermatitis.

e Includes fatigue and asthenia, lethargy and malaise. 0. The incidence is based on values reported as laboratory abnormalities. 8 months) in patients treated with placebo+docetaxel. b Adverse reactions incidences may not be attributable to darolutamide alone but may contain contributions from other medicinal products used in combination.

Renal impairment The available data in patients with severe renal impairment are limited. 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.

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.

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.

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. 5). 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. 5

1. 6). 4