Avisera

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Avisera

Medically reviewed

Marina Burgos

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 Avisera

Quick Facts

Property Description
Active ingredient Vinorelbine ditartrate
Form Solution for injection (IV) and soft capsules (oral)
Pharmacological class Antineoplastic Agent, Mitotic Inhibitor, Vinca Alkaloid
General purpose To manage uncontrolled cellular proliferation
Origin Semi-synthetic derivative

What Type of Medicine is Avisera? (Identity and Classification)

Avisera is a specialized, prescription-only medication primarily used in oncology as a form of chemotherapy. Its fundamental purpose is to control the spread and growth of abnormal cell populations by interfering with their ability to divide. The active ingredient, Vinorelbine, is the ditartrate salt of a semi-synthetic derivative that was chemically modified from natural alkaloids isolated from the Madagascan periwinkle plant.

Vinorelbine is classified as an antineoplastic agent within the larger drug group of vinca alkaloids. Functionally, the drug is a mitotic inhibitor or spindle poison, meaning it specifically targets the internal scaffolding of cells to block their ability to divide and reproduce. The drug acts by interfering with microtubule formation, which is key to its role in managing systemic diseases characterized by uncontrolled cellular growth.

How is Avisera Composed and What is its General Purpose? (Form, Composition, and Benefit)

Avisera is a single-agent product available in two primary dosage forms of Vinorelbine ditartrate: a solution for injection administered via the intravenous route and, in certain regions, soft capsules for oral intake. The oral formulation is a distinguishing feature, offering a non-intravenous option that is an alternative in select patients. The injection formulation consists of the active ingredient in an aqueous solution, while the oral capsule formulation typically utilizes a lipophilic vehicle. This provision of both intravenous and oral formulations offers therapeutic flexibility in treatment plans, supporting the drug's foundational role in targeted cell destruction.

Regulatory References

  1. Vinorelbine Tartrate - NCI Drug Dictionary

What side effects are possible with Avisera?

Possible Side Effects and Safety Information

Official regulatory documents classify the potential side effects of Avisera (Vinorelbine ditartrate) by frequency and the body system affected. The primary dose-limiting toxicity is myelosuppression, primarily manifesting as neutropenia, which is classified as very common (occurring in 10% or more of patients). Other very common effects include gastrointestinal issues such as nausea, vomiting, and constipation, as well as asthenia (weakness) and reactions at the injection site.

Adverse reactions are formally grouped by System Organ Class, with primary concerns in the Blood and Lymphatic System, the Gastrointestinal System, and the Nervous System (e.g., peripheral neuropathy).

Serious Adverse Reactions

Specific serious adverse reactions highlighted in official labeling include severe granulocytopenia, which increases the risk of serious infection, including fatal sepsis. Severe gastrointestinal complications, such as paralytic ileus or bowel obstruction, have been documented. Pulmonary toxicity, including Acute Respiratory Distress Syndrome (ARDS) and interstitial pneumonitis, is also listed. The medicine is classified as a moderate vesicant, with a documented risk of local tissue necrosis upon extravasation.

Classification Example Effects (Regulatory Documented)
Very Common (ge 10%) Neutropenia, Vomiting, Constipation, Asthenia
Common (1-10%) Thrombocytopenia, Diarrhea, Headache, Fever

Safety Considerations and Constraints

The regulatory profile includes specific constraints. The medication is generally contraindicated in patients with a known hypersensitivity to vinca alkaloids, pre-existing severe granulocytopenia, or severe hepatic impairment. Time-related safety notes confirm that the lowest blood count (nadir) for neutropenia typically occurs between 7 and 10 days after administration.

Overdose and Emergency Response

Overdose and When to Seek Help

Immediate Medical Attention Required

If an overdose of Avisera is suspected or confirmed, seek emergency medical attention immediately. Overdose is defined as ingestion exceeding the prescribed daily amount. Even if initial symptoms are absent or appear mild, contact a local poison control center or emergency services without delay.

Documented Overdose Presentations

Overdose manifestations may be non-specific in the early stages. The primary physiological systems affected can include the central nervous system and cardiovascular system. Reported signs, particularly in massive overexposure, may include severe dizziness, confusion, pronounced drowsiness, or tremors.

Risk Factors and Severe Outcomes

In instances of accidental or intentional massive exposure, the greatest concern is the potential for delayed, progressive organ injury. Specific organ systems at risk often include the liver and kidneys, which may display damage hours or days after the ingestion. Severe outcomes cited in generalized regulatory frameworks for high-risk substances include profound hypotension, respiratory depression, seizures, and potentially coma or death.

Emergency Response

Urgent medical management is necessary to control symptoms and mitigate the risk of severe complications. This management may involve supportive care, continuous physiological monitoring, and potentially decontamination procedures if administered shortly after ingestion. Immediate attention ensures timely initiation of supportive measures against delayed, life-threatening effects.

Therapeutic Uses of Avisera

What Avisera Treats: Main Uses and Benefits

Avisera (Vinorelbine) is used in the systemic management of certain advanced malignancies, playing a role in therapeutic areas that involve conditions marked by increased physiological stress. The medication is primarily used for managing Non-Small Cell Lung Cancer (NSCLC) that has reached advanced or metastatic stages, and is also utilized for managing metastatic breast cancer, relevant in contexts involving heightened systemic burden.

Applied in situations requiring short-term symptomatic assistance, the treatment is used for managing the disease activity and lessening the overall tumor burden. A clinical goal of treatment is to provide support in addressing disease activity and to aid in disease stabilization. This contributes to easing the overall symptom load during periods of heightened symptoms, supporting the patient during difficult episodes by easing overall distress and assisting with maintaining functional stability.

“A clinical goal of treatment is to provide support in addressing disease activity and aid in disease stabilization.”

Quick Fact: Support for Symptoms Related to Tumor Burden
Main Use Cases Advanced NSCLC and metastatic breast cancer progression
Intended Therapeutic Focus Disease stabilization and managing tumor activity
Key Benefit Contributes to easing overall symptom load

Regulatory References

  1. NIH MedlinePlus Drug Information

Eligibility and Restrictions for Use

Official Eligibility and Non-Eligibility Rules

Regulatory documents strictly define who can and cannot use Avisera (Vinorelbine), focusing on baseline patient health status and specific physiological conditions. Use is generally established for adult patients receiving treatment for the approved oncological indications.

Classification Eligibility Rule (Official Labeling)
Absolute Contraindication Known hypersensitivity to vinorelbine or other vinca alkaloids.
Hematological Exclusion Neutrophil count below 1,500 cells/mm^3 or platelet count below 100,000 cells/mm^3.
Organ Function Limit Severe hepatic impairment not related to the tumor process.
Age Group Status Pediatric population (children/adolescents) is not recommended; safety and effectiveness have not been established.
Reproductive Status Pregnancy and Lactation/Breastfeeding are contraindicated.

Conditional Use and Restrictions

While renal impairment typically requires no dose modification, caution is advised for patients with a history of ischemic heart disease or pre-existing neuropathy. Furthermore, the concurrent use of the yellow fever vaccine is specifically contraindicated, and other live attenuated vaccines are not recommended.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The interaction profile of Avisera (Vinorelbine) is governed by its metabolic clearance and specific prohibitions documented in official regulatory labeling.

Interaction Scope and Mechanism

Field Official Regulatory Statement
Metabolic Basis Vinorelbine is metabolized primarily by the CYP3A4 enzyme in the liver. Inhibition or induction of this enzyme by co-administered drugs may alter Avisera's systemic exposure.
Transporter Basis Vinca alkaloids are identified as substrates for the membrane transporter P-glycoprotein (P-gp); caution is advised with strong modulators of this protein.
Non-Interacting Drugs Regulatory data confirms that co-administration with Cisplatin, 5-Fluorouracil, and Doxorubicin does not alter Vinorelbine's pharmacokinetics or binding [FDA].

Interaction-Related Constraints and Restrictions

Contraindicated Combinations: The yellow fever vaccine is formally contraindicated due to the documented risk of fatal generalized vaccine disease [SmPC]. Co-administration with other live attenuated vaccines is generally not recommended due to immunosuppressive risk.

Exposure Alteration: Potent CYP3A4 inhibitors (such as Itraconazole) may significantly increase Avisera's plasma concentration, leading to heightened toxicity. Conversely, strong CYP3A4 inducers (such as Phenytoin) may reduce efficacy.

Pharmacodynamic Effects: Concomitant use with Mitomycin is associated with an increased risk of acute pulmonary effects, including bronchospasm and dyspnea. Immunosuppressants such as Ciclosporin or Tacrolimus may result in excessive immunodepression.

Population-Specific Caution: Patients with moderate hepatic impairment require dose adjustment because the compromised CYP3A4 activity heightens the metabolic interaction risk, while severe hepatic impairment is an absolute contraindication to treatment.

Mechanism of Action

How Avisera Works: Mechanism of Action

Targeted Disruption of the Cell's Structural Engine

Avisera (Vinorelbine) exerts its effect by acting as a polymerization inhibitor that selectively targets tubulin, the protein component of microtubules. The drug binds to the beta-tubulin subunit at the vinca-binding domain, preventing the essential assembly of these structural components into the mitotic spindle. This action directly modulates the machinery required for cell division, which initiates the resulting molecular cascade.

Activating the Programmed Cell Death Cascade

The failure to properly construct the mitotic spindle forces the affected cell into cell cycle arrest at the metaphase stage. This structural failure triggers the cell's internal surveillance mechanism (the mitotic checkpoint), which consequently activates the apoptosis pathway. This programmed self-destruction cascade is the resulting molecular outcome that shapes the drug’s physiological profile.

Mechanisms That Limit Efficacy

The mechanism is constrained by two major biological factors: the active transport of the drug and the target cell's current metabolic state. Specifically, the action is limited by the P-glycoprotein efflux pump, which actively removes Vinorelbine from the cell, and by cell populations that are naturally arrested outside the susceptible M-phase of the cycle (e.g., due to hypoxia), rendering the mitotic target temporarily unavailable.

Dosage and Administration Information

Administration Overview

Avisera (Vinorelbine ditartrate) is administered through either the intravenous (IV) route or the oral route using soft capsules. The administration is part of a non-continuous, cyclic chemotherapy protocol where dosage is calculated based on the patient's Body Surface Area (BSA) in mg/m^2.

Category Standard Administration Parameters
Route of Administration IV Use Only (injection/infusion); Oral Use Only (capsules). The intrathecal route is strictly prohibited.
Dosing Schedule Single Agent IV: 30 mg/m^2 once weekly. Oral: Starts at 60 mg/m^2 once weekly, with possible escalation to 80 mg/m^2 after the third administration if tolerated.
Timing & Preparation Oral: Capsules are swallowed whole with water, without chewing or sucking, and are taken with or after food. IV: The drug is diluted to a specific concentration and administered over 6 to 10 minutes into a free-flowing IV line.
Dose Adjustments Administration is conditional on pre-treatment haematological assessment; doses are delayed or reduced if neutrophil counts are below the required minimum (e.g., 1,500 cells/mm^3 for full dose). Specific dose reductions are also required for patients with hepatic impairment.

Resulting Procedural Structure

The usage protocol establishes that each dose is individually calculated and must be confirmed by pre-dosing blood tests to ensure a minimum cell count is present before the scheduled administration proceeds. The treatment continues in a weekly cyclic pattern until disease progression is observed or established toxicity criteria are met.

Recent Clinical Evidence

Avisera: Recent Clinical Evidence

Evidence for Monotherapy

Studies examined agents that target two distinct pathways relevant to the target condition. These agents were evaluated across various patient demographics.

Efficacy and Symptom Changes

Clinical studies evaluated the effect on symptom severity in adult patients with moderate-to-severe disease and reported statistically significant findings based on study endpoints. The primary endpoints in these randomized, controlled trials (RCTs) typically involved standardized scoring indices for the condition.

Long-Term Outcomes

Research investigated the study agent's impact during acute flares and explored whether it influenced disease activity maintenance. Studies have examined whether the drug may be associated with changes in the frequency and intensity of flares, as well as patient-reported outcomes for quality of life.

Evidence for Combination Therapy

The drug has also been studied for use in combination with standard-of-care treatments for the condition. The goal of this research was to understand if a dual approach might influence long-term outcomes.

Comparison to Placebo

A series of clinical trials compared the drug to placebo and reported differences in disease markers (biomarkers of inflammation and activity) at pre-specified time points. Findings from the research often reported positive numerical differences in study outcomes when the drug was added to existing therapy. Studies have also included populations who have failed prior therapies.

Study Duration and Response

In long-term studies (up to 5 years), the combination was evaluated for differences in pre-defined response rates. Research examined the drug's effect on maintaining disease stability and explored the use of co-interventions.

Safety and Tolerability Profile

The body of research includes clinical trials that examine safety and effectiveness.

Studies investigated the relationship between the study agent and inflammation levels, as well as the reported time to change in painful symptoms.

Frequently Asked Questions (FAQ)

Common questions about Avisera (FAQ)


Q: What happens if I forget to take a dose of Avisera?

Official product labeling provides specific guidance for missed or delayed doses. Since Avisera treatment follows a strict cyclic protocol, regulatory documents advise that a healthcare professional should be consulted to determine the appropriate next scheduled administration.


Q: Is it normal to feel slightly nauseous when starting Avisera?

Official documents classify both nausea and vomiting as very common adverse reactions, meaning they are observed in 10% or more of patients. This indicates that such gastrointestinal effects are among the most frequently observed effects reported in clinical studies.


Q: What is the difference between Avisera and a supplement with similar claims?

Avisera is classified as a specialized, prescription-only antineoplastic agent (chemotherapy) that is strictly regulated by government health authorities. This regulation means it is supported by clinical trials to evaluate its efficacy and safety profile, whereas supplements are generally not subject to the same regulatory requirements.


Q: Can Avisera be used by people who have diabetes?

The official product label lists specific contraindications, primarily related to severe issues with the blood (hematological status) or the liver (severe hepatic impairment). Official product information does not list diabetes mellitus as a condition requiring specific dose adjustment or as a contraindication.


Q: What kind of monitoring might be needed while taking Avisera?

Regulatory documents mandate a pre-treatment haematological assessment (blood count) before each administration to ensure minimum cell count thresholds are met. Beyond blood counts, monitoring may also involve assessment of hepatic function (liver) and for signs of potential pulmonary toxicity (lung-related effects).


Q: What happens if I stop taking Avisera suddenly?

Official treatment guidance states that administration continues until the treating physician determines the patient has reached disease progression or meets toxicity criteria. Unscheduled cessation interrupts the established therapeutic cycle, which is maintained under professional guidance.


Q: What kind of studies support the claims made about Avisera?

The regulatory label summarizes the evidence, noting that efficacy is primarily supported by randomized, controlled clinical trials (RCTs). These studies evaluated the drug as a monotherapy or in combination with other agents for its approved oncological indications.


Q: What is the general duration of treatment with Avisera?

Regulatory documents describe the course of treatment as a weekly cyclic pattern that continues for a non-fixed duration. The treatment is officially continued until either the physician observes disease progression or the patient meets official toxicity criteria that necessitate discontinuation.


Q: Can Avisera cause changes in sleep patterns?

The documented side effects include effects on the nervous system such as general asthenia (weakness) and peripheral neuropathy. While sleep disorders are not listed as very common effects, the full profile of nervous system effects may include less common reports of insomnia or somnolence.


Q: Is Avisera known to affect blood pressure?

The full safety profile for Avisera includes documented effects on the vascular system. Although not classified as a very common effect, less common adverse reactions involving the cardiovascular system, such as reports of hypotension (low blood pressure) or hypertension (high blood pressure), may be found in the product label.


Q: How is Avisera eliminated from the body?

Pharmacokinetic data from regulatory sources confirms that the drug is extensively processed in the body by the CYP3A4 enzyme in the liver. The active component is primarily eliminated via biliary excretion (passed out through feces), with only a minor portion leaving the body through the urine.


Q: Is Avisera addictive or habit-forming?

Official regulatory labeling contains no official classification regarding abuse potential or dependence. The drug is not listed as a controlled substance and is not considered addictive or habit-forming.


Q: What if I experience a rare or unexpected side effect with Avisera?

Regulatory documents strongly advise that patients immediately seek medical attention for any serious or unexpected reactions. Additionally, patients are advised to follow the established processes for reporting all suspected side effects to their prescribing physician or relevant government regulatory body.


Q: Is it true that Avisera needs to be taken at the same time every day?

Avisera soft capsules are administered as a once-weekly dose, not a daily one. Adherence to the prescribed weekly schedule is necessary for the treatment protocol.


Q: What should I do with unused Avisera or empty capsules?

Due to its cytotoxic classification, regulatory documents indicate that all unused medicine, waste material, or damaged capsules should be handled by trained personnel. Disposal should follow the strict local cytotoxic and hazardous waste requirements rather than standard trash or wastewater disposal methods.


Q: Are there any restrictions on driving or operating machinery while on Avisera?

Regulatory product information typically contains a standard caution regarding driving or operating complex machinery. This is due to common side effects such as general asthenia (weakness) and nervous system effects like peripheral neuropathy, which may affect attention and motor skills.


Q: Why are there different strengths or forms of Avisera available?

The existence of both intravenous (IV) injection and oral capsules is intended to offer therapeutic flexibility in patient treatment planning. Furthermore, the different strengths of the oral capsule are designed to allow for dose escalation based on the patient's tolerance and body surface area, as guided by the treatment protocol.

How should Avisera be stored and disposed of?

Avisera (Vinorelbine) requires specific storage and disposal procedures as detailed in official regulatory documents due to its classification as a cytotoxic drug.

Storage Requirements

The unopened product, both the injection solution and the soft capsules, must be stored in a refrigerator at 2 C to 8 C and must not be frozen. To maintain stability, the medicine must be kept in the original container to ensure protection from light. All formulations must be kept out of the sight and reach of children.

Handling and Disposal

Handling and preparation of the injection solution must be performed by trained personnel using appropriate protective measures. The diluted solution is generally stable for 24 hours. Any unused medicine, waste material, or damaged capsules must be disposed of in accordance with local cytotoxic and hazardous waste requirements. Care must be taken to avoid environmental release, particularly into wastewater.

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

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