Versavo 400 — Bevacizumab 400 mg/16 mL (1 Vial) Cold chain · Storage +2…+8 °C

Versavo is available as a concentrate for solution for infusion with precise dosing of active components:

• Active Compound: Bevacizumab — 400 mg in one 16 mL vial (concentration of 25 mg/mL).
• Excipients: Trehalose dihydrate, sodium phosphate, polysorbate 20, and water for injections. These components maintain the stability of the antibody molecule and provide the necessary pH level.
• Dosage Form: A glass vial containing a clear or slightly opalescent liquid, packed in a cardboard box with tamper-evident control.

Pharmacodynamics: Bevacizumab selectively binds to the VEGF protein, preventing its interaction with receptors on the surface of endothelial cells. This leads to the regression of existing tumor vessels, normalization of pressure within the tumor tissue, and inhibition of the formation of new vessels, which is critical for disease control.

Pharmacokinetics: The drug is characterized by a long half-life (about 18–20 days), allowing a stable therapeutic concentration in the blood to be maintained with administration once every 2 or 3 weeks. Metabolism occurs via proteolysis throughout the body, without involving liver enzymes.

Versavo 400 mg is used as part of comprehensive treatment regimens for the following diseases:

• 🔹 Colorectal Cancer: Metastatic forms of the disease in combination with fluoropyrimidine-based chemotherapy.
• 🔹 Lung Cancer: Metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC).
• 🔹 Kidney Cancer: Advanced or metastatic renal cell cancer in combination with interferon alfa-2a.
• 🔹 Glioblastoma: Recurrent form of brain tumor in adult patients.
• 🔹 Ovarian and Cervical Cancer: Advanced stages of the disease, including relapses.

The administration regimen is determined by an oncologist individually based on the patient's weight and tumor type:

• Standard Regimen: The dosage is usually 5 mg/kg, 7.5 mg/kg, 10 mg/kg, or 15 mg/kg of the patient's body weight.
• Method of Administration: Only as an intravenous infusion (drip). It is strictly forbidden to administer as a bolus or intramuscularly!
• Duration of the First Infusion: It is 90 minutes. With good tolerability, the duration of subsequent procedures can be reduced to 30–60 minutes.
• Frequency: Infusions are carried out with an interval of 2 or 3 weeks according to the treatment protocol.

The drug has several strict limitations that require special attention:

• ⛔ Pregnancy and Lactation: Bevacizumab is extremely dangerous for the fetus and passes into breast milk. It is categorically contraindicated.
• ⛔ CNS Metastases: Untreated brain metastases due to a high risk of intracranial hemorrhage.
• ⛔ Wound Healing Impairment: Therapy must not be started within 28 days following major surgical operations.
• ⛔ Renal/Hepatic Impairment: Severe forms require careful risk assessment by an oncologist.

Versavo is often prescribed with other drugs, requiring compatibility monitoring:

• ❌ Sunitinib: The combination may cause the development of microangiopathic hemolytic anemia.
• ❌ Platinum Drugs and Taxanes: These increase the risk of infections and neutropenia, requiring monitoring of blood tests.
• ❌ Anthracyclines: Co-administration may increase the risk of developing congestive heart failure.
• ⚠️ Advice: Always inform your doctor if you are taking any blood thinners (anticoagulants), as this increases the risk of bleeding.

Reproductive health issues are critical during Bevacizumab therapy:

• Contraception: Women of childbearing age must use reliable methods of contraception during treatment and for at least 6 months after the last dose.
• Fertility: The drug may cause reversible or irreversible ovarian failure, which should be discussed with a doctor before starting the course.
• Lactation: Breastfeeding should be discontinued for the entire duration of treatment due to the risk of harmful effects on the infant.

Versavo therapy requires monitoring due to the possibility of specific reactions:

• 🟢 Common: Fatigue, weakness, diarrhea or constipation, stomatitis.
• 🟡 Cardiovascular: Arterial hypertension (increased pressure) is one of the most common events.
• 🟡 Bleeding: Nosebleeds, bleeding gums (observed in a significant number of patients).
• 🟠 Serious: Gastrointestinal perforation, protein in the urine (proteinuria), thromboembolism.
• ⚠️ Urgent: Seek medical attention immediately if severe abdominal pain, shortness of breath, sudden visual impairment, or severe bleeding occurs.

If the recommended dose is exceeded, the risk of side effects increases significantly:

• Symptoms: Acute headache (related to a sharp rise in pressure), severe weakness, increased severity of the side effects mentioned above.
• Treatment: No specific antidote for bevacizumab exists.
• Aid Measures: Immediate stop of infusion, symptomatic treatment of hypertension, and monitoring of vital signs.

Compliance with the temperature regimen is the only guarantee for maintaining the antibody's properties:

• 🌡️ Temperature: Store strictly in a refrigerator at a temperature between 2°C and 8°C. Do not freeze!
• 📦 Protection: Store the vial in the original cardboard box to protect it from exposure to light.
• 💧 Prepared Solution: After dilution, it is recommended to use immediately. Storage for no more than 24 hours at 2–8°C is allowed.
• 👶 Safety: Keep in a place absolutely inaccessible to children. Do not shake the vial!