• Prostate and other male cancers

Nubeqa Generic Name & Formulations

General Description

Darolutamide 300mg; tabs.

Pharmacological Class

Androgen receptor inhibitor.

How Supplied



Generic Availability


Nubeqa Indications


Non-metastatic, castration-resistant prostate cancer (nmCRPC). Metastatic hormone-sensitive prostate cancer (mHSPC) in combination with docetaxel.

Nubeqa Dosage and Administration


Swallow whole. Take with food. 600mg twice daily; continue until disease progression or unacceptable toxicity occurs. Give concurrent GnRH analog or patient should have had bilateral orchiectomy. For mHSCP: give the 1st of 6 docetaxel cycles within 6 weeks after the start of Nubeqa; may continue Nubeqa even if a docetaxel cycle is delayed, interrupted, or discontinued. Severe renal impairment (eGFR 15–29mL/min/1.73m2) not on hemodialysis: 300mg twice daily. Moderate hepatic impairment (Child-Pugh Class B): 300mg twice daily. Dose modification: see full labeling.


Not established.

Nubeqa Contraindications

Not Applicable

Nubeqa Boxed Warnings

Not Applicable

Nubeqa Warnings/Precautions


Risk of ischemic heart disease (may be fatal); monitor. Optimize management of cardiovascular risk factors (eg, hypertension, diabetes, or dyslipidemia). Discontinue if Grade 3 or 4 ischemic heart disease occurs. Risk of seizures; consider discontinuing if it occurs during treatment. Embryo-fetal toxicity. Advise males (w. female partners of reproductive potential) to use effective contraception during and for 1 week after last dose.

Nubeqa Pharmacokinetics

See Literature

Nubeqa Interactions


Antagonized by combined P-gp and strong or moderate CYP3A4 inducers; avoid. Potentiated by combined P-gp and strong CYP3A4 inhibitors; monitor and adjust dose. Avoid concomitant use with BCRP substrates; if unavoidable, monitor and consider dose reduction of the substrate drug. May potentiate OATP1B1 or OATP1B3 substrates; monitor and consider dose reduction of these drugs.

Nubeqa Adverse Reactions

Adverse Reactions

For nmCRPC: fatigue, pain in extremity, rash, lab abnormalities (increased AST and bilirubin, decreased neutrophil count). For mHSCP: constipation, decreased appetite, rash, hemorrhage, increased weight, hypertension, lab abnormalities (anemia, hyperglycemia, hypocalcemia, decreased lymphocyte and neutrophil count, increased AST/ALT).

Nubeqa Clinical Trials

See Literature

Nubeqa Note

Not Applicable

Nubeqa Patient Counseling

See Literature