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Bonmab

Bonmab

bevacizumab

Manufacturer:

BIOCAD

Distributor:

Ambitech
Concise Prescribing Info
Contents
Bevacizumab
Indications/Uses
Adults w/ advanced cancer in large bowel, in combination w/ fluoropyrimidine-based chemotherapy treatment; metastatic breast cancer, in combination w/ paclitaxel or capecitabine chemotherapy medicinal products; advanced NSCLC, together w/ platinum-containing chemotherapy regimen; advanced NSCLC when cancer cells have specific mutations of protein called epidermal growth factor receptor, in combination w/ erlotinib; advanced kidney cancer, in combination w/ interferon; advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer, in combination w/ carboplatin & paclitaxel; advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer whose disease has come back at least 6 mth after last time, treated w/ chemotherapy regimen containing platinum agent & in combination w/ carboplatin & gemcitabine; advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer whose disease has come back before 6 mth after last time, treated w/ chemotherapy regimen containing platinum agent & in combination w/ paclitaxel, or topotecan, or pegylated lipos doxorubicin; relapsed glioblastoma, administered as single agent; persistent, recurrent or metastatic cervical cancer, in combination w/ paclitaxel & cisplatin or alternatively, paclitaxel & topotecan in patients who cannot receive platinum therapy.
Dosage/Direction for Use
IV Recommended dose: 5 mg, 7.5 mg, 10 mg, or 15 mg/kg once every 2 or 3 wk depending on body wt & type of cancer to be treated.
Contraindications
Hypersensitivity to bevacizumab, Chinese hamster ovary cell products or to other recombinant or humanized Abs. Pregnancy.
Special Precautions
Discontinue for GI perforations, tracheoesophageal fistula, grade 4 fistula, or fistula formation involving any organ; in patients who develop wound healing complications that require medical intervention or necrotizing fasciitis; for grade 3-4 hemorrhage; for severe arterial thromboembolic events; for grade 4 VTE; for hypertensive crisis or hypertensive encephalopathy; posterior reversible encephalopathy syndrome; for nephrotic syndrome; for severe infusion-related reactions & administer medical therapy; in patients who develop CHF. W/hold for at least 28 days prior to elective surgery. Do not administer for at least 28 days after surgery, & until wound is fully healed; for recent hemoptysis. Severe or fatal hemorrhages. Monitor BP & treat HTN; w/hold if not medically controlled; resume once controlled. Monitor urine protein; w/hold until <2 g of protein in urine. Do not drive & use machines until symptoms that affect vision or concentration or ability to react, sleeplessness & fainting disappear. May cause fetal harm. Advise females of potential risk to fetus & the need for use of effective contraception; potential risk for ovarian failure. May impair fertility. Discontinue breastfeeding during treatment & for at least 6 mth after last dose.
Adverse Reactions
Allergic reactions including difficulty in breathing or chest pain, redness or flushing of skin or rash, chills & shivering, nausea, or vomiting. High BP, feeling of numbness or tingling in hands or feet, decreased number of cells in blood, including WBC, & cells that help blood to clot, feeling weak & having no energy, tiredness, diarrhea, & abdominal pain. Perforation of gut, bleeding, including bleeding in lungs in patients w/ NSCLC, blocking of arteries by blood clot, blocking of blood vessels of lungs by blood clot, blocking of veins of legs by blood clot, heart failure, problems w/ wound healing after surgery, redness, peeling, tenderness, pain, or blistering on fingers or feet, decreased number of RBC, lack of energy, stomach & intestinal disorder, muscle & joint pain, muscular weakness, dry mouth in combination w/ thirst &/or reduced or darkened urine, inflammation of moist lining of mouth & gut, lungs, & air passages, reproductive, & urinary tracts, sores in mouth & tube from mouth to stomach, which may be painful & cause difficulty swallowing, pain, including headache, back pain & pain in pelvis & regions, localized pus collection, infection, & in particular infection in blood or bladder, reduced blood supply to brain or stroke, sleepiness, nose bleed, increase in heart rate (pulse), blockage in gut or bowel, abnormal urine test (protein in urine), shortness of breath or low levels of O2 in blood, infections of skin or deeper layers under skin, fistula. Constipation, loss of appetite, fever, & problems w/ eyes (including increased production of tears), changes in speech, change in sense of taste, runny nose, dry skin, flaking & inflammation of skin, change in skin color, & loss of body wt. Voice changes & hoarseness.
Drug Interactions
May cause severe side effects w/ sunitinib maleate (prescribed for renal & GI cancer). Increased risk of severe side effects w/ platinum or taxane-based therapies for lung or metastatic breast cancer.
MIMS Class
Targeted Cancer Therapy
ATC Classification
L01FG01 - bevacizumab ; Belongs to the class of VEGF/VEGFR (Vascular Endothelial Growth Factor / Receptors) inhibitors. Used in the treatment of cancer.
Presentation/Packing
Form
Bonmab conc for soln for infusion 100 mg/4 mL
Packing/Price
1's
Form
Bonmab conc for soln for infusion 400 mg/16 mL
Packing/Price
1's
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