Index of drugs

Scattered malignant melanoma with metastases or without metastases to o.u.n. Primary, malignant brain tumors.

1 vial (10 ml) contains 208 mg fotemustine in powder form (after reconstitution, the reconstituted solution has a volume of 4.16 ml (200 mg fotemustine in 4 ml solution).

An anti-cancer drug, a derivative of a nitrosourea. Fotemustine is a cytostatic, anti-mitotic drug with alkylating properties and causing carbamoylation. It has a wide range of anti-cancer activity. The chemical structure of fotemustine contains alanine bioisosteres that allow penetration across the blood-brain barrier. There is a one- or two-stage elimination after intravenous infusion. The drug is characterized by a short period of biological half-life. In 25-30% it is bound to plasma proteins. It is almost completely metabolised.

Hypersensitivity derivatives of nitrosourea. Severe bone marrow dysfunction. Pregnancy and breastfeeding. Do not use the product in combination with a yellow fever vaccine.

It is not recommended to use the drug in children due to the lack of appropriate tests. Photonustine is not recommended for patients receiving other chemotherapeutics during the previous 4 weeks (or 6 weeks if using a nitrosourea derivative). The medicine can only be used if the platelet count is at least 100,000 / mm³ and the number of granulocytes is at least 2000 / mm³. Before each new administration, blood counts should be performed frequently, and the dose may be adjusted as necessary depending on the haematological results. Maintenance therapy can only be instituted when the platelet count and / or granulocytes are at a minimum of 100,000 plates / mm³ and 2000 granulocytes / mm³. The product contains ethanol (2.66 g / dose) - caution should be used in patients with alcoholism, liver disease or epilepsy.

The drug is contraindicated in pregnant or breast-feeding women.

The most common side effects are delayed haematopoietic system characterized by: anemia (14%), thrombocytopenia (40.3%) and leukopenia (46.3%) with the highest decreases (nadir) occurring after 4 to 5 weeks and 5 to 6 weeks after the first administration; pancytopenia may occur. Very common: thrombocytopenia, leucopenia (3-4 degrees), anemia (3-4 degrees), nausea, vomiting within 2 h after injection, moderate, transient elevation of transaminases, alkaline phosphatase, bilirubin. Common: diarrhea, abdominal pain, episode of fever, vein irritation at the injection site. Uncommon: transient neurological disorders (disturbances of consciousness, paresthesia, lack of taste), transient increase in blood urea, pruritus. Rare: ARDS (adult respiratory distress syndrome) during combination therapy with dacarbazine; the risk of myelodysplastic syndrome and acute myeloid leukemia (after large, cumulative doses of fotemustine, used in combination or not, with other chemotherapy, radiotherapy or without radiation therapy).

The solution for infusion should be prepared immediately before administration. Reconstitute photoemustine contained in the vial in 4 ml of solvent (sterile alcohol solution), then after calculating the dose for the patient, dilute the solution with a minimum of 250 ml of 5% intravenous Glucose solution, administered as an intravenous infusion over 1 hour. Do not dissolve the preparation in 0.9% NaCl solution.Monochemioterapia. Initial treatment: 3 consecutive doses with weekly breaks, then after 4-5 weeks you can continue treatment. Maintenance treatment: 1 dose every 3 weeks. The usual dose is 100 mg / m²pc.Multi-drug chemotherapy. 2 consecutive doses (100 mg / m²pc.) with weekly breaks. After 4-5 weeks, continuation of treatment according to the scheme for monotherapy. If the combination with dacarbazine is required, the following scheme is recommended:initial treatment fotemustine 100 mg / m²pc / day on days 1 and 8, dacarbazine 250 mg / m²pc / day on days 15, 16, 17 and 18; after 5 weeksbreaks maintenance treatment every 3 weeks: fotemustine 100 mg / m²pc / day on day 1; dacarbazine 250 mg / m²pc / day on days 2, 3, 4, and 5. During the treatment, blood counts should be performed and the dose should be adjusted as necessary depending on the results of hematological examinations. If the platelet count is at least 100,000 / mm³ and the number of granulocytes is at least 2000 / mm³ 100% dose should be used; if the platelet count is between 80,000 and 100,000 / mm³ and the number of granulocytes is from 1500 to 2000 / mm³ 75% of the dose should be used; if the number of granulocytes is from 1000 to 1500 / mm³ 50% of the dose should be used. Where the platelet count is below 80,000 / mm³ and the number of granulocytes below 1000 / mm³ treatment should be postponed. An 8-week interval should be maintained between initiation of initial treatment and introduction of maintenance treatment. Between two cycles of maintenance treatment should be kept 3-week. time interval. Maintenance therapy can only be instituted when the platelet count and / or granulocytes are at a minimum of 100,000 plates / mm³ and 2000 granulocytes / mm³. The solution for infusion should be protected from light.