Bevacizumab
Pronouncation: (beh-vah-SIH-zoo-mab)Class: Monoclonal antibody
Trade Names:
Avastin
- Injection 25 mg/mL
Pharmacology
Feedback for Bevacizumab
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Binds to vascular endothelial growth factor, interfering with endothelial cell proliferation.
Pharmacokinetics
Absorption
Time to reach steady state is predicted to be 100 days.
Elimination
Estimated t ½ is approximately 20 days.
Special Populations
Renal Function ImpairmentNo pharmacokinetic studies have been conducted in patients with renal function impairment.
Hepatic Function ImpairmentNo pharmacokinetic studies have been conducted in patients with hepatic function impairment.
Age and genderDemographic data suggest that no dosage adjustments are needed for age or gender.
Indications and Usage
In combination with IV 5-fluorouracil (5-FU)–based chemotherapy as first- or second-line treatment of metastatic carcinoma of the colon or rectum. In combination with carboplatin and paclitaxel as first-line treatment of unresectable, locally advanced, recurrent, or metastatic nonsquamous, non-small cell lung cancer.
Unlabeled Uses
In combination with erlotinib to treat metastatic renal cell carcinoma.
Contraindications
Standard considerations.
Dosage and Administration
Metastatic Carcinoma of the Colon or RectumAdults
IV 5 or 10 mg/kg every 14 days in combination with IV 5-FU–based chemotherapy. The recommended dose is 5 mg/kg every 14 days when administered with irinotecan/5-FU/leucovorin, and 10 mg/kg every 14 days when administered with 5-FU/leucovorin/oxaliplatin.
Nonsquamous, Non-Small Cell Lung CancerAdults
IV The recommended dosage is 15 mg/kg every 21 days.
General Advice
- For IV infusion only. Not for intradermal, subcutaneous, IM, or IV push or bolus administration.
- Administer diluted solution immediately after reconstitution; if necessary, store for up to 8 h under refrigeration (36° to 46°F).
- Do not administer or mix bevacizumab with dextrose solutions.
- Administer first dose via IV infusion over 90 min following chemotherapy. If first infusion is well tolerated, second infusion may be administered over 60 min. If the 60-min infusion is well tolerated, subsequent infusions may be administered over 30 min.
- Discard any unused solution. Do not save for future administration.
Storage/Stability
Store vials in refrigerator (36° to 46°F) in original carton until time of use. Protect from light and freezing. Do not shake vials.
Drug Interactions
None well documented.
Laboratory Test Interactions
None well documented.
Adverse Reactions
The following adverse reactions were reported with combined use of bevacizumab and 5-FU/irinotecan/leucovorin, 5-FU/leucovorin/oxaliplatin, or carboplatin/paclitaxel based regimens.
Cardiovascular
Hypertension (60%); hypotension (15%); deep vein thrombosis (9%); intra-abdominal thrombosis, syncope (3%).
CNS
Dizziness (26%); fatigue (19%); sensory neuropathy (17%); neurologic disorders (5%); headache (3%).
Dermatologic
Alopecia (32%); skin ulcer (6%).
EENT
Nasal septum perforation.
GI
Abdominal pain (61%); vomiting (52%); anorexia (43%); constipation (40%); diarrhea (34%); stomatitis (32%); dyspepsia, GI hemorrhage (24%); taste disorder (14%); nausea (12%); dry mouth (7%); colitis (6%); ileus (4%); anastomotic ulceration, intestinal necrosis, mesenteric venous occlusion.
Genitourinary
Proteinuria (36%).
Hematologic-Lymphatic
Leukopenia (37%); neutropenia (27%); febrile neutropenia, hemorrhage, thrombocytopenia (5%); infection with neutropenia (4%); pancytopenia.
Metabolic-Nutritional
Weight loss (15%); dehydration (10%); hyponatremia (4%).
Respiratory
Upper respiratory tract infection (47%); epistaxis (35%); dyspnea (26%); voice alteration (9%); pneumonitis/pulmonary infiltrates (5%).
Miscellaneous
Pain (61%); asthenia (10%); infection without neutropenia (7%); polyserositis.
Precautions
WarningsGI perforationGI perforation (sometimes associated with intra-abdominal abscess) and wound dehiscence, in some instances fatal, may occur. Permanently discontinue therapy in patients with GI perforation or wound dehiscence requiring medical intervention. Serious, and in some instances fatal, hemoptysis may occur in patients with non-small cell lung cancer. Patients with recent hemoptysis should not receive bevacizumab. Wound healing complicationsBevacizumab administration can result in the development of wound dehiscence, in some instances resulting in fatality. Permanently discontinue therapy in patients with wound dehiscence requiring medical intervention. The appropriate interval between termination of bevacizumab and subsequent elective surgery required to avoid the risks of impaired wound healing/wound dehiscence has not been determined. HemorrhageFatal pulmonary hemorrhage can occur in patients with non-small cell lung cancer treated with chemotherapy and bevacizumab. The incidence of severe or fatal hemoptysis was 31% in patients with squamous histology and 2.3% in patients with non-small cell lung cancer excluding predominant squamous histology. Patients with recent hemoptysis (at least ½ teaspoon of red blood) should not receive bevacizumab. |
MonitorMonitor patient for signs and symptoms of GI perforation (eg, abdominal pain in association with constipation and/or vomiting) or wound dehiscence. Monitor BP every 2 to 3 wk during therapy. Monitor for development or worsening of proteinuria with serial urinalyses. |
Pregnancy
Category C .
Lactation
Undetermined.
Children
Safety and efficacy not established.
Arterial thrombotic events
Arterial thrombotic events, including cerebral infarction, transient ischemic attacks, MI, and angina, have occurred. Permanently discontinue therapy in patients who experience a severe arterial thromboembolic event during therapy.
CHF
Risk of developing CHF may be increased compared with administration of other chemotherapy alone. The safety of continuation or resumption of bevacizumab in patients with cardiac dysfunction has not been studied.
Hypertension
Temporarily suspend therapy in patients who develop severe hypertension (greater than 200/110 mm Hg) that is not controlled with medical management. Permanently discontinue therapy in patients who develop hypertensive crisis.
Immunogenicity
As with other proteins, immunogenicity may occur.
Nephrotic syndrome
May occur. Discontinue bevacizumab in patients with nephrotic syndrome.
Neutropenia and infection
Severe neutropenia, febrile neutropenia, and infection with severe neutropenia can occur with concurrent myelosuppressive chemotherapy.
Non-GI fistula formation
Biliary, bladder, bronchopleural, tracheo-esophageal, and vaginal fistula formation has been reported.
Proteinuria
Risk of developing proteinuria may be increased compared with administration of 5-FU alone. Temporarily suspend therapy in patient who develops moderate to severe proteinuria pending further evaluation.
Reversible posterior leukoencephalopathy syndrome
Has been reported and can present as blindness (and other visual disturbances), confusion, headache, lethargy, neurologic disturbances, and seizures.
Surgery
Do not initiate therapy for at least 28 days following major surgery and until complete healing of the surgical incision has occurred. Because of potential for impaired wound healing, suspend bevacizumab therapy several weeks prior to elective surgery.
Overdosage
Symptoms
Severe headache.
Patient Information
- Advise patient or caregiver that medication will be prepared and administered by a health care provider in a health care setting.
- Advise patient or caregiver that medication will be administered in combination with other chemotherapy medications.
- Advise family or caregiver to report any of the following to health care provider: coughing up blood; injection-site reaction; rash, itching, or hives; stomach pain in association with constipation and/or vomiting; swelling of the face, lips, eyes, or tongue; wheezing, shortness of breath, or difficulty breathing; any other unusual or unexplained feelings or symptoms.
- Advise women of childbearing potential to use effective contraception during and for at least 3 mo following treatment.
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Bevacizumab - Includes detailed dosage instructions.
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