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PRO-BICALUTAMIDE is a brand name for Bicalutamide, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ............................................................................. 3 CONTRAINDICATIONS ................................................................................................... 3 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
PRO-BICALUTAMIDE (bicalutamide) should only be prescribed by a qualified healthcare professional who is experienced with the treatment of prostate cancer and the use of anti- androgens. • Bicalutamide 150 mg/day dose should not be used (see WARNINGS & PRECAUTIONS, General).
• Rare hepatic failure, including fatal outcomes (see WARNINGS & PRECAUTIONS, Hepatic). • Uncommon interstitial lung disease, including fatal outcomes (see WARNINGS & PRECAUTIONS, Respiratory). General During treatment with bicalutamide, somnolence has been reported and those patients who experience this symptom should observe caution when driving or using machines.
Localized Prostate Cancer patients Bicalutamide 150 mg is NOT to be administered. 4-year median follow-up, the use of bicalutamide 150 mg as immediate therapy for the treatment of localized prostate cancer in patients otherwise undergoing watchful waiting is associated with increased mortality.
Health Canada previously assessed bicalutamide 150 mg versus castration in the locally advanced patient population and found level 1 scientific evidence (one of the 2 randomized clinical trials) of increased mortality in bicalutamide 150 mg treated patients.
Patients taking bicalutamide 50 mg per day for the treatment of metastatic prostate cancer are not affected by this new information. Anti-androgen Withdrawal Syndrome In some patients with metastatic prostate cancer, anti-androgens (steroidal and non-steroidal), may promote, rather than inhibit, the growth of prostate cancer.
A decrease in PSA and/or clinical improvement following discontinuation of anti-androgens has been reported. It is recommended that patients prescribed an anti-androgen, who have PSA progression, should have the anti- androgen discontinued immediately and be monitored for 6 - 8 weeks for a withdrawal response prior to any decision to proceed with other prostate cancer therapy.
Cardiovascular PRO-BICALUTAMIDE is indicated for use in combination with either an LHRH analogue or surgical castration. Combined androgen blockade with an anti-androgen plus LHRH analogue or surgical castration increases risk of cardiovascular disease (heart attack, cardiac failure, sudden cardiac death) and adversely affects independent cardiovascular risk factors (serum lipoproteins, insulin sensitivity and obesity).
Physicians should carefully consider whether the benefits of Page 5 of 33 combined androgen blockade outweigh the potential cardiovascular risk. Assessment of cardiovascular risk factors, monitoring for signs and symptoms suggestive of development of cardiovascular disease, and management according to local clinical practice and guidelines should be considered.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Bicalutamide in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Effect on QT/QTc interval PRO-BICALUTAMIDE is indicated for use in combination with either an LHRH analogue or surgical castration. Combined androgen blockade with an anti-androgen plus LHRH analogue or surgical castration has the potential to prolong QT/QTc interval on ECG.
g. g. g. flecainide, propafenone) antiarrhythmic medications (See DRUG INTERACTIONS), physicians should assess the benefit risk ratio, including the potential for Torsade de Pointes prior to initiating PRO- BICALUTAMIDE. Endocrine and Metabolism A reduction in glucose tolerance and/or glycated hemoglobin (HbAlc) has been observed in males receiving bicalutamide in combination with LHRH analogues.
This may manifest as diabetes or loss of glycemic control in those with pre-existing diabetes. Consideration should therefore be given to monitoring blood glucose and/or glycated hemoglobin (HbAlc) in patients receiving bicalutamide in combination with LHRH analogues.
Gynecomastia, Breast Pain Gynecomastia has been reported in patients receiving bicalutamide. For metastatic (M1) patients receiving bicalutamide 50 mg, concomitant surgical or medical castration may reduce the effects of gynecomastia.
Hematologic Anemia is a known physiologic consequence of testosterone suppression. Assessment of anemia risk and management according to local clinical practice and guidelines should be considered. There may be an increased risk of hemorrhage in patients taking coumarin anticoagulants that are started on bicalutamide.
(see ADVERSE REACTIONS and DRUG INTERACTIONS). Hepatic Bicalutamide is extensively metabolized in the liver. Data suggests that the elimination of bicalutamide may be slower in subjects with severe hepatic impairment and this could lead to increased accumulation of bicalutamide.
Therefore, PRO-BICALUTAMIDE should be used with caution in patients with moderate to severe hepatic impairment. Hepatotoxicity including rare hepatic failure has been observed with bicalutamide, and fatal outcomes have been reported.
Bicalutamide therapy should be discontinued if changes are severe (also see Post-Market Adverse Drug Reactions). Page 6 of 33 Musculoskeletal Changes in Bone Density PRO-BICALUTAMIDE is indicated for use in combination with either an LHRH analogue or surgical castration.
Decreased bone mineral density can be anticipated with long term combined androgen blockade with an anti-androgen plus LHRH analogue or surgical castration. Combined androgen blockade is associated with increased risks of osteoporosis and skeletal bone fractures.
The risk of skeletal fracture increases with the duration of combined androgen blockade. Assessment of osteoporosis risk and management according to clinical practice and guidelines should be considered. In patients with significant risk factors for decreased bone mineral content and/or bone mass such as […]