Fotemustine for injection

Fotemustine is an antimitotic cell inhibitor of the nitrosourea class, with alkylation and carbamoylation effects, and animal experiments have shown that it has broad-spectrum anti-tumor activity. Its chemical structure contains a biological isostere of alanine (1-aminoethyl phosphate), which is easy to penetrate cells and pass through the blood-brain barrier.

(R,S)-Di-ethyl{1-[3-(2-chloroethyl)-3-nitrosourea]ethyl}phosphonate

For the treatment of primary malignant brain tumors and disseminated malignant melanoma (including intracerebral sites).

Prepare the solution immediately before use. Once the solution is prepared, it must be administered under light-proof conditions. The intravenous injection should be controlled for more than 1 hour. Dissolve the contents of the fotemustine bottle with the sterile ethanol solution in the 4ml ampoule, then calculate the dosage, dilute the solution with 250ml.5% isotonic glucose, and use it for intravenous infusion.

The main effects are hematological, characterized by thrombocytopenia (40.3%) and leukopenia (46.3%), which occur later, reaching the lowest point 4 to 5 weeks and 5 to 6 weeks after the first dose of induction therapy, respectively. If other chemotherapy and/or other drugs that may induce hematotoxicity are used in combination before treatment with this product, hematological toxicity may be aggravated. In addition, moderate nausea and vomiting (46.7%), moderate temporary reversible increase in transaminases, alkaline phosphatase and bilirubin (29.5%), fever (3.3%), injection site phlebitis (2.9%), diarrhea (2.6%), abdominal pain (1.3%), temporary increase in blood urea nitrogen (0.8%), itching (0.7%), and temporary reversible neurological dysfunction (impaired consciousness, paresthesia, loss of taste) (0.7%) occurred within 2 hours after medication.

1. It is contraindicated for pregnant and lactating women; 2. It is contraindicated for those who use yellow fever vaccine and phenytoin sodium as preventive treatment (see drug interactions); 3. It is contraindicated for those who use it in combination with live attenuated vaccines.

Precautions during pregnancy and lactation: It is forbidden to use during pregnancy and lactation.

When this product is used in combination with large doses of dacarbazine (400-800 mg/m-2), pulmonary toxicity (adult respiratory distress syndrome) may occur. When used in combination, the following alternating dosing regimen is recommended: use 100 mg/m-2 of this product on d1 and d8 respectively; use dacarbazine continuously on d15, d16, d17, and d18 at a dose of 250 mg/m-2 d-1.

Protect from light and store at 2-8℃.

208mg