Vero-Etoposide (Capsules) Instructions for Use

Marketing Authorization Holder

Veropharm, JSC (Russia)

ATC Code

L01CB01 (Etoposide)

Active Substance

Etoposide (Rec.INN registered by WHO)

Dosage Form

Vero-Etoposide

Capsules 50 mg: 4 or 20 pcs.

Dosage Form, Packaging, and Composition

4 pcs. – blister packs (1) – cardboard packs
4 pcs. – blister packs (5) – cardboard packs.

Clinical-Pharmacological Group

Antineoplastic drug

Pharmacotherapeutic Group

Antineoplastic agent – alkaloid

Pharmacological Action

Antineoplastic agent. It is a semi-synthetic derivative of podophyllotoxin. The mechanism of action is associated with the inhibition of topoisomerase II.

It inhibits mitosis, blocks cells in the S-G₂ interphase of the cell cycle, and in higher doses acts in the G₂ phase. 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 bioavailability averages 50%.

Distribution into the cerebrospinal fluid is low and variable; the concentration in normal lung tissue is higher than in the presence of lung metastases; a similar level of concentrations is found in the tissues of primary tumors and in normal myometrial tissues.

A direct correlation has been noted between the etoposide binding coefficient 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 hours. It is excreted by the kidneys – 44-60%, with feces – up to 16%, with bile – 6% or less.

Indications

Germ cell tumors (testicular tumors, choriocarcinoma), ovarian cancer, small cell and non-small cell lung cancer, Hodgkin’s disease [lymphogranulomatosis], non-Hodgkin’s lymphomas, stomach cancer (for monotherapy and as part of combination therapy), Ewing’s sarcoma, Kaposi’s sarcoma, neuroblastoma, breast cancer (with metastases to the liver, to the pleura), acute non-lymphoblastic leukemia, mesothelioma.

ICD codes

Dosage Regimen

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

Calculate the total dose per treatment cycle as a function of body surface area (mg/m²).

Administer orally once daily for a predetermined number of days, as defined by the treatment cycle.

Repeat the treatment cycle after a specific time interval, typically every 3 to 4 weeks, depending on hematological recovery.

Take capsules on an empty stomach, at least one hour before or two hours after a meal, to ensure optimal bioavailability.

Swallow capsules whole with a full glass of water; do not chew or crush.

Adjust the dose based on the severity of hematological toxicity observed in previous cycles.

Withhold therapy if the neutrophil count falls below 0.5 x 10⁹/L or the platelet count falls below 50 x 10⁹/L.

Substantially reduce the dose in patients with impaired renal function; use creatinine clearance to guide the adjustment.

Exercise caution and consider dose modification in patients with pre-existing liver impairment.

Do not administer to children under 2 years of age.

Monitor complete blood count with differential and platelet count before each dose and regularly throughout the treatment cycle.

Adverse Reactions

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, increased fatigue; damage to the peripheral nervous system.

From metabolism hyperuricemia; when using high doses – metabolic acidosis.

From the cardiovascular system tachycardia, arterial hypotension.

From the reproductive system azoospermia, amenorrhea.

Allergic reactions chills, fever, bronchospasm.

Dermatological reactions alopecia.

Contraindications

Severe myelodepression, severe impairment of liver and kidney function, pregnancy, children under 2 years of age, hypersensitivity to podophyllin or its derivatives.

Use in Pregnancy and Lactation

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

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

In experimental studies, it has been established that Etoposide has teratogenic and embryotoxic effects.

Use in Hepatic Impairment

Contraindicated in severe liver dysfunction.

Use with caution in patients with impaired liver function.

Use in Renal Impairment

Contraindicated in severe renal impairment.

In moderate and mild renal impairment, the dose should be reduced in accordance with creatinine clearance values.

Pediatric Use

Contraindicated in children under 2 years of age.

Use with caution in children over 2 years of age.

Special Precautions

Use with caution in patients with prior radiation or chemotherapy, with chickenpox, herpes zoster, with infectious lesions of the mucous membranes, with cardiac arrhythmias, with an increased risk of myocardial infarction, impaired liver function, diseases of the nervous system (epilepsy), chronic alcoholism, in children over 2 years of age.

In case of impaired renal function, the dose should be reduced in accordance with creatinine clearance values.

Before starting and during therapy, the peripheral blood picture should be monitored.

Vaccination of patients and their family members is not recommended.

Experimental studies have established that Etoposide has a mutagenic effect.

Effect on the ability to drive vehicles and operate machinery

During treatment, one should refrain from activities requiring increased attention and rapid psychomotor reactions.

Drug Interactions

With simultaneous use with other drugs causing myelodepression, additive suppression of bone marrow function is possible.

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

Cyclosporine in high doses may reduce the clearance of etoposide and increase the duration of its action, which may enhance leukopenia.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°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.