Gemzar is an antitumor agent, the cytotoxic effect of which is due to the suppression of DNA synthesis.
Release form and composition
Gemzara dosage form is a lyophilisate from which a solution is prepared for infusion.
The active ingredient of the drug - gemcitabine hydrochloride - is an antimetabolite, which is a structural analogue of pyrimidine.
One bottle contains:
- 200 mg or 1 gram of gemcitabine (in the form of hydrochloride);
- Mannitol and sodium acetate as auxiliary components.
Indications for use
According to the instructions to Gemzar, the drug should be used for:
- Locally advanced or metastatic non-small cell lung cancer (as monotherapy in the elderly with a functional status of 2; in other groups of patients, as a first-line agent in combination with carboplatin or cisplatin);
- Local recurrent, metastatic or unresectable breast cancer (in this case, Gemzar is used in combination with paclitaxel after completing a course of neoadjuvant or adjuvant therapy with anthracyclines);
- Locally advanced or metastatic urothelial carcinoma (including cancer of the renal pelvis, urethra, bladder, ureter);
- Locally advanced or metastatic malignant ovarian epithelial tumors (as a single drug or in combination with carboplatin in cases where the disease continues to progress after the end of the first line of therapy using platinum derivatives);
- Biliary tract cancer;
- Locally advanced or metastatic cancer of the pancreas and cervix.
It has also been proven that Gemzar is effective for advanced refractory testicular cancer and small cell lung cancer.
According to the abstract, contraindications to the use of Gemzar are:
- Age up to 18 years;
- Hypersensitivity to gemcitabine or any of the auxiliary components of the drug.
With caution, the drug should be prescribed for dysfunction of the kidneys and / or liver, inhibition of hematopoietic function (bone marrow dysfunction, which may be the result, including chemotherapy or radiation therapy), for acute viral, bacterial or fungal infections.
Dosing and Administration
According to the instructions to Gemzar, the solution prepared from the lyophilisate is intended exclusively for intravenous administration.
The standard dose for an adult patient is 1 gram per square meter of body surface. The solution is injected into a vein drip 1 time per week for 3 weeks. Duration of infusion - 30 minutes.
Patients undergoing gemcitabine treatment are shown a weekly study of the composition of peripheral blood. In cases where in 1 cu. mm leukocyte concentration exceeds 1000, and the number of platelets - 100 000, there is no need for dose adjustment. Reducing the concentration of leukocytes to indicators of 500-1000 and / or platelets to 50 000-100 000 is an indication to reduce the dose to 70% of the recommended. If the number of leukocytes does not exceed 500 per cubic meter. mm, and the number of platelets less than 50 000 in 1 cu. mm, the use of Gemzar should be discontinued.
Gemcitabine is allowed to be diluted with only 0.9% isotonic NaCl solution, in which no preservatives are present. The maximum allowable concentration of this substance is 40 mg / ml. Do not prepare a more concentrated solution, because there is a risk of incomplete dissolution of gemcitabine.
The group of very frequent adverse reactions due to the use of Gemzar includes:
- Anemia, leukopenia, thrombocytopenia;
- Edema (including peripheral);
- Liver dysfunction (as a rule, violations are insignificant and do not require discontinuation of the drug);
- Nausea, vomiting;
- Accompanied itching rash on the skin (mild);
- Alopecia (hair loss is assessed as minor);
- Hematuria and light proteinuria;
- Flu-like syndrome.
Relatively frequent side effects of Gemzar: febrile neutropenia, anorexia, sleep disturbance, headache and back pain, increased drowsiness, rhinitis, cough, diarrhea or constipation, stomatitis, increased sweating, itching, myalgia.
The infrequent, rare and side effects that occur in individual cases include: reactions at the injection site, thrombocytosis, arrhythmia (mainly supraventricular), heart failure, decreased blood pressure, myocardial infarction, bronchospasm, ulcers, vesicles, anaphylactoid and anaphylactic reactions.
Signs of radiation toxicity during the period of Gemzar therapy were rarely observed.
Before starting treatment, the absolute number of platelets should be at least 100,000 / μl, granulocytes - at least 1500 / μl.
To determine the non-hematological toxicity of Gemzar, one should regularly examine the patient and evaluate the functional state of his liver and kidneys.
During each cycle or at the beginning of a new cycle, depending on the degree of toxicity, the dose can be gradually reduced.
The increase in the frequency of injections and the duration of the infusion may lead to an increase in the toxicity of Gemzar.
Gemcitabine can cause drowsiness, so care should be taken when driving and working with complex mechanisms.
Synonyms of Gemzar: Gemcitabine, Gemzitover, Gemziter, Gemtseks, Gemita, Gemtsitar, Ongetsin, Cytogem, Gemtaz, Tolgetsit.
Drugs with a similar mechanism of action: 5-Fluorouracil-Ebeve, Alexan, Vaidaza, Dacogen, Xeloda, Lizomustin, Tutabin, UFT. Ftorafur, Fluorouracil, Cytarabine, Cytosar, Cytostadine, Kabetsin, Fluorolek, Capecitovere.
Terms and conditions of storage
Gemzar is a prescription drug. It should be stored at a temperature of 15-25 ºС in a place protected from sunlight. The shelf life of the lyophilisate is 3 years, the solution prepared from it is 24 hours.