Nubeqa (Darolutamide)

Nubeqa is indicated for prostate‑cancer treatment within the androgen‑receptor signalling pathway.

• Non‑metastatic castration‑resistant prostate cancer (nmCRPC): delays metastasis and prolongs overall survival.
• High‑risk localized prostate cancer (in combination with radiation therapy): improves biochemical recurrence‑free survival.
• Metastatic castration‑resistant prostate cancer (mCRPC) after prior hormonal therapy: provides an additional line of hormonal control.

• Darolutamide selectively binds to the androgen receptor, preventing androgen‑mediated transcription and tumor cell proliferation. It has a high affinity for the receptor, blocks nuclear translocation, and retains activity despite common resistance‑conferring AR mutations, thereby inhibiting growth of prostate cancer cells.

Adverse reactions reported with darolutamide include both frequent and rare events.

Common Side Effects

• Fatigue: mild to moderate tiredness reported by many patients.
• Rash: skin erythema or maculopapular eruptions.
• Hypertension: increase in blood pressure requiring monitoring.
• Diarrhoea: loose stools, often transient.
• Nausea: occasional feeling of queasiness.
• Elevated liver enzymes: mild transaminase rise.

Serious or Rare Side Effects

• Seizures: infrequent but documented neurological events.
• Severe hepatic injury: marked elevation of liver enzymes or hepatitis.
• Cardiovascular events: myocardial infarction or stroke.
• Pulmonary embolism: rare clotting complication.
• Anaphylaxis: severe allergic reaction.
• Severe skin reactions: Stevens‑Johnson syndrome or toxic epidermal necrolysis.

Before initiating darolutamide, clinicians should evaluate patient history and monitor key parameters.

• Hepatic function: assess baseline liver enzymes and repeat periodically.
• Cardiovascular risk: screen for hypertension, arrhythmia and prior events.
• Seizure history: avoid in patients with prior seizures.
• Drug interactions: review concomitant medications that affect CYP3A4.
• Pregnancy and lactation: contraindicated in women of childbearing potential; ensure effective contraception.
• Store at ambient temperature: keep below 25 °C, in original packaging, protected from moisture and light.

Darolide may interact with several medicines that influence its metabolism or transport.

Major Interactions (Avoid)

• Strong CYP3A4 inducers (e.g., rifampicin, carbamazepine): may reduce darolutamide exposure.
• Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole): may increase exposure and toxicity.
• BCRP and OATP1B3 inhibitors (e.g., cyclosporine): heightened plasma levels.

Moderate Interactions (Monitor Closely)

• Anticoagulants (e.g., warfarin): potential alteration of INR.\n- Statins metabolised by CYP3A4 (e.g., simvastatin, atorvastatin): may require dose adjustment.
• Antihypertensive agents: additive blood‑pressure effects.
• Proton pump inhibitors: possible effect on absorption.
• Herbal supplements: St St