Mvasi

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Mvasi

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Medically reviewed

Laura Arias

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Mvasi

Mvasi is a biosimilar biologic medicine used as a targeted anti-cancer agent that works by inhibiting the blood vessel growth necessary for tumors to survive. Its active ingredient is bevacizumab-awwb, confirmed to be highly similar to the original reference product, Avastin.

Property Description
Active ingredient Bevacizumab-awwb
Form Concentrate for solution for infusion
Pharmacological class Angiogenesis Inhibitor (VEGF Inhibitor)
Prescription Status Prescription Only (Pr)
Origin / Manufacturer Biologic (Recombinant Monoclonal Antibody) / Amgen

What Type of Medicine Is Mvasi?

Mvasi is formally a biosimilar medicine belonging to the class of monoclonal antibodies. The active component, bevacizumab-awwb, is a complex therapeutic protein produced by Amgen, which defines it as a biologic drug. This is a prescription-only (Pr) medication used in the adult cancer patient population. The drug's classification as a biosimilar means it has been clinically recognized to have no meaningful differences in effectiveness or safety compared to the reference biologic. These biologic products are considered biosimilar because they work just as effectively and are just as safe to use as the original medication. Its precise pharmacological classification is a Vascular Endothelial Growth Factor (VEGF) Inhibitor, a form of targeted therapy.

What Is Mvasi Made Of and How Does It Function?

The medicine contains the active ingredient bevacizumab-awwb dissolved in a sterile, preservative-free aqueous solution. It is supplied as a concentrate for solution for infusion in single-dose vials, such as the 100 mg/4 mL or 400 mg/16 mL strengths. As an Angiogenesis Inhibitor, its primary high-level function is to disrupt the natural process by which tumors create new blood vessels (angiogenesis). The drug’s intended action is the blocking of the necessary signals for blood vessel growth.

What Is the General Purpose of Mvasi?

The general purpose of Mvasi is to serve as an antineoplastic agent and a targeted therapy in cancer management. By interrupting the signaling pathway for new blood vessel formation, the drug limits the blood supply and oxygen that a tumor needs to grow. This strategic inhibition of the tumor's blood supply helps to slow the overall progression of malignancy. Mvasi provides a systemic method for controlling tumor development, commonly used as a component of a multi-drug regimen.

Regulatory References

  1. Bevacizumab Injection: MedlinePlus Drug Information

What side effects are possible with Mvasi?

Mvasi (bevacizumab-awwb) is a biosimilar monoclonal antibody and VEGF Inhibitor. Its safety profile is documented in official regulatory labeling and is characterized by adverse reactions related to its mechanism of inhibiting blood vessel growth. The information below is based on data from regulatory authorities, including the FDA and EMA.


Serious Adverse Reactions

Official labeling includes a Boxed Warning that highlights several serious and potentially fatal adverse reactions associated with treatment:

  • Gastrointestinal (GI) Perforations and Fistulae: Increased risk of holes or tears developing in the stomach or intestine, and the formation of abnormal connections between organs (fistulae).
  • Surgery and Wound Healing Complications: The incidence of surgical complications and poor wound healing is increased. Mvasi must be withheld for a period before and after elective surgery until the wound is fully healed.
  • Hemorrhage: Risk of severe or fatal bleeding events, including GI bleeding and pulmonary hemorrhage (hemoptysis).

System-Organ-Class Safety Patterns

Adverse reactions are classified by the physiological systems they affect:

System-Organ Class Key Adverse Reactions (Regulatory Focus)
Vascular/Cardiac Hypertension, Arterial and Venous Thromboembolic Events (ATE/VTE), Congestive Heart Failure (CHF).
Renal/Urinary Proteinuria, Nephrotic Syndrome (rare).
Nervous System Headache, Posterior Reversible Encephalopathy Syndrome (PRES) (rare).

Most Common Adverse Reactions

Reactions that occur in more than 10% of patients across clinical studies include Epistaxis (nosebleeds), Headache, Proteinuria, Rhinitis (runny nose), Dry skin, and Fatigue. Infusion-related reactions have been reported, primarily occurring with the first dose.

Population-Specific Safety Notes

The label includes constraints for specific groups. Females of reproductive potential face a documented risk of Ovarian Failure and are required to use effective contraception during and for six months following treatment due to the potential for embryo-fetal toxicity. Patients with cervical cancer have an increased risk of specific non-GI fistulae.


This information defines the risks that must be understood, distinguishing between common reactions and serious complications tied to the drug's fundamental mechanism of action. The explicit safety statements guide necessary monitoring for conditions like hypertension and proteinuria.

Overdose and Emergency Response

Overdose and when to seek help

The official regulatory documentation for Mvasi (bevacizumab-awwb) focuses on the documented manifestations and mandated emergency actions in the event of a suspected overdose or accidental over-infusion.

The documented clinical presentations of an overdose are limited, deriving from a case where a patient received an accidental over-infusion, approximately three times the recommended maximum dose. This event resulted in the development of Grade 3 hypertension, which progressed to a hypertensive crisis, accompanied by a severe headache.


Overdose Profile Statement Regulator-Mandated Action/Finding
Known Antidote No specific antidote is known for Mvasi overdose.
Management Management should consist of general measures, including symptomatic and supportive treatment.

Individuals who suspect an overdose or receive an accidental over-infusion must seek immediate medical attention. The official government guidance specifies that emergency services should be contacted immediately if severe signs are present, including collapse, having a seizure, trouble breathing, or being unable to be awakened. Since no specific antidote is known, treatment relies on managing the symptoms and providing supportive care, with hospital monitoring being essential to manage potential complications like a hypertensive crisis. No population-specific overdose risks are explicitly noted in the regulatory documents.

Therapeutic Uses of Mvasi

Quick Facts: Uses and Domains

  • Metastatic Colorectal Cancer: May be used for first- or second-line treatment of cancer of the colon or rectum that has spread.
  • Non-Small Cell Lung Cancer: Indicated for unresectable, locally advanced, recurrent, or metastatic non-squamous non-small cell lung cancer.
  • Recurrent Glioblastoma: Used for the management of glioblastoma that has recurred after previous treatment.
  • Metastatic Kidney Cancer: Used for the treatment of renal cell carcinoma that has spread.
  • Cervical Cancer: Indicated for persistent, recurrent, or metastatic carcinoma of the cervix.
  • Ovarian/Peritoneal Cancer: Used in the treatment of epithelial ovarian, fallopian tube, or primary peritoneal cancer.

Mvasi is a treatment option that may be utilized for various types of cancer that have advanced or returned. It is indicated for use in managing metastatic colorectal cancer, often alongside intravenous fluorouracil-based chemotherapy. The treatment is also approved for patients with unresectable, locally advanced, recurrent, or metastatic non-squamous non-small cell lung cancer.

Furthermore, Mvasi is part of a treatment regimen for adult patients with recurrent glioblastoma following prior therapy. The agent may also be used with interferon alfa to address metastatic renal cell carcinoma. For persistent, recurrent, or metastatic carcinoma of the cervix, this medication may be administered in combination with specific chemotherapy agents. Its indications also include certain stages and recurrences of epithelial ovarian, fallopian tube, or primary peritoneal cancer.

Eligibility and Restrictions for Use

Who can and cannot use Mvasi?

Mvasi eligibility is strictly defined by regulatory documents, excluding certain populations and mandating specific conditions for treatment initiation and continuation. The medicine is indicated for use in adult patients across all approved cancer types, including recurrent glioblastoma in adults. No dose adjustment is required for patients 65 years of age or older.

Category Official Eligibility Status (Regulatory Basis)
Pediatric Use Safety and efficacy have not been established in children and adolescents (under 18 years of age).
Pregnancy Contraindicated in women who are pregnant, as the drug may cause fetal harm. Females of reproductive potential must use effective contraception during and for 6 months after treatment.
Lactation Women are advised not to breastfeed during treatment and for 6 months following the final dose.
Organ Impairment Safety and efficacy have not been studied in patients with renal or hepatic impairment.

The official labeling mandates permanent discontinuation of Mvasi if the patient develops certain severe conditions, including gastrointestinal perforation (any grade), a severe arterial thromboembolic event, a Grade 4 venous thromboembolic event, or a hypertensive crisis. Treatment must also not be initiated until at least 28 days following major surgery and until the surgical wound is fully healed. The medicine is also typically not administered to patients with a recent history of significant hemoptysis (coughing up blood).

What should I know about interactions with other medicines?

Mvasi Interactions with other medicines and products

Mvasi (bevacizumab-awwb) is a monoclonal antibody whose interaction profile is defined by its pharmacological class, resulting in a documented absence of many common drug interactions.

Category Official Regulatory Statements
Medicinal product categories with documented interactions Vascular Endothelial Growth Factor (VEGF) Receptor Tyrosine Kinase Inhibitors (TKIs) and Anticoagulant Agents.
Specific interacting medicines (if explicitly listed) Sunitinib Malate (cited in regulatory warnings related to increased PD toxicity risks).
Mechanistic basis of interactions No Pharmacokinetic (PK) Interaction: Studies documented Mvasi does not alter the clearance of co-administered chemotherapy (e.g., paclitaxel, irinotecan). Pharmacodynamic (PD) Additive Toxicity: Increased risk noted when combined with other VEGF pathway inhibitors.
Interaction-related restrictions Combination with Sunitinib: Formal regulatory documents restrict this combination due to an increased risk of severe PD toxicities, including microangiopathic hemolytic anemia. Non-Mixing Restriction: The infusion must not be mixed with glucose (dextrose) solutions.

Interaction Classifications (High-Level)

Classification Regulatory Statement
Interaction severity classification Strong Warning/Restriction for co-administration with Sunitinib.
Interaction-context constraints The potential for additive risk of serious bleeding events exists when Mvasi is used concurrently with anticoagulant agents.

Connection to the overall interaction profile: The official profile is characterized by the documented absence of standard PK interactions with small-molecule drugs, consistent with a biologic agent. The primary constraints are Pharmacodynamic (PD), involving restricted co-administration with other targeted therapies like Sunitinib and notes on the additive risk of bleeding when used alongside anticoagulants.

Mechanism of Action

Mvasi (bevacizumab-awwb) operates solely through the mechanism of angiogenesis inhibition. Its action is initiated by the active ingredient binding directly to all known isoforms of the circulating Vascular Endothelial Growth Factor A (VEGF-A) ligand. This interaction is a form of ligand sequestration.

By neutralizing VEGF-A, the drug functionally prevents the ligand from reaching and activating its receptors, VEGFR-1 and VEGFR-2, on the surface of endothelial cells. This functional antagonism of the VEGF-VEGFR signaling axis halts the crucial cellular processes, specifically the proliferation and migration of endothelial cells, required to form new blood vessels.

The resulting physiological consequence is the regression and collapse of the abnormal, immature vasculature supporting the malignant cell mass. This vascular disruption restricts the supply of oxygen and essential nutrients, thereby limiting the metabolic and proliferative potential of the tissue.

Dosage and Administration Information

How Mvasi is Used in Clinical Practice

Mvasi (bevacizumab-awwb) is a biosimilar medicine administered through a cyclic intravenous (IV) infusion only, under the supervision of a physician experienced in cancer treatment. It is supplied as a concentrate for solution for infusion in single-dose vials, which must be diluted prior to use.


Official Dosing and Schedule

Administration follows a weight-based regimen, with the dose calculated in milligrams per kilogram (mg/kg) and tailored to the specific indication. Doses typically range from 5 mg/kg to 15 mg/kg. The frequency of administration is generally every 2 weeks or every 3 weeks (q2W or q3W), aligning with the overall chemotherapy treatment cycle.

Treatment is intended to continue until the disease progresses or unacceptable toxicity develops. The label specifies that Mvasi treatment must be withheld for at least 28 days before and after any major elective surgery and should not be initiated until the surgical wound is fully healed.


Administration Requirements

Feature Procedural Instruction
Route Intravenous infusion only; not administered as a bolus or IV push.
Preparation The concentrate must be diluted in 100 mL of 0.9% Sodium Chloride solution. Dextrose solutions must not be used for dilution.
Infusion Rate The first dose is infused over 90 minutes. Subsequent infusions may be reduced to 60 minutes, and then to 30 minutes if the prior rate was tolerated.
Population The medicine is indicated for use in the adult population.

These standardized instructions establish the required conditions for the proper, controlled administration of Mvasi.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Mvasi

The research evidence for Mvasi (bevacizumab-awwb) is founded on the regulatory principle of biosimilarity. This means official bodies have determined that Mvasi is highly similar to the original reference product, Avastin (bevacizumab), which means the evidence for the reference product is considered by regulatory bodies under the established principle of extrapolation. The overall evidence landscape consists of dedicated comparative trials showing similarity and the established findings from decades of research for the reference product.


Evidence for Use in Non-Small Cell Lung Cancer

For non-small cell lung cancer (NSCLC), researchers conducted a dedicated comparative randomized controlled trial (RCT). This specific study was designed to evaluate clinical similarity to the reference product in a sensitive patient population. The main findings from this comparative trial reported that the measurements for the Objective Response Rate (a measure of tumor shrinkage) aligned with the prespecified criteria used to evaluate clinical similarity between the Mvasi group and the reference product group.

It remains important to note that this comparative research explored short-term symptom changes and similarity, and was not designed to prove effectiveness against chemotherapy alone.


Evidence by Extrapolation for Other Cancers

Most of the evidence for Mvasi's other approved uses—including metastatic colorectal cancer, and various gynecologic cancers (cervical, ovarian, fallopian tube, and primary peritoneal cancers)—comes from the extensive research conducted on the reference product. The evidence draws from the findings of large Randomized Controlled Trials (RCTs) that examined measures such as Progression-Free Survival (PFS) and Overall Survival (OS).

Similarly, evidence for recurrent glioblastoma and metastatic renal cell carcinoma is primarily extrapolated. For recurrent glioblastoma, research into whether the drug changed Overall Survival measurements has yielded mixed or limited data across the primary studies, meaning evidence certainty remains low regarding changes to long-term survival in that setting.


Limitations and Evidence Gaps

Mvasi was assessed for high similarity to the reference product, but it has not been directly studied in a dedicated, large-scale RCT for every cancer type it treats. Data for specific patient groups, such as children and adolescents, remain insufficient, as Mvasi is generally studied in the adult cancer patient population. Furthermore, long-term effects are not fully established in all specific indications.

Key Studies & References

  1. Mvasi (bevacizumab-awwb) FDA Full Prescribing Information
  2. Bevacizumab combined with chemotherapy for glioblastoma: a meta-analysis of randomized controlled trials
  3. Bevacizumab in ovarian cancer: A critical review of phase III studies (GOG-0218, ICON7, OCEANS)

Frequently Asked Questions (FAQ)

Common questions about Mvasi (FAQ)

Q: What is Mvasi specifically approved to treat?

A: According to official prescribing information, Mvasi is approved to treat several specific types of cancer. These include metastatic colorectal cancer, non-squamous non-small cell lung cancer, recurrent glioblastoma, metastatic renal cell carcinoma, cervical cancer, and certain epithelial ovarian cancers. The specific use is always determined by the patient's individual clinical situation and the approved regimen.

Q: Is Mvasi used for different types or stages of cancer?

A: Yes, the regulatory documents indicate Mvasi is approved for multiple cancer types and in different contexts. The drug is indicated for advanced, metastatic, or recurrent forms of the approved cancers. The specific indication will define the appropriate combination therapy and line of treatment.

Q: Why is Mvasi sometimes administered alongside other chemotherapy drugs?

A: The official regulatory label specifies that Mvasi is approved for use in combination with certain other agents, such as specific intravenous fluorouracil-based chemotherapy or carboplatin and paclitaxel. The label indicates that using it with these other drugs is part of the approved treatment regimen for its specified uses.

Q: Where is Mvasi typically administered—in a clinic, hospital, or at home?

A: Mvasi must be administered by a healthcare professional as an intravenous (IV) infusion only. The official information specifies that Mvasi must be prepared and delivered in a controlled setting, which usually includes a clinic or hospital infusion center, rather than being administered at home.

Q: Are there any delayed side effects that might appear after a course of Mvasi treatment has ended?

A: Regulatory safety information notes that certain serious adverse reactions, like Congestive Heart Failure (CHF), have been reported in patients treated with this class of medication. Due to this potential risk, regulatory guidance supports continued patient monitoring by a healthcare professional following the completion of treatment.

Q: Why is there a warning about blood clots associated with Mvasi?

A: The official warnings highlight that serious and sometimes fatal arterial and venous thromboembolic events (blood clots) have been reported in patients treated with Mvasi. The regulatory guidance highlights this potential risk, noting that the incidence of these events may be increased in patients receiving this medicine.

Q: What kind of vision or eye-related issues have been reported with Mvasi?

A: Official safety documents mention that serious vision problems can be associated with a rare condition called Posterior Reversible Encephalopathy Syndrome (PRES). Additionally, a common adverse reaction reported in clinical studies is lacrimation disorder, which involves excessive watery eyes.

Q: Is it considered normal to feel certain sensations, such as mild tingling, during the infusion?

A: Infusion-related reactions can occur and may include symptoms such as fever, chills, lightheadedness, or trouble breathing. Separately, peripheral sensory neuropathy (a tingling or numbness) is also a reported side effect of the treatment. Patients are advised to report any unusual sensations during or after treatment to their healthcare professional.

Q: What are the signs of an infusion-related reaction to Mvasi?

A: Official safety information describes signs of an infusion-related reaction, which can include symptoms like high blood pressure, fever, chills, lightheadedness, headache, and trouble breathing. Severe reactions have been observed, and regulatory guidance recommends immediate reporting of signs to the care team.

Q: Is it generally safe to receive common vaccinations, like a flu shot, while on Mvasi treatment?

A: Regulatory drug interaction documents note that interactions are possible with certain other agents, including vaccines. Official guidance states that the healthcare professional should be informed of all vaccinations the patient receives, as interactions are possible.

Q: Can Mvasi affect the way non-cancer medications work?

A: The official prescribing information includes a section on drug interactions, indicating that Mvasi can potentially affect the way other non-cancer medicines work, or vice-versa. Regulatory guidance supports informing the doctor of all medications being taken so that any potential interactions can be managed.

Q: Can a patient with a documented history of certain heart problems be prescribed Mvasi?

A: According to official warnings, Mvasi may cause Congestive Heart Failure (CHF), and the risk may be higher in patients previously treated with an anthracycline (another type of cancer drug). If CHF develops, the prescribing information advises that Mvasi treatment must be permanently discontinued as a safety measure.

Q: How long do patients typically remain on Mvasi treatment protocols?

A: Official guidance generally recommends that Mvasi treatment be continued for as long as the underlying disease does not progress or until a patient experiences unacceptable toxicity. The duration of therapy is typically determined by the patient’s response and tolerability, as outlined in the clinical protocol.

Q: Why is Mvasi stored under refrigerated conditions?

A: Mvasi is a sensitive biological product that requires specific storage conditions to remain stable and effective. Official instructions require that the unopened vial be stored in the refrigerator at a temperature between 2 C to 8 C (36 F to 46 F) and protected from light.

Q: What is the general process for monitoring a patient during Mvasi treatment?

A: Regulatory documents require close monitoring of patients during and after treatment due to the risk of serious side effects. This involves monitoring for signs of bleeding, high blood pressure, and wound healing complications. Urine protein levels are also routinely monitored as part of this process.

Q: What kinds of laboratory tests are usually required before starting Mvasi?

A: Monitoring for high blood pressure and potential renal injury (kidney problems) is required by official safety information. This level of monitoring typically involves blood pressure checks and appropriate baseline and periodic laboratory tests, including blood and urine tests.

Q: Is Mvasi a standard first-line treatment for its approved uses in certain cancers?

A: The regulatory label indicates that Mvasi is approved for first-line treatment in specific contexts, such as for certain patients with non-squamous non-small cell lung cancer, metastatic colorectal cancer, and ovarian cancer. The official documentation specifies the exact combinations and patient groups for which first-line use is approved.

Q: Why is Mvasi only administered intravenously?

A: Mvasi is formulated as a sterile solution intended only for intravenous infusion. The official administration guidelines explicitly state that it must not be given as an intravenous push or bolus (a rapid injection) because of its required method of delivery.

Q: Are there high-level differences in eligibility criteria for Mvasi among different approved cancer types?

A: Yes, regulatory indications show high-level differences in eligibility across the approved cancer types. The specific combination drug, the line of therapy (such as first-line versus second-line), and other clinical factors required for Mvasi use vary significantly based on the cancer type and stage.

How should Mvasi be stored and disposed of?

The storage and disposal of Mvasi (bevacizumab-awwb) are strictly defined by regulatory requirements for biologic products.

Storage Conditions

Item Requirement
Temperature Store unopened vials in a refrigerator at 2 C to 8 C (36 F to 46 F).
Protection Keep the vial in its original carton until use to protect from light.
Handling DO NOT FREEZE or SHAKE the vial.

Stability and Disposal

The diluted Mvasi solution may be stored at 2 C to 8 C for up to 8 hours if not immediately administered. As a single-dose, preservative-free solution, any unused portion remaining in the vial must be discarded. All medication must be kept out of the reach of children, and disposal should align with local pharmaceutical waste regulations.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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