VEPEZID

Active material: Etoposide
When ATH: L01CB01
CCF: Anticancer drug
When CSF: 22.03.01
Manufacturer: Bristol-MYERS SQUIBB s. r. L. {Italy}

Pharmaceutical form, composition and packaging

20 PC. – vials of dark glass (1) – packs cardboard.

5 ml – bottles (1) – cardboard boxes.

DESCRIPTION OF ACTIVE SUBSTANCES.

Pharmacological action

The antitumor agent. It is a semi-synthetic derivative of podophyllotoxin. The mechanism of action is associated with the inhibition of topoisomerase II. Inhibits mitosis, blocks cells in S-G₂-interphase of the cell cycle, at higher doses acts in G₂-phases. The cytotoxic effect on normal healthy cells is observed only when etoposide is used in high doses..

Pharmacokinetics

When taken orally, etoposide is absorbed from the gastrointestinal tract.. The average bioavailability is 50%. CSF distribution is low and variable; concentration in normal lung tissue is higher, than with lung metastases; a close level of concentrations in the tissues of primary tumors and in normal tissues of the myometrium is determined.

A direct correlation was noted between the binding coefficient of etoposide and the level of albumin in the blood plasma of healthy people and patients with cancer.. It is metabolized in the liver.

The final T_1/2 averages 7 no. Report the news – 44-60%, with faeces – to 16%, the bile – 6% less.

Testimony

Germ cell tumors (testicular tumors, xoriokarцinoma), ovarian cancer, small cell and non-small cell lung cancer, limfogranulematoz, non-Hodgkin's lymphoma, stomach cancer (for monotherapy and as part of combination therapy), sarkoma Juinga, Kaposi's sarcoma, sympathicoblastoma, mammary cancer (with liver metastases, in the pleura), acute nelimfoblastnyj leukemia, mesothelioma.

Dosage regimen

Establish individually, depending on the evidence and disease stage, the state of the hematopoietic system, scheme anticancer therapy.

Side effect

From the hematopoietic system: leukopenia, anemia; less often – thrombocytopenia.

From the digestive system: nausea, vomiting; rarely – anorexia, mucositis, diarrhea; when used in high doses – toxic reactions from the liver.

From the central and peripheral nervous system: drowsiness, fatigue; damage to the peripheral nervous system.

Metabolism: hyperuricemia; with high doses of – metabolic acidosis.

Cardio-vascular system: tachycardia, hypotension.

Reproductive system: azoospermia, amenorrhea.

Allergic reactions: chills, fever, bronchospasm.

Dermatological reactions: alopecia.

Contraindications

Severe myelodepression, expressed human liver and kidneys, pregnancy, Children up to age 2 years, hypersensitivity to podophyllin or its derivatives.

Pregnancy and lactation

Etoposide is contraindicated in pregnancy. If necessary, use during lactation should stop breastfeeding.

During treatment and for 3 months after its completion, patients of childbearing age must use effective methods of contraception.

IN experimental studies found, that etoposide has a teratogenic and embryotoxic effect.

Cautions

Use with caution in patients with previous radiation or chemotherapy, with chicken pox, Herpes Zoster, with infectious lesions of the mucous membranes, with cardiac arrhythmias, with an increased risk of myocardial infarction, abnormal liver function, diseases of the nervous system (epilepsy), alcoholism, in children older 2 years.

In case of impaired renal function, the dose is reduced in accordance with the CC values..

Before starting and against the background of ongoing therapy, the picture of peripheral blood should be monitored..

It is not recommended to vaccinate patients and their families.

In experimental studies found, that etoposide is mutagenic.

Effects on ability to drive vehicles and management mechanisms

During treatment, you should refrain from exercising, requiring attention and quick emotional reactions.

Drug Interactions

When used simultaneously with other drugs, causing myelodepression possibly additive inhibition of bone marrow function.

With simultaneous use with cisplatin, a decrease in the clearance of etoposide and an increase in its toxicity are possible..

High-dose cyclosporine may decrease the clearance of etoposide and increase its duration of action., may increase leukopenia.