Gemcitabine-Ebeve, 10 mg/ml 100 ml

Antitumor agent.

It has cytostatic action which is connected 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 necessary for DNA synthesis are formed in the cell, which leads to a decrease in their concentration in the cell.

Triphosphate nucleosides actively compete for inclusion in the DNA chain and can also be incorporated into RNA.

After intracellular gemcitabine metabolites are incorporated into the DNA strand, one additional nucleotide is added to its growing strands, resulting in complete inhibition of further DNA synthesis and programmed cell death.

Indications

Non-small cell lung cancer (stages IIIa-IV); advanced pancreatic carcinomas.

Active ingredient

Composition

1 ml contains:

gemcitabine 10 mg

How to take, the dosage

It is set individually, depending on the indication and stage of the disease, the state of the hematopoiesis system, the scheme of anti-tumor therapy.

Interaction

The risk and severity of leukopenia and thrombocytopenia increases after prior cytostatic therapy.

Special Instructions

It has some activity in advanced breast, ovarian, renal, bladder and prostate cancer, small cell lung cancer.

With caution it is used with disorders of hematopoiesis processes; disorders of liver and/or kidney function. During the treatment period the peripheral blood picture should be regularly monitored. In case of development of toxic hematological effect it is required to correct the dosage regimen depending on the degree of leukopenia and thrombocytopenia.

The safety and effectiveness of gemcitabine in children has not been studied.

Impact on driving and operating machinery

At the time of treatment, one should refrain from potentially hazardous activities requiring increased attention and rapid psychomotor reactions.

Contraindications

Hypersensitivity to gemcitabine.

Side effects

Blood system disorders: leukopenia, thrombocytopenia, anemia.

Digestive system disorders: nausea, vomiting, diarrhea; rarely – constipation.

As to the urinary system: proteinuria, hematuria; rarely – peripheral edema; in rare cases – renal failure.

Dermatological reactions: skin rash, itching, alopecia, stomatitis; rarely – scaling, vesicular rash, eczema.

Laboratory measures: transient increase of liver transaminases activity, alkaline phosphatase, increased concentration of bilirubin in plasma.

Respiratory system disorders: rare – bronchospasm, dyspnea.

CNS and peripheral nervous system disorders: rarely – somnolence, weakness, paresthesia.

Cardiovascular system: rare – arterial hypotension, pulmonary edema; in single cases – myocardial infarction, arrhythmias.

Others: flu-like syndrome.

Similarities