Gemcitabine

When ATH:
L01BC05

Characteristic.

Pyrimidine analog antimetabolite group. White or off-white solid:, soluble in water, sparingly soluble in methanol and practically insoluble in ethanol and polar organic solvents. Molecular weight 299,66.

In medical practice it is applied in the form of a hydrochloride.

Pharmacological action.
Antitumor.

Application.

- Bladder Cancer.

- Non-small cell lung cancer.

Gemcitabine monotherapy or in combination with cisplatin, is shown as a first-line drug for the treatment of patients with locally advanced or metastatic non-small cell lung cancer.

- Pancreatic cancer.

Gemcitabine is indicated for the treatment of patients with locally advanced or metastatic adenocarcinoma of the pancreas.

Gemcitabine monotherapy or in combination with other antitumor agents is also active in breast cancer, ovarian cancer, locally advanced small cell lung cancer and refractory testicular cancer Locally.

Contraindications.

Hypersensitivity, mielosuprescia, severe liver and kidney, Viral (enable vetryanaya, shingles) and other infections, childhood (Safety and efficacy have not determined).

Pregnancy and breast-feeding.

Contraindicated in pregnancy.

Category actions result in FDA - D. (There is evidence of the risk of adverse effects of drugs on the human fetus, obtained in research or practice, However, the potential benefits, associated with drugs in pregnant, may justify its use, in spite of the possible risk, if the drug is needed in life-threatening situations or severe disease, when safer agents should not be used or are ineffective.)

At the time of treatment should stop breastfeeding.

Side effects.

Cardio-vascular system and blood (hematopoiesis, hemostasis): most often - myelosuppression (anemia, leukopenia, thrombocytopenia), petechiae, gipotenziya, less frequently - arrhythmia, stroke, hypertension, myocardial infarction, bleeding (occurred, primarily, in patients with pancreatic cancer), rarely - heart failure (I observed in patients, treatment for lung cancer).

From the respiratory system: less frequently - bronhospasticskie reaction (breathlessness, labored breathing, tightness in the chest and / or wheezing), rarely - a toxic effect on the lung parenchyma or pneumonia (cough, breathlessness), pulmonary edema (cough, labored breathing).

From the digestive tract: nausea, vomiting (69% cases), diarrhea (19%), stomatitis (≤11%), increased activity of transaminases and alkaline phosphatase.

With the genitourinary system: naibolee part - proteinuria, peripheral edema (fingers, feet or ankles), in rare cases, swelling may be of generalized, renal failure, giperʙiliruʙinemija, hematuria, hemolytic uremic syndrome.

For the skin: more often - a rash (30%), alopecia (usually insignificant), skin rashes, itching.

Other: often (41%) - Flu-like symptoms (fever, headache, backache, chills, myalgia, weakness, anorexia, catarrhal phenomena, Sweating), infection (16%), Me Part - paraesthesia, Education extravasates (irritation, pain or redness) at the injection site, drowsiness, rare - disease Gasser (black tarry stools, blood in the urine or feces, fever, increased or decreased urination, pinpoint red spots on the skin, swelling of the face, fingers, feet or ankles, unusual bleeding or hemorrhage, unusual tiredness or weakness, yellow skin or sclera).

Cooperation.

Other drugs, causing depression of bone marrow function, and potentiate the effect of radiation therapy and additive depress bone marrow function. Azathioprine, khlorambutsil, glucocorticoids, cyclophosphamide, cyclosporine, mercaptopurine and other immunosuppressive agents increase the risk of infection. With the introduction of live virus vaccines is possible intensification of the vaccine virus replication and increased side effects, the introduction of inactivated vaccines - suppression of antiviral antibodies.

Overdose.

Symptoms: suppression of bone marrow function (anemia, leukopenia or neutropenia, perhaps, infection, thrombocytopenia), paraesthesia (numbness or tingling in the hands or feet), strongly expressed skin rash.

Treatment: monitor the number of blood cells, if necessary, appoint maintenance therapy. With strong suppression of the bone marrow transfusion possible necessary blood components. Patients who develop leukopenia observed for signs of infection, if necessary, prescribe antibiotics. Neutropenic patients with an increase in body temperature of broad-spectrum antibiotics prescribed empirically until the results of bacteriological examinations and related diagnostic tests. The specific antidote is absent.

Dosing and Administration.

B /, drop (during 30 m), dose 1 g / m² 1 once a week, Course - 3 Sun, refresher course in 1 Sun.

Precautions.

The use of gemcitabine should be under the strict control of blood parameters (1 once every 2 Sun). By reducing the number of leukocytes <1500/mm³ and platelets <100000/mm³ dose adjustment is required. The indication for discontinuation of the drug is to reduce the number of leukocytes <500/mm³ and platelets <50000/mm³.

If confirmed or suspected pneumonia, called gemcitabine, Treatment should be stopped immediately.

Women of childbearing potential must use effective methods of contraception (the possibility of teratogenicity).

To use caution in the elderly (increased risk of toxic effects on the blood), patients, previously treated with cytotoxic drugs or radiation therapy. It should refrain from potentially hazardous activities, require attention and speed of mental and motor responses.

During the period of treatment is not recommended vaccination virus vaccines. Appointment virus vaccines may not be earlier 3 Months - 1 years after discontinuation of the drug. Immunization of oral polio vaccine people, It is in close contact with the patient, especially family members, should be postponed.

The appearance of signs of bone marrow suppression, unusual bleeding or hemorrhage, black tarry stools, blood in the urine or feces or point of red spots on the skin require immediate doctor's advice.

Dental intervention must be completed prior to initiation of therapy or deferred until the normalization of the blood picture. During treatment caution when using toothbrushes, threads or toothpicks.

Cautions.

When applying more gemcitabine 1 once a week or holding infusion over 60 min Adverse Effects, associated with therapy with gemcitabine, may occur more frequently and be more severe.

Prior treatment with cytostatics increases the frequency and severity of leukopenia and thrombocytopenia (progressive reduction in the number of white blood cells and platelets may occur after completion of therapy).

The use of gemcitabine should be performed by trained medical personnel in compliance with established precautions when cooking, dilution of injectable solutions (in a sterile box with the use of disposable surgical gloves and masks) and disposal of needles, syringes, bottles, ampoules and the remainder of the unused product.

Accidental splashes of gemcitabine on the skin and mucous membranes affected area immediately with soap and water or carefully with a strong jet of water, respectively,.