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Note: This document contains side effect information about bevacizumab. Some of the dosage forms listed on this page may not apply to the brand name Avastin.
Applies to bevacizumab: intravenous solution
Intravenous route (Solution)
Gastrointestinal perforation, some cases fatal, has occurred in up to 3% of bevacizumab-treated patients. Bevacizumab is also associated with an increased incidence of surgical and wound healing complications, including serious and fatal complications. Discontinue bevacizumab if gastrointestinal perforation occurs. Discontinue bevacizumab in patients who develop wound healing complications that require medical intervention. Withhold bevacizumab at least 28 days prior to elective surgery. Do not administer bevacizumab for at least 28 days after surgery and until the wound is fully healed. Severe or fatal hemorrhage, including hemoptysis, gastrointestinal bleeding, CNS hemorrhage, epistaxis, and vaginal bleeding, has occurred up to 5-fold more frequently in bevacizumab-treated patients. Do not administer bevacizumab to patients with a recent history of hemoptysis. Discontinue in patients who develop Grade 3 to 4 hemorrhage.
Intravenous route (Solution)
Gastrointestinal Perforations, Surgery and Wound Healing Complications, and HemorrhageGastrointestinal perforation: Occurs in up to 3.2% of bevacizumab product-treated patients. Discontinue bevacizumab-awwb for gastrointestinal perforation.Surgery and Wound Healing Complications: Discontinue in patients with wound dehiscence. Discontinue at least 28 days prior to elective surgery. Do not initiate bevacizumab-awwb for at least 28 days after surgery and until surgical wound is fully healed.Hemorrhage: Severe of fatal hemorrhage, hemoptysis, gastrointestinal bleeding, CNS hemorrhage, and vaginal bleeding are increased in bevacizumab product-treated patients. Do not administer bevacizumab-awwb to patients with serious hemorrhage or recurrent hemoptysis.
Along with its needed effects, bevacizumab (the active ingredient contained in Avastin) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur while taking bevacizumab:
Incidence not known
Some side effects of bevacizumab may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Applies to bevacizumab: intravenous solution
Very common (10% or more): Abdominal pain (up to 61%), vomiting (up to 52%), anorexia (up to 43%), constipation (up to 40%), diarrhea (up to 34%), stomatitis (up to 32%), dyspepsia (up to 24%), gastrointestinal hemorrhage (up to 24%), flatulence (up to 19%)
Common (1% to 10%): Dry mouth, colitis, constipation, nausea
Very rare (less than 0.01%): TE fistula, upper aerodigestive tract hemorrhage
Frequency not reported: Intestinal obstruction, intestinal necrosis, mesenteric venous occlusion, ileus, anastomotic ulceration, gastrointestinal perforation and wound dehiscence (complicated by intra-abdominal abscesses), tracheoesophageal fistulae
All three TE fistulas occurred during the bevacizumab maintenance phase of the study in the context of persistent esophagitis. Additionally, six other cases of TE fistula have been reported in other lung and esophageal cancer studies using bevacizumab and chemotherapy alone or with concurrent radiation treatment.
The incidence of gastrointestinal perforation (gastrointestinal perforation, fistula formation, and/or intraabdominal abscess) in patients with colorectal cancer and in patients with non-small cell lung cancer (NSCLC) receiving bevacizumab was 2.4% and 0.9%, respectively.
Very common (10% or more): Hypertension (up to 34%), hypotension (up to 15%)
Common (1% to 10%): Deep vein thrombosis, congestive heart failure
Frequency not reported: Arterial thromboembolic events (including cerebrovascular accident (stroke), myocardial infarction, transient ischemic attack, angina), fatal arterial thrombotic events, cerebral ischemia, supraventricular tachycardia, both serious and non-serious hemorrhagic events
Risk factors for the development of arterial thromboembolic events have included a history of arterial thromboembolism prior to bevacizumab exposure, age 65 years and above, and bevacizumab therapy. These events have occurred at a higher rate in these high-risk groups.
In one study, the rate of congestive heart failure (defined as NCI-CTC grade 3 and 4) in the bevacizumab plus paclitaxel arm was 2.2% versus 0.3% in the control arm. Among patients receiving anthracyclines, the rate of CHF was 3.8% for bevacizumab treated patients and 0.6% for patients receiving paclitaxel alone. Congestive heart failure occurred in six of 44 (14%) patients with relapsed acute leukemia (a non-FDA approved indication) receiving bevacizumab and concurrent anthracyclines in a single arm study. The safety of continuation or resumption of bevacizumab in patients with cardiac dysfunction has not been studied.
Very common (10% or more): Dizziness (up to 26%), sensory neuropathy (24%)
Common (1% to 10%): Confusion, abnormal gait, CNS hemorrhage, cerebrovascular ischemia
Rare (less than 0.1%): Brain-capillary leak syndrome (reversible posterior hyponatremia
Frequency not reported: Dysgeusia
RPLS is a neurological disorder associated with hypertension, fluid retention, and cytotoxic effects of immunosuppressive drugs on the vascular endothelium. The syndrome can present with headache, seizure, lethargy, confusion, blindness and other visual and neurologic disturbances. Mild to severe hypertension may be present, but is not necessary for diagnosis. The onset of symptoms has been reported to occur from sixteen hours to one year after initiation of bevacizumab. Magnetic resonance imaging is necessary to confirm the diagnosis of RPLS.
Very common (10% or more): Leukopenia (37%), neutropenia (21%)
Common (1% to 10%): Thrombocytopenia
Frequency not reported: Hemorrhagic events, pancytopenia, febrile neutropenia, decreased hemoglobin, anemia, prothrombin time prolongations, infection with severe neutropenia
Postmarketing reports: Gallbladder perforation
Very common (10% or more): Hyperglycemia (up to 26%), hypomagnesemia (up to 24%), hyponatremia (up to 19%), hypoalbuminemia (16%), weight loss (up to 16%), hypokalemia (up to 16%)
Common (1% to 10%): Bilirubinemia
Frequency not reported: Increased blood potassium, decreased blood phosphorus, increased blood alkaline phosphatase
Very common (10% or more): Myalgia (up to 15%)
Common (1% to 10%): Bone pain, back pain
Postmarketing reports: Osteonecrosis of the jaw
Frequency not reported: Ureteral stricture
Very common (10% or more): Upper respiratory infection (up to 47%), severe or fatal hemoptysis (up to 31%), epistaxis (up to 35%), dyspnea (up to 26%)
Frequency not reported: Pulmonary hypertension, fatal pulmonary hemorrhage, nasal septum perforation
Common (1% to 10%): Voice alteration
Patients with recent hemoptysis (greater than or equal to 1/2 tsp of red blood) should not receive bevacizumab.
In study 6, four of 13 (31%) bevacizumab-treated patients with squamous cell histology and two of 53 (4%) bevacizumab-treated patients with histology other than squamous cell, experienced serious or fatal pulmonary hemorrhage as compared to none of the 32 (0%) patients receiving chemotherapy alone. In study 5, the rate of pulmonary hemorrhage requiring medical intervention for the paclitaxel, carboplatin, plus bevacizumab arm was 2.3% (10 of 427) compared to 0.5% (2 of 441) for the paclitaxel plus carboplatin alone arm. There were seven deaths due to pulmonary hemorrhage reported by investigators in the paclitaxel, carboplatin, plus bevacizumab arm as compared to one in the paclitaxel plus carboplatin alone arm. Generally, these serious hemorrhagic events presented as major or massive hemoptysis without a history of minor hemoptysis during bevacizumab therapy.
Kidney biopsy of six patients with proteinuria showed findings consistent with thrombotic microangiopathy.
In study 5, patients age 65 and older receiving carboplatin, paclitaxel, and bevacizumab (the active ingredient contained in Avastin) had a greater relative risk for proteinuria as compared to younger patients.
Very common (10% or more): Proteinuria (up to 36%)
Uncommon (0.1% to 1%): Nephrotic syndrome
Very common (10% or more): Lacrimation increased
Postmarketing reports: Cases of serious ocular adverse reactions have been reported following unapproved intravitreal use of this drug compounded from vials approved for IV administration. These reactions included infectious endophthalmitis, intraocular inflammation such as sterile endophthalmitis, uveitis and vitreitis, retinal detachment, retinal pigment epithelial tear, intraocular pressure increased, intraocular hemorrhage (such as vitreous hemorrhage or retinal hemorrhage and conjunctival hemorrhage). Some of these reactions have resulted in various degrees of visual loss, including permanent blindness.
It has been suggested that reduction in macular edema after treatment may have resulted in anatomic changes at the fovea and may have triggered the visual hallucinations.
Very common (10% or more): Alopecia (up to 32%)
Common (1% to 10%): Rash/desquamation, skin ulcer
Frequency not reported: Exfoliative dermatitis, skin discoloration
Postmarketing reports: Necrotizing fasciitis
Very common (10% or more): Asthenia (up to 74%), pain (up to 62%), fatigue (up to 80%), headache (up to 37%), peripheral edema (up to 22%), taste disorder (up to 9%)
Common (1% to 10%): Infection with an unknown ANC
Uncommon (0.1% to 1%): Nongastrointestinal fistula formation, infection without neutropenia
Frequency not reported: Mesenteric venous occlusion, syncope, dehydration, somnolence, polyserositis, polyserositis
Frequency not reported: Sepsis, wound healing complications, urinary tract infection, positive assays for treatment-emergent anti-bevacizumab
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