Bevacizumab Side Effects

Brand Names: Avastin

Please note - some side effects for Bevacizumab may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Bevacizumab - for the Consumer

Bevacizumab Solution

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Bevacizumab Solution:

Changes in taste; constipation; diarrhea; dizziness; dry mouth; dry skin; hair loss; headache; increased thirst; indigestion; loss of appetite; minor nosebleeds; mouth pain or sores; muscle pain; nausea; pain, swelling, or redness at the injection site; sluggishness; stuffy or runny nose; tiredness; voice changes; vomiting; weakness; weight loss.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; blood in the urine; calf pain or tenderness; chest pain; confusion; cough; coughing or choking while eating; coughing up or vomiting blood; dark urine; difficult or painful urination; fainting; fever, chills, or persistent sore throat; frequent or urgent urination; loss of coordination; numbness of the arms or legs; one-sided weakness; peeling of skin; seizure; severe or persistent headache; severe or persistent nosebleed; severe or persistent stomach pain, constipation, or vomiting; severe or persistent weakness; shortness of breath; skin discoloration, irritation, or lesions; speech changes; sudden, severe dizziness; swelling, discoloration, or pain in the legs; swelling of the hands, ankles, or feet; trouble swallowing; unusual bruising or bleeding; unusual weight gain; vaginal pain, bleeding, or discharge; vision loss, blurred vision, or other vision changes; wheezing; wounds that do not heal.

Side Effects by Body System

General

General side effects including asthenia (up to 74%), pain (up to 62%), abdominal pain (up to 61%), infection (55%), fatigue (45%), headache (up to 37%), nongastrointestinal fistula formation (less than 0.3%), and polyserositis have been reported. Fatigue (10.7%), infection without neutropenia (9.1%), and infection with an unknown ANC (3.0%) have been reported with the use of paclitaxel in combination with bevacizumab.

Gastrointestinal

Gastrointestinal side effects including 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%), weight loss (up to 16%), dry mouth (up to 7%), colitis (up to 6%), constipation (up to 4%), intestinal obstruction, intestinal necrosis, mesenteric venous occlusion, and anastomotic ulceration have been reported. Gastrointestinal perforation and wound dehiscence, complicated by intraabdominal abscesses were reported to occur at an increased incidence in patients receiving bevacizumab as compared to controls. Tracheoesophageal (TE) fistula formation has been reported in a recent clinical study in patients with limited-stage small cell lung cancer (SCLC). There have been two confirmed serious adverse events of TE fistula (one fatal) reported in the first 29 patients enrolled in this study. A third, fatal event (upper aerodigestive tract hemorrhage and death of unknown cause) has also reported in which TE fistula was suspected but not confirmed. Vomiting (5.5%), diarrhea (4.7%), and nausea (4.1%), have been reported with the use of paclitaxel in combination with bevacizumab.

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.

Cardiovascular

Cardiovascular side effects including hypertension (up to 34%), hypotension (up to 15%), deep vein thrombosis (up to 9%), and congestive heart failure have been reported. An increased risk of serious arterial thromboembolic events including cerebrovascular accidents (stroke), myocardial infarctions, transient ischemic attacks, and angina related to bevacizumab has been reported. The risk of fatal arterial thrombotic events has also been increased. The risk of a serious arterial thrombotic event has been reported to be approximately twice as high in patients receiving infusional 5-FU based chemotherapy with bevacizumab, with an overall rate of up to 5%. Hypertension (16%) has been reported with the use of paclitaxel in combination with bevacizumab. Pulmonary hypertension has been reported.

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.

Nervous system

Nervous system side effects including dizziness (up to 26%), confusion (up to 6%), CNS hemorrhage (up to 5%), and abnormal gait (up to 5%) have been reported. Cases of a rare brain-capillary leak syndrome (reversible posterior leukoencephalopathy syndrome or RPLS) have also been reported. Sensory neuropathy (24.2%), headache (3.6%), and cerebrovascular ischemia (2.5%) have been reported with the use of paclitaxel in combination with bevacizumab.

Bevacizumab should not be administered to patients with a recent history of hemoptysis of greater than or equal to 1/2 teaspoon of red blood. Bevacizumab should discontinued in patients with hemorrhage.

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.

Hematologic

Hematologic side effects including leukopenia (37%), neutropenia (21%), thrombocytopenia (5%), both serious and nonserious hemorrhagic events, and pancytopenia have been reported. In one study, 18% of patients receiving bolus IFL (irinotecan, fluorouracil, and leucovorin) with bevacizumab (versus 15% of patients receiving IFL with placebo) experienced a grade 3 or grade 4 thromboembolic event. Increased rates of severe neutropenia, febrile neutropenia, and infection with severe neutropenia (including some fatalities) have been observed in patients treated with myelosuppressive chemotherapy plus bevacizumab.

Metabolic

Metabolic side effects including hypokalemia (up to 16%), bilirubinemia (up to 6%), and hyponatremia have been reported.

Musculoskeletal

Musculoskeletal side effects including myalgia (up to 15%) have been reported. Bone pain (3.9%) has been reported with the use of paclitaxel in combination with bevacizumab. A case of osteonecrosis of the jaw related to bevacizumab has also been reported.

Genitourinary

Genitourinary side effects including ureteral stricture have been reported.

Respiratory

Respiratory side effects including fatal pulmonary hemorrhage can occur in patients with non-small cell lung cancer treated with chemotherapy and bevacizumab. A 31% incidence of severe or fatal hemoptysis has been reported in patients with squamous histology and a 2.3% incidence has been reported in patients with non-small cell lung cancer excluding predominant squamous histology. Nasal septum perforation and dysphonia have also been reported.

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.

Renal

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 had a greater relative risk for proteinuria as compared to younger patients.

Renal side effects including an increase in the incidence (up to 3.0%) and severity of proteinuria have been reported. Nephrotic syndrome (0.5%) has been reported in patients receiving bevacizumab. Proteinuria (3.0%) has also been reported with the use of paclitaxel in combination with bevacizumab.

Ocular

Ocular side effects including cases of Charles Bonnet syndrome (visual hallucinations) have been reported after intravitreal bevacizumab injection for age-related macular degeneration.

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.

Dermatologic

Dermatologic side effects including rash/desquamation (2.5%) have been reported with the use of paclitaxel in combination with bevacizumab.

Other

Other side effects including epistaxis (up to 26%) and wound-healing complications (6%) have been reported.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This information does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug of drug combination is safe, effective, or appropriate for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of information provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.