Mvasi

Bevacizumab

In combination w/ fluoropyrimidine-based chemotherapy for adults w/ metastatic carcinoma of the colon or rectum (mCRC). In addition to platinum-based chemotherapy for the 1st-line treatment of adults w/ unresectable advanced, metastatic or recurrent NSCLC other than predominantly squamous cell histology. In combination w/ erlotinib for the 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/ interferon α-2a for the 1st-line treatment of adults w/ advanced &/or metastatic renal cell cancer (mRCC). In combination w/ carboplatin & paclitaxel for the front-line treatment of adults w/ advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer. In combination w/ carboplatin & gemcitabine, or carboplatin & paclitaxel for 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/VEGF receptor-targeted agents. In combination w/ paclitaxel, topotecan, or pegylated lipos doxorubicin for adults w/ platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received not >2 prior chemotherapy regimens & who have not received prior therapy w/ bevacizumab or other VEGF inhibitors/VEGF receptor-targeted agents. In combination w/ paclitaxel & cisplatin or, alternatively, paclitaxel & topotecan in patients who cannot receive platinum therapy, for adults w/ persistent, recurrent, or metastatic carcinoma of the cervix. Recurrent glioblastoma (GBM) in adult.

Initial dose should be delivered over 90 min as IV infusion then 2nd dose may be administer over 60 min if the 1st infusion is well tolerated. If the 60-min infusion is well tolerated, all subsequent infusions may be administered over 30 min. Adult 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 as IV infusion. 1st-line treatment of non-squamous NSCLC in combination w/ platinum-based chemotherapy 7.5 mg/kg or 15 mg/kg once every 3 wk as IV infusion for up to 6 cycles followed by bevacizumab 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 as IV infusion. Advanced &/or mRCC 10 mg/kg once every 2 wk as IV infusion. Epithelial ovarian, fallopian tube & primary peritoneal cancer front-line treatment 15 mg/kg once every 3 wk as IV infusion in addition to carboplatin & paclitaxel for up to 6 cycles followed by continued use of bevacizumab as single agent until disease progression or for a max of 15 mth or until unacceptable toxicity. Platinum-sensitive recurrent disease 15 mg/kg once every 3 wk as IV infusion in combination w/ either carboplatin & gemcitabine for 6-10 cycles or in combination w/ carboplatin & paclitaxel for 6-8 cycles, followed by continued use of bevacizumab as single agent until disease progression; Platinum-resistant recurrent disease 10 mg/kg once every 2 wk as IV infusion in combination w/ 1 of the following agents: paclitaxel, topotecan (given wkly) or pegylated lipos doxorubicin. In combination w/ topotecan (given on days 1-5, every 3 wk), 15 mg/kg once every 3 wk as IV infusion. Cervical cancer 15 mg/kg once every 3 wk as IV infusion in combination w/ 1 of the following chemotherapy regimens: paclitaxel & cisplatin or paclitaxel & topotecan. GBM 10 mg/kg every 2 wk.

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

Hypersensitivity reactions/infusion reactions. Do not administer as IV push or bolus. Not formulated for intravitreal use. Increased risk for GI & gall bladder perforation; in patients w/ history of prior radiation; GI-vag fistulae; fistulae. Permanently discontinue therapy in patients who develop GI perforation; w/ tracheoesophageal fistula or any grade 4 fistula; if medically significant HTN cannot be adequately controlled w/ antihypertensive therapy, or if patient develops hypertensive crisis or hypertensive encephalopathy; in patients who develop nephrotic syndrome; arterial thromboembolic reactions including CVA, transient ischemic attack & MI; who experience grade 3 or 4 bleeding during therapy. Consider discontinuation in cases of internal fistula not arising in GIT. Wound healing complications; do not initiate therapy for at least 28 days following major surgery or until the surgical wound is fully healed. W/held treatment in patients who experienced wound healing complications during therapy; for elective surgery. Discontinue therapy in patients who develop necrotising fasciitis. HTN; monitor BP during therapy. Posterior reversible encephalopathy syndrome. Monitor urinalysis for proteinuria prior to starting & during therapy. Patients receiving bevacizumab plus chemotherapy, w/ history of arterial thromboembolism, diabetes or >65 yr. Discontinue in patients w/ life-threatening thromboembolic reactions including pulmonary embolism. Closely monitor patients w/ ≤ grade 3 thromboembolic reactions. Monitor patients for signs & symptoms of CNS bleeding; discontinue treatment in cases of intracranial bleeding. Congenital bleeding diathesis, acquired coagulopathy or in patients receiving full dose of anticoagulants for the treatment of thromboembolism prior to starting bevacizumab treatment. Do not treat patients w/ recent pulmonary haemorrhage/haemoptysis. CV disease eg, pre-existing CAD, or CHF. Severe neutropenia, febrile neutropenia, or infection w/ or w/o severe neutropenia. Osteonecrosis of the jaw; avoid invasive dental procedures in patients who have previously received or are receiving IV bisphosphonates. Formation of aneurysms &/or artery dissections. Serious ocular adverse reaction may occur following unapproved intravitreal use. Eye disorders including infectious endophthalmitis, intraocular inflammation eg, sterile endophthalmitis, uveitis & vitritis, retinal detachment, retinal pigment epithelial tear, increased IOP, intraocular haemorrhage eg, vitreous or retinal haemorrhage & conjunctival haemorrhage resulting in visual loss including permanent blindness. Systemic effects following intravitreal use; non-ocular haemorrhages & arterial thromboembolic reactions. May affect ability to drive & use machines. Ovarian failure; may impair female fertility. Women of childbearing potential should use effective contraception during & up to 6 mth after treatment. Discontinue breast-feeding during therapy & for at least 6 mth following the last dose of bevacizumab. Childn <18 yr.

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 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, haemorrhage, DVT; pulmonary haemorrhage/haemoptysis, pulmonary embolism, hypoxia, dysphonia; GI perforation, intestinal perforation, ileus, intestinal obstruction, recto-vag fistulae, GI disorder, proctalgia; palmar-plantar erythrodysaesthesia syndrome; fistula, muscular weakness, back pain; pelvic pain; lethargy.

Risk of microangiopathic haemolytic anaemia w/ sunitinib malate. Increased rates of severe neutropenia, febrile neutropenia, or infection w/ or w/o severe neutropenia w/ platinum- or taxane-based therapies. Concomitant administration w/ RT. Decreased PFS &/or OS, & increased toxicity w/ anti-EGFR monoclonal Abs 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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