Description
Latin name
DACARBAZIN-LANS
Release form
Lyophilisate for preparation of solution for iv administration.
Packing
Bottle 0.1 g of lyophilisate. In the package 1 bottle.
Indications
² Ñ Melanoma
² Ñ Lymphogranulomatosis
² Ñ Soft tissue sarcoma (excluding Kaposi’s sarcoma).
There are reports of the effectiveness of dacarbazine in combination with other cytostatics in the treatment of osteogenic sarcoma, uterine sarcoma, pleural and peritoneal mesothelioma, small cell lung cancer, thyroid cancer, carcinoid, pheochromocytoma, insulinoma, neuroblastoma and gliomas.
Contraindications
– hypersensitivity to dacarbazine or to any of the auxiliary components of the drug
– severe inhibition of bone marrow hematopoiesis
– severe hepatic or renal failure
– pregnancy and lactation.
With caution: with myelodepression (including against the background of concomitant radiation and chemotherapy), acute viral infectious diseases (including chicken pox, herpes zoster), fungal or bacterial nature (risk of serious complications and generalization of the process), concomitant radiation therapy.
Use during pregnancy and lactation
Dacarbazine is contraindicated in pregnancy.
If necessary, use during lactation, breast-feeding should be discontinued.
Women of childbearing age should use reliable methods of contraception.
Experimental studies have revealed the toxic effects of dacarbazine on the fetus.
Dosage and administration of
When choosing doses and the mode of administration of the drug in each individual case, use the data of the specialized literature. The drug is administered strictly intravenously.
Doses up to 200 mg / m2 are administered slowly slowly over a period of 1-2 minutes. Higher doses should be given in the form of intravenous infusions over a period of 15-30 minutes. Typically, dacarbazine is used as a monotherapy in a dose of 200-250 mg / m2 daily for 5 days. Repeated courses are carried out with an interval of 3 weeks.
When combined with other cytostatics, dacarbazine is administered at a dose of 100-150 mg / m2 for 4-5 days in a row with an interval of 4 weeks or 375 mg / m2 every 15 days. Before administration, the drug is diluted with water for injection until a concentration of 10 mg / 1 ml is reached.
To obtain an infusion solution, a freshly prepared solution is diluted in 200-300 ml of 0.9% sodium chloride solution or 5% dextrose solution. The solution of dacarbazine should be protected from light.
Side effects of
From the hemopoietic organs: anemia, leukopenia, granulocytopenia, thrombocytopenia. Inhibition of myelopoiesis is a dose-limiting side effect. Leukocytopenia is usually observed on the 14th day, thrombocytopenia – on the 18th day after the end of therapy and lasts on average up to 1 week. Recovery of blood counts occurs by the 4th week.
From the digestive system: nausea, vomiting, decreased appetite, rarely stomatitis – diarrhea, increased activity of liver enzymes. Very rarely – hepatonecrosis caused by occlusion of the intrahepatic veins, possibly fatal (as a rule, this syndrome occurred during the 2nd course of treatment). Symptoms include fever, eosinophilia, abdominal pain, enlarged liver, and shock, the severity of which increases rapidly over several hours or days.
From the nervous system: headache, visual impairment, confusion with Inhibition of myelopoiesis is a dose-limiting side effect. Leukocytopenia is usually observed on the 14th day, thrombocytopenia – on the 18th day after the end of therapy and lasts on average up to 1 week. Recovery of blood counts occurs by the 4th week.
From the digestive system: nausea, vomiting, decreased appetite, rarely stomatitis – diarrhea, increased activity of liver enzymes. Very rarely – hepatonecrosis caused by occlusion of the intrahepatic veins, possibly fatal (as a rule, this syndrome occurred during the 2nd course of treatment). Symptoms include fever, eosinophilia, abdominal pain, enlarged liver, and shock, the severity of which increases rapidly over several hours or days.
From the nervous system: headache, visual impairment, confusion with Inhibition of myelopoiesis is a dose-limiting side effect. Leukocytopenia is usually observed on the 14th day, thrombocytopenia – on the 18th day after the end of therapy and lasts on average up to 1 week. Recovery of blood counts occurs by the 4th week.
From the digestive system: nausea, vomiting, decreased appetite, rarely stomatitis – diarrhea, increased activity of liver enzymes. Very rarely – hepatonecrosis caused by occlusion of the intrahepatic veins, possibly fatal (as a rule, this syndrome occurred during the 2nd course of treatment). Symptoms include fever, eosinophilia, abdominal pain, enlarged liver, and shock, the severity of which increases rapidly over several hours or days.
From the nervous system: headache, visual impairment, confusion with Leukocytopenia is usually observed on the 14th day, thrombocytopenia – on the 18th day after the end of therapy and lasts on average up to 1 week. Recovery of blood counts occurs by the 4th week.
From the digestive system: nausea, vomiting, decreased appetite, rarely stomatitis – diarrhea, increased activity of liver enzymes. Very rarely – hepatonecrosis caused by occlusion of the intrahepatic veins, possibly fatal (as a rule, this syndrome occurred during the 2nd course of treatment). Symptoms include fever, eosinophilia, abdominal pain, enlarged liver, and shock, the severity of which increases rapidly over several hours or days.
From the nervous system: headache, visual impairment, confusion with Leukocytopenia is usually observed on the 14th day, thrombocytopenia – on the 18th day after the end of therapy and lasts on average up to 1 week. Recovery of blood counts occurs by the 4th week.
From the digestive system: nausea, vomiting, decreased appetite, rarely stomatitis – diarrhea, increased activity of liver enzymes. Very rarely – hepatonecrosis caused by occlusion of the intrahepatic veins, possibly fatal (as a rule, this syndrome occurred during the 2nd course of treatment). Symptoms include fever, eosinophilia, abdominal pain, enlarged liver, and shock, the severity of which increases rapidly over several hours or days.
From the nervous system: headache, visual impairment, confusion with thrombocytopenia – on the 18th day after the end of therapy and lasts on average up to 1 week. Recovery of blood counts occurs by the 4th week.
From the digestive system: nausea, vomiting, decreased appetite, rarely stomatitis – diarrhea, increased activity of liver enzymes. Very rarely – hepatonecrosis caused by occlusion of the intrahepatic veins, possibly fatal (as a rule, this syndrome occurred during the 2nd course of treatment). Symptoms include fever, eosinophilia, abdominal pain, enlarged liver, and shock, the severity of which increases rapidly over several hours or days.
From the nervous system: headache, visual impairment, confusion with thrombocytopenia – on the 18th day after the end of therapy and lasts on average up to 1 week. Recovery of blood counts occurs by the 4th week.
From the digestive system: nausea, vomiting, decreased appetite, rarely stomatitis – diarrhea, increased activity of liver enzymes. Very rarely – hepatonecrosis caused by occlusion of the intrahepatic veins, possibly fatal (as a rule, this syndrome occurred during the 2nd course of treatment). Symptoms include fever, eosinophilia, abdominal pain, enlarged liver, and shock, the severity of which increases rapidly over several hours or days.
From the nervous system: headache, visual impairment, confusion with rarely stomatitis – diarrhea, increased activity of liver enzymes. Very rarely – hepatonecrosis caused by occlusion of the intrahepatic veins, possibly fatal (as a rule, this syndrome occurred during the 2nd course of treatment). Symptoms include fever, eosinophilia, abdominal pain, enlarged liver, and shock, the severity of which increases rapidly over several hours or days.
From the nervous system: headache, visual impairment, confusion with rarely stomatitis – diarrhea, increased activity of liver enzymes. Very rarely – hepatonecrosis caused by occlusion of the intrahepatic veins, possibly fatal (as a rule, this syndrome occurred during the 2nd course of treatment). Symptoms include fever, eosinophilia, abdominal pain, enlarged liver, and shock, the severity of which increases rapidly over several hours or days.
From the nervous system: headache, visual impairment, confusion with the severity of which rapidly increases over several hours or days.
From the nervous system: headache, visual impairment, confusion with the severity of which rapidly increases over several hours or days.
From the nervous system: headache, visual impairment, confusion withknowledge, severe drowsiness, convulsions, asthenic syndrome, paresthesia, facial skin hypesthesia.
From the reproductive system: amenorrhea, azoospermia.
Allergic reactions: skin rash, flushing of the face, fever syndrome, anaphylactic reactions.
From the skin and skin appendages: rarely – alopecia, hyperpigmentation and photosensitivity of the skin.
Local reactions: soreness at the injection site and along the vein. If the drug gets under the skin, sharp pain, necrosis of the surrounding tissues.
Other: flu-like syndrome, attachment of secondary infections, hepatic vein thrombosis, myalgia. With prolonged use, the risk of developing neoplasms increases.
Drug Interaction
Increases the effect (including toxic) of phenobarbital, azathioprine, 6-mercaptopurine, allopurinol. Inductors of microsomal liver enzymes (barbiturates, rifampicin, phenytoin) enhance the toxic effect of dacarbazine.
Dakarbazine may enhance the photosensitizing effect of methoxypsoralen.
Dacarbazine solution is chemically incompatible with heparin, hydrocortisone, L-cysteine and sodium hydrogen carbonate.
Overdose
Symptoms: increased depression of bone marrow and the severity of dyspeptic disorders.
Treatment: symptomatic, specific antidote unknown.
Storage conditions
Store in a dry, dark, at a temperature of 2-8 ° C.
Expiration
2 years.
Deystvuyuschee substances
Dakarbazyn
Possible product names
DAKARAZ 0 2 N1 FLAC
DAKARBAZIN-LENS 0.2 N1 FLAC LIOFIL D / IN
Dakarbazin-Lance 200mg lyoph. d / in / in. Fl. X1 B (R)
DAKARBAZIN-LENS LIOF.POR. 200 MG FL. No. 1
Dakarbazin-Lance since. d / in 200mg No. 1
