Mvasi

Bevacizumab

Treatment of adult patients 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. 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/ advanced &/or metastatic renal cell cancer, in combination w/ interferon alfa-2a.

IV infusion Initial dose should be delivered over 90 min. If well tolerated, the 2nd infusion may be administered over 60 min. If the 60-min infusion is well tolerated, all subsequent infusions may be administered over 30 min. Continue treatment until progression of the underlying disease or until unacceptable toxicity. Metastatic carcinoma of the colon or rectum (mCRC) 5 or 10 mg/kg once every 2 wk, or 7.5 or 15 mg/kg once every 3 wk. Metastatic breast cancer (mBC) 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. Mvasi is administered in addition to platinum-based chemotherapy for up to 6 cycles of treatment followed by Mvasi as a single agent until disease progression. Advanced &/or metastatic renal cell cancer (mRCC) 10 mg/kg once every 2 wk.

Hypersensitivity to bevacizumab or any of the excipients, Chinese Hamster Ovary (CHO) cell products or other recombinant human or humanised Abs. Pregnancy.

Should not be administered as an IV push or bolus. Risk of GI perforation & fistulae; non-GI fistulae; HTN; arterial thromboembolism; VTE; haemorrhage, especially tumour-associated haemorrhage; CHF; infusion/hypersensitivity reactions; osteonecrosis of the jaw. May adversely affect wound healing process. Do not initiate therapy for at least 28 days following major surgery or until the surgical wound is fully healed. Monitor BP during therapy. Increased risk of proteinuria in patients w/ history of HTN. Monitoring of proteinuria by dipstick urinalysis is recommended prior to starting & during therapy. Risk of pulmonary haemorrhage/haemoptysis in patients w/ NSCLC. Patients w/ recent pulmonary haemorrhage/haemoptysis (>2.5 mL of red blood) should not be treated w/ bevacizumab. Increased rates of severe neutropenia, febrile neutropenia or infection w/ or w/o neutropenia in patients concomitantly treated w/ some myelotoxic chemotherapy regimens. May promote formation of aneurysms &/or artery dissection. Rare reports of posterior reversible encephalopathy syndrome. Not formulated for intravitreal use. Eye disorders & systemic effects following intravitreal use. Safety & efficacy have not been studied in patients w/ renal or hepatic impairment. May impair female fertility. Women of childbearing potential must use effective contraception during & up to 6 mth after treatment. Women must discontinue breast-feeding during therapy & not breast-feed for at least 6 mth after last dose.

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.

Reports of microangiopathic haemolytic anaemia, HTN, elevated creatinine & neurological symptoms w/ sunitinib malate. Increased rates of severe neutropenia, febrile neutropenia, or infection w/ or w/o severe neutropenia w/ platinum- or taxane-based therapies in the treatment of NSCLC & mBC. EGFR monoclonal Abs should not be administered for the treatment of mCRC in combination w/ bevacizumab-containing chemotherapy.

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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