Universal reference book for medicines
Product name: GEMCITERA (GEMCITERA)

Active substance: gemcitabine

Type: Antitumor drug.
Antimetabolite
Manufacturer: Laboratorio TUTEUR SACIFIA (Argentina) manufactured by Laboratorio IMA SAIC (Argentina)
Description of the active substance:
This information is a reference and it is not enough that the drug has been prescribed by a doctor ..

PHARMACHOLOGIC EFFECT
Antitumor agent.
Has a cytostatic effect, which is associated with inhibition of DNA synthesis. In the cell it is metabolized to active diphosphate and triphosphate nucleosides. Diphosphate nucleosides inhibit the action of ribonucleotide reductase, with the participation of which deoxynucleoside triphosphates are formed in the cell, which are necessary for DNA synthesis, which leads to a decrease in their concentration in the cell. Triphosphate nucleosides actively compete for the incorporation of DNA into the strand, and can also be included in RNA. After integrating intracellular gemcitabine metabolites into the DNA chain, one additional nucleotide is added to its growing chains, which leads to complete inhibition of further DNA synthesis and programmed cell death.
PHARMACOKINETICS
With iv infusion of gemcitabine in doses of 500-2592 mg / m 2 for 0.4-1.2 hours C max in plasma was 3.2-45.5 μg / ml and was determined for 5 min at the end of infusion.
V d in the central part is 12.4 l / m 2 in women and 17.5 l / m 2 in men (individual differences - 91.9%). V d in the peripheral part is 47.4 l / m 2 and does not depend on the floor. There is practically no binding to proteins.
The system clearance varies from 29.2 l / h / m 2 to 92.2 l / h / m 2 .
In women, the clearance is about 25% lower than that of men. Less than 10% is excreted unchanged in urine. Kidney clearance is 2-7 l / h / m 2 . T 1/2 depends on age and sex and is 42-94 minutes. When administered once a week, gemcitabine is not cumulated.
Gemcitabine is rapidly metabolized with the participation of cytidine deaminase in the liver, kidneys, blood and other tissues.
Intracellular metabolism of the active substance produces mono-, di- and triphosphates of gemcitabine, which have pharmacological activity. These metabolites are not detected in either plasma or urine.
The main metabolite of 2-deoxy-2,2-difluoruridine does not have pharmacological activity and is determined in plasma and urine.

INDICATIONS
Non-small cell lung cancer (IIIa-IV stage);
late pancreatic carcinomas.
DOSING MODE
Established individually, depending on the indications and stage of the disease, the state of the hematopoiesis system, the scheme of antitumor therapy.

SIDE EFFECT
On the part of the hematopoiesis system: leukopenia, thrombocytopenia, anemia.

On the part of the digestive system: nausea, vomiting, diarrhea;
rarely - constipation.
From the urinary system: proteinuria, hematuria;
rarely - peripheral edema; in isolated cases - renal failure.
Dermatological reactions: skin rash, itching, alopecia, stomatitis;
rarely - peeling, vesicle rash, eczema.
On the part of laboratory indicators: a transient increase in the activity of hepatic transaminases, alkaline phosphatase, an increase in the concentration of bilirubin in plasma.

From the respiratory system: rarely - bronchospasm, shortness of breath.

From the side of the central nervous system and peripheral nervous system: rarely - drowsiness, weakness, paresthesia.

From the cardiovascular system: rarely - arterial hypotension, pulmonary edema;
in isolated cases - myocardial infarction, arrhythmia.
Other: influenza-like syndrome.

CONTRAINDICATIONS
Hypersensitivity to gemcitabine.

PREGNANCY AND LACTATION
The safety of gemcitabine in pregnancy in humans has not been studied.

In experimental studies, it has been shown that gemcitabine exerts embryo and fetotoxic effects, adversely affects the course of pregnancy and postnatal development.

Gemcitabine should be avoided during pregnancy.
Women of childbearing age in the period of treatment should use reliable methods of contraception.
If it is necessary to use during the lactation period, the question of stopping breastfeeding should be solved.

APPLICATION FOR FUNCTIONS OF THE LIVER
With caution apply for violations of kidney function, while performing periodic monitoring of their functional state.

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
With caution apply for violations of the liver, while performing periodic monitoring of its functional state.

APPLICATION FOR CHILDREN
The safety and efficacy of gemcitabine in children has not been studied.

SPECIAL INSTRUCTIONS
Has some activity in the late stages of breast, ovarian, kidney, bladder and prostate cancer, small cell lung cancer.

Use with caution in cases of disorders of hematopoiesis;
violations of the liver and / or kidneys. During the treatment period, the peripheral blood pattern should be monitored regularly. When the toxic hematological effect develops, correction of the dosing regimen is required depending on the degree of leukopenia and thrombocytopenia.
The safety and efficacy of gemcitabine in children has not been studied.

Impact on the ability to drive vehicles and manage mechanisms

During treatment should refrain from potentially dangerous activities that require increased attention and speed of psychomotor reactions.

DRUG INTERACTION
The risk of developing and severity of leukopenia and thrombocytopenia increases after previous therapy with cytostatics.

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