Maverex (Concentrate) Instructions for Use

Marketing Authorization Holder

Veropharm, LLC (Russia)

ATC Code

L01CA04 (Vinorelbine)

Active Substance

Vinorelbine (Rec.INN registered by WHO)

Dosage Form

Maverex

Concentrate for solution for infusion 10 mg/ml: fl. 1 ml, 3.5 ml or 5 ml 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Concentrate for solution for infusion clear, colorless or slightly colored.

Excipients : water for injections – up to 1 ml.

1 ml – glass bottles (1) – cardboard packs.
1 ml – glass bottles (5) – cardboard packs with dividers.
1 ml – glass bottles (10) – cardboard packs with dividers.
3.5 ml – glass bottles (1) – cardboard packs.
3.5 ml – glass bottles (5) – cardboard packs with dividers.
3.5 ml – glass bottles (10) – cardboard packs with dividers.
5 ml – glass bottles (1) – cardboard packs.
5 ml – glass bottles (5) – cardboard packs with dividers.
5 ml – glass bottles (10) – cardboard packs with dividers.

Clinical-Pharmacological Group

Antineoplastic drug

Pharmacotherapeutic Group

Antineoplastic agent – alkaloid

Pharmacological Action

Antineoplastic agent from the group of cytostatics, is a semi-synthetic derivative of one of the alkaloids of the periwinkle plant – vinblastine.

Like vinblastine, Vinorelbine blocks cell mitosis at the metaphase stage by binding to the protein tubulin.

Pharmacokinetics

After intravenous administration, Vinorelbine is widely distributed in tissues, V_d is more than 40 L/kg.

Binding to plasma proteins is moderate – 13.5%, to platelets – high – 78%.

The kinetics of vinorelbine in plasma is triphasic.

The mean T_1/2 of the active substance in the terminal phase is 40 h.

Systemic clearance is 1.3 L/h/kg.

It is excreted mainly with bile.

Indications

Non-small cell lung cancer, advanced breast cancer, hormone-resistant prostate cancer (in combination with low-dose oral corticosteroid treatment).

ICD codes

Dosage Regimen

Establish the dosage regimen individually based on the specific indication, disease stage, patient’s hematopoietic status, and the chosen anticancer therapy protocol.

Administer as a short-term intravenous infusion. Do not administer intrathecally as it will cause death.

For non-small cell lung cancer and advanced breast cancer, the typical monotherapy dose is 25-30 mg/m².

Infuse over 6-10 minutes into the side port of a free-flowing intravenous solution, followed by flushing with at least 75-125 mL of solution.

Repeat administration once weekly.

Before each weekly dose, mandatorily check the complete blood count.

Withhold the dose if the granulocyte count is below 2000 cells/mcL or if severe non-hematological toxicity, except alopecia, is present.

For combination chemotherapy, adjust the vinorelbine dose according to the specific protocol; it is often reduced.

In patients with severe hepatic impairment, reduce the dose.

Dilute the concentrate before administration. Use either 0.9% Sodium Chloride solution or 5% Dextrose solution to a final concentration of 1.5-3.0 mg/mL.

Use the diluted solution immediately; chemical and physical stability is limited. Discard any unused portion of the concentrate or infusion solution.

Take extreme care to avoid extravasation, which can cause severe local tissue necrosis, pain, and phlebitis.

Adverse Reactions

From the hematopoietic system granulocytopenia, anemia.

From the peripheral nervous system possible decrease (up to complete extinction) of osteotendinous reflexes; rarely – paresthesia; with prolonged use – increased fatigue of the muscles of the lower extremities.

From the digestive system nausea, less often – vomiting; due to the effect of the drug on the autonomic innervation of the intestine – constipation; in some cases – intestinal paresis; rarely – paralytic intestinal obstruction.

Allergic reactions difficulty breathing, bronchospasm; in isolated cases – skin reactions.

Other alopecia, jaw pain.

Local reactions phlebitis.

Contraindications

Baseline absolute neutrophil count <1500 cells/mcL, baseline platelet count <100000 cells/mcL; infectious diseases on the day of therapy initiation or suffered within the last 2 weeks; concomitant use with yellow fever vaccine; pregnancy, breastfeeding period; children and adolescents under 18 years of age, hypersensitivity to vinorelbine.

With caution

Patients with a history of coronary artery disease, severe general condition of patients, severe hepatic insufficiency; concomitant use with strong inhibitors or inducers of the CYP3A4 isoenzyme, vitamin K antagonists, with macrolides, cobicistat, protease inhibitors, lapatinib; patients from the Japanese population (due to more frequent cases of interstitial lung disorders in this category of patients).

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and breastfeeding.

Use in Hepatic Impairment

Use with caution in severe liver dysfunction.

Use in Renal Impairment

Due to low renal elimination, dose adjustment is not required in patients with renal impairment.

Pediatric Use

Contraindicated for use in children and adolescents.

Geriatric Use

Increased toxic effects of vinorelbine in elderly patients cannot be completely ruled out.

Special Precautions

Treatment with vinorelbine should be carried out only in a specialized hospital by personnel experienced in the treatment with chemotherapeutic agents.

Before starting treatment, as well as before each subsequent use of vinorelbine, it is necessary to monitor the composition of peripheral blood.

If the granulocyte count is less than 2000/mcL, the next injection is not performed, postponing it until a safe granulocyte level is reached.

Vinorelbine should be used with caution in patients with impaired liver function, in which case the dose should be reduced.

Radiotherapy to the liver area should not be prescribed during treatment with vinorelbine.

Avoid extravasation during intravenous infusion.

Entry of vinorelbine into the tissues surrounding the vein leads to pain, inflammation, and in severe cases, necrosis.

Avoid contact of vinorelbine solution with the eyes.

Drug Interactions

With simultaneous use with mitomycin C, the risk of respiratory depression and bronchospasm increases, especially in predisposed patients; with cisplatin – an increase in the frequency of toxic reactions.

Storage Conditions

Store at 2°C (36°F) to 8°C (46°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.