Abevmy

Abevmy

bevacizumab

Manufacturer:

Biocon

Distributor:

Biocon
Concise Prescribing Info
Contents
Bevacizumab
Indications/Uses
Treatment of adult w/ metastatic carcinoma of the colon or rectum in combination w/ fluoropyrimidine-based chemotherapy. 1st-line treatment of NSCLC in combination w/ platinum-based chemotherapy. Treatment of glioblastoma, as a single agent for adult w/ progressive disease following prior therapy. 1st-line treatment of adult w/ advanced &/or metastatic renal cell cancer (mRCC) in combination w/ interferon α-2a. Front-line treatment of adult w/ advanced stages III B, III C and IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer in combination w/ carboplatin & paclitaxel. Treatment of persistent, recurrent, or metastatic carcinoma of the cervix in adult, in combination w/ paclitaxel & cisplatin; or, alternatively, paclitaxel & topotecan (for those who cannot receive platinum therapy).
Dosage/Direction for Use
IV Adult Metastatic colorectal cancer (mCRC) 5 mg/kg or 10 mg/kg once every 2 wk or 7.5 mg/kg or 15 mg/kg of once every 3 wk. 1st-line treatment of NSCLC in combination w/ platinum-based chemotherapy 7.5 mg/kg or 15 mg/kg once every 3 wk, in addition to platinum-based chemotherapy for up to 6 cycles of treatment followed by continued use of Abevmy as a single agent until disease progression of the underlying disease or until unacceptable toxicity. Advanced &/or mRCC 10 mg/kg once every 2 wk in combination w/ interferon α. Glioblastoma [malignant glioma (WHO grade IV)] 10 mg kg once every 2 wk or 15 mg/kg once every 3 wk. Front-line treatment of epithelial ovarian, fallopian tube or primary peritoneal cancer 15 mg/kg once every 3 wk in addition to carboplatin & paclitaxel for up to 6 cycles followed by continued use of Abevmy as single agent for 15 mth or until disease progression. Cervical cancer 15 mg/kg of body wt once every 3 wk in combination w/ paclitaxel and cisplatin or paclitaxel & topotecan.
Contraindications
Hypersensitivity to bevacizumab & Chinese hamster ovary cell products or other recombinant human or humanized Abs. Pregnancy.
Special Precautions
Hypersensitivity or infusion reactions. Not for intravitreal use. Increased risk of GI perforation & developing GI-vag fistuale. Permanently discontinue in patients w/ GI perforation; tracheoesophageal fistula or any grade 4 fistula; in patients who develop nephrotic syndrome; arterial thromboembolic reactions; life-threatening grade 4 VTE; patients w/ grade 3 or 4 bleeding during treatment. Consider discontinuation for internal fistula not arising in the GI tract. Adequately control pre-existing HTN prior to initial treatment. Monitor BP during treatment. Severe HTN. Posterior reversible encephalopathy syndrome (PRES). Increased risk of arterial thromboembolic events in patients w/ a history of arterial thromboembolism, diabetes or age >65 yr; VTE. Monitor for signs and & symptoms of CNS bleeding. Discontinue treatment in cases of intracranial bleeding. Patients w/ congenital bleeding diathesis acquired coagulopathy or receiving full dose of anticoagulants for thromboembolism. Do not administer to patients w/ recent pulmonary hemorrhage/hemoptysis. Preexisting CV disease eg, preexisting CAD or CHF. Severe/febrile neutropenia or infection. Osteonecrosis of the jaw. Consider dental exam w/ appropriate preventive dentistry prior to treatment. Avoid procedures where possible to patients who have received or receiving IV bisphosphonates. Monitor proteinuria by appropriate urinalysis prior & during the treatment. Do not administer EGFR monoclonal Abs for treatment of mCRC in combination w/ bevacizumab-containing chemotherapy. Do not start therapy for at least 28 days after major surgery or till the surgical wound has healed completely. Temporarily suspend for at least 4 wk before elective surgery. Discontinue & promptly initiate appropriate treatment in patients who develop necrotising fasciitis. Occurrence of grade 3 & 4 lab abnormalities. Effective contraception should be advised during treatment for female patients of reproductive potential for 6 mth following the last dose of the treatment. Not to be used during pregnancy & lactation. Not to be used in childn <18 yr.
Adverse Reactions
Febrile neutropenia, paronychia, leukopenia, neutropenia, thrombocytopenia, anorexia, peripheral sensory neuropathy, dysarthria, headache, dysgeusia, eye disorder, increased lacrimation, HTN, VTE, dyspnoea, rhinitis, rectal haemorrhage, stomatitis, constipation, diarrhoea, nausea, vomiting, abdominal pain, wound healing complications, exfoliative dermatitis, dry skin, skin discoloration, arthralgia, 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, pulmonary haemorrhage/haemoptysis, pulmonary embolism, epistaxis, hypoxia, dysphonia, GI perforation, intestinal perforation, ileus, intestinal obstruction, recto-vag fistulae, GI disorder, proctalgia, palmar-plantar erythrodysaesthesia syndrome, fistula, myalgia, muscular weakness, back pain, pelvic pain, lethargy, dry mouth, haemorrhage, DVT.
Drug Interactions
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
Abevmy soln for infusion 100 mg/4 mL
Packing/Price
1's
Form
Abevmy soln for infusion 400 mg/16 mL
Packing/Price
1's
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