Vinblastine-LANS^® (Lyophilisate) Instructions for Use

Marketing Authorization Holder

Veropharm, LLC (Russia)

ATC Code

L01CA01 (Vinblastine)

Active Substance

Vinblastine (Rec.INN registered by WHO)

Dosage Form

Vinblastine-LANS®

Lyophilizate for preparation of solution for intravenous administration 5 mg: fl. 1 pc.

Dosage Form, Packaging, and Composition

5 mg – vials (1) – carton packs.

Clinical-Pharmacological Group

Antineoplastic drug

Pharmacotherapeutic Group

Antineoplastic agents; plant alkaloids and other natural substances; vinca alkaloids and their analogues

Pharmacological Action

Antineoplastic agent. The mechanism of action is associated with the blockade of tubulin and the arrest of cell division in the metaphase.

Pharmacokinetics

It penetrates the blood-brain barrier to a small extent. Plasma protein binding is 75%. It is biotransformed in the liver with the formation of active metabolites. It is predominantly excreted in the bile, partially by the kidneys.

Indications

Hodgkin’s lymphoma, non-Hodgkin lymphomas, germ cell tumors of the testis and ovaries, choriocarcinoma (resistant to the use of other chemotherapeutic drugs), Kaposi’s sarcoma, mycosis fungoides (generalized stages), Letterer-Siwe disease, urothelial cancer (cancer of the bladder, renal pelvis, ureters, urethra), breast cancer (when other treatment methods are ineffective).

ICD codes

Dosage Regimen

Determine the dosage individually based on the specific malignancy, disease stage, and the chosen combination chemotherapy protocol.

Administer the drug intravenously only. Avoid intrathecal administration as it is fatal.

Reconstitute the 5 mg lyophilisate with the supplied solvent or 5-10 ml of Sodium Chloride 0.9% solution. Use the solution immediately.

For adults, the initial dose is typically 3.7 mg/m² of body surface area. Adjust subsequent doses based on hematological tolerance and the severity of adverse reactions.

Administer doses at weekly intervals. Increase the dose in increments of 1.8 mg/m² until moderate leukopenia occurs (approximately 3000 WBC/µl). Do not exceed a single dose of 18.5 mg/m².

For pediatric patients, the initial dose is 2.5 mg/m². Adjust subsequent doses similarly, based on weekly blood counts. Do not exceed a single dose of 12.5 mg/m².

Reduce the dose by 50% if the direct serum bilirubin level is between 1.5-3.0 mg/dl. Reduce the dose by 75% if the direct serum bilirubin level exceeds 3.0 mg/dl.

Withhold therapy if severe leukopenia or granulocytopenia develops. Resume treatment only after blood counts have sufficiently recovered.

Monitor complete blood counts, including leukocyte and platelet counts, prior to each dose and regularly throughout therapy.

Monitor liver function tests (transaminases, LDH, bilirubin) and serum uric acid levels before and during treatment.

Adverse Reactions

From the CNS and peripheral nervous system neuropathy, neuritis of peripheral nerves, headache, depression, convulsions.

From the hematopoietic system leukopenia, granulocytopenia, thrombocytopenia, anemia.

From the digestive system anorexia, nausea, vomiting, abdominal pain, paralytic ileus, constipation, diarrhea, ulcerative stomatitis, hemorrhagic enterocolitis.

From the cardiovascular system increased blood pressure, development of myocardial infarction, cerebrovascular disorders, exacerbation of Raynaud’s disease symptoms.

From the respiratory system acute respiratory failure, bronchospasm.

From the reproductive system azoospermia, amenorrhea.

Other alopecia, bone pain.

Contraindications

Severe suppression of bone marrow hematopoiesis, pregnancy, breastfeeding period, bacterial and viral infections, hypersensitivity to vinblastine.

With caution

In case of prior or simultaneous myelosuppressive therapy and radiation therapy, with leukopenia, thrombocytopenia, liver damage, in elderly patients.

Use in Pregnancy and Lactation

Vinblastine is contraindicated for use during pregnancy. If it is necessary to use during lactation, breastfeeding should be discontinued.

When used in women of childbearing age, it is recommended to use reliable methods of contraception.

In experimental studies, the teratogenic effect of vinblastine has been established.

Use in Hepatic Impairment

In patients with impaired liver function, the risk of toxic effects of vinblastine is increased.

Use in Renal Impairment

There are no specific restrictions in case of impaired renal function.

Pediatric Use

It is possible to use in children according to indications.

Geriatric Use

Use with caution in elderly patients.

Special Precautions

Vinblastine should be used with caution in patients with chickenpox (including recently suffered or after contact with sick persons), herpes zoster, other acute infectious diseases, gout, nephrolithiasis (including in the anamnesis). In patients with impaired liver function, the risk of toxic effects of vinblastine is increased.

Use with caution during treatment with drugs that inhibit the activity of the CYP3A isoenzyme.

The maximum depression of hematopoiesis (primarily a decrease in the number of leukocytes in the peripheral blood) is reached 5-10 days after discontinuation of vinblastine. Normalization of the number of leukocytes in the peripheral blood is noted after 7-14 days. The development of thrombocytopenia (less than 200,000/µl) is most likely in patients who received prior anticancer or radiation therapy. Normalization of the platelet count is usually noted a few days after discontinuation of vinblastine.

The risk of developing leukopenia when using vinblastine is increased in patients with cachexia and ulcerative skin lesions, therefore, it is not recommended to prescribe it to patients with the above conditions. In patients with bone marrow metastases, a pronounced decrease in the number of leukocytes and platelets was noted after the use of vinblastine in average doses. In these cases, further use of vinblastine is not indicated.

During therapy, it is necessary to monitor the activity of liver transaminases and LDH, the level of bilirubin and the concentration of uric acid in the blood plasma.

During treatment, vaccination of patients and their family members is not recommended.

Intrathecal administration of vinblastine can be fatal. Accidental contact with the eyes may cause severe inflammation.

Drug Interactions

Concomitant use of drugs that have a neurotoxic effect (including isoniazid, asparaginase) is prohibited.

With simultaneous use with inhibitors of the CYP3A isoenzyme activity, earlier appearance and/or worsening of the severity of side effects of vinblastine is possible.

With simultaneous use with vinblastine, a decrease in the plasma concentration of phenytoin and a decrease in its anticonvulsant activity is possible, apparently due to a decrease in absorption, an increase in the rate of metabolism and elimination of phenytoin.

With simultaneous use of vinblastine in high doses with interferon alfa-n1, severe myelodepression is possible.

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.