Avegra

Bevacizumab

Adults w/ metastatic carcinoma of the colon or rectum in combination w/ fluoropyrimidine-based chemotherapy. 1st-line treatment of adult patients w/ metastatic breast cancer in combination w/ paclitaxel, or capecitabine in whom treatment w/ other chemotherapy options including taxanes or anthracyclines is not considered appropriate. 1st-line treatment of adult patients w/ unresectable advanced, metastatic or recurrent NSCLC other than predominantly squamous cell histology in addition to platinum-based chemotherapy. 1st-line treatment of adult patients 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 adult patients w/ advanced &/or metastatic renal cell cancer (mRCC) in combination w/ interferon α-2a. In combination w/ carboplatin & paclitaxel for the front-line treatment of adult patients w/ advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer; in combination w/ carboplatin & gemcitabine in adult patients 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 or VEGF receptor-targeted agents; in combination w/ paclitaxel, topotecan, or pegylated lipos doxorubicin in adult patients 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. As single agent in glioblastoma w/ progressive disease in adult patients following prior therapy. Adult patients 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.

IV infusion Administer 1st infusion over 90 min. If 1st infusion is well-tolerated, administer 2nd infusion over 60 min. May administer all subsequent infusions over 30 min, if 60-min infusion is well tolerated. Metastatic carcinoma of the colon or rectum 5 or 10 mg/kg once every 2 wk, or 7.5 or 15 mg/kg once every 3 wk. Metastatic breast cancer & glioblastoma 10 mg/kg once every 2 wk, or 15 mg/kg once every 3 wk. 1st-line treatment of non-squamous NSCLC In combination w/ platinum-based chemotherapy: 7.5 or 15 mg/kg once every 3 wk in addition to platinum-based chemotherapy for up to 6 cycles followed by Avegra as single agent until disease progression. 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. Advanced &/or mRCC 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 of treatment followed by continued use of Avegra as 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/ carboplatin & gemcitabine for 6 cycles & up to 10 cycles followed by continued use of Avegra as single agent until disease progression; platinum-resistant recurrent disease 10 mg/kg once every 2 wk in combination w/ 1 of the following agents: paclitaxel, topotecan (given wkly) or pegylated lipos doxorubicin. Alternatively, 15 mg/kg once every 3 wk in combination w/ topotecan on days 1-5 every 3 wk. Cervical cancer 15 mg/kg once every 3 wk in combination w/ 1 of the following chemotherapy regimens: paclitaxel & cisplatin, or paclitaxel & topotecan.

Hypersensitivity to bevacizumab & Chinese hamster ovary (CHO) cell products or other recombinant human or humanised Abs. Pregnancy.

Not to be administered as IV push or bolus; or mixed w/ glucose soln. Not formulated for intravitreal use. Permanently discontinue treatment in patients who develop GI perforation; tracheoesophageal fistula or any Grade 4 fistula; nephrotic syndrome; arterial thromboembolic reactions; medically significant HTN cannot be adequately controlled w/ antihypertensive therapy; hypertensive crisis or encephalopathy; experience Grade 3 or 4 bleeding during therapy; serious infections of skin or deeper layers under the skin. Discontinue treatment in patients who develop necrotizing fasciitis; PRES; life-threatening (Grade 4) thromboembolic reactions, including pulmonary embolism, intracranial bleeding; if infusion/hypersensitivity reactions occur. Consider discontinuation in cases of internal fistula not arising in GIT. Monitor during therapy for BP; proteinuria; thromboembolic reactions ≤Grade 3; CNS bleeding. Not to be initiated for at least 28 days following major surgery or until surgical wound is fully healed. Not to be used in patients w/ recent pulmonary haemorrhage/haemoptysis (>2.5 mL of red blood). Increased risk of GI & gall bladder perforation; GI-vag & non-GI fistulae; proteinuria in patient w/ history of HTN; arterial & venous thromboembolic reactions including pulmonary embolism; haemorrhage, especially tumour-associated haemorrhage; serious wound healing complications. May impair female fertility, recommend to consider fertility preservation prior to starting treatment. Women of childbearing potential should use effective contraception during & up to 6 mth after treatment. Discontinue lactation during & at least 6 mth following last dose of treatment. Not approved for use in childn <18 yr. May increase in thromboembolic reactions, including CVA, transient ischaemic attacks, MI in patients >65 yr.

Febrile neutropenia, leucopenia, neutropenia, thrombocytopenia; anorexia; peripheral sensory neuropathy, dysarthria, headache, dysgeusia; eye disorder, increased lacrimation; HTN, VTE; dyspnoea, rhinitis; rectal haemorrhage, stomatitis, constipation, diarrhoea, nausea, vomiting, abdominal pain; wound healing complications, exfoliative dermatitis, dry skin, skin discoloration; arthralgia; 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, pulmonary embolism, epistaxis, hypoxia, dysphonia; GI & intestinal perforation, ileus, intestinal obstruction, recto-vag fistulae, GI disorder, proctalgia; palmar-plantar erythrodysaesthesia syndrome; fistula, myalgia, 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 in patient treated w/ platinum- or taxane-based therapies in NSCLC & mBC. Decreased progression-free &/or overall survival & w/ increased toxicity compared w/ anti-EGFR monoclonal Abs eg, panitumumab & cetuximab in treatment of metastatic carcinoma of the colon or rectum.

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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