Avzivi: Uses, Dosage & Side Effects
A bevacizumab biosimilar – anti-VEGF monoclonal antibody used in combination with chemotherapy for the treatment of various cancers
Avzivi (bevacizumab) is a biosimilar monoclonal antibody used in the treatment of various types of cancer. It works by blocking vascular endothelial growth factor A (VEGF-A), a protein that promotes the formation of new blood vessels that tumors need to grow and spread. Avzivi is administered as an intravenous infusion in a hospital or infusion center, always in combination with chemotherapy. It is approved for use in metastatic colorectal cancer, metastatic non-small cell lung cancer, metastatic renal cell carcinoma, advanced epithelial ovarian cancer, cervical cancer, and recurrent glioblastoma. As a biosimilar, Avzivi has been rigorously demonstrated to be equivalent to the reference product Avastin in terms of quality, safety, and efficacy through comprehensive comparative clinical studies.
Quick Facts: Avzivi
Key Takeaways
- Avzivi is a biosimilar to Avastin (bevacizumab), a recombinant humanized monoclonal antibody that inhibits angiogenesis by blocking VEGF-A, cutting off the tumor's blood supply and slowing cancer growth.
- It is approved for use in combination with chemotherapy for multiple cancer types, including metastatic colorectal cancer, non-small cell lung cancer, renal cell carcinoma, ovarian cancer, cervical cancer, and glioblastoma.
- Avzivi is administered as an intravenous infusion in a healthcare setting; the first dose is given over 90 minutes, with subsequent infusions potentially shortened to 30 minutes if well tolerated.
- Important risks include gastrointestinal perforation, wound healing complications, hemorrhage, thromboembolic events, and hypertension – your oncologist will monitor you closely throughout treatment.
- Women of childbearing potential must use effective contraception during treatment and for at least 6 months after the last dose, as bevacizumab can cause serious harm to an unborn baby.
What Is Avzivi and What Is It Used For?
Avzivi contains the active substance bevacizumab, a recombinant humanized immunoglobulin G1 (IgG1) monoclonal antibody produced using Chinese hamster ovary (CHO) cell technology. As a biosimilar, Avzivi has been developed to be highly similar to the reference biological medicine Avastin, which was first approved by the U.S. Food and Drug Administration (FDA) in 2004 and by the European Medicines Agency (EMA) in 2005. Comprehensive analytical, non-clinical, and clinical studies have demonstrated that Avzivi is equivalent to Avastin in terms of quality, safety, and efficacy, meeting the stringent regulatory requirements for biosimilar approval.
Bevacizumab targets a protein called vascular endothelial growth factor A (VEGF-A), which plays a central role in the process of angiogenesis – the formation of new blood vessels from pre-existing ones. Angiogenesis is a normal physiological process essential for wound healing, tissue repair, and embryonic development. However, solid tumors exploit angiogenesis to establish their own blood supply, a process known as the "angiogenic switch." Without an adequate blood supply, tumors cannot grow beyond a few millimeters in diameter or spread (metastasize) to distant organs. VEGF-A is the most potent and specific driver of tumor angiogenesis, and its overexpression has been documented in virtually all solid tumor types.
By binding to VEGF-A with high affinity and preventing it from interacting with its receptors (VEGFR-1 and VEGFR-2) on the surface of vascular endothelial cells, bevacizumab inhibits tumor angiogenesis through several mechanisms. First, it directly prevents the formation of new blood vessels within and around the tumor. Second, it causes regression of existing immature tumor vasculature. Third, it normalizes the remaining tumor blood vessels, reducing their permeability and improving the delivery of concomitantly administered chemotherapy drugs to the tumor. This "vascular normalization" effect is considered a key mechanism by which bevacizumab enhances the efficacy of chemotherapy combinations.
Avzivi is indicated for use in adult patients for the following cancer types, always in combination with other anticancer medicines:
- Metastatic colorectal cancer (mCRC): In combination with fluoropyrimidine-based chemotherapy (e.g., FOLFOX, FOLFIRI, or capecitabine-based regimens) for first-line and second-line treatment. Bevacizumab was first shown to significantly improve overall survival in mCRC in the landmark AVF2107g trial, which demonstrated a median overall survival improvement of approximately 5 months when added to IFL chemotherapy.
- Metastatic non-small cell lung cancer (NSCLC): In combination with platinum-based chemotherapy (e.g., carboplatin and paclitaxel) for first-line treatment of patients with unresectable advanced, metastatic, or recurrent non-squamous NSCLC. The pivotal ECOG 4599 trial demonstrated a significant improvement in overall survival with the addition of bevacizumab to carboplatin-paclitaxel.
- Advanced and/or metastatic renal cell carcinoma (mRCC): In combination with interferon alfa-2a for first-line treatment.
- Epithelial ovarian, fallopian tube, and primary peritoneal cancer: In combination with carboplatin and paclitaxel for front-line treatment of advanced disease (FIGO stages IIIB, IIIC, and IV), in combination with carboplatin and gemcitabine for platinum-sensitive recurrent disease, and in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin for platinum-resistant recurrent disease.
- Cervical cancer: In combination with paclitaxel and cisplatin or paclitaxel and topotecan for persistent, recurrent, or metastatic cervical cancer.
- Recurrent glioblastoma (GBM): As monotherapy or in combination with lomustine for adult patients with recurrent glioblastoma following prior treatment (approved in certain regulatory jurisdictions).
The therapeutic benefits of bevacizumab have been established through numerous large-scale, randomized, controlled clinical trials involving thousands of patients across multiple tumor types. These trials have consistently demonstrated improvements in progression-free survival and, in several indications, overall survival when bevacizumab is added to standard chemotherapy regimens. Avzivi, as a biosimilar, benefits from this extensive clinical evidence base while also having demonstrated equivalence through its own dedicated comparative clinical program.
A biosimilar is a biological medicine that is highly similar to an already approved biological medicine (the "reference product"). Unlike generic medicines, which are chemically identical to the original, biosimilars are produced using living cells and are therefore structurally complex. To gain regulatory approval, a biosimilar must demonstrate through rigorous analytical, non-clinical, and clinical studies that it has no clinically meaningful differences from the reference product in terms of quality, safety, and efficacy. Avzivi has met all these requirements as a biosimilar to Avastin.
What Should You Know Before Taking Avzivi?
Contraindications
Avzivi must not be used in patients who are hypersensitive (allergic) to bevacizumab, to Chinese hamster ovary (CHO) cell products, or to any of the other ingredients in the formulation. Additionally, Avzivi is contraindicated in patients with untreated central nervous system (CNS) metastases, as the anti-angiogenic mechanism may increase the risk of CNS hemorrhage. Avzivi must not be used during pregnancy due to the essential role of angiogenesis in fetal development.
Before initiating Avzivi treatment, your oncologist will assess your overall health status and ensure that there are no absolute contraindications. A thorough medical history, physical examination, and relevant laboratory tests will be performed to identify any risk factors that may require additional monitoring or dose modifications.
Warnings and Precautions
Bevacizumab has been associated with serious and sometimes fatal gastrointestinal (GI) perforation. The incidence across clinical trials ranges from 0.3% to 3.2%. Signs of GI perforation include abdominal pain, nausea, vomiting, constipation, and fever. If you develop any of these symptoms, contact your healthcare team immediately. Avzivi should be permanently discontinued if GI perforation occurs.
Several important warnings and precautions apply to Avzivi treatment. Your oncologist will discuss these with you in detail before starting therapy:
- Wound healing complications: Bevacizumab inhibits angiogenesis, which is essential for normal wound healing. Treatment with Avzivi should not be initiated for at least 28 days after major surgery or until the surgical wound has fully healed. If wound healing complications develop during treatment, Avzivi should be withheld until the wound has adequately healed. Elective surgery should be planned with an appropriate washout period – treatment should be suspended for a suitable period prior to planned surgery.
- Hemorrhage: Bevacizumab is associated with an increased risk of hemorrhage, ranging from minor events such as nosebleeds (epistaxis) to severe and potentially fatal hemorrhagic events including hemoptysis (coughing up blood), gastrointestinal bleeding, CNS hemorrhage, and vaginal bleeding. Patients with non-squamous NSCLC have a higher risk of severe pulmonary hemorrhage. Do not use Avzivi in patients with a history of grade 3 or 4 hemorrhage within the previous month, or those receiving full-dose anticoagulation for thromboembolic events unless the bleeding risk is carefully assessed.
- Arterial thromboembolic events (ATE): An increased incidence of arterial thromboembolic events, including cerebrovascular accidents (stroke), transient ischemic attacks, and myocardial infarction, has been observed with bevacizumab treatment. Patients aged over 65 years and those with a prior history of arterial thromboembolism are at higher risk. Avzivi should be permanently discontinued if an arterial thromboembolic event occurs.
- Venous thromboembolic events (VTE): Deep vein thrombosis and pulmonary embolism have been reported. Patients should be monitored for signs and symptoms of VTE.
- Hypertension: Bevacizumab frequently causes hypertension (high blood pressure). Blood pressure should be monitored regularly before and during treatment. Most cases can be managed with standard antihypertensive medications. Avzivi should be temporarily withheld if severe hypertension cannot be controlled, and permanently discontinued if hypertensive crisis or hypertensive encephalopathy develops.
- Proteinuria: Protein in the urine (proteinuria) occurs commonly with bevacizumab. Urinalysis should be performed regularly during treatment. Avzivi should be withheld for proteinuria of 2 g or more per 24 hours, and permanently discontinued for nephrotic syndrome.
- Posterior reversible encephalopathy syndrome (PRES): Rare cases of PRES have been reported. Symptoms include headache, seizures, lethargy, confusion, visual disturbances, and hypertension. PRES can be confirmed by brain imaging (MRI). Avzivi should be discontinued if PRES develops.
- Infusion-related reactions: Severe infusion reactions, including hypertension, hypertensive crises, wheezing, oxygen desaturation, bronchospasm, chest pain, headache, and rigor, have been reported. If a severe reaction occurs, the infusion should be discontinued and appropriate medical therapy administered.
Pregnancy and Breastfeeding
Avzivi must not be used during pregnancy. Angiogenesis is critical for fetal development, and inhibition of VEGF has been shown to cause embryo-fetal toxicity in animal studies, including malformations and decreased fetal weight. Women of childbearing potential must use effective contraception during treatment and for at least 6 months after the last dose of Avzivi. If you become pregnant during treatment, inform your oncologist immediately.
Animal reproductive toxicology studies with bevacizumab have demonstrated dose-dependent embryo-fetal toxicity, including skeletal malformations, reduced fetal body weight, and increased embryo-fetal resorption. These effects were observed at doses below the recommended human clinical dose. Given the critical role of VEGF in fetal angiogenesis and organogenesis, the use of any VEGF inhibitor during pregnancy is expected to carry substantial risk of harm to the developing fetus. Avzivi is therefore contraindicated in pregnancy.
It is not known whether bevacizumab is excreted in human breast milk. Because human IgG1 antibodies are known to pass into breast milk, and because of the potential for serious adverse effects in nursing infants, breastfeeding should be discontinued during Avzivi treatment and for at least 6 months after the last dose. The decision to discontinue breastfeeding or to discontinue the drug should take into account the importance of the drug to the mother's treatment plan.
Fertility
Bevacizumab may impair female fertility. Ovarian failure, manifested as amenorrhea, irregular menses, and decreased levels of anti-Müllerian hormone (AMH) and follicle-stimulating hormone (FSH), has been reported in premenopausal women receiving bevacizumab. These effects were partially reversible after discontinuation of treatment, but long-term effects on fertility are not fully characterized. Women of childbearing potential should be counseled about these potential effects on fertility before initiating treatment.
Elderly Patients
Patients aged 65 years and older have an increased risk of developing certain side effects during bevacizumab treatment, particularly arterial thromboembolic events (including stroke and myocardial infarction), leukopenia, thrombocytopenia, neutropenia, proteinuria, and fatigue. Age alone is not a contraindication to treatment, but elderly patients require careful assessment and closer monitoring. The benefits and risks of Avzivi therapy should be discussed on an individual basis.
How Does Avzivi Interact with Other Drugs?
As a monoclonal antibody, bevacizumab is degraded through general protein catabolic pathways rather than through hepatic cytochrome P450 (CYP) enzyme-mediated metabolism. This means that traditional pharmacokinetic drug-drug interactions, which are common with small-molecule drugs, are not expected with Avzivi. Population pharmacokinetic analyses from the bevacizumab clinical development program involving more than 1,700 patients across multiple tumor types have confirmed that concomitant chemotherapy agents do not significantly alter bevacizumab clearance.
However, pharmacodynamic interactions – where the combined biological effects of two drugs produce clinically meaningful consequences – are an important consideration with bevacizumab. Since Avzivi is always administered in combination with chemotherapy, understanding these interactions is essential for safe and effective treatment.
| Drug / Drug Class | Interaction Type | Clinical Significance |
|---|---|---|
| Sunitinib | Pharmacodynamic | Increased risk of microangiopathic hemolytic anemia (MAHA). Combination not recommended. |
| Irinotecan | Pharmacokinetic/Pharmacodynamic | Bevacizumab may increase exposure to SN-38 (active metabolite of irinotecan) by ~33%. Increased risk of diarrhea and neutropenia. Monitor closely. |
| Platinum-based chemotherapy | No pharmacokinetic interaction | No dose adjustments needed. Monitor for overlapping toxicities (myelosuppression, proteinuria). |
| Taxanes (paclitaxel, docetaxel) | No pharmacokinetic interaction | No dose adjustments needed. Standard chemotherapy monitoring applies. |
| Fluoropyrimidines (5-FU, capecitabine) | No pharmacokinetic interaction | No dose adjustments needed. Safe to use in combination. |
| Anticoagulants (warfarin, heparin) | Pharmacodynamic | Increased bleeding risk. Monitor coagulation parameters closely if combination is necessary. |
| Antihypertensive agents | Pharmacodynamic | Bevacizumab commonly causes hypertension. Antihypertensive medication may need to be initiated or adjusted. |
| Other anti-VEGF agents | Pharmacodynamic | Additive anti-angiogenic effects. Combination generally not recommended outside clinical trials. |
Major Interactions
The most clinically significant drug interaction involving bevacizumab is the combination with sunitinib. In clinical experience, reports of microangiopathic hemolytic anemia (MAHA) – a condition characterized by hemolytic anemia, thrombocytopenia, and renal impairment – have been observed when bevacizumab was used concurrently with sunitinib malate. This combination is therefore not recommended and should be avoided.
The interaction between bevacizumab and irinotecan is also noteworthy. Although bevacizumab and irinotecan are commonly used together in the treatment of metastatic colorectal cancer (e.g., in the FOLFIRI regimen), studies have shown that bevacizumab can increase the plasma concentration of SN-38, the active metabolite of irinotecan, by approximately 33%. This pharmacokinetic interaction may contribute to an increased incidence of certain side effects, particularly severe diarrhea and neutropenia. Close monitoring and appropriate supportive care are recommended when these drugs are used together.
Minor Interactions
No clinically significant pharmacokinetic interactions have been identified between bevacizumab and any of the commonly co-administered chemotherapy agents, including platinum compounds (cisplatin, carboplatin, oxaliplatin), taxanes (paclitaxel, docetaxel), fluoropyrimidines (5-fluorouracil, capecitabine), gemcitabine, topotecan, pegylated liposomal doxorubicin, and interferon alfa-2a. The pharmacokinetics of these agents are not significantly altered by concomitant bevacizumab administration, and no dose adjustments are required.
However, since bevacizumab is always used in combination with other anticancer agents, overlapping toxicity profiles should be considered. For example, both bevacizumab and platinum-based chemotherapy can cause proteinuria and myelosuppression. Appropriate monitoring of renal function, blood counts, and other relevant parameters should be conducted throughout treatment.
Always inform your oncology team about all medications you are taking, including prescription drugs, over-the-counter medicines, herbal supplements, and vitamins. While bevacizumab itself has limited formal drug interactions, your overall treatment regimen needs to be carefully managed to minimize overlapping toxicities and ensure the best possible outcomes.
What Is the Correct Dosage of Avzivi?
Avzivi must always be prescribed and administered under the supervision of a physician experienced in the use of antineoplastic agents. The dosing of Avzivi is weight-based, calculated in milligrams per kilogram of body weight (mg/kg), and varies according to the specific cancer type being treated and the chemotherapy regimen it is combined with. Treatment is continued until disease progression or unacceptable toxicity occurs.
Adults
| Cancer Type | Dose | Frequency | Combination Regimen |
|---|---|---|---|
| Metastatic Colorectal Cancer (1st line) | 5 mg/kg or 10 mg/kg | Every 2 weeks (5 mg/kg) or every 3 weeks (7.5 mg/kg) | FOLFOX, FOLFIRI, or capecitabine-based |
| Metastatic Colorectal Cancer (2nd line) | 5 mg/kg or 10 mg/kg | Every 2 weeks | Fluoropyrimidine/irinotecan or fluoropyrimidine/oxaliplatin |
| Non-Small Cell Lung Cancer | 7.5 mg/kg or 15 mg/kg | Every 3 weeks | Platinum-based chemotherapy (up to 6 cycles), then maintenance |
| Renal Cell Carcinoma | 10 mg/kg | Every 2 weeks | Interferon alfa-2a |
| Ovarian Cancer (front-line) | 15 mg/kg | Every 3 weeks | Carboplatin and paclitaxel (up to 6 cycles), then maintenance up to 15 months total |
| Cervical Cancer | 15 mg/kg | Every 3 weeks | Paclitaxel and cisplatin, or paclitaxel and topotecan |
| Glioblastoma | 10 mg/kg | Every 2 weeks | Monotherapy or with lomustine |
How Avzivi Is Administered
Avzivi is supplied as a concentrate for solution for infusion at a concentration of 25 mg/mL. Before administration, the required dose is withdrawn from the vial and diluted to a total volume of 100 mL with 0.9% sodium chloride solution. The diluted solution is administered as an intravenous infusion using an infusion pump. Avzivi must never be administered as an intravenous push or bolus injection.
The infusion rate is adjusted based on tolerability:
Infusion Rate Schedule
- First infusion: Given over 90 minutes. The patient is closely monitored for infusion-related reactions.
- Second infusion: If the first infusion was well tolerated, the second infusion may be administered over 60 minutes.
- Subsequent infusions: If the 60-minute infusion is also well tolerated, all subsequent infusions may be given over 30 minutes.
Children and Adolescents
The safety and efficacy of bevacizumab have not been established in patients under 18 years of age. Avzivi is not recommended for use in children and adolescents. Limited published data on bevacizumab use in pediatric patients exist primarily in the context of recurrent or refractory solid tumors and CNS tumors in clinical trial settings. Any use in this population should only be considered within the framework of a clinical trial under specialist supervision.
Elderly Patients
No dose adjustment is required based on age alone. However, as noted previously, patients aged 65 years and older have a higher incidence of certain adverse events, particularly arterial thromboembolic events. The decision to treat elderly patients should be based on an individual assessment of the benefit-risk profile, taking into account the patient's overall health status, organ function, and the specific cancer being treated.
Dose Modifications
Dose reductions of Avzivi are not recommended. If adverse reactions occur, Avzivi should either be temporarily suspended or permanently discontinued, depending on the nature and severity of the event. Specific guidelines for dose suspension and discontinuation include:
- Temporarily suspend for: moderate to severe proteinuria (until <2 g/24h), severe hypertension not controlled by medication, wound healing complications, and planned elective surgery.
- Permanently discontinue for: gastrointestinal perforation or fistula, wound dehiscence requiring intervention, severe hemorrhage (grade 3–4), arterial thromboembolic events, hypertensive crisis or hypertensive encephalopathy, posterior reversible encephalopathy syndrome (PRES), and nephrotic syndrome.
Missed Dose
Since Avzivi is administered in a clinical setting under medical supervision, missed doses are managed by the oncology team. If a scheduled infusion is missed, it should be administered as soon as possible. The remaining treatment schedule should then be adjusted to maintain the prescribed interval between doses. Do not double the dose to compensate for a missed infusion.
Overdose
There is limited clinical data on bevacizumab overdose. The highest dose tested in clinical trials was 20 mg/kg intravenously every 2 weeks. Dose-dependent adverse reactions were observed, most notably severe hypertension and severe headache (including migraine). In the event of an overdose, patients should be closely monitored and receive appropriate supportive care. There is no specific antidote for bevacizumab overdose. Management is symptomatic and supportive.
What Are the Side Effects of Avzivi?
Like all medicines, Avzivi can cause side effects, although not everybody gets them. The safety profile of bevacizumab has been well characterized through extensive clinical trials involving more than 5,700 patients across multiple tumor types, as well as through ongoing post-marketing surveillance. Since Avzivi is always used in combination with chemotherapy, it can be difficult to distinguish side effects caused by bevacizumab from those caused by the concomitant chemotherapy. The frequencies listed below are based on clinical trial data for bevacizumab across all approved indications.
It is important to understand that cancer treatment often involves complex drug combinations, and many of the symptoms experienced during treatment may be related to the underlying disease, the chemotherapy, or other factors. Your oncology team will monitor you closely throughout treatment and manage any side effects that arise.
Very Common (may affect more than 1 in 10 people)
Reported in >10% of patients in clinical trials
- Hypertension (high blood pressure)
- Fatigue and asthenia (tiredness and weakness)
- Diarrhea
- Nausea
- Abdominal pain
- Proteinuria (protein in the urine)
- Epistaxis (nosebleeds)
- Decreased appetite and anorexia
- Stomatitis (mouth sores) and mucosal inflammation
- Dysphonia (change in voice quality)
- Headache
- Taste disturbance (dysgeusia)
- Eye disorders (increased lacrimation)
- Peripheral sensory neuropathy
- Leukopenia and neutropenia (when combined with chemotherapy)
Common (may affect up to 1 in 10 people)
Reported in 1–10% of patients in clinical trials
- Venous thromboembolic events (deep vein thrombosis, pulmonary embolism)
- Congestive heart failure
- Wound healing complications
- Hemorrhage (including gastrointestinal, pulmonary, and urogenital bleeding)
- Arterial thromboembolic events (stroke, myocardial infarction, transient ischemic attack)
- Infections (including urinary tract and upper respiratory infections)
- Constipation
- Rectal hemorrhage
- Dyspnea (shortness of breath)
- Dermatitis and skin discoloration
- Pain (including back pain, myalgia, and arthralgia)
- Ovarian failure
- Infusion-related reactions
Uncommon (may affect up to 1 in 100 people)
Reported in 0.1–1% of patients in clinical trials
- Gastrointestinal perforation and fistula
- Posterior reversible encephalopathy syndrome (PRES)
- Necrotizing fasciitis (rare, severe soft tissue infection)
- Nasal septum perforation
- Renal thrombotic microangiopathy
- Pulmonary hypertension
- Gallbladder perforation
- Osteonecrosis of the jaw (particularly with bisphosphonate co-administration)
Rare (may affect up to 1 in 1,000 people)
Reported in <0.1% of patients in clinical trials or post-marketing
- Anaphylaxis and severe hypersensitivity reactions
- Hypertensive encephalopathy
- Aortic dissection
- Microangiopathic hemolytic anemia (especially when combined with sunitinib)
Contact your oncology team or seek immediate medical attention if you experience any of the following: sudden severe abdominal pain, black or bloody stools, coughing up blood, sudden onset of severe headache or confusion, sudden weakness or numbness on one side of the body, chest pain, sudden shortness of breath, unusual bruising or bleeding, or signs of an allergic reaction (rash, itching, difficulty breathing, swelling of face or throat). These may indicate serious complications that require urgent medical evaluation.
The side effect profile may vary depending on the specific cancer type being treated and the chemotherapy drugs used in combination with Avzivi. For example, patients with NSCLC treated with bevacizumab plus platinum-based chemotherapy have a higher reported incidence of severe hemorrhage (particularly hemoptysis) compared to patients with other tumor types. Patients with colorectal cancer treated with bevacizumab-containing regimens may experience higher rates of gastrointestinal-related adverse events.
Most common side effects such as hypertension, proteinuria, and epistaxis are manageable with appropriate medical interventions and do not necessarily require treatment discontinuation. Your oncology team will regularly monitor your blood pressure, kidney function, blood counts, and overall health throughout your treatment course. Reporting any new or worsening symptoms promptly is essential for timely management of side effects.
How Should You Store Avzivi?
Proper storage of Avzivi is essential to maintain the quality, safety, and efficacy of the medication. Since Avzivi is a biological medicine containing a monoclonal antibody protein, it is sensitive to temperature extremes, freezing, and physical agitation. The following storage guidelines must be followed:
- Unopened vials: Store in a refrigerator at 2–8 °C (36–46 °F). Do not freeze. Do not shake. Keep the vials in the original outer carton to protect from light.
- After dilution: Chemical and physical in-use stability has been demonstrated for 24 hours at 2–8 °C and up to 8 hours at room temperature (not exceeding 25 °C / 77 °F). From a microbiological point of view, the diluted solution should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user.
- Shelf life: Check the expiration date on the vial label and outer carton. Do not use after the expiration date.
- Appearance: Avzivi is a clear to slightly opalescent, colorless to pale brown liquid. Do not use if the solution is cloudy, discolored, or contains visible particles.
- Disposal: Any unused medicinal product or waste material should be disposed of in accordance with local requirements for cytotoxic medicines. Do not dispose of Avzivi in household waste.
Since Avzivi is administered in a hospital or infusion center, storage is typically handled by the pharmacy or nursing staff. However, patients and caregivers should be aware of these requirements and report any concerns about the appearance or handling of the medication to the healthcare team.
What Does Avzivi Contain?
Avzivi is supplied as a sterile, preservative-free concentrate for solution for infusion. Understanding the composition of the medication is important for healthcare professionals preparing the infusion and for patients who may have allergies to specific ingredients.
Active Ingredient
The active substance is bevacizumab, a recombinant humanized IgG1 monoclonal antibody produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. Each milliliter of concentrate contains 25 mg of bevacizumab.
Excipients (Inactive Ingredients)
The other ingredients in Avzivi are:
- Trehalose dihydrate (a stabilizing sugar)
- Sodium phosphate monobasic monohydrate (buffer)
- Disodium phosphate anhydrous (buffer)
- Polysorbate 20 (surfactant to prevent protein aggregation)
- Water for injections
Avzivi contains sodium. Each 4 mL vial (100 mg) contains approximately 1.6 mg of sodium, and each 16 mL vial (400 mg) contains approximately 6.4 mg of sodium. This should be taken into consideration for patients on a controlled sodium diet.
Presentation
Avzivi is available in the following presentations:
- 100 mg/4 mL vial: Each vial contains 100 mg of bevacizumab in 4 mL of concentrate (25 mg/mL)
- 400 mg/16 mL vial: Each vial contains 400 mg of bevacizumab in 16 mL of concentrate (25 mg/mL)
The concentrate is a clear to slightly opalescent, colorless to pale brown liquid. The solution is sterile, pyrogen-free, and preservative-free. Each vial is for single use only; any unused portion must be discarded appropriately.
Frequently Asked Questions About Avzivi
Avzivi is a biosimilar to Avastin, meaning it contains the same active substance (bevacizumab) and has been demonstrated through comprehensive analytical, non-clinical, and clinical studies to be equivalent to Avastin in terms of quality, safety, and efficacy. Unlike generic drugs, which are chemically identical copies of small-molecule medicines, biosimilars are produced using living cells and are therefore structurally complex biological medicines. While there may be minor differences in clinically inactive components (excipients), the therapeutic effects of Avzivi are considered equivalent to those of Avastin. Your oncologist may prescribe Avzivi as an alternative to Avastin, and switching between the two is considered safe based on available evidence.
The duration of Avzivi treatment depends on the type of cancer being treated, the response to therapy, and whether side effects develop. In general, treatment is continued until the disease progresses (grows or spreads) or until unacceptable side effects occur. For some indications, such as ovarian cancer, bevacizumab may be continued as maintenance therapy for a defined period (e.g., up to 15 months total including concurrent and maintenance phases). For metastatic colorectal cancer and NSCLC, bevacizumab is often continued as maintenance therapy after completion of the initial chemotherapy phase, until disease progression. Your oncologist will make treatment duration decisions based on your individual circumstances, including tumor response and tolerability.
Bevacizumab impairs wound healing by inhibiting angiogenesis, which is essential for tissue repair. Therefore, Avzivi treatment should not be started for at least 28 days after major surgery and only after the surgical wound has fully healed. If you require elective surgery during treatment, Avzivi should be discontinued for an appropriate period before the procedure to minimize wound healing complications. The exact timing depends on the half-life of bevacizumab (approximately 20 days) and the nature of the surgery. Your oncologist and surgeon will coordinate the timing of surgery and treatment carefully. In case of emergency surgery, the risks of impaired wound healing must be weighed against the urgency of the procedure.
Avzivi is not typically a curative treatment when used for advanced or metastatic cancer. Instead, it is designed to slow the growth and spread of cancer by cutting off the tumor's blood supply, thereby extending survival and improving quality of life. In clinical trials, bevacizumab has been shown to significantly extend progression-free survival and, in some cancer types, overall survival when added to standard chemotherapy. However, the prognosis varies greatly depending on the specific cancer type, stage, and individual patient factors. In certain settings, such as adjuvant treatment for early-stage cancer, bevacizumab may contribute to a curative intent when combined with surgery and other treatments. Your oncologist will discuss realistic treatment goals and expectations based on your specific situation.
Hypertension (high blood pressure) is one of the most common side effects of bevacizumab, occurring in a significant proportion of patients. In most cases, elevated blood pressure can be effectively managed with standard antihypertensive medications (such as ACE inhibitors, ARBs, calcium channel blockers, or diuretics). Your blood pressure will be monitored regularly before each infusion. If hypertension develops, your oncologist may prescribe or adjust blood pressure medication. Treatment with Avzivi may need to be temporarily suspended if severe hypertension cannot be controlled with medical therapy. In the rare event of hypertensive crisis or hypertensive encephalopathy, Avzivi must be permanently discontinued. Good blood pressure control during treatment is important, so be sure to take any prescribed antihypertensive medications consistently and report any symptoms of severe headache, vision changes, or confusion promptly.
The combination of bevacizumab with immune checkpoint inhibitors (such as atezolizumab) has been investigated in certain cancer types and is an approved regimen in some settings. For example, the combination of atezolizumab plus bevacizumab is approved for the treatment of unresectable hepatocellular carcinoma (liver cancer) based on the IMbrave150 trial. In non-small cell lung cancer, bevacizumab has also been studied in combination with immunotherapy and chemotherapy. While Avzivi specifically may be used in such combinations based on oncologist discretion and local prescribing guidelines, patients should discuss these options with their oncology team. The combination of anti-angiogenic therapy with immunotherapy is an active area of clinical research across multiple cancer types.
References
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- U.S. Food and Drug Administration (FDA). Bevacizumab biosimilar prescribing information. Available at: www.fda.gov. Accessed January 2026.
- Hurwitz H, Fehrenbacher L, Novotny W, et al. Bevacizumab plus irinotecan, fluorouracil, and leucovorin for metastatic colorectal cancer. N Engl J Med. 2004;350(23):2335-2342. doi:10.1056/NEJMoa032691
- Sandler A, Gray R, Perry MC, et al. Paclitaxel-carboplatin alone or with bevacizumab for non-small-cell lung cancer. N Engl J Med. 2006;355(24):2542-2550. doi:10.1056/NEJMoa061884
- Perren TJ, Swart AM, Pfisterer J, et al. A phase 3 trial of bevacizumab in ovarian cancer. N Engl J Med. 2011;365(26):2484-2496. doi:10.1056/NEJMoa1103799
- Tewari KS, Sill MW, Penson RT, et al. Bevacizumab for advanced cervical cancer: final overall survival and adverse event analysis of a randomised, controlled, open-label, phase 3 trial (Gynecologic Oncology Group 240). Lancet. 2017;390(10103):1654-1663. doi:10.1016/S0140-6736(17)31607-0
- European Society for Medical Oncology (ESMO). Clinical Practice Guidelines: Anti-angiogenic therapies in oncology. Available at: www.esmo.org. Accessed January 2026.
- National Comprehensive Cancer Network (NCCN). Clinical Practice Guidelines in Oncology. Available at: www.nccn.org. Accessed January 2026.
- World Health Organization (WHO). WHO Expert Committee on Biological Standardization: Guidelines on evaluation of biosimilars. WHO Technical Report Series. 2022.
- Tabernero J, Vyas M, Giuliani R, et al. Biosimilars: a position paper of the European Society for Medical Oncology, with particular reference to oncology prescribers. ESMO Open. 2016;1(6):e000142. doi:10.1136/esmoopen-2016-000142
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Board-certified oncologists with expertise in solid tumor management, anti-angiogenic therapies, and biosimilar medicines.
Clinical Pharmacology Experts
Specialists in drug safety, pharmacokinetics, drug interactions, and evidence-based pharmacotherapy.
Medical Writers
Experienced medical communicators who translate complex clinical data into accessible, patient-friendly content.
Independent Review Board
External medical reviewers who verify accuracy, currency, and adherence to international clinical guidelines.