Etoposide-Teva: instructions for using the medicine, structure, Contraindications

Active material: Etoposide
When ATH: L01CB01
CCF: Anticancer drug
When CSF: 22.03.01
Manufacturer: TEVA Pharmaceutical Industries Ltd. (Israel)

Etoposide-Teva: dosage form, composition and packaging

The solution for infusion concentrate clear, yellowish, slightly viscous, free from visible particles.

Excipients: Citric acid anhydrous, Tween-80, Ethanol absolute, propylene glycol 300.

50 ml – bottles (1) – cardboard boxes.

The solution for infusion concentrate clear, yellowish, slightly viscous, free from visible particles.

Excipients: Citric acid anhydrous, Tween-80, Ethanol absolute, propylene glycol 300.

5 ml – bottles (1) – cardboard boxes.

The solution for infusion concentrate clear, yellowish, slightly viscous, free from visible particles.

Excipients: Citric acid anhydrous, Tween-80, Ethanol absolute, propylene glycol 300.

10 ml – bottles (1) – cardboard boxes.

The solution for infusion concentrate clear, yellowish, slightly viscous, free from visible particles.

Excipients: Citric acid anhydrous, Tween-80, Ethanol absolute, propylene glycol 300.

20 ml – bottles (1) – cardboard boxes.

The solution for infusion concentrate clear, yellowish, slightly viscous, free from visible particles.

Excipients: Citric acid anhydrous, Tween-80, Ethanol absolute, propylene glycol 300.

25 ml – bottles (1) – cardboard boxes.

Etoposide-Teva: pharmachologic effect

Etoposide is a semi-synthetic derivative of podofillotoksina derivatives,used as an antineoplastic funds. Etoposide provides zitotoksicescoe due to DNA damage. The drug blocks mitosis,causing the death of cells in the G2 phase and late S phase mitoticeski cycle. High concentrations of the drug cause lysis of cells in the premitoticheskoj phase. Etoposide also suppresses the penetration of nucleotides through the plasma membrane, that interferes with the synthesis and DNA recovery.

Etoposide-Teva: pharmacokinetics

After the introduction of the drug found in saliva, in liver tissue, spleen, kidney,miometrium, to a lesser extent in pleural fluid, bile, the tissues of the brain.

Etoposide penetrates through the placental and marginally – through the blood-brain barriers. Etoposide concentrations in cerebrospinal fluid range from identified values to 5% concentration in blood plasma. Data on the allocation of the drug in breast milk are not available. Plasma protein binding is approximately 90%.

Etoposide actively metabolised in the body. Allocation of etoposide in this phase is carried out in a manner. In adults with normal renal function and liver half-time in the initial phase, on average, approximately 1,5 hours with a half-life in final stage within 5-11 hours. Total clearance in adults varies 19-28 mL/min/m2. Renal clearance is 30 – 40% the total clearance. Etoposide return with urine in the form of unchanged substance and metabolites (about 40% of the administered dose) during 48-72 hours. 2 – 16% stands out from feces.

Etoposide-Teva: testimony

Basic indications to application of Etoposide are germ cell testicular tumors and ovarian cancer, small cell lung cancer.

There are reports on the effectiveness of etoposide in the treatment of bladder cancer, Hodgkin's disease, non-Hodgkin Lymphoma, acute monoblastnogo and mieloblastnogo leukemia, Ewing Sarcoma, trofoblasticheskih tumors, stomach cancer, Kaposi's Sarcoma and neuroblastoma.

Etoposide-Teva: dosing regimen

Etoposide is part of many schemes to cytostatic treatment, Therefore when choosing a route, regime and doses in each individual case data should guide literature.

Dose etoposide constitute 50-100 mg/m2 per day for 5 days, with repetition cycles every 3-4 of the week.

Also often used the introduction of etoposide in a day – in 1-St, 3-th and 5-th days.

Repeated courses are conducted only after normalization of peripheral blood.

When selecting dose myelosuppressive effect should be considered other drugs in combination, as well as previous radiation therapy and chemotherapy. Before using, you must take a visual assessment solution to detect particulate matter or discoloration.

Before the introduction of etoposide diluted 0,9% a solution of sodium chloride or 5% glucose/dextrose solution prior to final concentration 0,2 – 0,4 mg / ml. It should not be allowed contact with the buffer aqueous solutions with pH above 8.

Etoposide is introduced by 30-60-minute intravenous infusion.

Etoposide-Teva: side effects

From the hematopoietic system: The decline in the number of blood platelets and depends on the input of the dose and dose-limiting is the major toxic manifestation of etoposide. The maximum decrease in the number of granulozitov is usually observed on 7-14 the day after injection. Thrombocytopenia occurs less frequently, and the maximum reduction of platelets is observed on 9-16 the day after the introduction of etoposide. Restoration of the blood occurs usually on 20 the day after the introduction of the standard dose. Anemia is observed infrequently.

From the digestive system: Nausea and vomiting occurs in about one third of patients. Typically, these phenomena are modest, and lifting treatment due them have rarely. To control these side effects showing antiemetic drugs. Besides, experienced diarrhea, abdominal pain, stomatitis, esophagitis, dysphagia, anorexia. Sometimes there is light temporary hyperbilirubinemia and raising transaminaz in the serum. Most often this occurs when the application doses, exceeding recommended.

Cardio-vascular system: Rapid intravenous u 1-2% patients noted a temporary decrease in blood pressure, which is usually restored upon termination of the infusion and the introduction of liquids or other maintenance therapy. If necessary, resumption of the introduction of etoposide speed should be reduced.

Allergic reactions: Symptoms, resembling anaphylactic, such as chills, fever, tachycardia, bronchospasm, breathlessness, apnea. These reactions usually occur during or immediately after the introduction of etoposide and terminate upon cessation of infusion. However, deaths have been registered and, associated with bronchospasm. If you experience similar reactions therapy stopped and optionally injected vazopressornye preparations, corticosteroids, antihistamines and infusion-transfusion therapy.

Skin and skin appendages: Reversible alopecia, sometimes resulting in a complete loss of hair, occurs in approximately 66% patients. There was also the appearance of pigmentation, itching, krapivnicы. In one case there was a relapse of radiation Dermatitis.

Etoposide-Teva: Contraindications

• Increased sensitivity to the drug;
• Expressed mielosuprescia;
• Expressions of the liver;
• Acute infections;
• Pregnancy and lactation.

Etoposide-Teva: Pregnancy and lactation

The drug is contraindicated.

Etoposide-Teva: Special instructions

Etoposide is only intended for introduction in the form of the/in infusion, the other route is not permitted.

The introduction of the drug should be used with caution, to prevent extravasation during infusion. But, If ekstrawazation still occurred, the following activities are conducted: perfusion should stop, Once a sense of stinging; around the affected places to produce a corticosteroid injection, subcutaneous (hydrocortisone); apply to the affected area 1% gidrokortizonovuju ointment so far, disappears and Erythema; to the affected area apply a dry bandage on 24 o'clock.

Etoposide contains as filling ethanol: This can be a risk factor for patients, suffering from liver disease, alcoholism and epilepsy, as well as for children.

Etoposide-Teva: overdose

Cases of overdose when applying etoposide in humans have so far not registered. It can be assumed, the main manifestations of overdose would be toxic effects from the blood and gastrointestinal tract. In such cases, the shows are mainly symptomatic therapy.

There is no specific antidote.

Etoposide-Teva: drug interaction

Antitumor effect of etoposide is enhanced when applied in combination with cisplatin, However thus it is necessary to take into account the, that patients, before receiving treatment tsisplatinom, excretion of etoposide can be broken.

Etoposide cannot be mixed with other drugs in a single solution.

Etoposide-Teva: terms and conditions of storage

Store in the dark and out of reach of children at a temperature 15-25 ° C.

Shelf life: 3 year.