Adult Dosing

Metastatic Colorectal Cancer (mCRC)

• 5 mg/kg IV q2 wks with bolus-IFL
• 10 mg/kg IV q2 wks with FOLFOX4

Non-Squamous Non–Small Cell Lung Cancer (NSCLC)

• 15 mg/kg IV q3 wks with carboplatin/paclitaxel until disease progression

Glioblastoma

• 10 mg/kg IV q2 wks

Metastatic Renal Cell Carcinoma (mRCC)

• 10 mg/kg IV q2 wks in combination with interferon alfa

Pediatric Dosing

• Safety and effectiveness of bevacizumab have not been established in pediatric patients

[Outline]

• Adult Dosing
• Pediatric Dosing

• Metastatic Colorectal Cancer (mCRC)
• Non-Squamous Non–Small Cell Lung Cancer (NSCLC)
• Glioblastoma
• Treatment of metastatic renal cell carcinoma in combination with interferon alfa

• Hypersensitivity to any of the ingredients of the product

• In 0.3-2.4% patients treated with bevacizumab, serious and sometimes fatal GI perforation (reported within 50 days of treatment initiation) occurred; associated with abdominal pain, nausea, emesis, constipation, fever. If GI perforation occurs, discontinue bevacizumab permanently
• The incidence of wound healing and surgical complications, including serious and fatal complications, is increased in bevacizumab-treated patients. Permanently discontinue treatment in patients with wound dehiscence. The appropriate interval between termination of bevacizumab and subsequent elective surgery required to reduce the risks of impaired wound healing or wound dehiscence has not been determined. Discontinue at least 28 days prior to elective surgery. Do not initiate bevacizumab for at least 28 days after surgery and until the surgical wound is fully healed
• In patients receiving bevacizumab, severe or fatal hemorrhage, including hemoptysis, gastrointestinal bleeding, central nervous systems (CNS) hemorrhage, epistaxis, and vaginal bleeding occurred up to five-fold more frequently. Do not administer bevacizumab in patients with serious hemorrhage or recent hemoptysis

Renal Dose Adjustment

• Renal impairment: Dose adjustments not defined

Hepatic Dose Adjustment

• Hepatic impairment: Dose adjustments not defined

• Serious and sometimes fatal gastrointestinal perforation has occurred in 0.3% to 2.4% of bevacizumab-treated patients [US Black Box Warning]
• Wound dehiscence, sometimes fatal, has been reported in patients receiving bevacizumab. If wound dehiscence requiring medical intervention occurs, discontinue bevacizumab permanently [US Black Box Warning ]
• Necrotizing fasciitis, including fatal cases, has been reported secondary to wound healing complications, gastrointestinal perforation or fistula formation. Discontinue if necrotizing fasciitis develops
• Severe or fatal hemorrhage, including hemoptysis, gastrointestinal bleeding, central nervous system (CNS) hemorrhage, epistaxis, and vaginal bleeding occurred up to five-fold more frequently in patients treated with bevacizumab. The incidence of Grade 3 hemorrhagic events among patients receiving bevacizumab ranged from 1.2% to 4.6%. Bevacizumab is contraindicated in patients with serious hemorrhage or recent hemoptysis [US Black Box Warning ]
• Serious and sometimes fatal non-gastrointestinal fistula formation has been reported with the therapy. Suspend therapy in patients with fistula formation involving an internal organ
• Discontinue bevacizumab treatment in cases of severe arterial thromboembolic events, hypertensive crisis or hypertensive encephalopathy, reversible posterior leukoencephalopathy syndrome, nephrotic syndrome
• Suspend bevacizumab treatment temporarily for severe hypertension not controlled with medical management, at least 4 weeks prior to elective surgery, moderate to severe proteinuria pending further evaluation, and severe infusion reactions

Cautions: use cautiously in

• Arterial thromboembolic events
• Cardiovascular disease
• Proteinuria
• Anthracycline use
• Hx of thromboembolism
• Patients >65 yrs

Pregnancy Category:C

Breastfeeding: No information is available on the systemic use of bevacizumab during breastfeeding. An alternative drug may be preferred, especially while nursing a newborn or preterm infant. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 4 January 2011).Safety undetermined, use not recommended. Manufacturer recommends discontinuation of breastfeeding, or postponing of treatment (taking into account the importance of the drug to the mother)

• CNS: Reversible posterior leukoencephalopathy syndrome (RPLS), headache, dizziness
• NEURO: Sensory neuropathy, asthenia
• CV: CHF, thromboembolic events, hypertension, hypotension, MI, angina, stroke, syncope
• RESP: Hemoptysis, non-gastrointestinal fistulas, nasal septum perforation, pulmonary hemorrhage, pulmonary infiltrates, pneumonitis, URI, dysnea
• GI: Nausea, vomiting, diarrhea, GI perforation, GI fistula, GI bleeding intraabdominal abscess, intestinal necrosis, ileus, abdominal pain, anorexia, stomatitis, constipation, taste disorder, gallbladder perforation
• GU: Nephrotic syndrome, proteinuria, impaired fertility
• EENT: Tracheoesophageal fistula, nasal septal perforation, epistaxis, voice changes, dry mouth
• DERM: Exfoliative dermatitis, skin ulcers
• HEMA: Bleeding, thrombotic microangiopathy, neutropenia, leukopenia, thrombocytopenia, pancytopenia
• METABOLIC: Hypokalemia hyponatremia, weight loss
• MISC: Wound dehiscence, impaired wound healing, severe infusion reactions, major hemorrhage, severe infections, polyserositis, fatigue

• Monoclonal antibody; inhibits growth of new blood vessels (angiogenesis) by binding to vascular endothelial growth factor (VEGF), preventing its attachment to binding sites on vascular endothelium
• Unknown metabolism
• Renally excreted: Unknown
• Half-life: 20 days

US Trade Name(s)

• Avastin

US Availability

Avastin

• INJ: 100 mg/4 mL
• INJ: 400 mg/16 mL

Canadian Trade Name(s)

• Avastin

Canadian Availability

Avastin

• INJ: 100 mg/4 mL
• INJ: 400 mg/16 mL

UK Trade Name(s)

• Avastin

UK Availability

Avastin

• INJ: 100 mg/4 mL
• INJ: 400 mg/16 mL

Australian Trade Name(s)

• Avastin

Australian Availability

Avastin

• INJ: 100 mg/4 mL
• INJ: 400 mg/16 mL

[Outline]

Hematology/Oncology

Antineoplastics

Antineoplastic Monoclonal Antibodies

Pricing data from www.DrugStore.com in U.S.A.

• Avastin 400 MG/16ML SOLN [Vial] (GENENTECH)
  16 16ml = $2525.85
  48 16ml = $7374.16
• Avastin 100 MG/4ML SOLN [Vial] (GENENTECH)
  4 4ml = $645.96
  12 4ml = $1850.05

Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.