Avastin Roche安維汀

Avastin Roche

bevacizumab

Manufacturer:

Roche

Distributor:

DKSH
/
Agencia Lei Va Hong
Concise Prescribing Info
Contents
Bevacizumab
Indications/Uses
In combination w/ fluoropyrimidine-based chemotherapy for treatment of metastatic colorectal cancer (mCRC). In combination w/ paclitaxel for 1st-line treatment of metastatic breast cancer (mBC). In addition to platinum-based chemotherapy for 1st-line treatment of unresectable advanced, metastatic or recurrent non-small cell lung cancer (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 treatment of advanced &/or metastatic renal cell cancer (mRCC). Monotherapy for treatment of glioblastoma w/ progressive disease following prior therapy. In combination w/ carboplatin & paclitaxel for the front-line treatment of advanced (FIGO stages IIIB, IIIC & IV) epithelial ovarian, fallopian tube or primary peritoneal cancer. In combination w/ carboplatin & gemcitabine or carboplatin & paclitaxel for treatment of 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 or VEGF receptor-targeted agents. In combination w/ paclitaxel, topotecan or pegylated liposomal doxorubicin for treatment of adult patients w/ platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who received no more than 2 prior chemotherapy regimen & have not received prior therapy. In combination w/ paclitaxel & cisplatin or paclitaxel & topotecan in patients who cannot receive platinum therapy for treatment of patients w/ persistent, recurrent or metastatic carcinoma of the cervix.
Dosage/Direction for Use
IV infusion Adult 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. NSCLC in combination w/ platinum-based chemotherapy 7.5 or 15 mg/kg once every 3 wk in addition to platinum-based chemotherapy for up to 6 cycles, then as monotherapy. mRCC, Glioblastoma 10 mg/kg once every 2 wk. NSCLC w/ EGFR activating mutations in combination w/ erlotinib 15 mg/kg once every 3 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, then as monotherapy. Platinum-sensitive recurrent disease 15 mg/kg once every 3 wk in combination w/ carboplatin & gemcitabine for 6-10 cycles, or w/ carboplatin & paclitaxel for 6-8 cycles, then as monotherapy. Platinum-resistant recurrent disease 10 mg/kg given once every 2 wk in combination w/ paclitaxel or pegylated liposomal doxorubicin; or 15 mg/kg w/ topotecan (given on days 1-5, every 3 wk) once every 3 wk. Cervical cancer 15 mg/kg once every 3 wk in combination w/ either paclitaxel & cisplatin or paclitaxel & topotecan.
Contraindications
Hypersensitivity to bevacizumab, to Chinese hamster ovary cell products or other recombinant human or humanised Abs. Pregnancy.
Special Precautions
GI & gall bladder perforation; fistulae; necrotizing fasciitis; HTN; arterial or venous thromboembolism. Do not initiate for at least 28 days following major surgery or until surgical wound is fully healed. Withhold for elective surgery. Monitor BP during treatment. Posterior reversible encephalopathy syndrome. Monitor for proteinuria by dipstick urinalysis prior to, & during therapy. Monitor for signs & symptoms of CNS bleeding. Do not use where recent significant pulmonary haemorrhage/haemoptysis. Caution in patients w/ CV disease (eg, CHF). Neutropenia & infections. Hypersensitivity & infusion reactions. Osteonecrosis of the jaw. Not for intravitreal use. Eye disorders. Do not administer as IV push or bolus. Use of diuretics is not recommended in patients on cisplatin-based chemotherapy. May impair female fertility. Lactation. Childn & adolescent.
Adverse Reactions
Febrile neutropenia, leucopenia, thrombocytopenia, neutropenia, peripheral sensory neuropathy, HTN, nausea, vomiting, asthenia, fatigue. Sepsis, abscess, infection, anaemia, hyponatremia, dehydration, cerebrovascular accident, syncope, somnolence, headache, CHF, supraventricular tachycardia, thromboembolism (arterial), DVT, haemorrhage, pulmonary embolism, dyspnoea, hypoxia, epistaxis, intestinal perforation & obstruction, ileus, abdominal pain, GI disorder, stomatitis, palmar-plantar erythrodysaesthesia syndrome, muscular weakness, myalgia, arthralgia, proteinuria, UTI pain, lethargy, mucosal inflammation.
Drug Interactions
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.
ATC Classification
L01XC07 - bevacizumab ; Belongs to the class of monoclonal antibodies, other antineoplastic agents. Used in the treatment of cancer.
Presentation/Packing
Form
Avastin Roche infusion 100 mg/4 mL
Packing/Price
(single-use) 1's
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