Darolutamide (NUBEQA)

Prostate cancer, non-metastatic castration-resistant

Prostate cancer, metastatic castration-sensitive

Prostate cancer, non-metastatic castration-resistant

• Dose – Oral: 600 mg twice daily continuously until disease progression or unacceptable toxicity
• Given in combination with androgen deprivation therapy (ADT)

Prostate cancer, metastatic castration-sensitive

• Dose – Oral: 600 mg twice daily continuously until disease progression or unacceptable toxicity
• Given in combination with docetaxel and androgen deprivation therapy (ADT)

Available as 300 mg film-coated tablets. Tablets contain lactose. Tablets should NOT be crushed or broken. Store at room temperature.

Antiandrogen

Take with food

If a dose is missed, patients should be instructed not to take the missed dose but to resume with the next scheduled dose.

Common: AST increase.

Less Common: Cardiac arrest, Cardiac failure, Diarrhea, Fatigue, Hematuria, Urinary retention, Pneumonia, Rash, Hypertension, Pulmonary embolism.

The adverse effects listed above are not exhaustive. Please refer to the relevant product monograph for full details.

Baseline before treatment: CBC & differential, platelets, albumin, total bilirubin, INR, ALT, creatinine, sodium, potassium, PSA, blood pressure.

During treatment: PSA, blood pressure.

If clinically indicated: ECG.

• This drug can impact or be impacted by metabolic enzymes for absorption and excretion. Many drugs can also affect or be affected by these enzymes, so please consult with pharmacy to assess for interactions.
• Avoid grapefruit, grapefruit juice, Seville oranges, or Seville orange juice.
• Current drug interaction databases should be consulted for more information.

Avoid in pregnancy and lactation.

BC Cancer. BC Cancer Drug Manual. Darolutamide. Vancouver, British Columbia: BC Cancer Agency. Available at: http://www.bccancer.bc.ca/drug-database-site/Drug%20Index/Darolutamide_monograph.pdf. Updated August 1, 2021. Accessed January 22, 2024.

Lexicomp. Darolutamide Monograph. In: Lexi-Drugs. Hudson, Ohio: Lexi-Comp, Inc. Available at: https://online-lexi-com.qe2a-proxy.mun.ca/lco/action/doc/retrieve/docid/patch_f/6847193?cesid=7MfQoufogyZ&searchUrl=%2Flco%2Faction%2Fsearch%3Fq%3Ddarolutamide%26t%3Dname%26acs%3Dtrue%26acq%3Ddarolutamide. Updated January 29, 2024. Accessed January 30, 2024.

Cancer Care Ontario. Darolutamide Monograph. Drug Formulary. Toronto, Ontario: Cancer Care Ontario. Available at: https://www.cancercareontario.ca/en/drugformulary/drugs/monograph/68626. Updated March 2023. Accessed January 22, 2024.

Bayer Inc. NUBEQA® Product Monograph. Mississauga, Ontario. Updated November 22, 2023.