Treatment of non-small cell lung cancer (stage 3 or 4) and as monotherapy in patients with metastatic breast cancer (stage 4), when chemotherapy based on anthracycline or taxane-containing schemes has proven to be ineffective or unapplicable.
Composition:
1 ml of concentrate contains 10 mg of vinorelbine in the form of tartrate.
Action:
Contraindications:
Hypersensitivity to vinorelbine or other vinca alkaloids. Intrathecal administration. The number of neutrophils <1500 / mm3 or a serious infection that is present or recent (within the last 2 weeks). The number of tiles is less than 75,000 / mm3. Severe hepatic impairment not related to the neoplastic process. Women of childbearing age who do not use effective contraception. In combination with a vaccine against yellow fever. Pregnancy. Breast-feeding should be discontinued during treatment with vinorelbine.
Precautions:
Pregnancy and lactation:
This preparation should not be used during pregnancy. Animal reproductive toxicity studies have shown that vinorelbine caused embryo and fetal death and was teratogenic. Women of childbearing potential should use effective contraception during treatment with the preparation and inform the doctor if they become pregnant. If pregnancy occurs during treatment, the patient should be informed about the risks to the fetus and should be carefully monitored. The possibility of genetic counseling should also be considered. It is not known whether vinorelbine passes into breast milk. Breast-feeding should be discontinued prior to initiation of treatment with the preparation. Vinorelbine may have genotoxic effects. It is recommended that men treated with vinorelbine do not lead to begetting of children during treatment and up to 6 months (not less than 3 months) after treatment. Before starting treatment, you should seek advice on the storage of semen, due to the possibility of irreversible infertility due to treatment with vinorelbine.
Side effects:
Very common: neutropenia, anemia, constipation, reflexes, nausea, vomiting, diarrhea, stomatitis, inflammation of the esophagus, anorexia, alopecia, fatigue, fever, pains of different location, weakness, reactions at the injection site (erythema, pain, discoloration, phlebitis), increased total bilirubin, increased alkaline phosphatase, AST and ALT. Common: thrombocytopenia, neutropenic fever, septicemia caused by neutropenia (with possible mortality), paresthesia with sensory and motor symptoms, dyspnea, bronchospasm, increased creatinine, skin reactions, muscle pain, joint pain, infection, allergic reactions (skin reactions, respiratory reactions). Rare: ischemic heart disease (e.g. angina pectoris, ECG changes, myocardial infarction), weakness of the lower limbs, paralytic ileus, interstitial lung disease, pancreatitis, paralytic ileus, jaw pain, hyponatremia, injection site necrosis. Very rare: Guillain-Barre syndrome, abnormal secretion of antidiuretic hormone (SIADH). Degrees (G) of WHO toxicity - see Summary of Product Characteristics.
Dosage:
Intravenously. Adults. The preparation should be administered in cooperation with a doctor who has extensive experience in cytostatic treatment. The preparation may be administered in a slow bolus (5-10 min), after dilution in 20-50 ml of physiological saline or in a 5% Glucose solution (50 mg / ml), or in a short-term intravenous infusion (20-30 min) after dilution in 125 ml of physiological saline or 5% glucose (50 mg / ml). After administration of the drug, always use a saline infusion to flush the vein.Non-systemic lung cancer. As a monotherapy, the usual dose is 25-30 mg / m2 once a week. In multi-drug chemotherapy, the dosage regimen depends on the chemotherapy protocol. The drug can be used in the normal dose (25-30 mg / m2), but the frequency of administration may be reduced, e.g. to every 3 weeks.on day 1 and day 5 or on days 1 and 8, depending on the chemotherapy regimen.Metastatic breast cancer. The usual dose is 25-30 mg / m2 once a week. The maximum dose tolerated for one administration: 35.4 mg / m2 pc.Special groups of patients. In patients with severe hepatic impairment, caution and careful monitoring of haematological parameters is recommended; it may be necessary to reduce the dose. In patients with impaired renal function the dose does not have to be adjusted.
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