Casodex: Casodex in general, has been well tolerated with few withdrawals due to adverse events.
Frequency of Adverse Reactions:
Very Common (≥10%): Reproductive System and Breast Disorders: Breast tenderness1, Gynecomastia1.
General Disorders: Hot flushes1.
Common (≥1% and <10%): Gastrointestinal Disorders: Diarrhoea, nausea.
Hepatobiliary Disorders: Hepatic changes (elevated levels of transaminases, jaundice)2.
General Disorders: Asthenia, pruritus.
Uncommon (≥0.1% and <1%): Immune System Disorders: Hypersensitivity reactions, including angioneurotic edema and urticaria.
Respiratory, Thoracic and Mediastinal Disorders: Interstitial lung disease.
Rare (≥0.01% and <0.1%): Gastrointestinal Disorders: Vomiting.
Skin and Subcutaneous Tissue Disorders: Dry skin.
Hepatobiliary Disorders: Hepatic failure3.
1May be reduced by concomitant castration.
2Hepatic changes are rarely severe and were frequently transient, resolving or improving with continued therapy or following cessation of therapy (see Precautions).
3Hepatic failure has occurred very rarely in patients treated with Casodex, but a causal relationship has not been established with certainty. Periodic liver function testing should be considered (see Precautions).
In addition, the following adverse experiences were reported in clinical trials (as possible adverse drug reactions in the opinion of investigating clinicians, with a frequency of ≥1%) during treatment with Casodex plus an LHRH analogue. No causal relationship of these experiences to drug treatment has been made and some of the experiences reported are those that commonly occur in elderly patients:
Cardiovascular System: Heart failure.
Gastrointestinal System: Anorexia, dry mouth, dyspepsia, constipation, flatulence.
Central Nervous System: Dizziness, insomnia, somnolence, decreased libido.
Respiratory System: Dyspnoea.
Urogenital: Impotence, nocturia.
Skin and Appendages: Alopecia, rash, sweating, hirsutism.
Metabolic and Nutritional: Diabetes mellitus, hyperglycaemia, edema, weight gain, weight loss.
Whole Body: Abdominal pain, chest pain, headache, pain, pelvic pain, chills.
Casodex 150: The pharmacological action of bicalutamide may give rise to certain undesirable effects. These include the following:
Very Common (>10%): Gynecomastia, breast tenderness. The majority of patients receiving Casodex 150 as monotherapy experience gynecomastia and/or breast pain. In studies, these symptoms were considered to be severe in up to 5% of the patients. Gynecomastia may not resolve spontaneously following cessation of therapy, particularly after prolonged treatment.
Common or Frequent (≥1%): Hot flushes, pruritus, asthenia, alopecia, hair regrowth, dry skin, decreased libido, nausea, impotence and weight gain.
Uncommon or Infrequent (≥0.1% to <1%): Abdominal pain, depression, dyspepsia, hematuria and interstitial lung disease. Hypersensitivity reactions, including angioneurotic edema and urticaria.
Hepatic changes (elevated levels of transaminases, cholestasis and jaundice), which are rarely severe. The changes were frequently transient, resolving or improving with continued therapy or following cessation of therapy. Hepatic failure has occurred very rarely in patients treated with bicalutamide but a causal relationship has not been established with certainty. Periodic liver function testing should be considered. (See Precautions.)