Affected male offspring were also impotent.In an analysis conducted after a median follow-up of 160 weeks was reached, 213 (52.7%) patients treated with Bicalutamide-LHRH analog therapy and 235 (57.5%) patients treated with flutamide-LHRH analog therapy had died. These could be symptoms of a serious liver problem. @�j˺�Հ���DG�j�jή�}6ʋj�X����WP�TO�4&�j�fUV��������ּޜ�����6m�)ۗK)PdRץ��k �q��r�2�'Y:�)��i㏛z}-��Ȧ�o������0�}��i <4��\ߋv�.��;�I�I1�����������"R�8͹�p�9��"�r���a���.៲}�� &������yp�A� 8����wT�~8ė��c�`d�=��:/i�$g��ƕ#�&��p�˶n�'�i7�+�����K��1�1�qL@FI�E�6����BG(A脽tN�ՉV������x*J� �kc��MY�"�OY.QW����n�_�qQolc��#����x|��*m��M��֜��%�� � �o�G�>*wk�f�gЉv߭0ts����=��o� �$��@��0�W������4m��g�8���DE!�1#8��� �?0TD>��? In general, patients should start treatment at … You may report side effects to FDA at 1-800-FDA-1088.Store Bicalutamide tablets at room temperature between 68°F to 77°F (20°C to 25°C).Medicines are sometimes prescribed for purposes other than those listed in a patient information leaflet. You should start taking danazol on the first day of your next period unless you have been told otherwise. You can ask your healthcare provider or pharmacist for information about Bicalutamide tablets that is written for health professionals. Tell your doctor if you have or have ever had liver disease. Regular monitoring of your prostate cancer with your healthcare provider is important to determine if your disease is worse.Tell your healthcare provider if you have trouble breathing with or without a cough or fever. Based on an interim analysis of the two trials for survival, the Data Safety Monitoring Board recommended that Bicalutamide treatment be discontinued in the M1 patients because the risk of death was 25% (HR 1.25, 95% CI 0.87 to 1.81) and 31% (HR 1.31, 95% CI 0.97 to 1.77) higher in the Bicalutamide treated group compared to that in the castrated group, respectively.Bicalutamide 150 mg daily is not approved for use in patients with locally advanced (T3-4, NX, M0) cancer of the prostate. Bicalutamide should be taken as one 50 mg tablet in the morning or evening at the same time each day. There was no statistical evidence that the growth rate was reduced during treatment. This medicine may cause swelling of the breasts (gynecomastia) and breast pain in some patients.
It may be taken with or without food. Bicalutamide 50mg film-coated Tablets (called bicalutamide throughout this leaflet) are used for the treatment of advanced prostate carcinoma. Male patients who have female partners should use effective birth control during treatment with this medicine and for 130 days after the last dose. Administration of Bicalutamide to pregnant females resulted in feminization of the male offspring leading to hypospadias at doses of 10 mg/kg/day (approximately 0.7 times the human exposure at the recommended dose) and above. %PDF-1.6 %����

If your dose is different, do not change it unless your doctor tells you to do so. There were no tumorigenic effects suggestive of genotoxic carcinogenesis.In repeat-dose toxicology studies, atrophy of seminiferous tubules of the testes has been observed for all species examined, which is a predicted class effect with antiandrogens.

2) Schellhammer PF, Sharifi R, Block NL, et al. Dialysis is not likely to be helpful since Bicalutamide is highly protein bound and is extensively metabolized. There are no human data on the use of Bicalutamide in pregnant women. Take it at the same time each day. Do not take a double dose to make up for a missed one.Bicalutamide may cause other side effects. You should take this for 3 monhts proior to treatment and for 3 months after treatment to keep the prostate stable.