Treatment of acute bacterial infections of the skin and soft tissues (ABSSSI) in adults. Official guidance on the proper use of antibacterial agents should be taken into account.
Composition:
1 vial contains 500 mg of dalbavancin as the hydrochloride salt; after reconstitution, 1 ml contains 20 mg of dalbavancin.
Action:
Lipoglycopeptide antibiotic with bactericidal activity. Clinical efficacy was found against pathogens responsible for ABSSSI, which were susceptible to dalbavancin in vitro: Staphylococcus aureus, Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae, groupStreptococcus anginosus (includingS. anginosus, S. intermedius and S. constellatus). Clinical efficacy against the following pathogens has not been established, although researchin vitro suggest that these pathogens would be sensitive to dalbavancin in the absence of acquired resistance mechanisms: group G streptococci,Clostridium perfringens, Peptostreptococcus spp. All Gram-negative bacteria are resistant to dalbavancin. Systemic exposure to dalbavancin is proportional to the dose after single doses in the range of 140-1120 mg, indicating linear pharmacokinetics. No accumulation was observed after repeated infusions once a week for up to 8 weeks. Dalbawancin is 93% bound to plasma proteins. It is metabolized to a small extent (<25%). Metabolites - hydroxydalbavancin and mannosyl aglycone have significantly less antibacterial activity compared to the parent substance. The drug is excreted mainly in the urine (in the form of dalbavancin and metabolite); approx. 20% of the dose - with faeces. Medium T0,5 in the final phase of elimination is 372 h (range 333-405 h).
Contraindications:
Hypersensitivity to dalbavancin or to any of the excipients.
Precautions:
Use with caution in patients with CCr <30 ml / min; in patients with moderate to severe hepatic impairment (Child-Pugh B and C); in patients with hypersensitivity to other glycopeptides, due to the possibility of cross-sensitivity hypersensitivity. If an allergic reaction occurs, treatment with dalbavancin should be stopped and appropriate treatment of allergic reactions should be initiated. There are limited data on the efficacy and safety of dalbavancin when more than 2 doses are used (one week apart). In key studies in the case of ABSSSI, the types of infection to be treated were limited tocellulite/ rose, abscesses and wound infection. There is no experience regarding the use of dalbavancin in the treatment of patients with severely reduced immunity. In mixed infections, if Gram-negative bacteria are suspected, therapy with Gram-negative bacteria should be initiated. If reactions reminiscent of a "red-headed syndrome" occur during administration, stopping the infusion or slowing it down may cause these reactions to subside. For any patient who develops diarrhea during or after treatment with dalbavancin, the possibility of pseudomembranous colitis should be considered; if this disease is diagnosed, the antibiotic should be discontinued and appropriate treatment instituted. If superinfection with non-sensitive organisms occurs during therapy, appropriate measures should be implemented.
Pregnancy and lactation:
Due to lack of data, do not use during pregnancy unless it is absolutely necessary. It is not known whether dalbavancin is excreted in human milk (excreted in animal milk). The effect of dalbavancin on the gastro-intestinal flora and the flora of the breast-fed infant can not be excluded. A decision should be made to continue / stop the breast or continue / discontinue dalbavancin treatment, taking into account the benefits of breast stone for the infant and the benefits of therapy for the woman.
Side effects:
Common: headache, nausea, diarrhea, vomiting, rash, increased GGT activity. Rare: fungal infections of the vagina and vulva, urinary tract infections, fungal infections, colitisClostridium difficile, oral candidosis, anemia, thrombocytosis, eosinophilia, leukopenia, neutropenia, decreased appetite, insomnia, taste disorders, dizziness, flushing, inflammation of the veins, cough, constipation, abdominal pain, dyspepsia, abdominal discomfort, pruritus, urticaria , vulval and vaginal itching, infusion-related reactions, increased LDH activity, increased ALT activity, increased AST, increased uric acid levels in the blood, abnormal liver function tests, elevated transaminases, increased ALP activity, increased platelet count, increased body temperature, increased activity of liver enzymes. Very rare: anaphylactoid reactions, bronchospasm. Side effects associated with the class of drugs: ototoxicity is associated with the use of glycopeptide (vancomycin and teicoplanin); in patients receiving an ototoxic such as aminoglycoside, the risk of ototoxicity may be increased.
Dosage:
Intravenously. Adults: 1000 mg once a week, followed by 500 mg weekly.Special groups of patients. Impaired renal function. No dosage adjustment is necessary for patients with CCr ≥ 30-79 ml / min or for patients on regular hemodialysis (3 times a week); Dalbavancin can be administered regardless of hemodialysis. For patients with CCr <30 ml / min and who are not regularly on hemodialysis, the recommended dosage regimen should be reduced to 750 mg once weekly and then to 375 mg after one week.Hepatic dysfunction. No dosage adjustment is necessary for patients with mild hepatic impairment (A according to Child-Pugh). In patients with moderate or severe hepatic impairment (Child-Pugh B and C), there is no data to determine the correct dosage - be careful.Elderly people. No dose adjustment is necessary. Children and youth. The safety and efficacy of dalbavancin in patients <18 years has not yet been established.Way of giving. Administer by intravenous infusion over 30 min. The drug must be reconstituted and then diluted before administration. The diluted solution for infusion must have a final concentration of 1-5 mg / ml.
(C)
