Bevalast

Adults w/ metastatic carcinoma of the colon or rectum (mCRC) in combination w/ fluoropyrimidine-based chemotherapy. 1st-line treatment of adults w/ metastatic breast cancer (mBC) in combination w/ paclitaxel. Adults w/ metastatic breast cancer (mBC) in whom treatment w/ other chemotherapy options including taxanes or anthracyclines is not considered appropriate (patients who have received taxane & anthracycline containing regimens in the adjuvant setting w/in the last 12 mth should be excluded from treatment) in combination w/ capecitabine. 1st-line treatment of adults w/ unresectable advanced, metastatic or recurrent NSCLC other than predominantly squamous cell histology in addition to platinum-based chemotherapy. 1st-line treatment of adults w/ unresectable advanced, metastatic or recurrent non-squamous NSCLC w/ epidermal growth factor receptor (EGFR) activating mutations in combination w/ erlotinib. 1st line treatment of adults w/ advanced &/or metastatic renal cell cancer (mRCC) in combination w/ interferon alfa-2a. Adults w/ advanced [International Federation of Gynecology & Obstet (FIGO) stages III B, III C & IV] epithelial ovarian, fallopian tube, or primary peritoneal cancer in combination w/ carboplatin & paclitaxel. Adults w/ 1st recurrence of platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy w/ bevacizumab or other VEGF inhibitors/receptor-targeted agents in combination w/ carboplatin & gemcitabine or w/ carboplatin & paclitaxel. Adults w/ platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no >2 prior chemotherapy regimens & who have not received prior therapy w/ bevacizumab or other VEGF inhibitors/receptor-targeted agents in combination w/ paclitaxel, topotecan, or pegylated lipos doxorubicin. Adults w/ persistent, recurrent, or metastatic carcinoma of the cervix in combination w/ paclitaxel & cisplatin or alternatively paclitaxel & topotecan in patients who cannot receive platinum therapy.

mCRC 5 mg/kg or 10 mg/kg once every 2 wk or 7.5 mg/kg or 15 mg/kg once every 3 wk. mBC 10 mg/kg once every 2 wk or 15 mg/kg once every 3 wk. NSCLC In combination w/ platinum-based chemotherapy for up to 6 cycles of treatment followed by Bevacizumab as a single agent until disease progression 7.5 mg/kg or 15 mg/kg once every 3 wk. 1st-line treatment of non-squamous NSCLC w/ EGFR activating mutations in combination w/ erlotinib 15 mg/kg once every 3 wk. Advanced &/or mRCC 10 mg/kg once every 2 wk. Epithelial ovarian, fallopian tube & primary peritoneal cancer Front-line treatment in addition to carboplatin & paclitaxel 15 mg/kg once every 3 wk for up to 6 cycles followed by continued use of Bevacizumab as single agent until disease progression or for max of 15 mth. Platinum-sensitive recurrent disease in combination w/ either carboplatin & gemcitabine 15 mg/kg once every 3 wk in combination w/ either carboplatin & gemcitabine for 6 cycles & up to 10 cycles or in combination w/ carboplatin & paclitaxel for 6 cycles & up to 8 cycles followed by continued use of Bevacizumab. Treatment of platinum-resistant recurrent disease 10 mg/kg once every 2 wk in combination w/ either paclitaxel, topotecan (given wkly) or pegylated lipos doxorubicin or 15 mg/kg once every 3 wk when Bevacizumab is administered w/ topotecan (on days 1-5 every 3 wk). Cervical cancer 15 mg/kg once every 3 wk in combination w/ paclitaxel & cisplatin or paclitaxel & topotecan. Initial dose should be delivered over 90 min as IV infusion. If the 1st infusion is well tolerated, the second infusion may be administered over 60 min. If the 60-min infusion is well tolerated, all subsequent infusions may be administered over 30 min.

Hypersensitivity to Bevacizumab & Chinese Hamster Ovary (CHO) cell products or other recombinant human/humanised Abs. Pregnancy.

Increased risk of GI & gall bladder perforation; fistulae between the vag & any part of the GI tract; development of fistulae; proteinuria; haemorrhage especially tumour-associated haemorrhage. Serious wound healing complications including anastomotic complications; discontinue therapy in patients who develop necrotizing fasciitis. Discontinue if patient develops hypertensive crisis or hypertensive encephalopathy; posterior reversible encephalopathy syndrome; patients who experience grade 3 or 4 bleeding. Arterial thromboembolic reactions including cerebrovascular accidents, transient ischemic attacks & MI. Risk of developing VTE including pulmonary embolism. Do not use in patients w/ pulmonary haemorrhage/haemoptysis. May promote the formulation of aneurysms &/or artery dissections. Caution in patients w/ pre-existing CAD or CHF. Increased rates of severe neutropenia, febrile neutropenia or infection w/ or w/o severe neutropenia. Risk of developing infusion/hypersensitivity reactions. Avoid in patients who have previously received or are receiving IV bisphosphonates invasive dental procedures. Not for intravitreal use. May impair female fertility. If patients are experiencing symptoms affecting their vision or conc, or their ability to react, they should be advised not to drive & use machines until symptoms abate. Women of childbearing potential have to use effective contraception during & up to 6 mth after treatment. Discontinue breastfeeding during therapy & not breast-feed for at least 6 mth following the last dose.

Febrile neutropenia, leucopenia, neutropenia, thrombocytopenia; anorexia, hypomagnesaemia, hyponatraemia; peripheral sensory neuropathy, dysarthria, headache, dysgeusia; eye disorder, increased lacrimation; HTN, VTE; dyspnoea, rhinitis, epistaxis, cough; rectal haemorrhage, stomatitis, constipation, diarrhoea, nausea, vomiting, abdominal pain; wound healing complications; exfoliative dermatitis, dry skin, skin discoloration; arthralgia, myalgia; proteinuria; ovarian failure; asthenia, fatigue, pyrexia, pain, mucosal inflammation; decreased wt.

Increased rates of severe neutropenia, febrile neutropenia or infection w/ or w/o severe neutropenia in patients treated w/ platinum or taxane based therapies in the treatment of NSCLC & mBC. RT. Decreased PFS &/or OS & increased toxicity w/ EGFR monoclonal Abs.

Targeted Cancer Therapy

L01FG01 - bevacizumab ; Belongs to the class of VEGF/VEGFR (Vascular Endothelial Growth Factor / Receptors) inhibitors. Used in the treatment of cancer.

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