Krabeva

Krabeva

bevacizumab

Manufacturer:

Duopharma HAPI

Distributor:

Duopharma HAPI
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 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 as front-line treatment of 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 anti-VEGF treatment. In combination w/ paclitaxel, topotecan or pegylated liposomal doxorubicin in platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer adult patients who received no >2 prior chemotherapy regimens & who have not received prior anti-VEGF treatment. 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: 7.5 mg/kg once every 3 wk. Addition to carboplatin: 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: 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 once 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, recombinant human or humanized Ab.
Special Precautions
Infusion/hypersensitivity reactions. Discontinue use if GI perforation; tracheoesophageal fistula or any grade 4 fistula; grade 3 or 4 intracranial bleeding; medically significant HTN, hypertensive crisis or encephalopathy; posterior reversible encephalopathy syndrome; arterial & grade 4 VTE; 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 unapproved intravitreal use; diabetic patients; 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. Concomitant use w/ anticoagulants. 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
Febrile neutropenia, leucopenia, neutropenia, thrombocytopenia; peripheral sensory, neuropathy; HTN; diarrhoea, nausea, vomiting, abdominal pain; asthenia, fatigue. Sepsis, abscess, cellulitis infection; anaemia, lymphopenia; dehydration, hyponatraemia; CVA, syncope, somnolence, headache; congestive cardiac failure, supraventricular tachycardia; arterial thromboembolism, DVT, haemorrhage; pulmonary embolism, dyspnoea, hypoxia, epistaxis; intestinal perforation & obstruction, ileus, recto-vag fistulae, GI disorder, stomatitis, proctalgia; palmar-plantar erythrodysaesthesia syndrome; muscular weakness, myalgia, arthralgia, back pain; proteinuria, UTI; pain, lethargy, mucosal inflammation; pelvic pain; dysphonia.
Drug Interactions
Microangiopathic haemolytic anaemia w/ sunitinib malate.
MIMS Class
Targeted Cancer Therapy
ATC Classification
L01FG01 - bevacizumab ; Belongs to the class of VEGF/VEGFR (Vascular Endothelial Growth Factor) inhibitors. Used in the treatment of cancer.
Presentation/Packing
Form
Krabeva infusion conc 100 mg/4 mL
Packing/Price
1's
Form
Krabeva infusion conc 400 mg/16 mL
Packing/Price
1's
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