MJuSTOFORAN
Active material: Fotemustine
When ATH: L01AD05
CCF: Anticancer drug
ICD-10 codes (testimony): C43, C71
When CSF: 22.01.01
Manufacturer: Servier Laboratories (France)
PHARMACEUTICAL FORM, COMPOSITION AND PACKAGING
Powder for solution for infusion light yellow.
| 1 fl. | |
| fotemustin | 208 mg |
Solvent: ethanol 95% – 3.35 ml, water d / and – to 4 ml.
Dark glass bottles (1) together with the solvent (4 ml – amp.) – packs cardboard.
Pharmacological action
Zitostaticski protivoopujolevy product of a group of derivative nitrozomocevina alkilirutm and karbamilirujushhim with action. Chemical structure of the drug includes drug bioizomer alanine (amino-1-jetilfosfonovaja acid), which facilitates the penetration of the drug in the cells and GEB.
Pharmacokinetics
After the on/in the farmakokinetika fotemustina is Mono- or bieksponencialny nature with short T1/2. Linking plasma protein is low (25-30%). Fotemustin GEB.
Testimony
— disseminirovannaya malignant melanoma (metastasis to the brain);
-malignant brain tumors.
Dosage regimen
Mjustoforan® introducing / in. Patient treatment can begin, If the number of platelets ≥ 100 000/MKL and granulocytes ≥ 2000/µl.
Between the beginning of induction therapy and starting maintenance therapy is recommended interval 5 weeks, between the two cycles of maintenance therapy – 3 of the week.
At conduct alone preparation is administered in a dose of 100 mg / m2. Induktsionnaya therapy – 3 consecutive injections with an interval of 1 week (1, 8 and 15 day) and followed by a break in 4-5 weeks. Maintenance therapy – 1 injection in 3 of the week.
Combination therapy with dakarbazinom. Induktsionnaya therapy – Mjustoforan® dose 100 mg / m2/sut 1 and 8 day treatment; the Dacarbazine dose 250 mg / m2/sut 15, 16, 17 and 18 day treatment. Then break – 5 weeks. Maintenance therapy – Mjustoforan® dose 100 mg / m2/sut 1 day; the Dacarbazine dose 250 mg / m2/SUT in 2, 3, 4 and 5 day. Interval 3 the week between 2 cycles.
During treatment Mjustoforanom® There is a need to control the number of platelets, white blood cells and granulocytes in their blood. In the case of hematological toxicity dose Mjustoforana® can be reduced or the imposition of a drug should be deferred in accordance with the following pattern.
| The number of blood cells | % from the previous dose |
| granulocitы >2000/µL and platelets >100 000/l | 100% |
| granulocitы >1500-2000/MKL and/or platelets 80 000-100 000/l | 75% |
| granulocitы >1000-1500/µL and platelets 80 000-100 000/l | 50% |
| granulocytes ≤ 1000/MKL and/or platelets <80 000/l | to defer the introduction of regular doses of |
Terms of preparation and administration of the solution
Solution prepared immediately before introduction. The contents of the bottle should dissolve in 4 ml of the supplied diluent and mix during 2-3 min to dissolve powder (the resulting solution has a volume of 4.16 ml, ie. in 4 ml solution contains 200 mg fotemustina). After the calculation of the required dose for injection solution Additionally bred 250 ml 5% glucose solution (in patients with diabetes mellitus as a solvent can be used 0.9% sodium chloride solution). Solution introducing/in drip for 1 no, protecting from light (bottle with the solution placed in an opaque cover).
Side effect
From the hematopoietic system: thrombocytopenia (40.3%), maximum expressed through 4-5 weeks after the first injection; leukopenia (46.3%), maximum expressed through 5-6 weeks after the first injection.
From the digestive system: nausea, vomiting during 2 hours after injection (46.7%), stomach ache (1.3%), diarrhea (2.6%); a moderate increase in transaminases, ALP and bilirubin (29.5%) plasma.
From the central and peripheral nervous system: disturbance of consciousness, paresthesia, dysgeusia (0.7%).
From the urinary system: increasing the level of urea in the blood (0.8%).
Local reactions: phlebitis at the injection site (2.6%).
Other: fever (3.3%), itching (0.7%).
Contraindications
- Pregnancy;
- breast-feeding;
-increased sensitivity to drugs groups nitrozomocevina history.
The drug should not be appointed earlier, than 3 a week after the introduction dacarbazina due to the risk of developing respiratory distress syndrome adult.
Pregnancy and lactation
Mjustoforan® contraindicated during pregnancy. If necessary, the appointment during lactation should stop breastfeeding.
Cautions
The ability of the drug to oppress hematosis intensifies, If simultaneously or previously applied substances, oppressing haematopoiesis. It is not recommended to prescribe a drug, If after previous treatment with chemotherapy means less than 4 weeks (and in the case of treatment drugs nitrozomocevina – 6 weeks).
Men and women during and at least 6 months after treatment must use reliable methods of contraception.
Avoid getting the product to the skin and mucous membranes. In the event of accidental contact with skin and mucous membranes should be thoroughly washed with SOAP and water, In case of eye – plenty of water. Avoid inhalation of the drug.
During preparations solution Mjustoforana® We recommend that you work in a mask and latex gloves. Pregnant women are forbidden to work with Mjustoforanom®.
When working with Mjustoforanom® should comply with the necessary rules of use and destruction of cytotoxic drugs.
Monitoring of laboratory parameters
Before each next introduction the drug should carry out an analysis of the picture peripheral blood.
During treatment Mjustoforanom® recommended systematic monitoring of the liver (especially during and after induction therapy).
Use in Pediatrics
The efficacy and safety of Mjustoforana® the children have not been studied.
Overdose
No specific antidote. In the case of an overdose of the drug must be abolished, appoint supportive therapy and to strengthen control of hematological indicators.
Drug Interactions
In an application (one day) fotemustina and dacarbazina in high doses, marked by sporadic cases of adults respiratory distress syndrome. If necessary, the use of combination therapy with these drugs should adhere to the recommended dosage.
During and after treatment (no less 3 Months) Mjustoforanom® You should avoid vaccination living weakened vaccines and.
If you are applying to Mjustoforana® and fenitoina concentration in the serum last may decline.
Conditions of supply of pharmacies
The preparation is available on medical prescription.
Conditions and terms
List B. The drug should be stored in the dark, inaccessible to children at 2 ° to 8 ° C. Shelf life – 2 year. Do not use after the expiry date, on the package.
Ready solution should be used immediately after cooking.
