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ZIRABEV ® (bevacizumab-bvzr) is an FDA-approved biosimilar to Avastin® (bevacizumab)1*
ZIRABEV offers the potential to help address treatment costs and was approved by the FDA based on the totality of evidence supporting high similarity to Avastin1-3
73% of commercially insured patients have access to ZIRABEV nationwide, as of April 20223‡§
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Approved for the eligible indications of Avastin, with an identical dosing and administration schedule1
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Learn more about the ZIRABEV clinical data in support of biosimilarity
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FDA-approved biosimilars such as bevacizumab-bvzr (ZIRABEV®) are recommended as treatment options in the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®)1,4-7*||
Helpful support for your patients and practice is available
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Pfizer Oncology Together™ Co-Pay Savings Program for Injectables
Eligible,¶ commercially insured patients# may pay as little as $0 per ZIRABEV treatment.** See full Terms and Conditions below.
This program covers up to $25,000 per calendar year††
- There are no income requirements for patients to qualify
- Patients enrolled in state- or federally funded prescription insurance programs are not eligible for this program
- For information on enrollment, claims submissions, and reimbursement, visit PfizerOncologyTogether.com to download the Co-Pay Savings Program Brochure
FOR LIVE, PERSONALIZED SUPPORT
Call 1-877-744-5675 (Monday-Friday, 8 AM-8 PM ET)
*Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences between the biosimilar and the reference product.
†WAC is a manufacturer's undiscounted or list price to wholesalers/direct purchasers and, therefore, is not inclusive of discounts to payers, providers, distributors, and other purchasing organizations. Data as of May 2022.
‡Medical policy data are current as of April 2022. Please verify patient benefits to confirm coverage.
§Percentage of commercial lives where ZIRABEV is covered at parity or at an advantage to Avastin.
||NCCN Guidelines® recommend the use of an FDA-approved biosimilar as an appropriate substitute for bevacizumab. See the NCCN Guidelines for detailed recommendations, including specific treatment regimens. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.
¶|Terms and Conditions: By using this program, you acknowledge that you currently meet the eligibility criteria and will comply with the terms and conditions described below:
- The Pfizer Oncology Together Co-Pay Savings Program for Injectables for ZIRABEV® is not valid for patients who are enrolled in a state or federally funded insurance program, including but not limited to Medicare, Medicaid, TRICARE, Veterans Affairs health care, a state prescription drug assistance program, or the Government Health Insurance Plan available in Puerto Rico (formerly known as “La Reforma de Salud”).
- Program offer is not valid for cash-paying patients.
- Patients prescribed ZIRABEV for hepatocellular carcinoma are not eligible for this co-pay savings program.
- With this program, eligible patients may pay as little as $0 co-pay per ZIRABEV treatment, subject to a maximum benefit of $25,000 per calendar year for out-of-pocket expenses for ZIRABEV including co-pays or coinsurances.
- The amount of any benefit is the difference between your co-pay and $0.
- After the maximum of $25,000 you will be responsible for the remaining monthly out-of-pocket costs.
- Patient must have private insurance with coverage of ZIRABEV.
- This offer is not valid when the entire cost of your prescription drug is eligible to be reimbursed by your private insurance plans or other private health or pharmacy benefit programs.
- You must deduct the value of this assistance from any reimbursement request submitted to your private insurance plan, either directly by you or on your behalf.
- You are responsible for reporting use of the program to any private insurer, health plan, or other third party who pays for or reimburses any part of the prescription filled using the program, as may be required.
- You should not use the program if your insurer or health plan prohibits use of manufacturer co-pay assistance programs.
- This program is not valid where prohibited by law.
- This program cannot be combined with any other savings, free trial or similar offer for the specified prescription.
- Co-pay card will be accepted only at participating pharmacies.
- This program is not health insurance.
- This program is good only in the U.S. and Puerto Rico.
- This program is limited to 1 per person during this offering period and is not transferable.
- No other purchase is necessary.
- Data related to your redemption of the program assistance may be collected, analyzed, and shared with Pfizer, for market research and other purposes related to assessing Pfizer's programs. Data shared with Pfizer will be aggregated and de-identified; it will be combined with data related to other assistance redemptions and will not identify you.
- Pfizer reserves the right to rescind, revoke or amend this program without notice.
- This program may not be available to patients in all states.
- For more information about Pfizer, visit www.pfizer.com.
- For more information about the Pfizer Oncology Together Co-Pay Savings Program for Injectables, visit pfizeroncologytogether.com, call 1-877-744-5675, or write to
Pfizer Oncology Together Co-Pay Savings Program for Injectables
P.O. Box 220366
Charlotte, NC 28222 - Program terms and offer will expire at the end of each calendar year. Before the calendar year ends, you will receive information and eligibility requirements for continued participation.
#For patients to be eligible for the Injectables Co-Pay Program for ZIRABEV, they must have commercial insurance that covers ZIRABEV and they cannot be enrolled in a state or federally funded insurance program. Whether a co-pay expense is eligible for the Injectables Co-Pay Program for ZIRABEV benefit will be determined at the time the benefit is paid. Co-pay expenses must be in connection with a separately paid claim for ZIRABEV administered in the outpatient setting.
**The Injectables Co-Pay Program for ZIRABEV will pay the co-pay for ZIRABEV up to the annual assistance limit of $25,000 per calendar year per patient.
††The Injectables Co-Pay Program for ZIRABEV provides assistance for eligible, commercially insured patients prescribed ZIRABEV for co-pays or coinsurance incurred for ZIRABEV up to $25,000 per calendar year. It does not cover or provide support for supplies, services, procedures, or any other physician-related services associated with ZIRABEV treatment.
- ZIRABEV [prescribing information]. New York, NY: Pfizer Inc.; May 2021.
- US Food and Drug Administration. Guidance for Industry: Scientific Considerations in Demonstrating Biosimilarity to a Reference Product. Silver Spring, MD: FDA, US Dept of Health and Human Services; April 2015. Accessed April 25, 2022. https://www.fda.gov/media/82647/download.
- Data on file. Pfizer Inc.; New York, NY.
- Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer V.5.2021. © 2021 National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the guideline, go online to NCCN.org.
- Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Colon Cancer V.2.2021. © 2021 National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the guideline, go online to NCCN.org.
- Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Kidney Cancer V.4.2021. © 2021 National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the guideline, go online to NCCN.org.
- Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Ovarian Cancer V.1.2021. © 2021 National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the guideline, go online to NCCN.org.
Avastin is a registered trademark of Genentech, Inc.
Warnings and Precautions
- Gastrointestinal Perforations and Fistulae. Serious and sometimes fatal gastrointestinal perforation occurred at a higher incidence in patients receiving bevacizumab products compared to patients receiving chemotherapy. The incidence ranged from 0.3% to 3% across clinical studies. Non-GI fistulae incidence ranged from <1% to 1.8%, and was highest in patients with cervical cancer. Avoid ZIRABEV 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. Discontinue for gastrointestinal perforations, tracheoesophageal fistula, grade 4 fistula, or fistula formation involving any internal organ
- Surgery and Wound Healing Complications. The incidence of wound healing and surgical complications, including serious and fatal complications, is increased in bevacizumab-treated patients. In patients who experience wound healing complications during ZIRABEV treatment, withhold ZIRABEV until adequate wound healing. Withhold for at least 28 days prior to elective surgery. Do not administer for at least 28 days following major surgery and until adequate wound healing. The safety of resumption of bevacizumab products after resolution of wound healing complications has not been established. Discontinue for wound healing complications of necrotizing fasciitis
- Hemorrhage. Severe or fatal hemorrhage, including hemoptysis, GI bleeding, hematemesis, central nervous system hemorrhage, epistaxis, and vaginal bleeding occurred up to 5-fold more frequently in patients receiving bevacizumab. In clinical studies, the incidence of grade ≥3 hemorrhagic events among patients receiving bevacizumab ranged from 0.4% to 7%. Do not administer ZIRABEV to patients with serious hemorrhage or a recent history of hemoptysis (≥1/2 tsp of red blood). Discontinue ZIRABEV in patients who develop grade 3-4 hemorrhage
- Additional serious and sometimes fatal adverse events with increased incidence in the bevacizumab-treated arm vs chemotherapy arm included:
- Arterial thromboembolic events (ATE) (grade ≥3, 5%, highest in patients with GBM). Discontinue in patients who develop a severe ATE
-
Renal injury and proteinuria. Monitor proteinuria during ZIRABEV therapy. Patients with a 2+ or greater urine dipstick reading should undergo 24-hour urine collection. Withhold for proteinuria ≥2 grams per 24 hours and resume when less than 2 grams per 24 hours. Discontinue in patients who develop nephrotic syndrome
- Grade 3-4 proteinuria ranged from 0.7% to 7% in clinical studies
- Nephrotic syndrome (<1%)
- Additional serious adverse events with increased incidence in the bevacizumab-treated arm vs chemotherapy arm included:
- Venous thromboembolism events (VTE) (grade ≥3, 11% seen in Study GOG-0240). Discontinue ZIRABEV in patients with a grade 4 VTE, including pulmonary embolism
- Hypertension (grade 3-4, 5%-18%). Monitor blood pressure during treatment and, for ZIRABEV-associated hypertension, continue monitoring after discontinuation. Withhold for severe hypertension. Discontinue for hypertensive crisis or hypertensive encephalopathy
- Posterior reversible encephalopathy syndrome (PRES) (<0.5%). Discontinue ZIRABEV in patients who develop PRES. Symptoms usually resolve or improve within days after discontinuing bevacizumab products, although some patients have experienced ongoing neurologic sequelae
- Congestive heart failure (CHF) (grade ≥3 left ventricular dysfunction, 1%). Discontinue ZIRABEV in patients who develop CHF
- Infusion-related reactions. Infusion-related reactions with the first dose of bevacizumab occurred in <3% of patients, and severe reactions occurred in 0.4% of patients. Decrease the rate of infusion for mild infusion-related reactions. Interrupt the infusion in patients with clinically significant infusion-related reactions and consider resuming at a slower rate following resolution. Discontinue in patients who develop a severe infusion-related reaction and administer appropriate medical therapy
- Ovarian failure. Inform females of reproductive potential of the risk of ovarian failure prior to initiating treatment with ZIRABEV
Pregnancy Warning
- Based on the mechanism of action and animal studies, bevacizumab products may cause fetal harm
- Advise female patients that bevacizumab products may cause fetal harm and to inform their health care provider of a known or suspected pregnancy
- Advise females of reproductive potential to use effective contraception during treatment with ZIRABEV and for 6 months after the last dose of ZIRABEV
- Advise nursing women that breastfeeding is not recommended during treatment with ZIRABEV and for 6 months following their last dose of treatment
- Bevacizumab products may impair fertility
Most Common Adverse Events
- Across studies, the most common adverse reactions observed in bevacizumab patients at a rate >10% were:
- Epistaxis, headache, hypertension, rhinitis, proteinuria, taste alteration, dry skin, hemorrhage, lacrimation disorder, back pain, exfoliative dermatitis
- Across all studies, bevacizumab was discontinued in 8% to 22% of patients because of adverse reactions
Indication-Specific Adverse Events
- In first-line metastatic colorectal cancer (mCRC), the most common grade 3-4 events in Study 2107, which occurred at a (≥2%) higher incidence in the bevacizumab plus IFL vs IFL groups, were asthenia (10% vs 7%), abdominal pain (8% vs 5%), pain (8% vs 5%), hypertension (12% vs 2%), deep vein thrombosis (9% vs 5%), intra-abdominal thrombosis (3% vs 1%), syncope (3% vs 1%), diarrhea (34% vs 25%), constipation (4% vs 2%), leukopenia (37% vs 31%), and neutropenia (21% vs 14%)
- In second-line mCRC, the most common grade 3-5 (nonhematologic) and 4-5 (hematologic) events in Study E3200, which occurred at a higher incidence (≥2%) in the bevacizumab plus FOLFOX4 vs FOLFOX4 groups, 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 underestimate the true adverse event rates due to the reporting mechanisms used in this study
- In non-small cell lung cancer (NSCLC), grade 3-5 (nonhematologic) and grade 4-5 (hematologic) adverse events in Study E4599 occurring at a (≥2%) higher incidence in bevacizumab-treated patients vs controls 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%)
- In recurrent glioblastoma (rGBM) Study EORTC 26101, 22% of patients discontinued treatment in the bevacizumab with lomustine arm due to adverse reactions compared with 10% of patients in the lomustine arm. In patients receiving bevacizumab with lomustine, the adverse reaction profile was similar to that observed in other approved indications
- In metastatic renal cell carcinoma (mRCC), the most common grade 3-5 adverse events in Study BO17705, occurring at a (≥2%) higher incidence in bevacizumab-treated patients vs controls, 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)
- In persistent, recurrent, or metastatic cervical cancer, grade 3 or 4 adverse reactions in Study GOG-0240, occurring at a higher incidence (≥2%) in 218 patients receiving bevacizumab plus chemotherapy compared to 222 patients receiving chemotherapy alone, were abdominal pain (12% vs 10%), 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%), hypertension (11% vs 0.5%), thrombosis (8% vs 3%), 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%)
- In stage III or IV epithelial ovarian, fallopian tube, or primary peritoneal cancer after primary surgery:
- 608 patients received carboplatin and paclitaxel plus bevacizumab followed by bevacizumab (CPB15+), 607 patients received carboplatin and paclitaxel plus bevacizumab followed by placebo (CPB15), and 602 patients received carboplatin and paclitaxel plus placebo followed by placebo (CPP)
- Grade 3-4 adverse reactions occurring at a higher incidence (≥2%) in either of the bevacizumab arms vs the chemotherapy-only 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%)
- In platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer (psOC), grade 3-4 adverse reactions in Study AVF4095g, occurring at a higher incidence (≥2%) in 247 patients receiving bevacizumab plus carboplatin and gemcitabine (chemotherapy) compared to 233 patients receiving placebo plus 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%)
- In platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, grade 3-4 adverse reactions in Study GOG-0213, occurring at a higher incidence (≥2%) in 325 patients receiving bevacizumab plus carboplatin and paclitaxel (chemotherapy) compared to 332 patients receiving 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 (3.0% vs 0%)
- In platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer (prOC), grade 3-4 adverse reactions in Study MO22224, occurring at a higher incidence (≥2%) in 179 patients receiving bevacizumab plus 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%)
Metastatic Colorectal Cancer
ZIRABEV, in combination with intravenous fluorouracil-based chemotherapy, is indicated for the first- or second-line treatment of patients with metastatic colorectal cancer (mCRC).
ZIRABEV, in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy, is indicated for the second-line treatment of patients with mCRC who have progressed on a first-line bevacizumab product-containing regimen.
Limitation of Use: ZIRABEV is not indicated for adjuvant treatment of colon cancer.
First-Line Non-Squamous Non-Small Cell Lung Cancer
ZIRABEV, in combination with carboplatin and paclitaxel, is indicated for the first-line treatment of patients with unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer (NSCLC).
Recurrent Glioblastom
ZIRABEV is indicated for the treatment of recurrent glioblastoma (GBM) in adults.
Metastatic Renal Cell Carcinoma
ZIRABEV, in combination with interferon alfa, is indicated for the treatment of metastatic renal cell carcinoma (mRCC).
Persistent, Recurrent, or Metastatic Cervical Cancer
ZIRABEV, in combination with paclitaxel and cisplatin or paclitaxel and topotecan, is indicated for the treatment of patients with persistent, recurrent, or metastatic cervical cancer.
Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
ZIRABEV, in combination with carboplatin and paclitaxel, followed by ZIRABEV as a single agent, is indicated for the treatment of patients with stage III or IV epithelial ovarian, fallopian tube, or primary peritoneal cancer following initial surgical resection.
ZIRABEV, in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan, is indicated for the treatment of patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than 2 prior chemotherapy regimens.
ZIRABEV, in combination with carboplatin and paclitaxel, or with carboplatin and gemcitabine, followed by ZIRABEV as a single agent, is indicated for the treatment of patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.
Please see full Prescribing Information for additional Important Safety Information.
IndicationS
Metastatic Colorectal Cancer
ZIRABEV, in combination with intravenous fluorouracil-based chemotherapy, is indicated for the first- or second-line treatment of patients with metastatic colorectal cancer (mCRC).
ZIRABEV, in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy, is indicated for the second-line treatment of patients with mCRC who have progressed on a first-line bevacizumab product-containing regimen.
Limitation of Use: ZIRABEV is not indicated for adjuvant treatment of colon cancer.
First-Line Non-Squamous Non-Small Cell Lung Cancer
ZIRABEV, in combination with carboplatin and paclitaxel, is indicated for the first-line treatment of patients with unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer (NSCLC).
Recurrent Glioblastoma
ZIRABEV is indicated for the treatment of recurrent glioblastoma (GBM) in adults.
Metastatic Renal Cell Carcinoma
ZIRABEV, in combination with interferon alfa, is indicated for the treatment of metastatic renal cell carcinoma (mRCC).
Persistent, Recurrent, or Metastatic Cervical Cancer
ZIRABEV, in combination with paclitaxel and cisplatin or paclitaxel and topotecan, is indicated for the treatment of patients with persistent, recurrent, or metastatic cervical cancer.
Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
ZIRABEV, in combination with carboplatin and paclitaxel, followed by ZIRABEV as a single agent, is indicated for the treatment of patients with stage III or IV epithelial ovarian, fallopian tube, or primary peritoneal cancer following initial surgical resection.
ZIRABEV, in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan, is indicated for the treatment of patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than 2 prior chemotherapy regimens.
ZIRABEV, in combination with carboplatin and paclitaxel, or with carboplatin and gemcitabine, followed by ZIRABEV as a single agent, is indicated for the treatment of patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.
Please see full Prescribing Information.
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