Bicalutamide

Cytostatic · Anti-androgen

Indications

Treatment of advanced prostatic cancer in combination with LHRH analogue therapy or surgical castration. Immediate therapy in localised prostate cancer patients not being treated by radical prostatectomy or radiotherapy. Immediate therapy in locally advanced prostate cancer either alone or as an adjunct to radical prostatectomy or radiotherapy. Locally advanced, non-metastatic prostate cancer when surgical castration or other medical intervention is inappropriate or unacceptable.

Dosage

Adults: Treatment of advanced prostatic cancer in combination with LHRH analogue therapy or surgical castration: 50 mg daily commencing at least 3 days before starting LHRH analogue or at same time as surgical castration. Immediate therapy in localised prostate cancer either alone or as an adjunct to radical prostatectomy or radiotherapy or when surgical castration or other medical intervention is inappropriate: 150 mg daily taken continuously daily for at least 2 yr or until disease progression. Children: Not applicable.

Adverse Effects

Hot flushes, pruritus, breast tenderness, gynaecomastia, nausea, asthaenia, dry skin, hepatic changes (frequently transient). Vomiting, diarrhoea. Rarely angina, heart failure, conduction disturbances, arrhythmia, thrombocytopenia. Abdominal pain, depression, dyspepsia, alopecia, hair regrowth, haematuria, decreased libido, impotence, weight gain, anaemia, anorexia, dizziness, somnolence, GI upset, skin reactions, oedema, chest pain, diabetes, erectile dysfunction. Reports of photosensitivity and QT prolongation.

Risk Factor (Pregnancy/Lactation)

Pregnancy: Risk cannot be ruled out. Lactation: Caution advised or effect undetermined. Precautions: Moderate to severe hepatic impairment. Consider periodic liver function tests; discontinue if changes are severe. Consider withdrawing in patients with objective progression of disease together with elevated PSA. Severe renal impairment. Risk factors for QT prolongation. Avoid excessive sunlight or UV light.

Interactions

Cisapride, astemizole, cimetidine, ketoconazole, oral anticoagulants, cyclosporin, calcium antagonists, drugs metabolised by CYP3A4, drugs that prolong QT interval.

Advice to Patient

Take with or without meals. Contact prescriber if there is yellowing of eye or skin, chills, lack of sleep, unusual bruising or bleeding, colour change of urine or stool, sleep walking, nervousness, skin rash, irritation or redness, difficulty in breathing, chest pain, palpitations, inability to urinate, muscle pain, weakness or tremors, constant, nausea, vomiting, constipation, diarrhoea. If you have diabetes, regularly check blood glucose level and inform prescriber about the changes.

Pharmacokinetics

Absorption: well absorbed. Metabolism: Extensively hepatic. Half-life elimination: Active enantiomer: Approx 6 days ( Approx 10 days in severe hepatic impairment). Time to peak, plasma: Active enantiomer: Approx 31 hours. Excretion: Urine and feces.

Compiled by Healify Pharmacy from published drug references. How we compile it →

Always consult a pharmacist or doctor.