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Bevacizumab

    DEA Class; Rx

    Common Brand Names; Avastin, Mvasi, bevacizumab-awwb, Zirabev, bevacizumab-bvzr, Alymsys, bevacizumab-maly, bevacizumab-adcd, Vegzelma

    • Antineoplastics, Monoclonal Antibody; 
    • Antineoplastics, VEGF Inhibitor

    Humanized monoclonal antibody against vascular endothelial growth factor
    Used for metastatic colorectal cancer, hepatocellular cancer, renal cell cancer, non-small cell lung cancer, cervical cancer, recurrent glioblastoma, and epithelial ovarian, fallopian tube, or primary peritoneal cancer
    May cause infusion-related reactions that require a reduced infusion rate or discontinuation of therapy; also associated with wound healing complications requiring treatment interruption for 28 days before and after surgery

    Indicated for Metastatic Colorectal Cancer

    Avastin, Mvasi, Zirabev, Alymsys,Vegzelma

    In combination with fluorouracil-based chemotherapy

    • First-line or second-line treatment for metastatic colorectal carcinoma (mCRC) in combination with fluorouracil (5-FU)-based chemotherapy

    In combination with a fluoropyrimidine plus irinotecan or oxaliplatin-based chemotherapy

    • Second-line treatment of patients with mCRC who have progressed on a first-line bevacizumab-containing regimen
    • Use in combination with a fluoropyrimidine (eg, 5-FU, capecitabine) plus irinotecan or oxaliplatin-based chemotherapy

    Indicated for unresectable, locally advanced, recurrent or metastatic, nonsquamous non-small cell lung cancer (NSCLC) in combination with carboplatin and paclitaxel

    Indicated for metastatic renal cell carcinoma in combination with interferon alfa-2a

    Indicated, in combination with paclitaxel plus cisplatin or topotecan, for persistent, recurrent, or metastatic cervical cancer

    Also for Ovarian, Fallopian Tube, or Peritoneal Cancer

    Platinum-resistant

    • Indicated in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan for adults with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than 2 prior chemotherapy regimens

    Platinum-sensitive

    • Indicated for women with platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer either in combination with carboplatin and paclitaxel or in combination with carboplatin and gemcitabine chemotherapy, followed by bevacizumab alone

    Treatment of stage III or IV disease following initial surgical resection

    • Indicated in combination with carboplatin and paclitaxel, followed by bevacizumab as a single agent, for patients with stage III or IV epithelial ovarian, fallopian tube, or primary peritoneal cancer following initial surgical resection

    Indicated for treatment of recurrent glioblastoma

    Indication for metastatic breast cancer (HER2-negative) revoked by FDA in November 2011 due to failure to delay tumor growth or provide survival benefit

    Off-label indication for exudative age-related macular degeneration

    Indicated, in combination with atezolizumab, for unresectable or metastatic hepatocellular carcinoma (HCC) in patients who have not received prior systemic therapy

    Epithelial ovarian, fallopian tube or primary peritoneal cancer)

    Treatment following resection

    • Fatigue (72-80%)

    • Nausea (53-58%)

    • Arthralgia (33-41%)

    • Diarrhea (38-40%)

    • Headache (26-34%)

    • Hypertension (24-32%)

    • Epistaxis (30-31%)

    • Dyspnea (26-28%)

    • Stomatitis (19-25%)

    • Pain in extremity (19-25%)

    • Muscular weakness (13-15%)

    • Dysarthria (10-12%)

    Platinum-resistant

    • Neutropenia, Grade 2-4 (31%)

    • Hypertension, Grade 2-4 (19%)

    • Peripheral sensory neuropathy, Grade 2-4 (18%)

    • Mucosal inflammation, Grade 2-4 (13%)

    • Proteinuria, Grade 2-4 (12%)

    • Infection, Grade 2-4 (11%)

    • Palmar-plantar erythrodysesthesia, Grade 2-4 (11%)

    Platinum-sensitive

    • Fatigue (82%)

    • Nausea (72%)

    • Thrombocytopenia (58%)

    • Epistaxis (55%)

    • Headache (49%)

    • Hypertension (42%)

    • Diarrhea (38-39%)

    • Decreased appetite (35%)

    • Abdominal pain, stomatitis, vomiting (33%)

    • Hyperglycemia (31%)

    • Dyspnea (30%)

    • Arthralgia (28%)

    • Hypomagnesemia (27%)

    • Cough (26%)

    • Insomnia, back pain (21%)

    Bevacizumab products can result in minor hemorrhage, most commonly Grade 1 epistaxis; and serious, and in some cases fatal, hemorrhagic events

    Serious, sometimes fatal, arterial thromboembolic events (ATE) including cerebral infarction, transient ischemic attacks, myocardial infarction, angina, and a variety of other ATE; discontinue bevacizumab for severe ATE

    Increased risk of venous thromboembolic events (VTE) reported in patients treated with bevacizumab for cervical cancer; discontinue bevacizumab for life-threatening VTE

    Monitor blood pressure and treat hypertension; increased risk for severe hypertension; temporarily suspend treatment; discontinue if hypertensive crisis or hypertensive encephalopathy

    Increased relative risk for heart failure has been associated with therapy

    Posterior reversible encephalopathy syndrome (PRES) reported (0.5%); discontinue if PRES develops

    Proteinuria reported; temporarily suspend treatment for ≥2 g proteinuria/24 hr; discontinue if nephrotic syndrome occurs (incidence <1%)

    Evaluation for presence of varices recommended within 6 months of initiation of HCC therapy; there is lack of clinical data to support safety in patients with variceal bleeding within 6 months prior to treatment, untreated or incompletely treated varices with bleeding, or high risk of bleeding because these patients were excluded from clinical trials in HCC

    Based on findings from animal studies and its mechanism of action, drug may cause fetal harm in pregnant women

    No data available on the presence of bevacizumab in human milk, the effects on the breast fed infant, or the effects on milk production

    Adults

    Oncology: 15 mg/kg IV every 3 weeks or 10 mg/kg IV every 2 weeks.
    Ocular: The maximum tolerated intraocular dose has not been determined; in clinical trials, the highest dose was 2.5 mg/0.1 mL monocular.

    Geriatric

    Oncology: 15 mg/kg IV every 3 weeks or 10 mg/kg IV every 2 weeks.
    Ocular: The maximum tolerated intraocular dose has not been determined; in clinical trials, the highest dose was 2.5 mg/0.1 mL monocular.

    Adolescents

    Safety and efficacy have not been established.

    Children

    Safety and efficacy have not been established.

    Infants

    Safety and efficacy have not been established.

    Bevacizumab

    injectable solution

    • 25mg/mL (4-mL, 16-mL single-dose vials)

    Biosimilar to Avastin

    • Mvasi (bevacizumab-awwb)
    • Zirabev (bevacizumab-bvzr)
    • Alymsys (bevacizumab-maly)