bevacizumab (Rx)

Brand and Other Names:Avastin, Mvasi, more...bevacizumab-awwb, Zirabev, bevacizumab-bvzr
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable solution

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

Biosimilar to Avastin

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

Metastatic Colorectal Cancer

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 (ie, irinotecan, 5-FU, leucovorin): 5 mg/kg IV q2Weeks  
  • FOLFOX4 (ie, oxaliplatin, 5-FU, leucovorin): 10 mg/kg IV q2Weeks

In combination with a 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 (eg, 5-FU, capecitabine) plus irinotecan or oxaliplatin-based chemotherapy
  • 5 mg/kg IV q2Weeks or 7.5 mg/kg IV q3Weeks

Non-Small Cell Lung Cancer

Avastin, Mvasi, Zirabev

Indicated for unresectable, locally advanced, recurrent or metastatic, nonsquamous non-small cell lung cancer (NSCLC) in combination with carboplatin and paclitaxel

15 mg/kg IV q3Weeks  

Renal Cell Carcinoma

Avastin, Mvasi, Zirabev

Indicated for metastatic renal cell carcinoma in combination with interferon alfa-2a

10 mg/kg IV q2Weeks (Avastin may be used as monotherapy off-label)  

Cervical Cancer

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 q3Weeks in combination with 1 of the following chemotherapy regimens: paclitaxel and cisplatin, or paclitaxel and topotecan  

Ovarian, Fallopian Tube, or Peritoneal Cancer

Avastin

Platinum-resistant

  • Indicated in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan for women with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than 2 prior chemotherapy regimens
  • Bevacizumab 10 mg/kg IV q2Weeks in combination with 1 of the following IV chemotherapy regimens: paclitaxel, pegylated liposomal doxorubicin, or topotecan weekly OR
  • Bevacizumab 15 mg/kg IV q3Weeks in combination with topotecan q3Weeks  

Platinum-sensitive

  • Indicated for women with platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer either in combination with carboplatin and paclitaxel or in combination with carboplatin and gemcitabine chemotherapy, followed by bevacizumab alone
  • Women are said to be 'platinum-sensitive' if a relapse occurs ≥6 months following the last treatment with a platinum-based chemotherapy
  • Bevacizumab 15 mg/kg IV q3Weeks in combination with carboplatin and paclitaxel for 6-8 cycles, OR
  • Bevacizumab 15 mg/kg IV q3Weeks in combination with carboplatin and gemcitabine for 6-10 cycles, followed by
  • Bevacizumab 15 mg/kg q3Weeks as a single agent until disease progression

Treatment of stage III or IV disease following initial surgical resection

  • Indicated in combination with carboplatin and paclitaxel, followed by bevacizumab as a single agent, for patients with stage III or IV epithelial ovarian, fallopian tube, or primary peritoneal cancer following initial surgical resection
  • Bevacizumab 15 mg/kg IV q3Weeks in combination with carboplatin and paclitaxel for up to 6 cycles, followed by
  • Bevacizumab 15 mg/kg IV q3Weeks as a single agent, for a total of up to 22 cycles or until disease progression, whichever occurs earlier

Glioblastoma

Avastin, Mvasi, Zirabev

Indicated for treatment of recurrent glioblastoma

10 mg/kg IV q2Weeks  

Breast Cancer

Indication for metastatic breast cancer (HER2-negative) revoked by FDA in November 2011 due to failure to delay tumor growth or provide survival benefit

Exudative ARMD (Off-label)

Off-label indication for exudative age-related macular degeneration

Off-label: 1.25 mg (in 0.05mL of solution) administered by intravitreal injection once monthly

Reference: CATT Research Group, N Engl J Med 2011;364:1897-1908

The need to repackage the drug from the available size vial into a smaller doses increases risk for transmission of infection if improper aseptic technique occurs

Hepatocellular Carcinoma

Avastin only

Indicated, in combination with atezolizumab, for unresectable or metastatic hepatocellular carcinoma (HCC) in patients who have not received prior systemic therapy

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

Refer to prescribing information for atezolizumab for more information

Dosage Modifications

Discontinue treatment

  • Gastrointestinal perforation, any grade
  • Tracheoesophageal fistula, any grade
  • Grade 4 fistula
  • Fistula formation involving any internal organ
  • Necrotizing fasciitis
  • Grade 3 or 4 hemorrhage
  • Severe arterial thromboembolic events
  • Grade 4 venous thromboembolic events, including pulmonary embolism
  • Hypertensive crisis or hypertensive encephalopathy
  • Posterior reversible encephalopathy syndrome (PRES)
  • Nephrotic syndrome, any grade
  • Congestive heart failure, any grade
  • Severe infusion reactions

Withhold treatment

  • Any wound healing complications; resume after resolution of wound healing complications has not been established
  • Recent history of hemoptysis ≥1/2 tsp (2.5 mL)
  • Severe hypertension not controlled with medical management; resume once controlled
  • Proteinuria ≥2 grams/24 hr in absence of nephrotic syndrome; withhold until proteinuria <2 grams/24 hr

Infusion reaction

  • Mild, clinically significant: Decrease infusion rate
  • Clinically significant: Interrupt infusion; resume at a decreased rate of infusion after symptoms resolve

Dosing Considerations

Withhold for at least 28 days before elective surgery

Do not administer until at least 28 days following major surgery and until adequate wound healing

Limitation of use (colorectal cancer)

  • Not indicated for adjuvant treatment of colon cancer

Orphan Designations

Coadministration with platinum-based antineoplastic and fluorouracil or capecitabine for treatment of stomach cancer

Melanoma stages IIb-IV

Hereditary hemorrhagic telangiectasia

Pancreatic cancer

Mesothelioma

Coat disease

Sponsor

  • Genentech, Inc; 1 DNA Way; South San Francisco, CA 94080-4990
  • MicroSert, Ltd; Bar Yehuda Street; Nesher (Coat disease)

Safety and efficacy not established

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Interactions

Interaction Checker

and bevacizumab

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

            All Interactions Sort By:
             activity indicator 

            Contraindicated (0)

              Serious - Use Alternative (2)

              • palifermin

                palifermin increases toxicity of bevacizumab by Other (see comment). Avoid or Use Alternate Drug. Comment: Palifermin should not be administered within 24 hr before, during infusion of, or within 24 hr after administration of antineoplastic agents. Coadministration of palifermin within 24 hr of chemotherapy resulted in increased severity and duration of oral mucositis.

              • sunitinib

                bevacizumab, sunitinib. Other (see comment). Avoid or Use Alternate Drug. Comment: Coadministration of bevacizumab and sunitinib is not recommended. Cases of microangiopathic hemolytic anemia (MAHA) have been reported. .

              Monitor Closely (15)

              • cholera vaccine

                bevacizumab decreases effects of cholera vaccine by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs and corticosteroids (used in greater than physiologic doses), may reduce the immune response to cholera vaccine.

              • daunorubicin

                bevacizumab, daunorubicin. Other (see comment). Use Caution/Monitor. Comment: Potential for increased risk of cardiotoxicity (CHF). Caution is warranted.

              • dengue vaccine

                bevacizumab decreases effects of dengue vaccine by immunosuppressive effects; risk of infection. Use Caution/Monitor. Immunosuppressive therapies (eg, irradiation, antimetabolites, alkylating agents, cytotoxic drugs, corticosteroids [greater than physiologic doses]) may reduce immune response to dengue vaccine.

              • dichlorphenamide

                dichlorphenamide and bevacizumab both decrease serum potassium. Use Caution/Monitor.

              • doxorubicin

                bevacizumab, doxorubicin. Other (see comment). Use Caution/Monitor. Comment: Potential for increased risk of cardiotoxicity (CHF). Caution is warranted.

              • doxorubicin liposomal

                bevacizumab, doxorubicin liposomal. Other (see comment). Use Caution/Monitor. Comment: Potential for increased risk of cardiotoxicity (CHF). Caution is warranted.

              • epirubicin

                bevacizumab, epirubicin. Other (see comment). Use Caution/Monitor. Comment: Potential for increased risk of cardiotoxicity (CHF). Caution is warranted.

              • idarubicin

                bevacizumab, idarubicin. Other (see comment). Use Caution/Monitor. Comment: Potential for increased risk of cardiotoxicity (CHF). Caution is warranted.

              • irinotecan

                bevacizumab, irinotecan. Other (see comment). Use Caution/Monitor. Comment: Potential for increased risk of diarrhea and neutropenia during concomitant administration of bevacizumab and irinotecan.

              • irinotecan liposomal

                bevacizumab, irinotecan liposomal. Other (see comment). Use Caution/Monitor. Comment: Potential for increased risk of diarrhea and neutropenia during concomitant administration of bevacizumab and irinotecan.

              • paclitaxel

                bevacizumab will decrease the level or effect of paclitaxel by Other (see comment). Use Caution/Monitor. Possible decreased paclitaxel exposure after 4 treatment cycles of bevacizumab in combination with paclitaxel and carboplatin.

              • paclitaxel protein bound

                bevacizumab will decrease the level or effect of paclitaxel protein bound by Other (see comment). Use Caution/Monitor. Possible decreased paclitaxel exposure after 4 treatment cycles of bevacizumab in combination with paclitaxel and carboplatin.

              • ponesimod

                ponesimod and bevacizumab both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution if coadministered because of additive immunosuppressive effects during such therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs to avoid unintended additive immunosuppressive effects.

              • siponimod

                siponimod and bevacizumab both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution if coadministered because of additive immunosuppressive effects during such therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs to avoid unintended additive immunosuppressive effects.

              • sorafenib

                bevacizumab, sorafenib. Other (see comment). Use Caution/Monitor. Comment: Monitor for development of hand-foot skin reactions during combination therapy.

              Minor (0)

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                Adverse Effects

                >10% (Epithelial ovarian, fallopian tube or primary peritoneal cancer)

                Treatment following resection

                • Fatigue (72-80%)
                • Nausea (53-58%)
                • Arthralgia (33-41%)
                • Diarrhea (38-40%)
                • Headache (26-34%)
                • Hypertension (24-32%)
                • Epistaxis (30-31%)
                • Dyspnea (26-28%)
                • Stomatitis (19-25%)
                • Pain in extremity (19-25%)
                • Muscular weakness (13-15%)
                • Dysarthria (10-12%)

                Platinum-resistant

                • Neutropenia, Grade 2-4 (31%)
                • Hypertension, Grade 2-4 (19%)
                • Peripheral sensory neuropathy, Grade 2-4 (18%)
                • Mucosal inflammation, Grade 2-4 (13%)
                • Proteinuria, Grade 2-4 (12%)
                • Infection, Grade 2-4 (11%)
                • Palmar-plantar erythrodysesthesia, Grade 2-4 (11%)

                Platinum-sensitive

                • Fatigue (82%)
                • Nausea (72%)
                • Thrombocytopenia (58%)
                • Epistaxis (55%)
                • Headache (49%)
                • Hypertension (42%)
                • Diarrhea (38-39%)
                • Decreased appetite (35%)
                • Abdominal pain, stomatitis, vomiting (33%)
                • Hyperglycemia (31%)
                • Dyspnea (30%)
                • Arthralgia (28%)
                • Hypomagnesemia (27%)
                • Cough (26%)
                • Insomnia, back pain (21%)

                >10% (Metastatic Renal Cell Carcinoma)

                Decreased appetite (36%)

                Fatigue (33%)

                Hypertension (28%)

                Epistaxis (27%)

                Headache (24%)

                Diarrhea (21%)

                Decreased weight (20%)

                Proteinuria (20%)

                Myalgia (19%)

                Back pain (12%)

                >10% (Metastatic Colorectal Cancer)

                Leukopenia (37%)

                Diarrhea (34%)

                Neutropenia (21%)

                Hypertension (12%)

                >10% (HCC)

                Increased AST (86%)

                Increased alkaline phosphatase (70%)

                Decreased platelet (68%)

                Decreased lymphocytes (62%)

                Increased ALT (62%)

                Decreased albumin (60%)

                Decreased hemoglobin (58%)

                Decreased sodium (54%)

                Increased glucose (48%)

                Decreased leukocytes (32%)

                Decreased calcium (30%)

                Hypertension (30%)

                Decreased phosphorus (26%)

                Fatigue/asthenia (26%)

                Decreased neutrophil (23%)

                Increased potassium (23%)

                Hypomagnesia (22%)

                Proteinuria (20%)

                Pruritus (19%)

                Diarrhea (19%)

                Decreased appetite (18%)

                Pyrexia (18%)

                Increased AST, Grade 3-4 (16%)

                Hypertension, Grade 3-4 (15%)

                Constipation (13%)

                Decreased lymphocytes, Grade 3-4 (13%)

                Decreased sodium, Grade 3-4 (13%)

                Abdominal pain (12%)

                Nausea (12%)

                Rash (12%)

                Cough (12%)

                Infusion-related reactions (11%)

                1-10% (Epithelial ovarian, fallopian tube or primary peritoneal cancer)

                Treatment following resection

                • Nasal mucosal disorder (7-10%)

                Platinum resistant

                • Epistaxis (5%)

                Platinum-sensitive

                • Rhinorrhea (10%)
                • Hyperkalemia (9%)
                • Hemorrhoids (8%)
                • Sinus congestion (8%)
                • Gingival bleeding (7%)

                1-10% (Metastatic Colorectal Cancer)

                Asthenia (10%)

                Deep vein thrombosis (9%)

                Abdominal pain (8%)

                Pain (8%)

                Constipation (4%)

                Intra-abdominal thrombosis (3%)

                Syncope (3%)

                1-10% (Metastatic Renal Cell Carcinoma)

                Dysphonia (5%)

                1-10% (HCC)

                Increased glucose, Grade 3-4 (9%)

                Increased ALT, Grade 3-4 (8%)

                Increased bilirubin, Grade 3-4 (8%)

                Decreased phosphorus, Grade 3-4 (4.7%)

                Increased alkaline phosphatase, Grade 3-4 (4%)

                Increased leukocytes, Grade 3-4 (3.4%)

                Decreased hemoglobin, Grade 3-4 (3.1%)

                Proteinuria, Grade 3-4 (3%)

                Infusion-related reactions, Grade 3-4 (2.4%)

                Decreased neutrophils (2.3%)

                Fatigue/asthenia, Grade 3-4 (2%)

                Increased potassium, Grade 3-4 (1.9%)

                Diarrhea, Grade 3-4 (1.8%)

                Decreased albumin, Grade 3-4 (1.5%)

                Decreased appetite, Grade 3-4 (1.2%)

                <1% (HCC)

                Decreased calcium, Grade 3-4 (0.3%)

                Postmarketing Reports

                Body as whole: Polyserositis

                Cardiovascular: Pulmonary hypertension, RPLS, mesenteric venous occlusion, arterial (including aortic) aneurysms, dissections, and rupture

                Osteonecrosis of the jaw

                Eye disorders (from unapproved intravitreal use for treatment of various ocular disorders): Permanent loss of vision, endophthalmitis (infectious and sterile), intraocular inflammation, retinal detachment, increased IOP, hemorrhage (including conjunctival, vitreous hemorrhage, or retinal hemorrhage), vitreous floaters, ocular hyperemia, ocular pain or discomfort

                Gastrointestinal: Gastrointestinal ulcer, intestinal necrosis, anastomotic ulceration

                Hemic and lymphatic: Pancytopenia

                Hepatobiliary disorders: Gallbladder perforation

                Infections and infestations: Necrotizing fasciitis, usually secondary to wound healing complications, gastrointestinal perforation or fistula formation

                Musculoskeletal: Osteonecrosis of the jaw

                Renal: Renal thrombotic microangiopathy

                Respiratory: Nasal septum perforation

                Dysphonia

                Persistent, recurrent, or metastatic carcinoma of the cervix

                Systemic events (from unapproved intravitreal use for treatment of various ocular disorders): Arterial thromboembolic events, hypertension, gastrointestinal perforation, hemorrhage

                Non-mandibular osteonecrosis and posterior reversible encephalopathy syndrome (PRES)

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                Warnings

                Contraindications

                None

                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 ≥2 g proteinuria/24 hr; discontinue if nephrotic syndrome occurs (incidence <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 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
                • 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
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                Pregnancy & Lactation

                Pregnancy

                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

                Animal data

                • In animal reproduction studies, IV administration of bevacizumab to pregnant rabbits every 3 days during organogenesis at doses ~1-10 times the clinical dose of 10 mg/kg produced fetal resorptions, decreased maternal and fetal weight gain and multiple congenital malformations including corneal opacities and abnormal ossification of the skull and skeleton including limb and phalangeal defects
                • Animal models link angiogenesis and VEGF and VEGF Receptor 2 (VEGFR2) to critical aspects of female reproduction, embryofetal development, and postnatal development

                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

                Lactation

                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

                Pregnancy Categories

                A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

                B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

                C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

                D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

                X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

                NA: Information not available.

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                Pharmacology

                Mechanism of Action

                Recombinant humanized monoclonal antibody to VEGF; blocks the angiogenic molecule VEGF thereby inhibiting tumor angiogenesis, starving tumor of blood and nutrients

                Absorption

                Steady-state concentration is 84 days

                Accumulation ratio: 2.8 (following 10 mg/kg dose)

                Distribution

                Vd: 2.9 L (mean); 3.2 L (males); 2.7 L (females)

                Elimination

                Clearance: 0.23 L/day (mean); 0.26 L/day (males); 0.21 L/day (women)

                Half-life: 20 days

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                Administration

                IV Compatibilities

                0.9% NaCl

                IV Incompatibilities

                D5W or any dextrose-containing solution

                IV Preparation

                Visually inspect for particulate matter and discoloration prior to administration

                Do not use vial if solution is cloudy, discolored, or contains particulate matter

                Aseptically withdraw necessary amount & dilute in a total volume of 100 mL NS

                Diluted solutions for infusion may be stored at 2-8°C for 8 hr

                Do not shake vials or diluted solutions

                IV Administration

                IV infusion only; do not administer as IV push or bolus

                First infusion: Infuse over 90 min

                Second infusion: Infuse over 60 min if first infusion is tolerated

                Subsequent infusions: Infuse over 30 min if second infusion over 60 min is tolerated

                Elective surgery

                • Withhold for at least 28 days before elective surgery
                • Do not administer until at least 28 days following surgery and until adequate wound healing

                Storage

                Do not freeze

                Protect vials from light

                Unused vials: Refrigerate at 2-8°C (36-46°F)

                Diluted solutions: Refrigerate at 2-8°C (36-46°F) for up to 8 hours

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                Images

                BRAND FORM. UNIT PRICE PILL IMAGE
                Avastin intravenous
                -
                25 mg/mL vial
                Avastin intravenous
                -
                25 mg/mL vial
                Avastin intravenous
                -
                25 mg/mL vial

                Copyright © 2010 First DataBank, Inc.

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                Patient Handout

                Patient Education
                bevacizumab intravenous

                BEVACIZUMAB - INJECTION

                (BE-va-SIZ-oo-mab)

                COMMON BRAND NAME(S): Avastin, Mvasi, Zirabev

                USES: This medication is a man-made antibody (IgG1) used to treat various types of cancer. This drug works by blocking a certain protein (vascular endothelial growth factor-VEGF) thereby decreasing the blood supply to the tumor and slowing tumor growth.This monograph is about the following bevacizumab products: bevacizumab, bevacizumab-awwb, and bevacizumab-bvzr.

                HOW TO USE: This medication is given by infusion into a vein by a health care professional. The first dose is usually given over 90 minutes. If you tolerate the first dose well, then later infusions may be given over a shorter time (60 or 30 minutes).The dosage is based on your medical condition, response to previous therapy, and your weight. Tell your doctor if your weight changes.Use this medication regularly in order to get the most benefit from it. Try not to miss any doses.

                SIDE EFFECTS: Dry mouth, cough, voice changes, loss of appetite, diarrhea, vomiting, constipation, mouth sores, nausea, or headache may occur. If any of these effects persist or worsen, notify your doctor or pharmacist right away.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: fast heartbeat, symptoms of heart failure (such as swelling ankles/feet, unusual tiredness, unusual/sudden weight gain), signs of infection (such as fever, persistent sore throat), muscle cramps, muscle loss, yellowing eyes/skin, dark urine, difficulty urinating, signs of kidney problems (such as change in the amount of urine, frothy urine).Symptoms of a severe infusion reaction that may occur during bevacizumab treatment include difficulty breathing, flushing, severe dizziness, nausea/vomiting, shaking, or chest pain. Tell your healthcare professional if you have any of these symptoms during your treatment. Your doctor will monitor you closely and will temporarily stop your treatment if a reaction occurs.This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high. Your doctor may control your blood pressure with medication.Bevacizumab may rarely cause blood clots (such as pulmonary embolism, stroke, heart attack, deep vein thrombosis). You may be at increased risk for blood clots if you have a history of blood clots, heart/blood vessel disease, or if you are immobile (such as on very long plane flights or being bedridden). If you use estrogen-containing products, these may also increase your risk. Before using this medication, if you have any of these conditions report them to your doctor or pharmacist. Get medical help right away if any of these side effects occur: shortness of breath/rapid breathing, chest/jaw/left arm pain, unusual sweating, confusion, sudden dizziness/fainting, pain/swelling/warmth in groin/calf, sudden/severe headaches, trouble speaking, weakness on one side of the body, sudden vision changes.This medication can cause bleeding. Some episodes may be minor including nosebleeds, minor gum bleeding, and vaginal bleeding. If these persist or worsen, tell your doctor or pharmacist promptly.This medication can also cause serious (possibly fatal) bleeding, such as bleeding from the stomach/intestines or in the brain. You should not receive this medication if you have any serious bleeding problems. In addition, this medication can rarely cause a tear in the stomach/intestines (gastrointestinal perforation). Get medical help right away if you have any signs of these serious side effects, including bloody or black/tarry stools, persistent or severe stomach/abdominal pain, constipation with vomiting, vomit that is bloody or looks like coffee grounds, coughing up blood, shortness of breath, dizziness/fainting, unusual or persistent tiredness/weakness, severe headache, sudden/severe back pain, fever.This medication may also cause wounds to heal slowly or poorly or cause the wounds to break open. It can also rarely cause very serious (possibly fatal) skin and tissue infections that spread quickly. Get medical help right away if you have wounds that are not healing well, a fever, severe pain/redness/heat/swelling at the surgery site or other areas on the skin, fluid-filled blisters in the skin, discolored/scaling/peeling skin, confusion, dizziness, or fainting. You should not receive this medication for at least 4 weeks before and after a major surgery and until the wound from the surgery is fully healed.Rarely, bevacizumab may cause a condition called PRES (posterior reversible encephalopathy syndrome). Get medical help right away if you develop persistent headache, seizures, sudden vision changes, mental/mood changes (such as confusion).A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

                PRECAUTIONS: See also Side Effects section.Before using bevacizumab, tell your doctor or pharmacist if you are allergic to it; or to any bevacizumab products; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: stomach/intestinal ulcers, bleeding problems (such as recent bloody vomiting or coughing up blood), recent major surgery, recent injuries/wounds, high blood pressure, blood vessel problems (such as an aneurysm or a tear/break in the aorta or other blood vessels), kidney disease, diabetes.Before having surgery or any medical procedure, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Bevacizumab can make you more likely to get infections or may worsen any current infections. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.Older adults may be at greater risk for side effects (e.g., blood clots, kidney effects such as protein in the urine). See also Side Effects section.This medication can affect fertility in females. Ask your doctor for more details.During pregnancy, this medication should be used only when clearly needed. It may harm an unborn baby. Discuss the risks and benefits with your doctor. Women of child-bearing age should use reliable forms of birth control while using this medication and for 6 months after stopping treatment. If you become pregnant or think you may be pregnant, tell your doctor right away.Based on information from related drugs, this medication may pass into breast milk. Because of the possible risk to the infant, breast-feeding is not recommended while using this medication and for 6 months after stopping treatment. Consult your doctor before breast-feeding.

                DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.A product that may interact with this drug is: sunitinib.

                OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe headache.

                NOTES: Laboratory and/or medical tests (e.g., blood pressure monitoring, urine tests for protein, kidney function tests, bilirubin levels, complete blood counts-CBC) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

                MISSED DOSE: It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

                STORAGE: Not applicable. This medication is given in a clinic and will not be stored at home.

                MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

                Information last revised August 2021. Copyright(c) 2021 First Databank, Inc.

                IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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                Formulary

                FormularyPatient Discounts

                Adding plans allows you to compare formulary status to other drugs in the same class.

                To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

                Adding plans allows you to:

                • View the formulary and any restrictions for each plan.
                • Manage and view all your plans together – even plans in different states.
                • Compare formulary status to other drugs in the same class.
                • Access your plan list on any device – mobile or desktop.

                The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

                Tier Description
                1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
                2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
                3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
                4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                NC NOT COVERED – Drugs that are not covered by the plan.
                Code Definition
                PA Prior Authorization
                Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
                QL Quantity Limits
                Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
                ST Step Therapy
                Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
                OR Other Restrictions
                Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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                Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.