Gemzar 1000mg bottle №1

Packaging

1 bottle.

Mechanism of action

Antitumor drug, antimetabolite from the group of pyrimidine analogs.
The drug shows cyclospecificity, acting on cells in phases S and G₁/ S.
Gemcitabine is metabolized within the cell by the action of nucleoside kinase to form active diphosphate and triphosphate nucleosides. Diphosphate nucleosides inhibit ribonucleotide reductase, which acts as the sole catalyst of the reactions leading to the formation of deoxynucleoside triphosphates necessary for DNA synthesis. Triphosphate nucleosides actively compete with deoxycytidine triphosphate for incorporation into DNA and RNA molecules. After embedding intracellular metabolites of gemcitabine into the DNA strand, another additional nucleotide is added to its growing strands. As a result of these events, complete inhibition of further DNA synthesis and programmed cell lysis, known as apoptosis, occurs.

Indications and usage

- bladder cancer;
- locally advanced or metastatic non-small cell lung cancer (as a first-line drug as monotherapy or in combination with cisplatin);
- pancreatic cancer (locally advanced or metastatic adenocarcinoma of the pancreas).
In monotherapy or in combination with other antitumor agents, Gemzar is also active in breast cancer, ovarian cancer, locally advanced small cell lung cancer and locally advanced refractory testicular cancer.

Contraindications

- pregnancy;
- lactation period;
- Hypersensitivity to the drug.

Pregnancy and Breastfeeding

The drug is contraindicated in pregnancy and lactation.
During treatment, women and men should use reliable methods of contraception.

Dosage and administration

Atbladder cancer with monotherapy Gemzar administered in / in the drip in a dose of 1.25 g / m² for 30 minutes at 1, 8, and 15 days of each 28-day cycle.
In combination with Cisplatin, Gemzar is administered at a dose of 1 g / m² at 1, 8 and 15 days of each 28-day cycle. Cisplatin is administered at a dose of 70 mg / m² in 1 (immediately after Gemzar) or 2 day of each 28-day cycle.
Atnon-small cell lung cancer with monotherapy Gemzar administered in / in the drip in a dose of 1 g / m² for 30 minutes once a week for 3 weeks, followed by a weekly break. After this, repeat similar 4-week cycles. In combination with cisplatin, Gemzar is administered intravenously in a drip in a dose of 1.25 g / m² on days 1 and 8 of each 21-day cycle or at a dose of 1 g / m² at 1, 8 and 15 days of each 28-day cycle.
Atpancreatic cancer with monotherapy Gemzar administered in / in the drip in a dose of 1 g / m² for 30 minutes once a week for 7 weeks, followed by a week-long break. On subsequent cycles, the injection is performed 1 time per week for 3 weeks, followed by a weekly break.
In patients receiving gemzar, before each administration it is necessary to control the number of platelets, leukocytes and granulocytes in the blood.

Adverse reactions

Hemic and lymphatic: anemia, leukopenia, thrombocytopenia.
Gastrointestinal: nausea, vomiting, anorexia, diarrhea, stomatitis, increased levels of liver enzymes in the blood serum.
Urogenital: proteinuria, hematuria; rarely, symptoms similar to hemolytic uremic syndrome. Treatment with Gemzar should be stopped when the first signs of microangiopathic hemolytic anemia occur, such as a sharp decrease in hemoglobin level with concomitant thrombocytopenia and an increase in serum bilirubin, creatinine, and / or LDH levels. Renal impairment may be irreversible even after discontinuation of treatment (hemodialysis may be required).
Dermatologic: skin rash accompanied by itching, partial alopecia.
Respiratory: dyspnea; rarely - bronchospasm, interstitial pneumonia, pulmonary edema, respiratory distress syndrome. If these symptoms occur, treatment with gemcitabine should be discontinued.
Cardiovascular: often - peripheral edema; in isolated cases - arterial hypotension.
On the part of the body as a whole: often - flu-like symptoms (including fever, headache, chills, myalgia, asthenia); possible cough, rhinitis, malaise, increased sweating.
Allergic reactions: rarely - Anaphylactic reactions.

Special notes

With caution, Gemzar should be prescribed to patients with impaired liver or kidney function. The safety and effectiveness of Gemzar in patients with severe impaired liver and kidney function has not been studied.
During treatment, it is necessary to periodically monitor the function of the liver and kidneys.
It is shown that an increase in the duration of infusion and the frequency of injections leads to an increase in toxicity.
With the introduction of Gemzar dose of 1 g / m² (up to 6 weeks of treatment) against the background of radiation therapy in the chest area in patients with non-small cell lung cancer, significant toxicity was observed in the form of severe and potentially life-threatening esophagitis and pneumonia.
The optimal regimen for the safe administration of Gemzar in combination with therapeutic modes of radiation therapy has not yet been determined.
Use in pediatrics
Safety and efficacy of Gemzar in children have not been studied.
Control of laboratory parameters
In patients receiving gemzar, before each dose, it is necessary to control the number of platelets, leukocytes and granulocytes in the blood.

Overdosage

Symptoms: increased toxic effects. Clinically acceptable toxicity was observed with the introduction of Gemzar in single doses up to 5.7 g / m² IV for 30 minutes every 2 weeks.
Treatment: If an overdose is suspected, the patient must be provided with constant medical supervision, including blood counting. If necessary, symptomatic therapy is indicated. The gemcitabine antidote is unknown.

The drug (unopened vials) should be stored at room temperature (not above 30 ° C).
The prepared Gemzar solution can be stored at room temperature (not exceeding 30 ° C) for 24 hours; do not freeze, because crystallization may occur.

3 years.