Bicadex Adverse Reactions

In this section undesirable effects are defined as follows: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to ≤1/100); rare (≥1/10,000 to ≤1/1,000); very rare (≤1/10,000), not known (cannot be estimated form the available data).
Blood and lymphatic system disorders: Bicalutamide 150 mg (monotherapy): Common: Anaemia.
Bicalutamide 50 mg (combination therapy): Very common: Anaemia.
Immune system disorders: Bicalutamide 150 mg (monotherapy): Uncommon: Hypersensitivity, angioedema and urticaria.
Bicalutamide 50 mg (combination therapy): Uncommon: Hypersensitivity, angioedema and urticaria.
Metabolism and nutrition disorders: Bicalutamide 150 mg (monotherapy): Common: Decreased appetite.
Bicalutamide 50 mg (combination therapy): Common: Decreased appetite.
Psychiatric disorders: Bicalutamide 150 mg (monotherapy): Common: Decreased libido, depression.
Bicalutamide 50 mg (combination therapy): Common: Decreased libido, depression.
Nervous system disorders: Bicalutamide 150 mg (monotherapy): Common: Dizziness, somnolence.
Bicalutamide 50 mg (combination therapy): Very common: Dizziness.
Common: Somnolence.
Cardiac disorders: Bicalutamide 150 mg (monotherapy): Not known: QT prolongation (see Precautions and Interactions).
Bicalutamide 50 mg (combination therapy): Common: Myocardial infarction (fatal outcomes have been reported)^g, cardiac failure^g.
Not known: QT prolongation (see Precautions and Interactions).
Vascular disorders: Bicalutamide 150 mg (monotherapy): Common: Hot flush.
Bicalutamide 50 mg (combination therapy): Very common: Hot flush.
Respiratory, thoracic and mediastinal disorders: Bicalutamide 150 mg (monotherapy): Uncommon: Interstitial lung disease^e (fatal outcomes have been reported).
Bicalutamide 50 mg (combination therapy): Uncommon: Interstitial lung disease^e (fatal outcomes have been reported).
Gastrointestinal disorders: Bicalutamide 150 mg (monotherapy): Common: Abdominal pain, constipation, dyspepsia, flatulence, nausea.
Bicalutamide 50 mg (combination therapy): Very common: Abdominal pain, constipation, nausea.
Common: Dyspepsia, flatulence.
Hepato-biliary disorders: Bicalutamide 150 mg (monotherapy): Common: Hepatotoxicity, jaundice, hypertransaminasaemia^c.
Rare: Hepatic failure^f (fatal outcomes have been reported).
Bicalutamide 50 mg (combination therapy): Common: Hepatotoxicity, jaundice, hypertransaminasaemia^c.
Rare: Hepatic failure^f (fatal outcomes have been reported).
Skin and subcutaneous tissue disorders: Bicalutamide 150 mg (monotherapy): Very common: Rash.
Common: Alopecia, hirsutism/hair re-growth, dry skin^d, pruritus.
Rare: Photosensitivity reaction.
Renal and urinary disorders: Bicalutamide 150 mg (monotherapy): Common: Haematuria.
Bicalutamide 50 mg (combination therapy): Very common: Haematuria.
Reproductive system and breast disorders: Bicalutamide 150 mg (monotherapy): Very common: Gynaecomastia and breast tenderness^a.
Common: Erectile dysfunction.
Bicalutamide 50 mg (combination therapy): Very common: Gynaecomastia and breast tenderness^b.
Common: Erectile dysfunction.
General disorders and administration site conditions: Bicalutamide 150 mg (monotherapy): Very common: Asthenia.
Common: Chest pain, oedema.
Bicalutamide 50 mg (combination therapy): Very common: Asthenia, oedema.
Common: Chest pain.
Investigations: Bicalutamide 150 mg (monotherapy): Common: Weight increased.
Bicalutamide 50 mg (combination therapy): Common: Weight increased.
^a The majority of patients receiving bicalutamide 150 mg as monotherapy experience gynaecomastia and/or breast pain. In studies these symptoms were considered to be severe in up to 5% of the patients. Gynaecomastia may not resolve spontaneously following cessation of therapy, particularly after prolonged treatment.
^b May be reduced by concomitant castration.
^c Hepatic changes are rarely severe and were frequently transient, resolving or improving with continued therapy or following cessation of therapy.
^d Due to the coding conventions used in the EPC studies, adverse events of 'dry skin' were coded under the COSTART term of 'rash'. No separate frequency descriptor can therefore be determined for the 150 mg bicalutamide dose however the same frequency as the 50 mg dose is assumed.
^e Listed as an adverse event following review of post-marketed data. Frequency has been determined from the incidence of reported adverse events of interstitial pneumonia in the randomised treatment period of the 150 mg EPC studies.
^f Listed as an adverse event following review of post-marketed data. Frequency has been determined from the incidence of reported adverse events of hepatic failure in patients receiving treatment in the open-label bicalutamide arm of the 150 mg EPC studies.
^g Observed in a pharmaco-epidemiology study of LHRH agonists and anti-androgens used in the treatment of prostate cancer. The risk appeared to be increased when Bicalutamide 50 mg was used in combination with LHRH agonists, but no increase in risk was evident when bicalutamide 150 mg was used as a monotherapy to treat prostate cancer.
Increase of PT/INR: During post-marketing cases of interactions between coumarin anticoagulants and bicalutamide have been reported (see Precautions and Interactions).