ZUELLIG PHARMA PTE. LTD.

<p><strong>Therapeutic indications</strong></p> <p><em><strong>Metastatic carcinoma of the colon or rectum(mCRC)</strong></em><br> Bevacizumab in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of patients with metastatic carcinoma of the colon or rectum.</p> <p><em><strong>Metastatic Breast Cancer (mBC)</strong></em><br> Bevacizumab in combination with paclitaxel is indicated for the treatment of patients who have not received chemotherapy for metastatic HER2-negative breast cancer.</p> <p>Bevacizumab in combination with capecitabine is indicated for first-line treatment of patients with HER2-negative metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. Patients who have received taxane and anthracycline-containing regimens in the adjuvant setting within the last 12 months should be excluded from treatment with bevacizumab in combination with capecitabine.</p> <p>The effectiveness of bevacizumab in metastatic breast cancer (mBC) is based on an improvement in progression-free survival. Currently, no data are available that demonstrate an improvement in disease-related symptoms or increased survival with bevacizumab in breast cancer.</p> <p><em><strong>Non-Small Cell Lung Cancer (NSCLC)</strong></em><br> Bevacizumab, in combination with carboplatin and paclitaxel, is indicated for first-line treatment of patients with unresectable, locally advanced, recurrent or metastatic non-squamous, non-small cell lung cancer.<br> Bevacizumab, in combination with erlotinib, is indicated for first-line treatment of patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer with Epidermal Growth Factor Receptor (EGFR) activating mutations.</p> <p><em><strong>Malignant Glioma (WHO Grade IV) - Glioblastoma</strong></em><br> Bevacizumab, as a single agent is indicated for the treatment of patients with glioblastoma after relapse or disease progression following prior therapy.</p> <p>The effectiveness of bevacizumab in glioblastoma is based on an improvement in objective response rate. There are no data demonstrating an improvement in disease-related symptoms or increased survival with bevacizumab.</p> <p><em><strong>Advanced and/or metastatic Renal Cell Cancer (mRCC)</strong></em><br> Bevacizumab in combination with interferon alfa-2a is indicated for first-line treatment of patients with advance and/or metastatic renal cell cancer.</p> <p><em><strong>Epithelial Ovarian, Fallopian Tube and Primary Peritoneal Cancer</strong></em><br> Bevacizumab, in combination with carboplatin and paclitaxel is indicated for the front-line treatment of advanced (FIGO stages III B, III C and IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer.</p> <p>Bevacizumab, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel is indicated for the treatment of patients with recurrent, platinum-sensitive, epithelial ovarian, fallopian tube, or primary peritoneal cancer who have not received prior bevacizumab or other VEGF-targeted angiogenesis inhibitors.</p> <p>Bevacizumab in combination with paclitaxel, topotecan or pegylated liposomal doxorubicin is indicated for the treatment of patients with recurrent, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor-targeted agents.</p> <p><em><strong>Cervical Cancer</strong></em><br> Bevacizumab in combination with paclitaxel and cisplatin or paclitaxel and topotecan is indicated for the treatment of persistent, recurrent, or metastatic carcinoma of the cervix.</p>

<p><u><strong>Therapeutic indications</strong></u></p> <p><em><strong>Adults with Rheumatoid arthritis</strong></em></p> <p>Treatment of signs and symptoms and inhibiting the progression of structural damage in adult patients with moderately to severely active rheumatoid arthritis. Etanercept can be used in combination with methotrexate in patients who do not respond adequately to methotrexate alone.</p> <p><em><strong>Paediatric Patients with Juvenile Idiopathic arthritis</strong></em></p> <p>Treatment of polyarthritis (rheumatoid factor positive or negative) and extended oligoarthritis in children and adolescents from the age of 2 years who have had an inadequate response to, or who have proved intolerant of, methotrexate.</p> <p>Treatment of psoriatic arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, methotrexate.</p> <p>Treatment of enthesitis-related arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, conventional therapy.</p> <p><em><strong>Adults with Psoriatic Arthritis</strong></em></p> <p>Etanecept is indicated for reducing signs and symptoms of active arthritis in adult patients with psoriatic arthritis. Etanecept can be used in combination with methotrexate in patients who do not respond adequately to methotrexate alone.</p> <p><strong><em>Axial Spondyloarthritis</em></strong></p> <p><em><strong>Adults with Ankylosing Spondylitis (AS)</strong></em></p> <p>Treatment of signs and symptoms of active ankylosing spondylitis in adults who have had an inadequate response to conventional therapy.</p> <p><em><strong>Adults with Non-radiographic Axial spondyloarthritis</strong></em></p> <p>Etanercept is indicated for the treatment of adults with severe non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated CRP and/or MRI evidence, who have had an inadequate response to non-steroidal anti-inflammatory drugs (NSAIDs).</p> <p><em><strong>Adults with Plaque Psoriasis</strong></em></p> <p>Treatment of adults with moderate to severe plaque psoriasis who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy, including ciclosporin, methotrexate or PUVA.</p> <p><em><strong>Pediatric Patients with Plaque Psoriasis</strong></em></p> <p>Etanercept is indicated for the treatment of chronic severe plaque psoriasis in children and adolescents from the age of 6 years who are inadequately controlled by, or are intolerant to other systemic therapies or phototherapies.</p>

<p><u><strong>Therapeutic indications</strong></u></p> <p><strong><em>Adults with Rheumatoid Arthritis</em></strong></p> <p>Treatment of signs and symptoms and inhibiting the progression of structural damage in adult patients with moderately to severely active rheumatoid arthritis. Etanercept can be used in combination with methotrexate in patients who do not respond adequately to methotrexate alone.</p> <p><em><strong>Paediatric Patients with Juvenile Idiopathic Arthritis</strong></em></p> <p>Treatment of polyarthritis (rheumatoid factor positive or negative) and extended oligoarthritis in children and adolescents from the age of 2 years who have had an inadequate response to, or who have proved intolerant of, methotrexate.</p> <p>Treatment of psoriatic arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, methotrexate.</p> <p>Treatment of enthesitis-related arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, conventional therapy.</p> <p><em><strong>Adults with Psoriatic Arthritis</strong></em></p> <p>Etanercept is indicated for reducing signs and symptoms of active arthritis in adult patients with psoriatic arthritis. Etanercept can be used in combination with methotrexate in patients who do not respond adequately to methotrexate alone.</p> <p><em><strong>Axial Spondyloarthritis</strong></em></p> <p><em><strong>Adults with Ankylosing Spondylitis (AS)</strong></em></p> <p>Treatment of signs and symptoms of active ankylosing spondylitis in adults who have had an inadequate response to conventional therapy.</p> <p><em><strong>Adults with Non-radiographic Axial Spondyloarthritis</strong></em></p> <p>Etanercept is indicated for the treatment of adults with severe non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated CRP and/or MRI evidence, who have had an inadequate response to non-steroidal anti-inflammatory drugs (NSAIDs).</p> <p><em><strong>Adults with Plaque Psoriasis</strong></em></p> <p>Treatment of adults with moderate to severe plaque psoriasis who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy, including ciclosporin, methotrexate or PUVA.</p> <p><em><strong>Pediatric Patients with Plaque Psoriasis</strong></em></p> <p>Etanercept is indicated for the treatment of chronic severe plaque psoriasis in children and adolescents from the age of 6 years who are inadequately controlled by, or are intolerant to other systemic therapies or phototherapies.</p>

<p><strong>INDICATIONS</strong></p> <p>Treatment of postmenopausal osteoporosis, to reduce the risk of vertebral fractures, and the treatment of established postmenopausal osteoporosis, to reduce the risk of hip fractures.</p> <p>The optimal duration of use of bisphosphonate for the treatment of osteoporosis has not been determined. All patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis.</p>