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Nubeqa Generic Name & Formulations
Legal Class
Rx
General Description
Darolutamide 300mg; tabs.
Pharmacological Class
Androgen receptor inhibitor.
How Supplied
Tabs—120
Manufacturer
Generic Availability
NO
Mechanism of Action
Darolutamide competitively inhibits androgen binding, androgen receptor nuclear translocation and androgen receptor-mediated transcription.
Nubeqa Indications
Indications
Non-metastatic, castration-resistant prostate cancer (nmCRPC). Metastatic hormone-sensitive prostate cancer (mHSPC) in combination with docetaxel.
Nubeqa Dosage and Administration
Adult
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.
Children
Not established.
Nubeqa Contraindications
Not Applicable
Nubeqa Boxed Warnings
Not Applicable
Nubeqa Warnings/Precautions
Warnings/Precautions
Risk for ischemic heart disease (may be fatal); monitor. Manage cardiovascular risk factors (eg, hypertension, diabetes, or dyslipidemia) optimally. Discontinue if Grade 3 or 4 ischemic heart disease occurs. Risk for 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
Absorption
Absolute bioavailability: ~30%.
Distribution
Plasma protein bound: 92%.
Elimination
Renal (63.4%), fecal (32.4%). Half-life: ~20 hours.
Nubeqa Interactions
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
