Generic Vepesid

1. Denomination

Vepesid

2. Active Substance

Etoposide

3. Indications for Use.

Herminogene seminima and oothecoma, cancer of lungs, cancer of adrenal cortex, cancer of urinary bladder, acute monoblastic leukemia, and that of myelogenous, lymphogranulomatosis, Non Hodgkin Lymphom, Kaposi’s sarcoma, Ewing’s sarcoma, cancer of stomach, chorionepithelioma, neuroblastoma.

4. Action

The mechanism of Etoposide’s action lies in delay of DNA synthesis and, respectively in suppression of growth of tumor cells.

5. Posology and Administration

Dosage regimen is set up in relation to the chemotherapy regimen in use. Intravenous drip-feed (it is dissolved in 0.9% solution of NaCl), during 30-60 minutes. It is administered in the following doses: 1) 100 mg/sq.m/daily from the 1-st to the 5-th day, the cycles should be repeated every 3-4 weeks; 2) 100-125 mg/sq.m in the 1-st, 3-d, 5-th days; the courses should be repeated in 3 weeks; 3) in oral intake 50 mg/sq.m. every day during 21 days, the cycles should be repeated every 4 weeks or 100-200 mg/sq.m 5 days running with a three weeks interval. Refresher courses of treatment should be carried out only after the factors of peripheral blood have been normalized. Before intravenous introduction it is dissolved in 250 ml of 0.9% solution of NaCl or 5% solution of dextrose up to the end concentration of 0.2-0.4 mg/ml. No contact with pH more than 8 buffered water solutions is allowed.

6. Counterindications

Hypersensitivity, liver and/or kidney failure, bad distress of cerebral blood forming, acute infections of virus, fungal and bacterial nature (including herpes and chicken pox).
Alcoholism, epilepsy, childhood (less than 2 years of age, as security and efficiency for children has not yet been determined).

7. Should Be Taken with Precautions, if…

With caution it should be taken in cases of arrythmia.  Patients who suffer from kidney and liver failure need correction of dosage regimen and regular control of kidney function.
The drug should be taken only under a constant medical supervision. It is necessary to carry out a regular blood composition monitoring before the start of treatment, in intervals and before each successive course. If before the treatment there has been carried out radiation and/or chemo therapy, the choice of dosage regimen of Etoposide should be implemented in compliance with the evidence of bone marrow function distress.
While working with Etoposide safety whites, mask, glasses, gloves should be put on. In case of a contact with skin or mucus coating - impaired parts should be rinsed with water and soap immediately.

8. Interface with Other Medications

Etoposide in no circumstances should be used without a doctor’s order. All the necessary recommendations on the use of this drug and eventual combination with other medications are under the responsibility of your attending doctor.

9. Overdosing

There has not been yet registered a case of human Etoposide overdosing. It may be suggested that the main evidence of overdosage might be blood and intestinal tract toxic effects.

10. Side Effects

Local reactions: phlebitis in case of intravenous introduction, in intravenous introduction and in penetration of the drug under the skin it may be locally-penetration action up to necrosis of surrounding tissues. On the part of blood forming organs fall of the number of leukocytes and granulocytes depends on the injected dose and it is the main toxic evidence that confines the dose.
On the part of digestive system: nausea, vomiting, moreover there are noticed diarrhea, abdominal pains, stomatitis, gullet inflammation, inflammatory processes of mouth cavity, gorge, gullet, larynx, anorexia. On the part of cardio-vascular system: temporary fall of arterial tension. Allergic reactions: chilly sensation, tachycardia, bronchial spasm, panting low arterial tension. On the part of skin integument: inversive baldness, sometimes it results in hair loss. Seldom: pigmentation, itching, radiation dermatitis. Others: seldom – drowsiness, increased fatigability, after-taste in mouth, cough as a consequence of lung disorders, malign exudative erythema (Stevens-Johnson syndrome), peeling, optic neuritis, amaurosis fugax of cortical genesis, muscle convulsions, metabolic acidosis, frequent nocturnal urination.

11. Pregnancy and Lactation

It is counterindicated during pregnancy and in lactation period.

12. Driving

The drug is not recommended to use for people who work as machinery operators of vehicle drivers.

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