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Avastin

Last reviewed on RxList: 4/10/2019
Avastin Side Effects Center

Last reviewed on RxList 4/10/2019

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. Common side effects of Avastin include:

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

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

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.

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.

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 tightness or heavy feeling, pain spreading to the jaw or shoulder, nausea, sweating, general ill feeling;
  • missed menstrual periods;
  • 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, anxiety, nosebleed.

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)

Avastin Professional Information

SIDE EFFECTS

The following serious adverse reactions are discussed in greater detail in other sections of 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 Reactions [see WARNINGS AND PRECAUTIONS].
  • Ovarian Failure [see WARNINGS AND PRECAUTIONS].
  • Congestive Heart Failure [see WARNINGS AND PRECAUTIONS.].

Clinical Trial 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 most common adverse reactions observed in patients receiving Avastin as a single agent or in combination with chemotherapy at a rate >10%, are epistaxis, headache, hypertension, rhinitis, proteinuria, taste alteration, dry skin, rectal hemorrhage, lacrimation disorder, back pain and exfoliative dermatitis.

The safety data below reflect exposure to Avastin in 4134 patients with mCRC, non-squamous NSCLC, glioblastoma, mRCC, cervical cancer, and epithelial ovarian, fallopian tube, or primary peritoneal cancer, including controlled studies (AVF2107g, E3200, E4599, EORTC 26101, BO17705, GOG-0240, MO22224, AVF4095, GOG-0213, and GOG-0218) at the recommended dose and schedule for a median of 6 to 23 doses.

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

Stage III Or IV Epithelial Ovarian, Fallopian Tube Or Primary Peritoneal Cancer Following Initial Surgical Resection

GOG-0218 was a multicenter, randomized, double-blind, placebo controlled, three arm study evaluating 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. Patients were randomized (1:1:1) to be treated with 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. Adverse reactions are presented in Table 2.

Table 2: Grade 1-5 Adverse Reactions Occuring at Higher Incidence ( ≥5%) in Patients Receiving Avastin with Chemotherapy vs. Chemotherapy Alone in Study 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)
Gastrointestinal disorders
Diarrhea 38% 40% 34%
Nausea 58% 53% 51%
Stomatitis 25% 19% 14%
General disorders and administration site conditions
Fatigue 80% 72% 73%
Musculoskeletal and connective tissue disorders
Arthralgia 41% 33% 35%
Muscular weakness 15% 13% 9%
Pain in extremity 25% 19% 17%
Nervous system disorders
Dysarthria 12% 10% 2%
Headache 34% 26% 21%
Respiratory, thoracic and mediastinal disorders
Dyspnea 26% 28% 20%
Epistaxis 31% 30% 9%
Nasal mucosal disorder 10% 7% 4%
Vascular disorders
Hypertension 32% 24% 14%
a NCI-CTC version 3,
* CPB15+,
** CPB15,
***CPP

Grade 3 – 4 adverse reactions occurring at a higher incidence (≥2%) in either of the Avastin arms versus the control arm were fatigue (CPB15+ - 9%, CPB15 - 6%, CPP - 6%), hypertension (CPB15+ - 10%, CPB15 - 6%, CPP - 2%), platelet count decreased (CPB15+ - 21%, CPB15 - 20%, CPP - 15%) and white blood cell count decreased (CPB15+ - 51%, CPB15 - 53%, CPP - 50%).

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. 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. Adverse reactions are presented in Table 3.

Table 3: Grade 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)
Blood and lymphatic system disorders
  Neutropenia 31% 25%
General disorders
  Mucosal inflammation 13% 6%
Infections
  Infection 11% 4%
Nervous system disorders
  Peripheral sensory   neuropathy 18% 7%
Renal and urinary disorders
  Proteinuria 12% 0.6%
Respiratory, thoracic and mediastinal disorders
  Epistaxis 5% 0%
Skin and subcutaneous tissue disorders
  Palmar-plantar   erythrodysaesthesia 11% 5%
Vascular disorders
  Hypertension 19% 6%
a NCI-CTC version 3

Grade 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%).

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

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. 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. Adverse reactions are presented in Table 4.

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

Grade 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%).

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. 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. Adverse reactions are presented in Table 5.

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

Grade 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%).

Metastatic Renal Cell Carcinoma (mRCC)

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 metastatic renal cell carcinoma. 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. Patients were treated until disease progression or unacceptable toxicity. The demographics of the safety population were similar to the demographics of the efficacy population.

Grade 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 6.

Table 6: 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)
Gastrointestinal disorders
  Diarrhea 21% 16%
General disorders and administration site conditions
  Fatigue 33% 27%
Metabolism and nutrition disorders
  Decreased appetite 36% 31%
  Weight decreased 20% 15%
Musculoskeletal and connective tissue disorders
  Myalgia 19% 14%
  Back pain 12% 6%
Nervous system disorders
  Headache 24% 16%
Renal and urinary disorders
  Proteinuria 20% 3%
Respiratory, thoracic and mediastinal disorders
  Epistaxis 27% 4%
  Dysphonia 5% 0%
Vascular disorders
  Hypertension 28% 9%
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 4: 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. 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. Adverse reactions are presented in Table 7.

Table 7: 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)
Metabolism and nutrition disorders
  Decreased appetite 34% 26%
  Hyperglycemia 26% 19%
  Hypomagnesemia 24% 15%
  Weight Decreased 21% 7%
  Hyponatremia 19% 10%
  Hypoalbuminemia 16% 11%
General disorders
  Fatigue 80% 75%
  Edema Peripheral 15% 22%
Infections and infestations
  Urinary Tract Infection 22% 14%
  Infection 10% 5%
Vascular disorders
  Hypertension 29% 6%
  Thrombosis 10% 3%
Nervous system disorders
  Headache 22% 13%
  Dysarthria 8% 1%
Gastrointestinal disorders
  Stomatitis 15% 10%
  Proctalgia 6% 1%
  Anal fistula 6% 0.0%
Blood and lymphatic system disorders
  Neutropenia 12% 6%
  Lymphopenia 12% 5%
Psychiatric disorders
  Anxiety 17% 10%
Reproductive system and breast disorders
  Pelvic pain 14% 8%
Respiratory, thoracic and mediastinal disorders
  Epistaxis 17% 1%
Renal and urinary disorders
  Blood Creatinine Increased 16% 10%
  Proteinuria 10% 3%
a NCI-CTC version 3

Grade 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%).

Metastatic Colorectal Cancer (mCRC)

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. Patients were randomized (1:1:1) to placebo with bolus IFL, Avastin with bolus IFL, or Avastin with 5 fluorouracil and leucovorin. The demographics of the safety population were similar to the demographics of the efficacy population.

All Grade 3−4 adverse reactions and selected Grade 1−2 adverse reactions (i.e., hypertension, proteinuria, thromboembolic events) were collected in the entire study population. Adverse reactions are presented in Table 8.

Table 8: Grade 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)
General disorders
  Asthenia 10% 7%
  Pain 8% 5%
Vascular disorders
  Hypertension 12% 2%
  Deep Vein Thrombosis 9% 5%
  Intra-Abdominal   Thrombosis 3% 1%
  Syncope 3% 1%
Gastrointestinal disorders
  Diarrhea 34% 25%
  Abdominal Pain 8% 5%
  Constipation 4% 2%
Blood and lymphatic disorders
  Leukopenia 37% 31%
  Neutropenia 21% 14%
a NCI-CTC version 3

The safety of Avastin was evaluated in 521 patients in an open-label, active-controlled study (E3200). Patients who were previously treated with irinotecan and fluorouracil for initial therapy for metastatic colorectal cancer. 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. The most frequent adverse reactions (selected Grade 3−5 non-hematologic and Grade 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 event rates due to the reporting mechanisms.,

First-Line Non Squamous Non Small Cell Lung Cancer (NSCLC)

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). Chemotherapy naïve 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 (1/2 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 Grade 3-5 non hematologic and Grade 4-5 hematologic adverse reactions were collected. Grade 3-5 non hematologic and Grade 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

EORTC 26101 was a multicenter, randomized, open-label study 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. 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 with lomustine 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.

Immunogenicity

As with all therapeutic proteins, there is a potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and 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 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 post-approval 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.

Body as a Whole: 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)

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© 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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