Avastin Side Effects

Generic Name: bevacizumab

Note: This page contains information about the side effects of bevacizumab. Some of the dosage forms included on this document may not apply to the brand name Avastin.

Not all side effects for Avastin may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to bevacizumab: intravenous solution

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:

More common
  • Black, tarry stools
  • bleeding gums
  • body aches or pain
  • burning, tingling, numbness, or pain in the hands, arms, feet, or legs
  • chest pain or discomfort
  • chills
  • cloudy urine
  • convulsions
  • cough
  • cracks in the skin
  • decreased urine output
  • difficult or labored breathing
  • dilated neck veins
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • ear congestion
  • extreme fatigue
  • fever
  • high blood pressure
  • irregular breathing
  • irregular heartbeat
  • lack or loss of strength
  • lightheadedness
  • loss of appetite
  • loss of heat from the body
  • loss of voice
  • mood changes
  • nasal congestion
  • nervousness
  • pain
  • pain, redness, or swelling in the arm or leg
  • painful or difficult urination
  • pinpoint red spots on the skin
  • pounding in the ears
  • rapid breathing
  • redness
  • runny nose
  • sensation of pins and needles
  • shortness of breath
  • slow or fast heartbeat
  • sore throat
  • sores on the skin
  • sores, ulcers, or white spots on the lips or in the mouth
  • stabbing pain
  • sunken eyes
  • sweating
  • swelling of the face, fingers, feet, or lower legs
  • swelling or inflammation of the mouth
  • swollen glands
  • thirst
  • tightness in the chest
  • trouble with breathing
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • vomiting of blood or material that looks like coffee grounds
  • watery or bloody diarrhea
  • weight gain
  • wheezing
  • wrinkled skin
  • yellow skin
Less common
  • Abdominal or stomach pain
  • bone pain
  • difficulty having a bowel movement (stool)
  • difficulty with swallowing
  • fainting
  • severe constipation
  • severe vomiting
  • stomach tenderness
Rare
  • Back pain
  • blisters
  • blurred vision
  • coma
  • confusion
  • dizziness
  • drowsiness
  • headache
  • increased thirst
  • muscle pain or cramps
  • open sores
  • pale skin
Incidence not known
  • Bloody mucus or unexplained nosebleeds
  • hoarseness
  • sudden weakness in the arms or legs
  • sudden, severe chest pain
  • voice changes

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:

More common
  • Acid or sour stomach
  • belching
  • bloody nose
  • change in taste or bad unusual or unpleasant (after) taste
  • change in walking and balance
  • clumsiness or unsteadiness
  • diarrhea
  • dry mouth
  • excess flow of tears
  • hair loss
  • heartburn
  • indigestion
  • low blood pressure
  • stomach discomfort, upset, or pain
  • thinning of the hair
  • weight loss

For Healthcare Professionals

Applies to bevacizumab: intravenous solution

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 (the active ingredient contained in Avastin)

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 (the active ingredient contained in Avastin) 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

Risk factors for the development of arterial thromboembolic events have included a history of arterial thromboembolism prior to bevacizumab (the active ingredient contained in Avastin) 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.

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.

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 (the active ingredient contained in Avastin)

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 (the active ingredient contained in Avastin) (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.

Hepatic

Hepatic side effects have included postmarketing reports of gallbladder perforation.

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 (the active ingredient contained in Avastin) Postmarketing cases of osteonecrosis of the jaw have 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 (the active ingredient contained in Avastin) 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, dysphonia, and pulmonary embolism 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

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 (the active ingredient contained in Avastin) Proteinuria (3.0%) has also been reported with the use of paclitaxel in combination with bevacizumab.

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.

Ocular

Ocular side effects including cases of Charles Bonnet syndrome (visual hallucinations) have been reported after intravitreal bevacizumab (the active ingredient contained in Avastin) 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 (the active ingredient contained in Avastin) Postmarketing reports have included necrotizing fasciitis.

Other

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

Immunologic

Immunologic side effects have included reports of positive assays for treatment-emergent anti-bevacizumab (the active ingredient contained in Avastin) antibodies.

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