Bevacizumab

What is Bevacizumab?

• Bevacizumab (Avastin) is a vascular endothelial growth factor inhibitor used alone or with other drugs to treat certain types of cervical, colorectal, lung, and kidney cancer, and glioblastoma (a type of brain cancer).

Angiogenesis Inhibitors Image

What are the uses of this medicine?

Bevacizumab (Avastin) is indicated for the treatment of:

• Metastatic colorectal cancer, in combination with intravenous fluorouracil-based chemotherapy for first- or second-line treatment.
• Metastatic colorectal cancer, in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on a first-line Avastin-containing regimen.
• Unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer, in combination with carboplatin and paclitaxel for first-line treatment.
• Recurrent glioblastoma in adults.
• Metastatic renal cell carcinoma in combination with interferon alfa.
• Persistent, recurrent, or metastatic cervical cancer, in combination with paclitaxel and cisplatin, or paclitaxel and topotecan.

Epithelial ovarian, fallopian tube, or primary peritoneal cancer:

• in combination with carboplatin and paclitaxel, followed by Avastin as a single agent, for stage III or IV disease following initial surgical resection.
• in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan for platinum-resistant recurrent disease who received no more than 2 prior chemotherapy regimens.
• in combination with carboplatin and paclitaxel or carboplatin and gemcitabine, followed by Avastin as a single agent, for platinum-sensitive recurrent disease.

Hepatocellular Carcinoma (HCC):

• in combination with atezolizumab for the treatment of patients with unresectable or metastatic HCC who have not received prior systemic therapy.

Limitations of Use:

• Avastin is not indicated for adjuvant treatment of colon cancer.

How does this medicine work?

• Bevacizumab (be” va siz’ ue mab) is a recombinant humanized monoclonal IgG1 antibody which is directed at and binds avidly to circulating vascular endothelial growth factor (VEGF).
• Receptors for VEGF (Flt-1 and KDR) are present on endothelial cells, and the engagement of VEGF with these receptors promotes angiogenesis. Inhibition of VEGF decreases formation of new blood vessels, which plays an important role in growth and spread of cancer cells.
• When used in combination with other antineoplastic agents, bevacizumab has been shown to extend both recurrence-free as well as overall patient survival in several forms of advanced cancer.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• No clinically meaningful drug interactions have been observed.

Is this medicine FDA approved?

• Bevacizumab was approved in the United States in 2004 for use in metastatic colon cancer.
• Indications were subsequently extended to selected forms of non-small cell lung cancer, breast and renal cancer and glioblastoma.
• However, the indication for use in breast cancer was withdrawn in 2011 because of lack of evidence that bevacizumab extended overall patient survival.

How should this medicine be used?

Recommended dosage: Metastatic colorectal cancer:

• 5 mg/kg every 2 weeks with bolus-IFL
• 10 mg/kg every 2 weeks with FOLFOX4
• 5 mg/ kg every 2 weeks or 7.5 mg/kg every 3 weeks with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy after progression on a first-line Avastin containing regimen

First-line non–squamous non–small cell lung cancer:

• 15 mg/kg every 3 weeks with carboplatin and paclitaxel

Recurrent glioblastoma:

• 10 mg/kg every 2 weeks

Metastatic renal cell carcinoma:

• 10 mg/kg every 2 weeks with interferon alfa

Persistent, recurrent, or metastatic cervical cancer:

• 15 mg/kg every 3 weeks with paclitaxel and cisplatin, or paclitaxel and topotecan

Stage III or IV epithelial ovarian, fallopian tube or primary peritoneal cancer following initial surgical resection:

• 15 mg/kg every 3 weeks with carboplatin and paclitaxel for up to 6 cycles, followed by 15 mg/kg every 3 weeks as a single agent, for a total of up to 22 cycles

Platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer:

• 10 mg/kg every 2 weeks with paclitaxel, pegylated liposomal doxorubicin, or topotecan given every week
• 15 mg/kg every 3 weeks with topotecan given every 3 weeks

Platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer:

• 15 mg/kg every 3 weeks with carboplatin and paclitaxel for 6-8 cycles, followed by 15 mg/kg every 3 weeks as a single agent
• 15 mg/kg every 3 weeks with carboplatin and gemcitabine for 6-10 cycles, followed by 15 mg/kg every 3 weeks as a single agent

Hepatocellular Carcinoma:

• 15 mg/kg after administration of 1,200 mg of atezolizumab every 3 weeks

Administration:

• Administer as an intravenous infusion.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Injection: 100 mg/4 mL (25 mg/mL) or 400 mg/16 mL (25 mg/mL) in a single-dose vial

This medicine is available in fallowing brand namesː

• Avastin;Alymsys;Mvasi;Zirabev

What side effects can this medication cause?

The most common side effects of this medicine include:

• epistaxis
• headache
• hypertension
• rhinitis
• proteinuria
• taste alteration
• dry skin
• hemorrhage
• lacrimation disorder
• back pain
• exfoliative dermatitis

What special precautions should I follow?

• Serious, and sometimes fatal, gastrointestinal perforation occurred at a higher incidence in patients receiving Avastin compared to patients receiving chemotherapy. Discontinue for gastrointestinal perforations, tracheoesophageal fistula, grade 4 fistula, or fistula formation involving any organ.
• In patients who experience wound healing complications during Avastin treatment, withhold Avastin until adequate wound healing. Withhold for at least 28 days prior to elective surgery. Do not administer Avastin for at least 28 days following a major surgery, and until adequate wound healing. The safety of resumption of AVASTIN after resolution of wound healing complication has not been established. Discontinue for wound healing complication of necrotizing fasciitis.
• Avastin can result in two distinct patterns of bleeding: minor hemorrhage, which is most commonly Grade 1 epistaxis, and serious hemorrhage, which in some cases has been fatal. Severe or fatal hemorrhages have occurred. Do not administer for recent hemoptysis. Discontinue for Grade 3-4 hemorrhage.
• Serious, sometimes fatal, arterial thromboembolic events (ATE) including cerebral infarction, transient ischemic attacks, myocardial infarction, and angina, occurred at a higher incidence in patients receiving Avastin compared to patients receiving chemotherapy. Discontinue for severe ATE.
• An increased risk of venous thromboembolic events (VTE) was observed across clinical studies. Discontinue for Grade 4 VTE.
• Severe hypertension occurred at a higher incidence in patients receiving Avastin as compared to patients receiving chemotherapy alone. Monitor blood pressure and treat hypertension. Withhold if not medically controlled; resume once controlled. Discontinue for hypertensive crisis or hypertensive encephalopathy
• Posterior reversible encephalopathy syndrome (PRES) was reported. Discontinue Avastin in patients who develop PRES.
• The incidence and severity of proteinuria was higher in patients receiving Avastin as compared to patients receiving chemotherapy. Monitor urine protein. Discontinue for nephrotic syndrome. Withhold until less than 2 grams of protein in urine.
• Infusion-related reactions reported with Avastin. Decrease rate for infusion-related reactions. Discontinue for severe infusion-related reactions and administer medical therapy.
• Avastin may cause fetal harm. Advise females of potential risk to fetus and need for use of effective contraception.
• Based on its mechanism of action and findings from animal studies, Avastin may cause fetal harm when administered to pregnant women. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with Avastin and for 6 months after the last dose.
• Avastin is not indicated for use with anthracycline-based chemotherapy. The incidence of Grade ≥ 3 left ventricular dysfunction was in patients receiving Avastin compared to patients receiving chemotherapy alone. Discontinue Avastin in patients who develop CHF.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Based on findings from animal studies and its mechanism of action , Avastin may cause fetal harm in pregnant women.
• Advise pregnant women of the potential risk to a fetus.

Can this medicine be used in children?

• The safety and effectiveness of Avastin in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredients:

• BEVACIZUMAB

Inactive ingredients:

• TREHALOSE DIHYDRATE
• SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE
• SODIUM PHOSPHATE, DIBASIC, ANHYDROUS
• POLYSORBATE 20
• WATER

Who manufactures and distributes this medicine?

• Manufactured by:

Genentech, Inc. A Member of the Roche Group 1 DNA Way South San Francisco, CA

• Avastin® is a registered trademark of Genentech, Inc.

What should I know about storage and disposal of this medication?

• Store refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton until time of use to protect from light.
• Do not freeze or shake the vial or carton.

• Dailymed label info on Bevacizumab
• FDA Bevacizumab

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