Dacarbazine Medak
Instructions for use:
- 1. Release form and composition
- 2. Indications for use
- 3. Contraindications
- 4. Method of application and dosage
- 5. Side effects
- 6. Special instructions
- 7. Drug interactions
- 8. Analogs
- 9. Terms and conditions of storage
- 10. Terms of dispensing from pharmacies
Dacarbazine Medak is an antineoplastic agent with an alkylating effect.
Release form and composition
Lyophilisate for the preparation of a solution for intravenous administration: powder from white to slightly yellowish color or porous mass (100, 200, 500 or 1000 mg each in a dark yellow vial made of type I hydrolytic glass, sealed with a butyl rubber stopper and a crimped lid with aluminum cap, 1 (500 or 1000 mg) or 10 vials (100 or 200 mg) in a cardboard box together with the appropriate number of instructions for use).
1 bottle contains:
- active substance: dacarbazine - 100 mg, 200 mg, 500 mg or 1000 mg;
- auxiliary components (100/200/500/1000 mg, respectively): mannitol - 50/75 / 187.5 / 375 mg, anhydrous citric acid - 100/200/500/1000 mg.
Indications for use
Dacarbazine Medak is used for metastatic malignant melanoma.
Also used in combination therapy:
- common soft tissue sarcoma in adults (with the exception of Kaposi's sarcoma);
- widespread lymphogranulomatosis (Hodgkin's disease).
There is information about the effectiveness of the use of dacarbazine when combined with cytostatics in the treatment of uterine sarcoma, osteosarcoma, pleural and peritoneal mesothelioma, thyroid cancer, small cell lung cancer, pheochromocytoma, carcinoid, insulinoma, neuroblastoma and gliomas.
Contraindications
- hypersensitivity to drug components;
- severe thrombocytopenia or leukopenia;
- chronic liver / kidney disease;
- pregnancy;
- lactation period.
Method of administration and dosage
Dacarbazine Medak is administered intravenously.
- malignant melanoma: 200–250 mg / m2 of body surface per day for 5 days every 3 weeks, it is also possible to administer the drug at a dose of 850 mg / m2 of body surface on the first day of therapy, then once every 3 weeks;
- Hodgkin's disease: a daily dose of 375 mg / m2 of body surface every 15 days in combination with bleomycin, doxorubicin and vinblastine (ABVD regimen);
- soft tissue sarcoma: in adults with soft tissue sarcoma, Dacarbazine Medak is prescribed in a daily dose of 250 mg / m2 of body surface for 5 days every 3 weeks in combination with doxorubicin (ADIC regimen).
During treatment with dacarbazine, regular monitoring of indicators of kidney and liver function, as well as blood cells is necessary. As a result of dacarbazine therapy, severe side effects from the gastrointestinal tract are possible, in this regard, it is recommended to conduct antiemetic therapy and prescribe supportive measures.
With dacarbazine therapy, severe violations of the functions of the hematopoietic system and the gastrointestinal tract are possible, therefore, before each cycle of therapy, the benefit / risk ratio for the patient should be carefully evaluated. The duration of therapy is determined by the attending physician individually for each patient, taking into account the stage of the disease, side effects, ongoing therapy, response to therapy.
With advanced lymphogranulomatosis, 6 cycles of ABVD therapy are usually prescribed. With widespread soft tissue sarcoma and metastatic malignant melanoma, the duration of therapy is determined in each individual case, based on its effectiveness and tolerability.
Method of introduction
Doses up to 200 mg / m 2 are injected intravenously in a stream slowly. Large doses (from 200 to 850 mg / m 2) should be administered intravenously over 15-30 minutes. Before starting the administration of the drug, it is recommended to make sure that the veins are patent by jet injection of 5% dextrose solution or 0.9% sodium chloride solution. Also, these solutions can be used to remove the drug after the end of the injection from a syringe or dropper.
A solution of the drug dosages of 100 and 200 mg, reconstituted with water for injection (concentration 10 mg / ml) and ready for use without further dilution, is hypoosmotic (about 100 mosmol / kg) and therefore must be administered intravenously and slowly for more than 1 minute, this method of administration better than a quick bolus intravenous injection lasting a few seconds.
In patients with mild to moderate liver or kidney failure, dose adjustment is most often not required. Excretion of dacarbazine is slowed down in patients with combined liver and kidney failure.
Due to the lack of experience in the use of dacarbazine in elderly patients, there are no recommendations for the use of the drug in this category of patients.
Preparation of the solution and use of the drug
- 100 and 200 mg vials: before use, dissolve the contents of the vial with the addition of 10 ml (100 mg vial) or 20 ml (200 mg vial) water for injection (to obtain a concentration of 10 mg / ml), the solution must be injected slowly in a jet. For intravenous drip, the resulting solution must be diluted with 200–300 ml of 0.9% sodium chloride solution or 5% glucose solution, after which the drug must be administered as a short infusion for 15–30 minutes;
- bottles 500 and 1000 mg: before use, dissolve the contents of the bottle with the addition of 50 ml of water for injection. The concentration of the solution for infusion is 1.4–2 mg / ml (500 ml bottle) or 2.8–4 mg / ml (1000 mg bottle). To prepare this solution for infusion, it is necessary to dilute the solute with 200-300 ml of 0.9% sodium chloride solution or 5% dextrose solution, and then administer the drug as a short infusion for 20-30 minutes.
The preparation of the solution must be carried out in a separate equipped place using special consumables: masks, goggles, gloves, aprons.
The preparation of the solution must be carried out immediately before its use.
Dacarbazine Medak is very sensitive to light, therefore it is necessary to prepare, store and inject the solution under conditions excluding ultraviolet light. During administration, it is important to ensure that the drug solution is protected from light exposure, for example, by using a special light-shielded polyvinyl chloride infusion set.
The drug is intended for single use only. Dispose of unused solution. Disposal of materials used for preparation and administration of the solution should be carried out in accordance with the rules for handling cytotoxic drugs.
Side effects
- vessels: facial hyperemia;
- hematopoiesis: phlebitis, anemia, thrombocytopenia, leukopenia, pancytopenia, agranulocytosis, hemorrhage and bleeding;
- nervous system: headache, blurred vision, severe drowsiness, convulsions, confusion, paresthesia of the facial skin;
- digestive system: vomiting, diarrhea, anorexia, bleeding in the gastrointestinal tract;
- liver and biliary tract: liver necrosis due to occlusion of intrahepatic veins;
- kidneys and urinary tract: difficulty and pain in urination, amenorrhea, azoospermia;
- skin and subcutaneous tissue: redness, alopecia, soreness, necrosis of the subcutaneous tissue, hyperpigmentation, skin photosensitivity, erythema, maculopapular rash, urticaria;
- pathological condition of the injection site and general disorders: scar formation at the injection site, soreness, flu-like syndrome;
- laboratory and instrumental data: increased activity of liver enzymes.
special instructions
Dacarbazine treatment should be carried out under the supervision of a physician experienced in anticancer chemotherapy, under conditions that allow sufficient control of clinical, hematological and biochemical parameters throughout the course of treatment and after it.
When using the drug, the same rules must be followed as when using other cytostatics, due to their carcinogenic, mutagenic and teratogenic properties. When observing symptoms of functional disorders of the kidneys or liver, or signs of developing hypersensitivity reactions, it is necessary to stop the administration of the drug. If intrahepatic vein occlusion occurs, subsequent therapy with dacarbazine is contraindicated. Due to this risk, liver size and function should be monitored and blood counts (especially eosinophils) tested. In rare cases, when intrahepatic vein occlusion was suspected, early therapy with high doses of glucocorticosteroids (for example, hydrocortisone 300 mg / day) with or without fibrinolytics (in particular,tissue plasminogen activator or heparin).
With prolonged therapy, it is possible to provoke a cumulative effect of toxic effects on bone marrow function.
The likelihood of bone marrow suppression requires careful monitoring of the level of red blood cells, platelets and leukocytes. Hematopoietic disorders due to hepatotoxicity may require a temporary suspension of therapy or its cancellation. Extravasation during intravenous administration of the drug can cause severe pain or damage to surrounding tissues. When the first signs of extravasation appear (pain at the injection site or burning), the drug must be stopped immediately. The remaining dose must be injected into another vein. Dacarbazine has a moderately pronounced immunosuppressive effect. Alcohol and hepatotoxic drugs should be avoided during chemotherapy.
Due to the lack of data on the use of the drug in children, the use of dacarbazine is not recommended for patients in this group.
Women and men must use reliable contraception during treatment and for 6 months after completion.
Drug interactions
Dacarbazine is chemically incompatible with hydrocortisone, heparin, L-cysteine, and sodium bicarbonate.
With the simultaneous use of the drug or after the completion of treatment that affects hematopoiesis (therapy with cytostatic drugs, radiation therapy), an increase in myelotoxic effect may occur.
With the participation of cytochrome P450 isoenzymes (CYP1A1, CYP1A2, CYP2E1), dacarbazine is metabolized, which should be taken into account in its general purpose with other drugs in which metabolism is carried out by the same liver enzymes.
Possible enhancement of the action of methoxypsoralen due to photosensitization.
Analogs
Analogs of Dakarbazin Medak are: solutions - Dakarbazin-LENS, Dakarbazin Lahema.
Terms and conditions of storage
Store out of the reach of light at a temperature not exceeding 25 ° C. Keep out of the reach of children.
The shelf life is 3 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
