Bicalumutide
✅ Treats prostate cancer
✅ Blocks male hormones
✅ Slows tumor growth
✅ Improves survival rates
✅ Reduces cancer symptoms
Bicalumutide contains Bicalutamide.
✓ Medically reviewed by Morgan Ellis — Pharmacy Researcher · 8 years experience · Last reviewed: May 2026
⚡ Quick Answer — What is Bicalumutide?
Bicalumutide is an oral tablet from Cipla containing bicalutamide 50 mg — a non-steroidal androgen-receptor antagonist (anti-androgen) used for advanced or metastatic prostate cancer. Standard role: combined with an LHRH agonist (goserelin, leuprorelin) for combined androgen blockade (CAB). Standard dose: 50 mg once daily (with LHRH agonist) or 150 mg once daily (monotherapy). Main side effects: gynaecomastia and breast tenderness (common), hot flushes, hepatotoxicity (mandatory LFT monitoring), reduced libido, rare interstitial pneumonitis. Mandatory: baseline + monthly LFTs for first 4 months, then periodic.
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What Is Bicalumutide?
Bicalumutide is an oral tablet from Cipla containing bicalutamide 50 mg. Bicalutamide is a non-steroidal anti-androgen that competitively blocks the androgen receptor in prostate cancer cells, inhibiting the proliferative effect of testosterone and dihydrotestosterone (DHT). It is used in advanced or metastatic prostate cancer, almost always combined with an LHRH agonist (goserelin, leuprorelin, triptorelin) for combined androgen blockade (CAB).
How Does Bicalumutide Work?
Prostate cancer growth is driven by androgen-receptor signalling. Standard androgen deprivation therapy (ADT) suppresses ovarian androgen production through LHRH agonists. However, the adrenal glands continue to produce ~10% of total body androgens, and the residual signal is enough to drive disease progression in many patients. Bicalumutide blocks the androgen receptor itself, so the residual adrenal androgens cannot signal — producing more complete androgen blockade.
- Competitive androgen-receptor antagonist — binds the AR and prevents testosterone / DHT from activating it.
- Long half-life (~6 days) — once-daily oral dosing.
- Used to prevent “tumour flare” when starting LHRH agonist therapy — the initial LHRH-induced testosterone surge can transiently worsen disease, and pre-treatment with anti-androgen blocks this.
Uses and Indications
- Combined androgen blockade (CAB) in advanced or metastatic prostate cancer (with LHRH agonist)
- Tumour flare prevention at LHRH agonist initiation (2–4 weeks pre-treatment)
- Monotherapy 150 mg/day in locally advanced non-metastatic prostate cancer (alternative to LHRH agonist for patients prioritising sexual function preservation)
- After biochemical recurrence as part of intermittent or continuous androgen deprivation regimens
Bicalumutide Dosage and How to Take
Standard dose: 50 mg once daily (with LHRH agonist) or 150 mg once daily (monotherapy).
- Once daily at the same time each day. With or without food.
- Swallow whole with water.
- Mandatory monitoring: baseline LFTs (AST, ALT) and PSA. Repeat LFTs monthly for the first 4 months, then every 3–6 months. PSA every 3 months. Stop and investigate if AST/ALT > 3× upper limit of normal.
- Pre-LHRH-agonist tumour-flare prevention: start Bicalumutide 2–4 weeks before LHRH agonist initiation, continue for at least 1 month after.
- Do not stop without oncologist instruction.
Side Effects of Bicalumutide
Common:
- Gynaecomastia and breast tenderness (40–70% with monotherapy; less with CAB)
- Hot flushes
- Reduced libido and erectile dysfunction
- Fatigue, asthenia
- Diarrhoea (especially flutamide)
- Mild GI upset
Important — mandate monitoring:
- Hepatotoxicity — can be severe and unpredictable. Stop immediately for jaundice, dark urine, severe fatigue, or AST/ALT > 3× ULN. Most cases occur within first 4 months.
- Rare interstitial pneumonitis — new-onset cough, dyspnoea
Rare: haemolytic anaemia, photosensitivity, severe skin reactions.
Warnings and Precautions
- Pregnancy and breastfeeding: not applicable (male-only indication) but anti-androgens are fetotoxic if taken in error during pregnancy.
- Liver function: mandatory monthly LFTs for first 4 months. Stop for AST/ALT > 3× ULN.
- Diabetes: may worsen glycaemic control.
- Cardiovascular: ADT in general is associated with increased cardiovascular events. Optimise modifiable risk factors.
- Gynaecomastia prophylaxis: low-dose tamoxifen 10–20 mg/day or prophylactic breast radiotherapy reduces incidence (specialist).
- Driving: caution — fatigue and dizziness may impair driving.
Drug Interactions
| Combine with | Effect | What to do |
|---|---|---|
| Warfarin and other coumarin anticoagulants | Significant INR increase — bleeding risk | Check INR weekly initially. Reduce warfarin dose by 30–50%. |
| CYP3A4 inhibitors (minor effect) | Raise bicalutamide levels | Monitor for hepatotoxicity. |
| LHRH agonists (goserelin, leuprorelin) | Standard combination — combined androgen blockade | Standard CAB regimen. |
| Alcohol | Additive hepatotoxicity | Limit alcohol intake during treatment. |
Storage
- Store at room temperature, 15–25°C, in original blister.
- Keep out of reach of children, women, and pets — anti-androgens are fetotoxic.
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Frequently Asked Questions
Why is Bicalumutide usually combined with an LHRH agonist?
LHRH agonists (goserelin, leuprorelin) suppress testicular androgen production, but the adrenal glands continue producing ~10% of body androgens that can drive prostate cancer growth. Bicalumutide blocks the androgen receptor itself, so adrenal androgens cannot signal. The combination is called combined androgen blockade (CAB) and produces deeper androgen suppression than LHRH agonist alone in advanced disease.
What is “tumour flare” and why does Bicalumutide prevent it?
When LHRH agonist therapy starts, the pituitary is initially stimulated and testosterone surges for 1–2 weeks before downregulation kicks in. In patients with significant disease burden (bone metastases, urinary obstruction, spinal cord compression risk), this transient testosterone surge can worsen symptoms acutely. Starting Bicalumutide 2–4 weeks before the LHRH agonist blocks the receptor and prevents the flare.
How is gynaecomastia managed?
Breast tenderness and gynaecomastia affect 40–70% of patients on bicalutamide monotherapy at higher doses. Prophylaxis options: low-dose tamoxifen 10–20 mg/day (most evidence) or prophylactic breast radiotherapy as a single 8–12 Gy fraction before starting anti-androgen therapy. Discuss with the oncologist before starting if cosmetic concerns are significant.
What blood tests do I need?
Mandatory: baseline LFTs (AST, ALT) and PSA. Then LFTs monthly for the first 4 months, then every 3–6 months. PSA every 3 months. Stop Bicalumutide immediately and contact your oncologist if AST/ALT > 3× ULN, or for any jaundice, dark urine or severe fatigue.
Can I drink alcohol on Bicalumutide?
Limit alcohol — both alcohol and bicalutamide are hepatotoxic and the combination amplifies the risk of severe drug-induced liver injury. Occasional small amounts are usually tolerable; heavy or daily drinking should be avoided throughout treatment.
Bicalumutide vs flutamide vs enzalutamide — what is the difference?
All three are oral anti-androgens for prostate cancer. Bicalutamide: once-daily, well-tolerated, standard first-generation choice. Flutamide: three-times-daily, more diarrhoea and hepatotoxicity risk — largely replaced by bicalutamide. Enzalutamide: second-generation, more potent, used for castration-resistant disease (after CAB has failed) — see Bdenza.
Will Bicalumutide affect my heart?
Anti-androgen monotherapy has minimal direct cardiovascular effect, but the broader androgen deprivation therapy (LHRH agonist + anti-androgen) is associated with increased cardiovascular events including MI and stroke. Optimise cardiovascular risk factors: BP control, statin if hyperlipidaemic, smoking cessation, exercise, weight management.
Can I stop Bicalumutide if PSA stays low?
Discuss with your oncologist. In some intermittent-CAB protocols, CAB is held when PSA is suppressed below threshold and resumed when PSA rises — this can reduce side effects without compromising survival. Never stop unilaterally — PSA monitoring and timing of restart are critical.
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| Strength | 50 mg |
|---|---|
| Quantity | 10 Tablet/s, 30 Tablet/s, 60 Tablet/s, 90 Tablet/s, 180 Tablet/s |
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