Mvasi

Mvasi

bevacizumab

Manufacturer:

Amgen

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Bevacizumab
Indications/Uses
In combination w/ fluoropyrimidine-based chemotherapy for metastatic colon or rectum carcinoma (mCRC). In combination w/ paclitaxel as 1st-line treatment of metastatic breast cancer (mBC). In addition to platinum-based chemotherapy as 1st-line treatment of unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC). In combination w/ interferon α-2a as 1st-line treatment of advanced &/or metastatic renal cell cancer (mRCC). Glioblastoma w/ progressive disease following prior therapy as single agent. In combination w/ carboplatin & paclitaxel for advanced epithelial ovarian, fallopian tube or primary peritoneal cancer. In combination w/ carboplatin & gemcitabine or carboplatin & paclitaxel for recurrent, platinum-sensitive, epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior bevacizumab/other VEGF-inhibitor. In combination w/ paclitaxel, topotecan or pegylated liposomal doxorubicin in adult patients who received no >2 prior chemotherapy regimens & who have not received prior therapy. In combination w/ paclitaxel & cisplatin or paclitaxel & topotecan for persistent, recurrent or metastatic cervix carcinoma.
Dosage/Direction for Use
IV infusion mCRC 5 or 10 mg/kg once every 2 wk, or 7.5 or 15 mg/kg once every 3 wk. mBC 10 mg/kg once every 2 wk or 15 mg/kg once every 3 wk. Advanced, metastatic or recurrent NSCLC Addition to cisplatin-based chemotherapy: 7.5 mg/kg once every 3 wk. Addition to carboplatin-based chemotherapy: 15 mg/kg once every 3 wk. Advanced &/or mRCC & glioblastoma 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 followed by continued use as single agent for 15 mth or until disease progression. Recurrent 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 single agent 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 single agent until disease progression. Recurrent platinum-resistant: 10 mg/kg once every 2 wk in combination w/ paclitaxel, topotecan (given wkly) or pegylated liposomal doxorubicin. Alternatively, 15 mg/kg every 3 wk in combination w/ topotecan on days 1-5 every 3 wk. Cervical cancer 15 mg/kg once every 3 wk.
Contraindications
Hypersensitivity to bevacizumab, Chinese hamster ovary cell products or other recombinant human or humanised Ab.
Special Precautions
Infusion/hypersensitivity reactions. Discontinue use if GI perforation, tracheoesophageal fistula or any grade 4 fistula, medically significant HTN, hypertensive crisis or encephalopathy. posterior reversible encephalopathy syndrome, intracranial, grade 3 or 4 bleeding, arterial & venous thromboembolism, necrotising fasciitis, nephrotic syndrome develops. Not to be used in patients w/ recent pulmonary haemorrhage/haemoptysis. Congenital bleeding diathesis, acquired coagulopathy; severe eye infections following compounding for unapproved intravitreal use; diabetes; clinically significant CV disease eg, preexisting CAD or CHF; neutropenia. Not to be initiated for at least 28 days following major surgery & withheld therapy for elective surgery. Monitor signs & symptoms of CNS bleeding; BP during therapy. May affect ability to drive & use machines. Renal & hepatic impairment. May impair female fertility; women of childbearing potential should use effective contraception during & at least 6 mth following last dose. Not to be used during pregnancy & lactation. Not to be used in childn & adolescents <18 yr. Elderly >65 yr.
Adverse Reactions
GI perforations, haemorrhage, arterial thromboembolism. Febrile neutropenia, leucopenia, neutropenia, thrombocytopenia; anorexia, hypomagnesaemia, hyponatraemia; peripheral sensory neuropathy, dysgeusia, headache, dysarthria; eye disorder, increased lacrimation; HTN; dyspnea, epistaxis, rhinitis, cough; GI disorders; ovarian failure; exfoliative dermatitis, dry skin, skin discolouration; arthralgia; proteinuria; asthenia, fatigue, pyrexia, pain, mucosal inflammation; decreased wt. Sepsis, abscess, cellulitis, infection; anaemia, lymphopenia; dehydration, hyponatraemia; nervous system, cardiac & resp disorders; DVT, haemorrhage; palmar-plantar erythrodysaesthesia syndrome; musculoskeletal disorders; UTI; lethargy; pelvic pain.
Drug Interactions
Microangiopathic haemolytic anaemia w/ sunitinib malate.
ATC Classification
L01XC07 - bevacizumab ; Belongs to the class of monoclonal antibodies, other antineoplastic agents. Used in the treatment of cancer.
Presentation/Packing
Form
Mvasi infusion conc 25 mg/mL
Packing/Price
16 mL x 1's;4 mL x 1's
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