🔴 Red Flag (Important) Information
Hepatotoxicity: Monitor LFTs Risk of elevated liver enzymes, hepatitis, or hepatic failure (rarely fatal).
→ Monitor LFTs at baseline and periodically, especially during the first 6 months or if symptoms (jaundice, dark urine, fatigue) develop.
Cardiac risk: Monitor ECG (Can cause QT prolongation
Interstitial lung disease (ILD): Rare but potentially fatal.→ Stop immediately if new or worsening cough, dyspnoea, or pulmonary infiltrates occur.
Drug interactions:
→ Increases exposure to warfarin and other CYP3A4 substrates (e.g. midazolam, cyclosporine). → Monitor INR if used with anticoagulants; adjust doses as needed.
Generic name: Bicalutamide
Brand name: Teva Bicalutamide
Drug class: Non-steroidal anti-androgen
Formulation: Film-coated tablets (50 mg, 150 mg)
Mechanism of action:
Competitive inhibition of androgen receptors → prevents androgen-stimulated tumour growth → induces regression of prostate tumours.
50 mg: Advanced prostate cancer in combination with an LHRH agonist or following surgical castration.
150 mg:
Locally advanced, non-metastatic prostate cancer (T3–4, any N, M0 / T1–2, N+, M0).
As immediate monotherapy or adjuvant to surgery or radiotherapy when castration is not suitable.
Dose (50 mg): 1 tablet once daily, started ≥3 days before LHRH analogue or at time of orchiectomy.
Dose (150 mg): 1 tablet once daily for up to 2 years or until disease progression.
Route: Oral, with or without food.
Renal impairment: No adjustment.
Hepatic impairment: No change for mild; caution in moderate–severe (drug accumulation).
Hypersensitivity to bicalutamide or excipients.
Females, children, pregnancy, or breastfeeding.
Severe hepatic impairment (use caution).
Known galactose intolerance or lactase deficiency (contains lactose).
Monitor LFTs periodically during long-term use.
Use with caution in hepatic impairment — slower clearance.
Monitor cardiac function if risk factors or QT-prolonging agents.
Check INR when co-administered with warfarin (interaction).
CYP3A4 caution: may increase exposure to narrow-therapeutic-index drugs (cisapride, cyclosporine, astemizole).
Very common / Frequent:
Hot flushes, breast tenderness/gynaecomastia, decreased libido, erectile dysfunction, anaemia, fatigue, weight gain, oedema, abdominal pain, nausea, constipation, diarrhoea, transaminase elevation.
Less frequent:
Photosensitivity, rash, dizziness, depression, hypertension, interstitial lung disease, hepatic failure (rare).
Elderly: No dose adjustment needed.
Renal impairment: No change.
Hepatic impairment: Monitor closely; accumulation may occur.
Pregnancy/Lactation: Contraindicated.
Paediatrics: Not indicated.
Continue:
50 mg → indefinitely, alongside LHRH therapy or surgical castration.
150 mg → up to 2 years or until disease progression.
Stop immediately if:
Significant hepatotoxicity (ALT/AST >3× ULN, jaundice).
ILD/pneumonitis confirmed.
Severe hypersensitivity reaction.
Switch therapy:
On disease progression or toxicity → consider LHRH agonist, chemotherapy, or next-line anti-androgen (e.g. enzalutamide, abiraterone).
| Trade Name | |
|---|---|
| Drug Class | Anti-androgens |
| Cost | |
| Company | |
|---|---|
| Drug Rep | Admin |
| Indications | Prostate Cancer |
| Dosage |