Mvasi

Bevacizumab

In combination w/ fluoropyrimidine-based chemotherapy for metastatic carcinoma of the colon or rectum (mCRC). In combination w/ paclitaxel for 1st-line treatment of metastatic breast cancer (mBC). In combination w/ capecitabine for 1st-line treatment of mBC in whom treatment w/ other chemotherapy options including taxanes or anthracyclines is not considered appropriate. In addition to platinum-based chemotherapy for 1st-line treatment of unresectable advanced, metastatic or recurrent NSCLC other than predominantly squamous cell histology. In combination w/ erlotinib for 1st-line treatment of unresectable advanced, metastatic or recurrent non-squamous NSCLC w/ epidermal growth factor receptor (EGFR) activating mutations. In combination w/ interferon α-2a for 1st-line treatment of advanced &/or metastatic renal cell cancer. In combination w/ carboplatin & paclitaxel for front-line treatment of advanced [International Federation of Gynecology & Obstetrics (FIGO) stages IIIB, IIIC & IV] epithelial ovarian, fallopian tube, or primary peritoneal cancer. In combination w/ carboplatin & gemcitabine, or w/ carboplatin & paclitaxel for 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 or receptor-targeted agents. In combination w/ paclitaxel, topotecan, or pegylated lipos doxorubicin for 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 or VEGF receptor-targeted agents. In combination w/ paclitaxel & cisplatin or, alternatively, paclitaxel & topotecan in patients who cannot receive platinum therapy, for persistent, recurrent, or metastatic carcinoma of the cervix. Recurrent glioblastoma.

Adult Administer initial dose over 90 min as IV infusion. If well tolerated, 2nd infusion may be administered over 60 min. Subsequent infusions may be administered over 30 min if 60 min infusion is well tolerated. 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. Non-squamous NSCLC 1st-line treatment in combination w/ platinum-based chemotherapy: 7.5 mg/kg or 15 mg/kg once every 3 wk, in addition to platinum-based chemotherapy for up to 6 cycles of treatment followed as single agent until disease progression. 1st-line treatment w/ EGFR activating mutations in combination w/ erlotinib: 15 mg/kg once every 3 wk. Advanced &/or metastatic renal cell cancer 10 mg/kg once every 2 wk. Epithelial ovarian, fallopian tube, & primary peritoneal cancer Front-line treatment: 15 mg/kg once every 3 wk in addition to carboplatin & paclitaxel for up to 6 cycles followed by continued use as a single agent until disease progression or for max of 15 mth or until unacceptable toxicity. Platinum-sensitive recurrent disease: 15 mg/kg once every 3 wk, in combination w/ either carboplatin & gemcitabine for 6 cycles & up to 10 cycles, or w/ carboplatin & paclitaxel for 6 cycles & up to 8 cycles, followed by continued use as single agent. Platinum-resistant recurrent disease: 10 mg/kg once every 2 wk in combination w/ paclitaxel, topotecan (given wkly) or pegylated lipos doxorubicin; 15 mg/kg once every 3 wk in combination w/ topotecan (given on days 1-5, every 3 wk). Cervical cancer (in combination w/ paclitaxel & cisplatin or paclitaxel & topotecan) 15 mg/kg once every 3 wk. Recurrent glioblastoma 10 mg/kg every 2 wk.

Hypersensitivity to bevacizumab, Chinese Hamster Ovary cell products or other recombinant human or humanised Ab. Pregnancy.

Hypersensitivity (including anaphylactic shock)/infusion reactions. Permanently discontinue therapy in patients w/ tracheoesophageal fistula or any grade 4 fistula; if significant HTN cannot be adequately controlled w/ antihypertensives or develops hypertensive crisis or encephalopathy; in case of nephrotic syndrome; arterial thromboembolic reactions; life-threatening (grade 4) thromboembolic reactions including pulmonary embolism; grade 3 or 4 bleeding; intracranial bleeding. Discontinue in patients who develop necrotizing fasciitis. Withhold treatment in patients who experience wound healing complications during therapy & for elective surgery. Not to be administered as IV push or bolus; intravitreal. Do not initiate therapy for at least 28 days following major surgery or until the surgical wound is fully healed. Risk of developing venous thromboembolic reactions including pulmonary embolism, & haemorrhage especially tumour-associated haemorrhage during therapy. Increased risk for development of GI & gallbladder perforation, fistulae between the vag & any part of GI tract; prior radiation is major risk factor. Posterior reversible encephalopathy syndrome. Neutropenia & infections. Osteonecrosis of the jaw. Eye disorders. Formation of aneurysms &/or artery dissections in patients w/ risk factors before initiating treatment. Patients w/ history of arterial thromboembolism, diabetes or >65 yr; clinically significant CV disease eg, preexisting CAD or CHF; congenital bleeding diathesis, acquired coagulopathy or those receiving full dose of anticoagulants for treatment of thromboembolism prior to starting treatment; recent pulmonary haemorrhage/haemoptysis (>2.5 mL of red blood). Control preexisting HTN prior to treatment. Monitor BP during therapy; proteinuria prior to starting & during therapy. Closely monitor patients w/ thromboembolic reactions ≤ grade 3; signs & symptoms of CNS bleeding. Consider dental exam & preventive dentistry prior to initiating treatment. Use of diuretics is not advised in patients receiving cisplatin-based chemotherapy regimen. Concomitant use w/ IV bisphosphonates. May affect ability to drive & use machines. May impair fertility. Women of childbearing potential have to use effective contraception during & up to 6 mth after treatment. Discontinue breastfeeding during & for at least 6 mth following last dose.

Febrile neutropenia, leucopenia, neutropenia, thrombocytopenia; anorexia, hypomagnesaemia, hyponatraemia; peripheral sensory neuropathy, dysarthria, headache, dysgeusia; eye disorder, increased lacrimation; HTN; dyspnoea, rhinitis, epistaxis, cough; rectal haemorrhage, stomatitis, constipation, diarrhoea, nausea, vomiting, abdominal pain; wound healing complications, exfoliative dermatitis, dry skin, skin discolouration; arthralgia, myalgia; proteinuria; ovarian failure; asthenia, fatigue, pyrexia, pain, mucosal inflammation; decreased wt. Sepsis, abscess, cellulitis, infection, UTI; anaemia, lymphopenia; hypersensitivity, infusion reactions; dehydration, CVA, syncope, somnolence; CHF, supraventricular tachycardia; arterial thromboembolism, VTE, haemorrhage, DVT; pulmonary haemorrhage/haemoptysis, pulmonary embolism, hypoxia, dysphonia; GI & intestinal perforation, ileus, intestinal obstruction, recto-vag fistulae, GI disorder, proctalgia; palmar-plantar erythrodysaesthesia syndrome; fistula, muscular weakness, back pain; pelvic pain; lethargy.

Microangiopathic haemolytic anaemia may occur w/ sunitinib malate. Increased rates of severe neutropenia, febrile neutropenia or infection w/ or w/o neutropenia w/ platinum- or taxane-based therapies. Concomitant use w/ RT; anti-EGFR monoclonal Ab (eg, panitumumab, cetuximab).

Targeted Cancer Therapy

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

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