Vegzelma

In combination w/ fluoropyrimidine-based chemotherapy in adults w/ colon or rectal metastatic carcinoma; w/ carboplatin & gemcitabine, or carboplatin & paclitaxel in 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 vascular endothelial growth factor (VEGF) inhibitors or VEGF receptor-targeted agents; w/ paclitaxel, topotecan, or pegylated lipos doxorubicin in 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 or VEGF receptor-targeted agents; w/ paclitaxel & cisplatin or, alternatively, paclitaxel & topotecan in patients who cannot receive platinum therapy in adults w/ persistent, recurrent, or metastatic cervical carcinoma; w/ radiation & temozolomide in adults w/ recently diagnosed glioblastoma. 1st-line treatment in adults in combination w/ paclitaxel for metastatic breast cancer; w/ capecitabine for metastatic breast cancer in whom treatment w/ other chemotherapy options including taxanes or anthracyclines is not considered appropriate; w/ erlotinib for unresectable advanced, metastatic or recurrent non-squamous NSCLC w/ epidermal growth factor receptor (EGFR) activating mutations; w/ interferon α-2a for advanced &/or metastatic renal cell cancer. Additive therapy to platinum-based chemotherapy for 1st-line treatment of adults w/ unresectable advanced, metastatic or recurrent NSCLC other than predominantly squamous cell histology. In combination w/ carboplatin & paclitaxel for front-line treatment of adults w/ advanced [International Federation of Gynecology & Obstet (FIGO) stages III B, III C & IV] epithelial ovarian, fallopian tube, or primary peritoneal cancer. Monotherapy or in combination w/ irinotecan for recurrent or advanced glioblastoma.

IV infusion Administer initial dose over 90 min, 2nd infusion over 60 min, & subsequent infusions over 30 min, if well tolerated. Continue treatment until progression of underlying disease or unacceptable toxicity. Colon or rectal metastatic carcinoma 5 mg/kg or 10 mg/kg once every 2 wk, or 7.5 mg/kg or 15 mg/kg once every 3 wk. Epithelial ovarian, fallopian tube & primary peritoneal cancer: Front line treatment Administer 15 mg/kg once every 3 wk up to 6 cycles in addition to carboplatin & paclitaxel followed by monotherapy until disease progression for max of 15 mth or until unacceptable toxicity, whichever occurs earlier. Platinum-sensitive recurrent disease Administer 15 mg/kg once every 3 wk for 6 cycles & up to 10 cycles in combination w/ either carboplatin & gemcitabine, or for 6 cycles & up to 8 cycles in combination w/ carboplatin & paclitaxel followed by monotherapy until disease progression. Platinum-resistant recurrent disease 10 mg/kg once every 2 wk in combination w/ either paclitaxel, topotecan, or pegylated lipos doxorubicin. If given w/ topotecan (give on days 1-5 every 3 wk): 15 mg/kg once every 3 wk. Cervical cancer 15 mg/kg once every 3 wk in combination w/ either paclitaxel & cisplatin, or paclitaxel & topotecan. Metastatic breast cancer 10 mg/kg once every 2 wk, 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 until disease progression. 1st-line treatment of non-squamous NSCLC in combination w/ platinum-based chemotherapy Administer 7.5 mg/kg or 15 mg/kg once every 3 wk up to 6 cycles followed by monotherapy. Advanced &/or metastatic renal cell cancer 10 mg/kg once every 2 wk. Malignant glioblastoma (WHO Grade IV) 10 mg/kg once every 2 wk in combination w/ temozolomide & RT for 6 wk. After 4 wk of treatment discontinuation, start treatment every 4 wk for 6 cycles. After 6 treatment cycles, start 15 mg/kg once every 3 wk as monotherapy & continue until disease progression. Recurrent treatment: 10 mg/kg once every 2 wk or 15 mg/kg once every 3 wk.

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

Risk of developing infusion/hypersensitivity reactions including anaphylactic shock. Not to be taken by patients w/ polysorbate allergy. Not to be administered as IV push or bolus. Not formulated for intravitreal use. Permanently discontinue in patients who develop GI perforation, nephrotic syndrome or arterial thromboembolic reactions; w/ tracheoesophageal fistula or any Grade 4 fistula; if medically significant HTN cannot be adequately controlled w/ antihypertensives, or patient develops hypertensive crisis or encephalopathy; who experience Grade 3 or 4 bleeding during therapy. Consider treatment discontinuation in cases of internal fistula not arising in GIT; patients developing posterior reversible encephalopathy syndrome (PRES). Not to be initiated for at least 28 days following major surgery or until surgical wound is fully healed. Withhold therapy in patients who experienced wound healing complications during therapy; for elective surgery. Discontinue treatment in patients who develop necrotising fasciitis; w/ life threatening (Grade 4) thromboembolic reactions including pulmonary embolism; in cases of intracranial bleeding; if hypersensitivity reaction occurs. Not to be treated in patients w/ recent pulmonary haemorrhage/haemoptysis. Increased risk of GI & gall bladder perforation; GI-vag fistulae; HTN; haemorrhage especially tumour associated haemorrhage; severe & febrile neutropenia, or infection w/ or w/o severe neutropenia. History of prior radiation; PRES; HTN; arterial thromboembolism. Serious wound healing complications including anastomotic complications. Proteinuria. Arterial thromboembolic reactions including CVAs, TIA & MI; venous thromboembolic reactions including pulmonary embolism. Pulmonary haemorrhage/haemoptysis. May promote formation of aneurysms &/or artery dissections in patients w/ or w/o HTN. Osteonecrosis of jaw. Infectious endophthalmitis, intraocular inflammation eg, sterile endophthalmitis, uveitis & vitritis, retinal detachment & pigment epithelial tear, increased IOP, intraocular haemorrhage eg, vitreous or retinal & conjunctival haemorrhage; systemic effects following intravitreal use including non-ocular haemorrhages. Patients w/ uncontrolled HTN; diabetes; untreated metastases; congenital bleeding diathesis, acquired coagulopathy or those receiving full dose of anticoagulants for treatment of thromboembolism prior to starting treatment; risk factors eg, HTN or history of aneurysm; clinically significant CV disease eg, pre-existing CAD or CHF. Closely monitor patients w/ thromboembolic reactions ≤Grade 3; for signs & symptoms of CNS bleeding. Adequately control preexisting HTN before therapy. Monitor BP during therapy; proteinuria by dipstick urinalysis prior to starting & during therapy. Consider dental exam & appropriate preventive dentistry prior to starting treatment. Avoid invasive dental procedures in patients who have previously received or are receiving IV bisphosphonates. Not to be administered or mixed w/ glucose soln. Not advised to use diuretics to manage HTN in patients who receive cisplatin-based chemotherapy regimen. Not to drive or use machines if patients are experiencing symptoms that affect their vision or conc. Renal & hepatic impairment. May impair female fertility. Discuss fertility preservation strategies w/ women of child-bearing potential prior to starting treatment. Women of childbearing potential should use effective contraception during & up to 6 mth after treatment. Discontinue breastfeeding during therapy & not to breastfeed for at least 6 mth following last dose. Childn <18 yr. Not indicated for treatment of cancers of colon, rectum, breast, lung, ovarian, fallopian tube, peritoneum, cervix, kidney & glioblastoma in paed patients. Elderly >65 yr.

Febrile neutropenia, leucopenia, neutropenia, thrombocytopenia; anorexia, hypomagnesaemia, hyponatraemia; peripheral sensory neuropathy, dysarthria, headache, dysguesia; 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. Sepsis, abscess, cellulitis, infection, UTI; anaemia, lymphopenia; hypersensitivity, infusion reactions; dehydration; CVA, syncope, somnolence; CHF, supraventricular tachycardia; arterial thromboembolism, haemorrhage, DVT; pulmonary haemorrhage/haemoptysis & 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 w/ sunitinib malate. Increased rates of severe neutropenia, febrile neutropenia, or infection w/ or w/o severe neutropenia (including some fatalities) w/ platinum- or taxane-based therapies in treatment of NSCLC & metastatic breast cancer. Concomitant use w/ anti-EGFR monoclonal Abs panitumumab & cetuximab + chemotherapy.

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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