Nubeqa Darolutamide Application Scope

Treatment of non-metastatic castration-resistant prostate cancer (nmCRPC). And treatment of metastatic castration-sensitive prostate cancer (mCSPC, also known as mHSPC) in combination with docetaxel chemotherapy.

Nubeqa Darolutamide Characteristics

Ingredients: Darolutamide
Properties: An androgen receptor inhibitor (ARI) . It competitively inhibits androgen binding, nuclear translocation of the androgen receptor, and androgen receptor-mediated transcription. It has a unique chemical structure that binds with high affinity to the receptor.
Packaging Specification: NUBEQA 300 mg film-coated tablets are supplied in bottles containing 120 tablets
Storage: Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F)
Expiry Date: Printed on packaging (LOT and EXP)—follow the actual pack for expiration details
Executive Standard: For the U.S.: Prescribing information approved by FDA. EMA’s Summary of Product Characteristics applies in EU
Approval Number: In Taiwan, China, the approval number is 衛部藥輸字第027936號 (region-specific example provided)
Date of Revision: U.S. Prescribing Information updated: August 20, 2025
Manufacturer: Orion Corporation, Orion Pharma, Espoo, Finland

Guidelines for the Use of Nubeqa Darolutamide

Dosage and Administration:
- Recommended Dose:
  - The recommended dosage is 600 mg (two 300 mg tablets) taken orally twice daily (total daily dose 1200 mg).
  - For patients with severe renal impairment (eGFR 15-29 mL/min/1.73 m²) not on dialysis or moderate hepatic impairment (Child-Pugh B), the recommended dosage is 300 mg (one tablet) taken twice daily (total daily dose 600 mg) . No dose adjustment is needed for mild to moderate renal impairment or mild hepatic impairment.
- Administration:
  - Take Nubeqa with food
  - Swallow the tablets whole; do not crush or chew them
  - Patients should also concurrently receive a gonadotropin-releasing hormone (GnRH) analog or should have had a bilateral orchiectomy
- Missed Dose: Take as soon as remembered before the next scheduled dose. Do not take two doses together
Adverse Reactions:
- Common Adverse Reactions: Fatigue, arthralgia (pain in limbs), rash, neutropenia (↓ white blood cells), increased AST/ALT, bilirubin, anemia, weight gain, hypertension, high blood sugar, hypocalcemia
- Serious Adverse Reactions:
  - Ischemic heart disease
  - Other serious AEs (≥1%): urinary retention, pneumonia, hematuria; fatal AEs: death, heart failure, cardiac arrest, deterioration, pulmonary embolism
Contraindications: None reported. However, hypersensitivity to darolutamide or any component of the product would be a contraindication.
Precautions:
- Monitor for ischemic heart events and seizures; advise seeking immediate attention for symptoms
- Can impair male fertility—advise patients accordingly
- Embryo-fetal toxicity—males with partners may become pregnant should use effective contraception during and for 1 week after treatment

Nubeqa Interactions

Avoid concomitant use with dual P-gp and strong/moderate CYP3A4 inducers (↓ Nubeqa exposure)
Monitor/reduce dose if used with dual P-gp and strong CYP3A4 inhibitors (↑ exposure)
NUBEQA inhibits BCRP and OATP1B1/OATP1B3 transporters:May increase exposure to substrate drugs (e.g., rosuvastatin). Avoid when possible or monitor and adjust dose

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
This content is for reference only. Prescription drugs must be used under a doctor’s guidance and purchased from authorized sources.