Bevacizumab

Bevacizumab is a prescription medication used to treat Metastatic Colorectal Cancer, Non-small Cell Lung Cancer, Renal Cell Carcinoma, Cervical Cancer, Ovarian, Fallopian Tube, or Peritoneal Cancer, Glioblastoma, and Hepatocellular Carcinoma. 

• Bevacizumab is available under the following different brand names: Avastin, Mvasi, Bevacizumab-awwb, Zirabev, Bevacizumab-bvzr 

Adult dosage

Injectable solution

• 25mg/mL (4-mL, 16-mL single-dose vials)

Biosimilar to Avastin

• Mvasi (bevacizumab-awwb)
• Zirabev (bevacizumab-bvzr)

Metastatic Colorectal Cancer

• Adult dosage
• Avastin, Mvasi, Zirabev
• In combination with fluorouracil-based chemotherapy
• First-line and second-line treatment for metastatic colorectal carcinoma (mCRC) in combination with fluorouracil (5-FU)-based chemotherapy
• Bolus-IFL (i.e., irinotecan, 5-FU, leucovorin): 5 mg/kg IV every 2 weeks
• FOLFOX4 (i.e., oxaliplatin, 5-FU, leucovorin): 10 mg/kg IV every 2 weeks
• In combination with fluoropyrimidine plus irinotecan or oxaliplatin-based chemotherapy 
• Second-line treatment of patients with mCRC who have progressed on a first-line bevacizumab-containing regimen
• Use in combination with a fluoropyrimidine (e.g., 5-FU, capecitabine) plus irinotecan or oxaliplatin-based chemotherapy
• 5 mg/kg IV every 2 weeks or 7.5 mg/kg IV every 3 weeks

Non-Small Cell Lung Cancer

Adult dosage

• Avastin, Mvasi, Zirabev 
• 15 mg/kg IV every 3 weeks

Renal Cell Carcinoma

Adult dosage

Avastin, Mvasi, Zirabev

• Indicated for metastatic renal cell carcinoma in combination with interferon alfa-1a
• 10 mg/kg IV every 2 weeks 

Cervical Cancer

Adult dosage

Avastin, Mvasi, Zirabev

• Indicated, in combination with in combination with paclitaxel plus cisplatin or topotecan, for persistent, recurrent, or metastatic cervical cancer
• 15 mg/kg IV every 3 weeks in combination with 1 of the following chemotherapy regimens: paclitaxel and cisplatin, or paclitaxel and topotecan

Ovarian, Fallopian Tube, or Peritoneal Cancer

Adult dosage

Avastin, Mvasi

Platinum-resistant

• Bevacizumab 10 mg/kg IV every 2 weeks in combination with 1 of the following IV chemotherapy regimens: paclitaxel, pegylated liposomal doxorubicin, or topotecan weekly, or
• Bevacizumab 15 mg/kg IV every 3 weeks in combination with topotecan every 3 weeks

Platinum-sensitive 

• Bevacizumab 15 mg/kg IV for 3 weeks in combination with carboplatin and paclitaxel for 6-8 cycles, or
• Bevacizumab 15 mg/kg IV every 3 weeks in combination with carboplatin and gemcitabine for 6-10 cycles, followed by
• Bevacizumab 15 mg/kg every 3 weeks as a single agent until disease progression
• Treatment of stage III or IV disease following initial surgical resection 
• Bevacizumab 15 mg/kg IV every 3 weeks in combination with carboplatin and paclitaxel for up to 6 cycles, followed by
• Bevacizumab 15 mg/kg IV every 3 weeks as a single agent, for a total of up to 22 cycles or until disease progression, whichever occurs earlier

Glioblastoma

Adult dosage

Avastin, Mvasi, Zirabev

• 10 mg/kg IV every 2 weeks

Hepatocellular Carcinoma

Adult dosage

Avastin only

• Bevacizumab 15 mg/kg IV on Day 1 (after administration of atezolizumab), plus
• Atezolizumab 1,200 mg/kg IV on Day 1
• Repeat every 3 weeks
• Continue until disease progression or unacceptable toxicity

Dosage Considerations – Should be Given as Follows: 

• See"Dosage."

Common side effects of Bevacizumab include:

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

Serious side effects of Bevacizumab include:

• hives, 
• difficult breathing, 
• swelling in the face or throat, 
• dizziness, 
• lightheadedness, 
• shortness of breath, 
• chills, 
• sweating, 
• headache, 
• wheezing, 
• swelling in the face, 
• easy bruising, 
• unusual bleeding (nose, mouth, vagina, rectum), 
• continuous bleeding, 
• severe stomach pain, 
• bloody or tarry stools, 
• coughing up blood, 
• vomit that looks like coffee grounds, 
• sudden numbness or weakness (especially on one side of the body), 
• sudden severe headache, 
• problems with vision or balance, 
• extreme weakness, 
• extreme tiredness, 
• confusion, 
• fainting, 
• seizure, 
• fistula (abnormal passageway) in the throat, lungs, gallbladder, kidney, bladder, or vagina, 
• chest pain, 
• stomach pain or swelling, 
• urine leakage, 
• choking or gagging while eating or drinking, 
• pain, swelling, warmth, or redness in one or both legs, 
• chest pain or pressure, 
• pain spreading to the jaw or shoulder, 
• missed menstrual periods, 
• puffy eyes, 
• swelling in the ankles or feet, 
• foamy urine, 
• swelling, 
• rapid weight gain, 
• fever, 
• mouth sores, 
• skin sores, 
• sore throat, 
• cough, 
• sudden redness, warmth, swelling, or oozing of the skin, 
• any skin wound or surgical incision that will not heal, 
• severe headache, 
• blurred vision, and 
• pounding in the neck or ears

Rare side effects of Bevacizumab include:

• none 

This is not a complete list of side effects and other serious side effects or health problems may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

• Bevacizumab has severe interactions with no other drugs.
• Bevacizumab has serious interactions with the following drugs:
  • palifermin
  • ropeginterferon alfa 2b
  • sunitinib
• Bevacizumab has moderate interactions with at least 15 other drugs.
• Bevacizumab has minor interactions with no other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this drug, tell your doctor or pharmacist of all the drugs you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Bevacizumab?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Bevacizumab?”

Cautions

• Bevacizumab products can result in minor hemorrhage, most commonly Grade 1 epistaxis; and serious, and in some cases fatal, hemorrhagic events
• Serious, sometimes fatal, arterial thromboembolic events (ATE) including cerebral infarction, transient ischemic attacks, myocardial infarction, angina, and a variety of other ATE; discontinue bevacizumab for severe ATE
• Increased risk of venous thromboembolic events (VTE) reported in patients treated with bevacizumab for cervical cancer; discontinue bevacizumab for life-threatening VTE
• Monitor blood pressure and treat hypertension; increased risk for severe hypertension; temporarily suspend treatment; discontinue if hypertensive crisis or hypertensive encephalopathy
• Increased relative risk for heart failure has been associated with therapy
• Posterior reversible encephalopathy syndrome (PRES) reported (0.5%); discontinue if PRES develops
• Proteinuria reported; temporarily suspend treatment for greater than 2 g proteinuria/24 hours; discontinue if nephrotic syndrome occurs (incidence less than 1%)
• Evaluation for presence of varices recommended within 6 months of initiation of HCC therapy; there is lack of clinical data to support safety in patients with variceal bleeding within 6 months prior to treatment, untreated or incompletely treated varices with bleeding, or high risk of bleeding because these patients were excluded from clinical trials in HCC
• Do not administer to patients with recent history of hemoptysis of 1/2 teaspoon or more of red blood; discontinue in patients who develop a Grades 3-4 hemorrhage
• Risk of ovarian failure reported especially in premenopausal women receiving bevacizumab in combination with mFOLFOX chemotherapy compared to mFOLFOX alone; inform females of reproductive potential of the risk of ovarian failure prior to starting treatment
• Based on its mechanism of action and findings from animal studies, may cause fetal harm when administered to pregnant women (see Pregnancy)
• Infusion-related reactions may occur and include hypertension, hypertensive crises associated with neurologic signs and symptoms, wheezing, oxygen desaturation, Grade 3 hypersensitivity, chest pain, headaches, rigors, and diaphoresis; stop infusion if severe and administer appropriate therapy
• Not indicated for use with anthracycline-based chemotherapy; incidence of Grade 3 or greater left ventricular dysfunction was 1% in patients receiving bevacizumab compared to 0.6% of patients receiving chemotherapy alone
• Wound healing
  • Impairs wound healing; discontinue before elected surgeries and do not initiate following surgery; withhold therapy until adequate wound healing
  • Discontinue treatment in patients with wound healing complications requiring medical intervention
  • Withhold for at least 28 days prior to elective surgery
  • Do not administer for at least 28 days following surgery and until the wound is fully healed
  • Necrotizing fasciitis including fatal cases, has been reported, usually secondary to wound healing complications, gastrointestinal perforation or fistula formation
  • Safety of resumption of bevacizumab products after resolution of wound healing complications has not been established
• GI perforation and fistula formation
  • Serious and sometimes fatal GI perforation occurs
  • Serious and sometimes fatal fistula formation involving tracheoesophageal, bronchopleural, biliary, vaginal, renal and bladder sites occurs at a higher incidence in bevacizumab-treated patients compared to controls
  • Patients who develop a gastrointestinal vaginal fistula may also have a bowel obstruction and require surgical intervention, as well as a diverting ostomy
  • Avoid in patients with ovarian cancer who have evidence of recto-sigmoid involvement by pelvic examination or bowel involvement on CT scan or clinical symptoms of bowel obstruction.

Pregnancy and Lactation

• Based on findings from animal studies and its mechanism of action, drug may cause fetal harm in pregnant women
• Limited postmarketing reports describe cases of fetal malformations with bevacizumab use in pregnancy; however, these reports are insufficient to determine drug-associated risks
• Contraception
  • Advise pregnant women of the potential risk to a fetus
  • Advise female patients of reproductive potential to use effective contraception during treatment and for 6 months following the last dose of bevacizumab
• Infertility
  • Inform females of reproductive potential of the risk of ovarian failure prior to starting; long term effects of bevacizumab exposure on fertility are unknown  
  • No data available on the presence of bevacizumab in human milk, the effects on the breast fed infant, or the effects on milk production
  • Human IgG is present in human milk, but published data suggest that breast milk antibodies do not enter the neonatal and infant circulation in substantial amounts
  • Because of the potential for serious adverse reactions in breastfed infants, advise women not to breastfeed during treatment and for 6 months after last dose