Avastin

Bevacizumab

In combination w/ fluoropyrimidine-based chemotherapy for metastatic carcinoma of colon or rectum. In combination w/ standard cytotoxic chemotherapy for 1st-line treatment of locally recurrent or metastatic breast cancer (mBC); w/ taxanes, capecitabine or gemcitabine for mBc after failure of 1st-line cytotoxic chemotherapy. In addition to platinum-based chemotherapy for 1st-line treatment of unresectable advanced, metastatic or recurrent NSCLC. 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/ RT & temozolomide for adults w/ newly diagnosed glioblastoma. Single agent or in combination w/ irinotecan for glioblastoma after relapse or disease progression. In combination w/ carboplatin & paclitaxel for front-line treatment of advanced (FIGO stages III B, III C & IV) epithelial ovarian, fallopian tube or primary peritoneal cancer. In combination w/ carboplatin & gemcitabine or carboplatin & paclitaxel for patients w/ 1st recurrent, platinum-sensitive, epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received chemotherapy in recurrent setting & not received prior bevacizumab treatment. In combination w/ paclitaxel, topotecan or pegylated lipos doxorubicin for patients w/ recurrent, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no >2 prior chemotherapy regimens. In combination w/ paclitaxel & cisplatin or paclitaxel & topotecan for persistent, recurrent or metastatic cervical carcinoma.

IV infusion Administer 1st infusion over 90 min, then 2nd infusion over 60 min & subsequent doses over 30 min, if well tolerated. Metastatic CRC 1st-line treatment: 5 mg/kg once every 2 wk or 7.5 mg/kg once every 3 wk. 2nd-line treatment: 5 mg/kg or 10 mg/kg once every 2 wk or 7.5 mg/kg or 15 mg/kg once every 3 wk. Continue treatment until disease progression. Locally recurrent or metastatic breast cancer 10 mg/kg once every 2 wk or 15 mg/kg once every 3 wk. Continue treatment until disease progression. Advanced, metastatic or recurrent NSCLC 1st-line treatment in combination w/ platinum-based chemotherapy: 7.5 mg/kg once every 3 wk in addition to cisplatin-based chemotherapy or 15 mg/kg once every 3 wk in addition to carboplatin-based chemotherapy, for up to 6 cycles followed by monotherapy until disease progression. 1st-line treatment w/ EGFR activating mutations in combination w/ erlotinib: 15 mg/kg once every 3 wk & continued until disease progression. Advanced &/or metastatic renal cell cancer 10 mg/kg once every 2 wk until disease progression. Glioblastoma [malignant glioma (WHO grade IV)] Newly diagnosed glioblastoma: 10 mg/kg once every 2 wk in combination w/ temozolomide & RT for 6 wk. Following 4-wk treatment break, re-initiate in combination w/ temozolomide for up to 6 cycles of 4 wk duration. Then, administer 15 mg/kg once every 3 wk as single agent until disease progression. Recurrent disease: 10 mg/kg once every 2 wk or 15 mg/kg once every 3 wk & continued until disease progression. 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 monotherapy for 15 mth or until disease progression. Recurrent disease: Platinum-sensitive: 15 mg/kg once every 3 wk in combination w/ carboplatin & paclitaxel for 6 cycles & up to 8 cycles followed by continued use as monotherapy until disease progression. Alternatively, 15 mg/kg every 3 wk in combination w/ carboplatin & gemcitabine for 6 cycles & up to 10 cycles followed by continued use as monotherapy until disease progression. Platinum-resistant: 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 every 3 wk in combination w/ topotecan given on days 1-5 every 3 wk. Continue until disease progression. Cervical cancer 15 mg/kg once every 3 wk in combination w/ 1 of the following chemotherapy regimens: paclitaxel & cisplatin or paclitaxel & topotecan. Continue until disease progression.

Hypersensitivity to bevacizumab, Chinese hamster ovary cell products or other recombinant human or humanised Abs.

Hypersensitivity, anaphylactic (including anaphylactic shock) & infusion-related reactions. Permanently discontinue in patients who develop anaphylactic reactions; severe (Grade ≥3) infusion-related reaction; GI perforation; tracheoesophageal fistula or any Grade 4 fistula; Grade 3 or 4 bleeding during therapy; hypertensive crisis or encephalopathy or if medically significant HTN cannot be adequately controlled w/ antihypertensive therapy; arterial thromboembolic events; nephrotic syndrome. Discontinue treatment in case of intracranial bleeding; life threatening (Grade 4) VTE including pulmonary embolism; development of necrotising fasciitis. Consider discontinuation of treatment in cases of internal fistula not arising in GI tract. Withhold treatment until wound is fully healed in patients experiencing wound healing complications during treatment; for elective surgery. Temporarily interrupt treatment if infusion-related reactions occur until resolution of symptoms. Not for intravitreal use. Not to be used in patients w/ recent pulmonary haemorrhage/haemoptysis (>½ tsp red blood); initiated for at least 28 days following major surgery or until surgical wound is fully healed. Increased risk of developing GI perforation; fistulae between vag & any part of GI tract; haemorrhage, especially tumour-associated; venous thromboembolic events; arterial thromboembolic events in patients w/ history of arterial thromboembolism, diabetes or >65 yr receiving concomitant chemotherapy. Increased incidence of HTN; rates of severe neutropenia, febrile neutropenia, or infection w/ severe neutropenia in patients treated w/ concomitant myelotoxic chemotherapy regimens. Patients w/ congenital bleeding diathesis, acquired coagulopathy or receiving full dose anticoagulants for thromboembolism prior to starting treatment; clinically significant CV disease eg, pre-existing CAD or CHF. Individual cases & clusters of serious ocular adverse events including infectious endophthalmitis & other ocular inflammatory conditions following unapproved intravitreal use. Posterior reversible encephalopathy syndrome. Adequately control pre-existing HTN before starting treatment. Closely monitor patients w/ ≤ Grade 3 thromboembolic events. Monitor for signs & symptoms of CNS bleeding; BP during therapy. Renal & hepatic impairment. May impair female fertility. Women of child-bearing potential should use contraceptive measures during therapy & for at least 6 mth following last dose. Not to be used during pregnancy. May inhibit angiogenesis in foetus. Discontinue nursing during therapy & not to breast feed for at least 6 mth following last dose. Childn & adolescent <18 yr.

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

Microangiopathic haemolytic anemia w/ sunitinib malate.

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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