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Avastin

Last reviewed on RxList: 6/15/2020
Avastin Side Effects Center

What Is Avastin?

Avastin (bevacizumab) is an antiangiogenic drug used to treat a certain type of brain tumor as well as cancers of the kidney, colon, rectum, lung, or breast. Avastin is usually given as part of a combination of cancer medicines.

What Are Side Effects of Avastin?

Common side effects of Avastin include:

Tell your doctor if you have serious side effects of Avastin including:

Dosage for Avastin

Dose of Avastin varies depending on the type of cancer being treated, and the patient's weight.

What Drugs, Substances, or Supplements Interact with Avastin?

There may be other drugs that can interact with Avastin. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Avastin During Pregnancy and Breastfeeding

Avastin should be used only when prescribed during pregnancy. Avastin may harm to a fetus. Women of child-bearing age should use an effective form of birth control while using this medication and for an extended period after stopping this drug. Based on information from related drugs, this medication may pass into breast milk. Breastfeeding while using this medication is not recommended. Do not breastfeed for extended periods after stopping this drug. Consult your doctor before breastfeeding.

Additional Information

Our Avastin (bevacizumab) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Digestive Disorders: Common Misconceptions See Slideshow
Avastin Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some side effects may occur during the injection. Tell your caregiver if you feel dizzy, light-headed, short of breath, chilled, sweaty, or have a headache, chest pain, wheezing, or swelling in your face.

Bevacizumab can make it easier for you to bleed. Call your doctor or seek emergency medical attention if you have:

  • easy bruising, unusual bleeding (nose, mouth, vagina, rectum), or any bleeding that will not stop;
  • signs of bleeding in your digestive tract--severe stomach pain, bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds; or
  • signs of bleeding in the brain--sudden numbness or weakness (especially on one side of the body), sudden severe headache, problems with vision or balance.

Bevacizumab can cause a rare but serious neurologic disorder affecting the brain. Symptoms may occur within hours of your first dose, or they may not appear for up to a year after your treatment started. Call your doctor at once if you have extreme weakness or tiredness, headache, confusion, vision problems, fainting, or seizure (blackout or convulsions).

Some people receiving bevacizumab have developed a fistula (an abnormal passageway) within the throat, lungs, gallbladder, kidney, bladder, or vagina. Call your doctor if you have: chest pain and trouble breathing, stomach pain or swelling, urine leakage, or if you feel like you are choking and gagging when you eat or drink.

Also call your doctor if you have:

  • pain, swelling, warmth, or redness in one or both legs;
  • chest pain or pressure, pain spreading to your jaw or shoulder;
  • missed menstrual periods;
  • kidney problems--puffy eyes, swelling in your ankles or feet, urine that looks foamy;
  • heart problems--swelling, rapid weight gain, feeling short of breath;
  • low white blood cell counts--fever, mouth sores, skin sores, sore throat, cough, trouble breathing;
  • signs of any skin infection--sudden redness, warmth, swelling, or oozing, or any skin wound or surgical incision that will not heal; or
  • increased blood pressure--severe headache, blurred vision, pounding in your neck or ears.

Side effects may be more likely in older adults.

Common side effects may include:

  • nosebleed, rectal bleeding;
  • increased blood pressure;
  • headache, back pain;
  • dry or watery eyes;
  • dry or flaky skin;
  • runny nose, sneezing; or
  • changes in your sense of taste.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Avastin (Bevacizumab)

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Avastin Professional Information

SIDE EFFECTS

The following clinically significant adverse reactions are described elsewhere in the labeling:

  • Gastrointestinal Perforations and Fistulae [see WARNINGS AND PRECAUTIONS].
  • Surgery and Wound Healing Complications [see WARNINGS AND PRECAUTIONS].
  • Hemorrhage [see WARNINGS AND PRECAUTIONS].
  • Arterial Thromboembolic Events [see WARNINGS AND PRECAUTIONS].
  • Venous Thromboembolic Events [see WARNINGS AND PRECAUTIONS].
  • Hypertension [see WARNINGS AND PRECAUTIONS].
  • Posterior Reversible Encephalopathy Syndrome [see WARNINGS AND PRECAUTIONS].
  • Renal Injury and Proteinuria [see WARNINGS AND PRECAUTIONS].
  • Infusion-Related Reactions [see WARNINGS AND PRECAUTIONS].
  • Ovarian Failure [see WARNINGS AND PRECAUTIONS].
  • Congestive Heart Failure [see WARNINGS AND PRECAUTIONS].

Clinical Trials Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.

The safety data in Warnings and Precautions and described below reflect exposure to Avastin in 4134 patients including those with mCRC (AVF2107g, E3200), non-squamous NSCLC (E4599), GBM (EORTC 26101), mRCC (BO17705), cervical cancer (GOG-0240), and epithelial ovarian, fallopian tube, or primary peritoneal cancer (MO22224, AVF4095, GOG-0213, and GOG-0218) at the recommended dose and schedule for a median of 6 to 23 doses. The most common adverse reactions observed in patients receiving Avastin as a single agent or in combination with chemotherapy at a rate >10% were epistaxis, headache, hypertension, rhinitis, proteinuria, taste alteration, dry skin, rectal hemorrhage, lacrimation disorder, back pain and exfoliative dermatitis.

Across clinical studies, Avastin was discontinued in 8% to 22% of patients because of adverse reactions [see Clinical Studies].

Metastatic Colorectal Cancer

In Combination With Bolus-IFL

The safety of Avastin was evaluated in 392 patients who received at least one dose of Avastin in a double-blind, active-controlled study (AVF2107g), which compared Avastin (5 mg/kg every 2 weeks) with bolus-IFL to placebo with bolus-IFL in patients with mCRC [see Clinical Studies]. Patients were randomized (1:1:1) to placebo with bolus-IFL, Avastin with bolus-IFL, or Avastin with fluorouracil and leucovorin. The demographics of the safety population were similar to the demographics of the efficacy population. All Grades 3-4 adverse reactions and selected Grades 1-2 adverse reactions (i.e., hypertension, proteinuria, thromboembolic events) were collected in the entire study population. Adverse reactions are presented in Table 2.

Table 2: Grades 3-4 Adverse Reactions Occurring at Higher Incidence (≥2%) in Patients Receiving Avastin vs. Placebo in Study AVF2107g

Adverse Reactiona Avastin with IFL
(N=392)
Placebo with IFL
(N=396)
Hematology
Leukopenia 37% 31%
Neutropenia 21% 14%
Gastrointestinal
Diarrhea 34% 25%
Abdominal pain 8% 5%
Constipation 4% 2%
Vascular
Hypertension 12% 2%
Deep vein thrombosis 9% 5%
Intra-abdominal thrombosis 3% 1%
Syncope 3% 1%
General
Asthenia 10% 7%
Pain 8% 5%
a NCI-CTC version 3

In Combination With FOLFOX4

The safety of Avastin was evaluated in 521 patients in an open-label, active-controlled study (E3200) in patients who were previously treated with irinotecan and fluorouracil for initial therapy for mCRC. Patients were randomized (1:1:1) to FOLFOX4, Avastin (10 mg/kg every 2 weeks prior to FOLFOX4 on Day 1) with FOLFOX4, or Avastin alone (10 mg/kg every 2 weeks). Avastin was continued until disease progression or unacceptable toxicity.

The demographics of the safety population were similar to the demographics of the efficacy population.

Selected Grades 3-5 non-hematologic and Grades 4-5 hematologic occurring at a higher incidence (≥ 2%) in patients receiving Avastin with FOLFOX4 compared to FOLFOX4 alone were fatigue (19% vs. 13%), diarrhea (18% vs. 13%), sensory neuropathy (17% vs. 9%), nausea (12% vs. 5%), vomiting (11% vs. 4%), dehydration (10% vs. 5%), hypertension (9% vs. 2%), abdominal pain (8% vs. 5%), hemorrhage (5% vs. 1%), other neurological (5% vs. 3%), ileus (4% vs. 1%) and headache (3% vs. 0%). These data are likely to under-estimate the true adverse reaction rates due to the reporting mechanisms.

First-Line Non Squamous Non-Small Cell Lung Cancer

The safety of Avastin was evaluated as first-line treatment in 422 patients with unresectable NSCLC who received at least one dose of Avastin in an active-controlled, open-label, multicenter trial (E4599) [see Clinical Studies]. Chemotherapy naive patients with locally advanced, metastatic or recurrent non-squamous NSCLC were randomized (1:1) to receive six 21-day cycles of paclitaxel and carboplatin with or without Avastin (15 mg/kg every 3 weeks). After completion or upon discontinuation of chemotherapy, patients randomized to receive Avastin continued to receive Avastin alone until disease progression or until unacceptable toxicity. The trial excluded patients with predominant squamous histology (mixed cell type tumors only), CNS metastasis, gross hemoptysis (½ teaspoon or more of red blood), unstable angina, or receiving therapeutic anticoagulation. The demographics of the safety population were similar to the demographics of the efficacy population.

Only Grades 3-5 non-hematologic and Grades 4-5 hematologic adverse reactions were collected. Grades 3-5 non-hematologic and Grades 4-5 hematologic adverse reactions occurring at a higher incidence (≥ 2%) in patients receiving Avastin with paclitaxel and carboplatin compared with patients receiving chemotherapy alone were neutropenia (27% vs. 17%), fatigue (16% vs. 13%), hypertension (8% vs. 0.7%), infection without neutropenia (7% vs. 3%), venous thromboembolism (5% vs. 3%), febrile neutropenia (5% vs. 2%), pneumonitis/pulmonary infiltrates (5% vs. 3%), infection with Grade 3 or 4 neutropenia (4% vs. 2%), hyponatremia (4% vs. 1%), headache (3% vs. 1%) and proteinuria (3% vs. 0%).

Recurrent Glioblastoma

The safety of Avastin was evaluated in a multicenter, randomized, open-label study (EORTC 26101) in patients with recurrent GBM following radiotherapy and temozolomide of whom 278 patients received at least one dose of Avastin and are considered safety evaluable [see Clinical Studies]. Patients were randomized (2:1) to receive Avastin (10 mg/kg every 2 weeks) with lomustine or lomustine alone until disease progression or unacceptable toxicity. The demographics of the safety population were similar to the demographics of the efficacy population. In the Avastin withlomustine arm, 22% of patients discontinued treatment due to adverse reactions compared with 10% of patients in the lomustine arm. In patients receiving Avastin with lomustine, the adverse reaction profile was similar to that observed in other approved indications.

Metastatic Renal Cell Carcinoma

The safety of Avastin was evaluated in 337 patients who received at least one dose of Avastin in a multicenter, double-blind study (BO17705) in patients with mRCC. Patients who had undergone a nephrectomy were randomized (1:1) to receive either Avastin (10 mg/kg every 2 weeks) or placebo with interferon alfa [see Clinical Studies]. Patients were treated until disease progression or unacceptable toxicity. The demographics of the safety population were similar to the demographics of the efficacy population.

Grades 3-5 adverse reactions occurring at a higher incidence ( >2%) were fatigue (13% vs. 8%), asthenia (10% vs. 7%), proteinuria (7% vs. 0%), hypertension (6% vs. 1%; including hypertension and hypertensive crisis), and hemorrhage (3% vs. 0.3%; including epistaxis, small intestinal hemorrhage, aneurysm ruptured, gastric ulcer hemorrhage, gingival bleeding, hemoptysis, hemorrhage intracranial, large intestinal hemorrhage, respiratory tract hemorrhage, and traumatic hematoma). Adverse reactions are presented in Table 3.

Table 3: Grades 1-5 Adverse Reactions Occurring at Higher Incidence (≥5%) of Patients Receiving Avastin vs. Placebo with Interferon Alfa in Study BO17705

Adverse Reactiona Avastin with Interferon Alfa
(N=337)
Placebo with Interferon Alfa
(N=304)
Metabolism and nutrition
Decreased appetite 36% 31%
Weight loss 20% 15%
General
Fatigue 33% 27%
Vascular
Hypertension 28% 9%
Respiratory, thoracic and mediastinal
Epistaxis 27% 4%
Dysphonia 5% 0%
Nervous system
Headache 24% 16%
Gastrointestinal
Diarrhea 21% 16%
Renal and urinary
Proteinuria 20% 3%
Musculoskeletal and connective tissue
Myalgia 19% 14%
Back pain 12% 6%
a NCI-CTC version 3

The following adverse reactions were reported at a 5-fold greater incidence in patients receiving Avastin with interferon-alfa compared to patients receiving placebo with interferon-alfa and not represented in Table 3: gingival bleeding (13 patients vs. 1 patient); rhinitis (9 vs. 0); blurred vision (8 vs. 0); gingivitis (8 vs. 1); gastroesophageal reflux disease (8 vs. 1); tinnitus (7 vs. 1); tooth abscess (7 vs. 0); mouth ulceration (6 vs. 0); acne (5 vs. 0); deafness (5 vs. 0); gastritis (5 vs. 0); gingival pain (5 vs. 0) and pulmonary embolism (5 vs. 1).

Persistent, Recurrent, Or Metastatic Cervical Cancer

The safety of Avastin was evaluated in 218 patients who received at least one dose of Avastin in a multicenter study (GOG-0240) in patients with persistent, recurrent, or metastatic cervical cancer[see Clinical Studies]. Patients were randomized (1:1:1:1) to receive paclitaxel and cisplatin with or without Avastin (15 mg/kg every 3 weeks), or paclitaxel and topotecan with or without Avastin (15 mg/kg every 3 weeks). The demographics of the safety population were similar to the demographics of the efficacy population.

Grades 3-4 adverse reactions occurring at a higher incidence (≥ 2%) in 218 patients receiving Avastin with chemotherapy compared to 222 patients receiving chemotherapy alone were abdominal pain (12% vs. 10%), hypertension (11% vs. 0.5%), thrombosis (8% vs. 3%), diarrhea (6% vs. 3%), anal fistula (4% vs. 0%), proctalgia (3% vs. 0%), urinary tract infection (8% vs. 6%), cellulitis (3% vs. 0.5%), fatigue (14% vs. 10%), hypokalemia (7% vs. 4%), hyponatremia (4% vs. 1%), dehydration (4% vs. 0.5%), neutropenia (8% vs. 4%), lymphopenia (6% vs. 3%), back pain (6% vs. 3%), and pelvic pain (6% vs. 1%). Adverse reactions are presented in Table 4.

Table 4: Grades 1-4 Adverse Reactions Occurring at Higher Incidence (≥ 5%) in Patients Receiving Avastin with Chemotherapy vs. Chemotherapy Alone in Study GOG-0240

Adverse Reactiona Avastin with Chemotherapy
(N=218)
Chemotherapy
(N=222)
General
Fatigue 80% 75%
Peripheral edema 15% 22%
Metabolism and nutrition
Decreased appetite 34% 26%
Hyperglycemia 26% 19%
Hypomagnesemia 24% 15%
Weight loss 21% 7%
Hyponatremia 19% 10%
Hypoalbuminemia 16% 11%
Vascular
Hypertension 29% 6%
Thrombosis 10% 3%
Infections
Urinary tract infection 22% 14%
Infection 10% 5%
Nervous system
Headache 22% 13%
Dysarthria 8% 1%
Psychiatric
Anxiety 17% 10%
Respiratory, thoracic and mediastinal
Epistaxis 17% 1%
Renal and urinary
Increased blood creatinine 16% 10%
Proteinuria 10% 3%
Gastrointestinal
Stomatitis 15% 10%
Proctalgia 6% 1%
Anal fistula 6% 0%
Reproductive system and breast
Pelvic pain 14% 8%
Hematology
Neutropenia 12% 6%
Lymphopenia 12% 5%
a NCI-CTC version 3

Epithelial Ovarian, Fallopian Tube Or Primary Peritoneal Cancer

Stage III Or IV Following Initial Surgical Resection

The safety of Avastin was evaluated in GOG-0218, a multicenter, randomized, double-blind, placebo controlled, three arm study, which evaluated the addition of Avastin to carboplatin and paclitaxel for the treatment of patients with stage III or IV epithelial ovarian, fallopian tube or primary peritoneal cancer following initial surgical resection [see Clinical Studies]. Patients were randomized (1:1:1) to carboplatin and paclitaxel without Avastin (CPP), carboplatin and paclitaxel with Avastin for up to six cycles (CPB15), or carboplatin and paclitaxel with Avastin for six cycles followed by Avastin as a single agent for up to 16 additional doses (CPB15+). Avastin was given at 15 mg/kg every three weeks. On this trial, 1215 patients received at least one dose of Avastin. The demographics of the safety population were similar to the demographics of the efficacy population.

Grades 3-4 adverse reactions occurring at a higher incidence (≥2%) in either of the Avastin arms versus thecontrol arm were fatigue (CPB15+ -9%, CPB15 -6%, CPP -6%), hypertension (CPB15+ -10%, CPB15 -6%,CPP -2%), thrombocytopenia (CPB15+ -21%, CPB15 -20%, CPP -15%) and leukopenia (CPB15+ -51%,CPB15 -53%, CPP -50%). Adverse reactions are presented in Table 5.

Table 5: Grades 1-5 Adverse Reactions Occurring at Higher Incidence (≥ 5%) in Patients Receiving Avastin with Chemotherapy vs. Chemotherapy Alone in GOG-0218

Adverse Reactiona Avastin with carboplatin and paclitaxel followed by Avastin alone*
(N=608)
Avastin with carboplatin and paclitaxel**
(N= 607)
Carboplatin and paclitaxel***
(N= 602)
General
Fatigue 80% 72% 73%
Gastrointestinal
Nausea 58% 53% 51%
Diarrhea 38% 40% 34%
Stomatitis 25% 19% 14%
Musculoskeletal and connective tissue
Arthralgia 41% 33% 35%
Pain in extremity 25% 19% 17%
Muscular weakness 15% 13% 9%
Nervous system
Headache 34% 26% 21%
Dysarthria 12% 10% 2%
Vascular
Hypertension 32% 24% 14%
Respiratory, thoracic and mediastinal
Epistaxis 31% 30% 9%
Dyspnea 26% 28% 20%
Nasal mucosal disorder 10% 7% 4%
a NCI-CTC version 3, * CPB15+, ** CPB15, ***CPP

Platinum-Resistant Recurrent Epithelial Ovarian, Fallopian Tube, Or Primary Peritoneal Cancer

The safety of Avastin was evaluated in 179 patients who received at least one dose of Avastin in a multicenter, open-label study (MO22224) in which patients were randomized (1:1) to Avastin with chemotherapy or chemotherapy alone in patients with platinum resistant, recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer that recurred within < 6 months from the most recent platinum based therapy [see Clinical Studies]. Patients were randomized to receive Avastin 10 mg/kg every 2 weeks or 15 mg/kg every 3 weeks. Patients had received no more than 2 prior chemotherapy regimens. The trial excluded patients with evidence of recto-sigmoid involvement by pelvic examination or bowel involvement on CT scan or clinical symptoms of bowel obstruction. Patients were treated until disease progression or unacceptable toxicity. Forty percent of patients on the chemotherapy alone arm received Avastin alone upon progression. The demographics of the safety population were similar to the demographics of the efficacy population.

Grades 3-4 adverse reactions occurring at a higher incidence ( ≥ 2%) in 179 patients receiving Avastin with chemotherapy compared to 181 patients receiving chemotherapy alone were hypertension (6.7% vs. 1.1%) and palmar-plantar erythrodysaesthesia syndrome (4.5% vs. 1.7%). Adverse reactions are presented in Table 6.

Table 6: Grades 2-4 Adverse Reactions Occurring at Higher Incidence (≥5%) in Patients Receiving Avastin with Chemotherapy vs. Chemotherapy Alone in Study MO22224

Adverse Reactiona Avastin with Chemotherapy
(N=179)
Chemotherapy
(N=181)
Hematology
Neutropenia 31% 25%
Vascular
Hypertension 19% 6%
Nervous system
Peripheral sensory neuropathy 18% 7%
General
Mucosal inflammation 13% 6%
Renal and urinary
Proteinuria 12% 0.6%
Skin and subcutaneous tissue
Palmar-plantar erythrodysaesthesia 11% 5%
Infections
Infection 11% 4%
Respiratory, thoracic and mediastinal
Epistaxis 5% 0%
a NCI-CTC version 3

Platinum-Sensitive Recurrent Epithelial Ovarian, Fallopian Tube, Or Primary Peritoneal Cancer

Study AVF4095g

The safety of Avastin was evaluated in 247 patients who received at least one dose of Avastin in a double-blind study (AVF4095g) in patients with platinum sensitive recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer [see Clinical Studies]. Patients were randomized (1:1) to receive Avastin (15 mg/kg) or placebo every 3 weeks with carboplatin and gemcitabine for 6 to 10 cycles followed by Avastin or placebo alone until disease progression or unacceptable toxicity. The demographics of the safety population were similar to the demographics of the efficacy population.

Grades 3-4 adverse reactions occurring at a higher incidence (≥ 2%) in patients receiving Avastin with chemotherapy compared to placebo with chemotherapy were: thrombocytopenia (40% vs. 34%), nausea (4% vs. 1.3%), fatigue (6% vs. 4%), headache (4% vs. 0.9%), proteinuria (10% vs. 0.4%), dyspnea (4% vs. 1.7%), epistaxis (5% vs. 0.4%), and hypertension (17% vs. 0.9%). Adverse reactions are presented in Table 7.

Table 7: Grades 1-5 Adverse Reactions Occurring at a Higher Incidence (≥ 5%) in Patients Receiving Avastin with Chemotherapy vs. Placebo with Chemotherapy in Study AVF4095g

Adverse Reactiona Avastin with Carboplatin and Gemcitabine
(N=247)
Placebo with Carboplatin and Gemcitabine
(N=233)
General
Fatigue 82% 75%
Mucosal inflammation 15% 10%
Gastrointestinal
Nausea 72% 66%
Diarrhea 38% 29%
Stomatitis 15% 7%
Hemorrhoids 8% 3%
Gingival bleeding 7% 0%
Hematology
Thrombocytopenia 58% 51%
Respiratory, thoracic and mediastinal
Epistaxis 55% 14%
Dyspnea 30% 24%
Cough 26% 18%
Oropharyngeal pain 16% 10%
Dysphonia 13% 3%
Rhinorrhea 10% 4%
Sinus congestion 8% 2%
Nervous system
Headache 49% 30%
Dizziness 23% 17%
Vascular
Hypertension 42% 9%
Musculoskeletal and connective tissue
Arthralgia 28% 19%
Back pain 21% 13%
Psychiatric
Insomnia. 21% 15%
Renal and urinary
Proteinuria 20% 3%
Injury and procedural
Contusion 17% 9%
Infections
Sinusitis 15% 9%
a NCI-CTC version 3

Study GOG-0213

The safety of Avastin was evaluated in an open-label, controlled study (GOG-0213) in 325 patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have not received more than one previous regimen of chemotherapy[see Clinical Studies]. Patients were randomized (1:1) to receive carboplatin and paclitaxel for 6 to 8 cycles or Avastin (15 mg/kg every 3 weeks) with carboplatin and paclitaxel for 6 to 8 cycles followed by Avastin as a single agent until disease progression or unacceptable toxicity. The demographics of the safety population were similar to the demographics of the efficacy population.

Grades 3-4 adverse reactions occurring at a higher incidence (≥ 2%) in patients receiving Avastin with chemotherapy compared to chemotherapy alone were: hypertension (11% vs. 0.6%), fatigue (8% vs. 3%), febrile neutropenia (6% vs. 3%), proteinuria (8% vs. 0%), abdominal pain (6% vs. 0.9%), hyponatremia (4% vs. 0.9%), headache (3% vs. 0.9%), and pain in extremity (3% vs. 0%). Adverse reactions are presented in Table 8.

Table 8: Grades 1-5 Adverse Reactions Occurring at Higher Incidence (≥ 5%) in Patients Receiving Avastin with Chemotherapy vs. Chemotherapy Alone in Study GOG-0213

Adverse Reactiona Avastin with Carboplatin and Paclitaxel
(N=325)
Carboplatin and Paclitaxel
(N=332)
Musculoskeletal and connective tissue
Arthralgia 45% 30%
Myalgia 29% 18%
Pain in extremity 25% 14%
Back pain 17% 10%
Muscular weakness 13% 8%
Neck pain 9% 0%
Vascular
Hypertension 42% 3%
Gastrointestinal
Diarrhea 39% 32%
Abdominal pain 33% 28%
Vomiting 33% 25%
Stomatitis 33% 16%
Nervous system
Headache 38% 20%
Dysarthria 14% 2%
Dizziness 13% 8%
Metabolism and nutrition
Decreased appetite 35% 25%
Hyperglycemia 31% 24%
Hypomagnesemia 27% 17%
Hyponatremia 17% 6%
Weight loss 15% 4%
Hypocalcemia 12% 5%
Hypoalbuminemia 11% 6%
Hyperkalemia 9% 3%
Respiratory, thoracic and mediastinal
Epistaxis 33% 2%
Dyspnea 30% 25%
Cough 30% 17%
Rhinitis allergic 17% 4%
Nasal mucosal disorder 14% 3%
Skin and subcutaneous tissue
Exfoliative rash 23% 16%
Nail disorder 10% 2%
Dry skin 7% 2%
Renal and urinary
Proteinuria 17% 1%
Increased blood creatinine 13% 5%
Hepatic
Increased aspartate aminotransferase 15% 9%
General
Chest pain 8% 2%
Infections
Sinusitis 7% 2%
a NCI-CTC version 3

Immunogenicity

As with all therapeutic proteins, there is a potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and the specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors, including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to bevacizumab in the studies described below with the incidence of antibodies in other studies or to other bevacizumab products may be misleading.

In clinical studies for adjuvant treatment of a solid tumor, 0.6% (14/2233) of patients tested positive for treatment-emergent anti-bevacizumab antibodies as detected by an electrochemiluminescent (ECL) based assay. Among these 14 patients, three tested positive for neutralizing antibodies against bevacizumab using an enzyme-linked immunosorbent assay (ELISA). The clinical significance of these anti-bevacizumab antibodies is not known.

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of Avastin. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

General: Polyserositis

Cardiovascular: Pulmonary hypertension, Mesenteric venous occlusion

Gastrointestinal: Gastrointestinal ulcer, Intestinal necrosis, Anastomotic ulceration

Hemic and lymphatic: Pancytopenia

Hepatobiliary disorders: Gallbladder perforation

Musculoskeletal and Connective Tissue Disorders: Osteonecrosis of the jaw

Renal: Renal thrombotic microangiopathy (manifested as severe proteinuria)

Respiratory: Nasal septum perforation

Read the entire FDA prescribing information for Avastin (Bevacizumab)

Related Resources for Avastin

Related Health

Read the Avastin User Reviews »

© Avastin Patient Information is supplied by Cerner Multum, Inc. and Avastin Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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