United States - English - NLM (National Library of Medicine)

allergan, inc. - dalbavancin hydrochloride (unii: 33wdq7t81e) (dalbavancin - unii:808ui9ms5k) - dalbavancin 500 mg in 25 ml - dalvance is contraindicated in patients with known hypersensitivity to dalbavancin.  risk summary there are no adequate and well-controlled studies with dalvance use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse developmental outcomes. no treatment-related malformations or embryo-fetal toxicity were observed in pregnant rats or rabbits at clinically relevant exposures of dalbavancin. treatment of pregnant rats with dalbavancin at 3.5 times the human dose on an exposure basis during early embryonic development and from implantation to the end of lactation resulted in delayed fetal maturation and increased fetal loss, respectively [ see data ] . the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. data animal data no evidence of embryo or fetal toxicity was found in the rat or rabbit at a dose of 15 mg/kg/day (1.2 and 0.7 times the human dose on an exposure basis, respectively). delayed fetal maturation was observed in the rat at a dose of 45 mg/kg/day (3.5 times the human dose on an exposure basis).   in a rat prenatal and postnatal development study, increased embryo lethality and increased offspring deaths during the first week post-partum were observed at a dose of 45 mg/kg/day (3.5 times the human dose on an exposure basis). risk summary there are no data on the presence of dalbavancin or its metabolite in human milk, the effects on the breast-fed child, or the effects on milk production. dalbavancin is excreted in the milk of lactating rats. when a drug is present in animal milk, it is likely that the drug will be present in human milk. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for dalvance and any potential adverse effects on the breast-fed child from dalvance or from the underlying maternal condition. the safety and effectiveness of dalvance for the treatment of absssi has been established in pediatric patients aged birth to less than 18 years. use of dalvance for this indication is supported by evidence from adequate and well-controlled studies in adults with additional pharmacokinetic and safety data in pediatric patients aged birth to less than 18 years [see adverse reactions ( 6.1 ), clinical pharmacology ( 12.3 ), and clinical studies (14.1)] . there is insufficient information to recommend dosage adjustment for pediatric patients with absssi and clcr less than 30 ml/min/1.73m2  [see dosage and administration ( 2.2 )]. of the 2473 patients treated with dalvance in phase 2 and 3 clinical trials, 403 patients (16.3%) were 65 years of age or older. the efficacy and tolerability of dalvance were similar to comparator regardless of age. the pharmacokinetics of dalvance was not significantly altered with age; therefore, no dosage adjustment is necessary based on age alone.  dalvance is substantially excreted by the kidney, and the risk of adverse reactions may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, care should be taken in dose selection in this age group. in patients with renal impairment whose known clcr is less than 30 ml/min and who are not receiving regularly scheduled hemodialysis, the recommended regimen for dalvance is 1125 mg, administered as a single dose, or 750 mg followed one week later by 375 mg. no dosage adjustment is recommended for patients receiving regularly scheduled hemodialysis, and dalvance can be administered without regard to the timing of hemodialysis. there is insufficient information to recommend dosage adjustment for pediatric patients younger than 18 years with clcr less than 30 ml/min/1.73m2 [see dosage and administration ( 2.3 ) , clinical pharmacology ( 12.3 )] . no dosage adjustment of dalvance is recommended for patients with mild hepatic impairment (child-pugh class a). caution should be exercised when prescribing dalvance to patients with moderate or severe hepatic impairment (child-pugh class b or c) as no data are available to determine the appropriate dosing in these patients [ see clinical pharmacology   ( 12.3 ) ] .

Canada - English - Health Canada

endo ventures ltd. - dalbavancin (dalbavancin hydrochloride) - powder for solution - 500mg - dalbavancin (dalbavancin hydrochloride) 500mg - glycopeptides

European Union - English - EMA (European Medicines Agency)

abbvie deutschland gmbh & co. kg - dalbavancin hydrochloride - soft tissue infections; skin diseases, bacterial - antibacterials for systemic use, - treatment of acute bacterial skin and skin structure infections (absssi) in adults.

Israel - English - Ministry of Health

tzamal bio-pharma ltd - dalbavancin - powder for concentrate for solution for infusion - dalbavancin 500 mg - dalbavancin - xydalba is indicated for the treatment of acute bacterial skin and skin structure infections (absssi) in adults

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

correvio uk ltd - dalbavancin hydrochloride - powder for solution for infusion - 500mg

Singapore - English - HSA (Health Sciences Authority)

premier diagnostics pte. ltd. - microbiology - mts™ is a quantitative assay for determining the minimum inhibitory concentration (mic) of antimicrobial agents against microorganisms and for detecting the resistance mechanisms

United States - English - NLM (National Library of Medicine)

theravance, inc. - telavancin hydrochloride (unii: 0701472zg0) (telavancin - unii:xk134822z0) - telavancin 15 mg in 1 ml - to reduce the development of drug-resistant bacteria and maintain the effectiveness of vibativ and other antibacterial drugs, vibativ should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. when culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. in the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. combination therapy may be clinically indicated if the documented or presumed pathogens include gram-negative organisms. appropriate specimens for bacteriological examination should be obtained in order to isolate and identify the causative pathogens and to determine their susceptibility to telavancin. vibativ may be initiated as empiric therapy before results of these tests are known. vibativ is indicated for the treatment of adult patients with complicated skin and skin structure infections (csssi) cause

United States - English - NLM (National Library of Medicine)

cumberland pharmaceuticals inc. - telavancin hydrochloride (unii: 0701472zg0) (telavancin - unii:xk134822z0) - vibativ is indicated for the treatment of adult patients with complicated skin and skin structure infections (csssi) caused by susceptible isolates of the following gram-positive microorganisms: staphylococcus aureus (including methicillin-susceptible and -resistant isolates), streptococcus pyogenes , streptococcus agalactiae , streptococcus anginosus group (includes s. anginosus, s. intermedius, and s. constellatus) , or enterococcus faecalis (vancomycinsusceptible isolates only). vibativ is indicated for the treatment of adult patients with hospital-acquired and ventilator-associated bacterial pneumonia (habp/vabp), caused by susceptible isolates of staphylococcus aureus (both methicillin-susceptible and -resistant isolates). vibativ should be reserved for use when alternative treatments are not suitable. combination therapy may be clinically indicated if the documented or presumed pathogens include gram-negative organisms. appropriate specimens for bacteriological examination should be obtained in order to isolate and identify the causative pathogens and to determine their susceptibility to telavancin. vibativ may be initiated as empiric therapy before results of these tests are known. to reduce the development of drug-resistant bacteria and maintain the effectiveness of vibativ and other antibacterial drugs, vibativ should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. when culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. in the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. use of intravenous unfractionated heparin sodium is contraindicated with vibativ administration because the activated partial thromboplastin time (aptt) test results are expected to be artificially prolonged for 0 to 18 hours after vibativ administration [see warnings and precautions (5.5) and drug interactions (7.1) ]. vibativ is contraindicated in patients with known hypersensitivity to telavancin. risk summary based on findings in animal reproduction studies, vibativ may cause fetal harm. there are no available data on vibativ use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. in embryo-fetal development studies in rats, rabbits, and minipigs, telavancin demonstrated the potential to cause limb and skeletal malformations when given intravenously during the period of organogenesis at doses providing approximately 1- to 2-fold the human exposure at the maximum recommended clinical dose (see data). advise pregnant women of the potential risk to a fetus. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. data animal data in embryo-fetal development studies in rats, rabbits, and minipigs, telavancin demonstrated the potential to cause limb and skeletal malformations when given intravenously during the period of organogenesis at doses up to 150, 45, or 75 mg/kg/day, respectively. these doses resulted in exposure levels approximately 1- to 2-fold the human exposure (auc) at the maximum recommended clinical dose. malformations observed at <1% (but absent or at lower rates in historical or concurrent controls), included brachymelia (rats and rabbits), syndactyly (rats, minipigs), adactyly (rabbits), and polydactyly (minipigs). additional findings in rabbits included flexed front paw and absent ulna, and in the minipigs included misshapen digits and deformed front leg. fetal body weights were decreased in rats. in a prenatal/perinatal development study, pregnant rats received intravenous telavancin at up to 150 mg/kg/day (approximately the same auc as observed at the maximum clinical dose) from the start of organogenesis through lactation. offspring showed decreases in fetal body weight and an increase in the number of stillborn pups. brachymelia was also observed. developmental milestones and fertility of the pups were unaffected. risk summary there are no data on the presence of telavancin in human milk, the effects on the breastfed child, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for vibativ and any potential adverse effects on the breastfed child from vibativ or from the underlying maternal conditions. pregnancy testing verify pregnancy status in females of reproductive potential prior to initiating vibativ. contraception females vibativ may cause fetal harm when administered to a pregnant woman [see use in specific populations (8.1)]. advise females of reproductive potential to use effective contraception during treatment and for 2 days after the final dose. infertility males based on findings in rats, vibativ may impair male fertility [see nonclinical toxicology (13.1)]. the effect on fertility was reversible in rats. the safety and effectiveness of vibativ have not been established in pediatric patients. in particular, there is a concern for poor clinical outcomes in pediatric patients less than one year of age due to immature renal function. increased mortality in adult patients with habp/vabp and renal impairment and decreased clinical response in adults with csssi and renal impairment were observed [see boxed warning and warnings and precautions (5.1, 5.2)] . of the 929 patients treated with vibativ at a dose of 10 mg/kg once daily in clinical trials of csssi, 174 (19%) were ≥65 years of age and 87 (9%) were ≥75 years of age. in the csssi trials, lower clinical cure rates were observed in patients ≥65 years of age compared with those <65 years of age. overall, treatment-emergent adverse events occurred with similar frequencies in patients ≥65 (75% of patients) and <65 years of age (83% of patients). fifteen of 174 (9%) patients ≥65 years of age treated with vibativ had adverse events indicative of renal impairment compared with 16 of 755 (2%) patients <65 years of age [see warnings and precautions (5.3), clinical trials (14.1) ]. of the 749 habp/vabp patients treated with vibativ at a dose of 10 mg/kg once daily in clinical trials of habp/vabp, 397 (53%) were ≥65 years of age and 230 (31%) were ≥75 years of age. treatment-emergent adverse events as well as deaths and other serious adverse events occurred more often in patients ≥ 65 years of age than in those <65 years of age in both treatment groups. telavancin is substantially excreted by the kidney, and the risk of adverse reactions may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, care should be taken in dose selection in this age group. the mean plasma auc values of telavancin were similar in healthy young and elderly subjects. dosage adjustment for elderly patients should be based on renal function [see dosage and administration (2), clinical pharmacology (12.3) ]. the habp/vabp and csssi trials included patients with normal renal function and patients with varying degrees of renal impairment. patients with underlying renal dysfunction or risk factors for renal dysfunction had a higher incidence of renal adverse events [see warnings and precautions (5.3) ]. in the habp/vabp studies higher mortality rates were observed in the vibativ-treated patients with baseline crcl ≤50 ml/min. use of vibativ in patients with pre-existing moderate/severe renal impairment should be considered only when the anticipated benefit to the patient outweighs the potential risk [see warnings and precautions (5.1, )]. vibativ-treated patients in the csssi studies with baseline creatinine clearance ≤50 ml/min had lower clinical cure rates. consider these data when selecting antibacterial therapy in patients with baseline moderate/severe renal impairment (crcl ≤50 ml/min) [see warnings and precautions (5.2 )]. dosage adjustment is required in patients with ≤50 ml/min renal impairment [see dosage and administration (2 )]. there is insufficient information to make specific dosage adjustment recommendations for patients with end-stage renal disease (crcl <10 ml/min), including patients receiving hemodialysis [see overdosage (10), clinical pharmacology (12.3) ]. hydroxypropyl-beta-cyclodextrin is excreted in urine and may accumulate in patients with renal impairment. serum creatinine should be closely monitored and, if renal toxicity is suspected, an alternative agent should be considered [see warnings and precautions (5.3), clinical pharmacology (12.3) ]. the habp/vabp and csssi trials included patients with normal hepatic function and with hepatic impairment. no dosage adjustment is recommended in patients with mild or moderate hepatic impairment [see clinical pharmacology (12.3) ].

United States - English - NLM (National Library of Medicine)

theravance biopharma r&d, inc. - telavancin hydrochloride (unii: 0701472zg0) (telavancin - unii:xk134822z0) - telavancin 15 mg in 1 ml - vibativ is indicated for the treatment of adult patients with complicated skin and skin structure infections (csssi) caused by susceptible isolates of the following gram-positive microorganisms: staphylococcus aureus (including methicillin-susceptible and -resistant isolates), streptococcus pyogenes , streptococcus agalactiae , streptococcus anginosus group (includes s. anginosus, s. intermedius, and s. constellatus) , or enterococcus faecalis (vancomycin-susceptible isolates only). vibativ is indicated for the treatment of adult patients with hospital-acquired and ventilator-associated bacterial pneumonia (habp/vabp), caused by susceptible isolates of staphylococcus aureus (both methicillin-susceptible and -resistant isolates). vibativ should be reserved for use when alternative treatments are not suitable. combination therapy may be clinically indicated if the documented or presumed pathogens include gram-negative organisms. appropriate specimens for bacteriological examination should be obtained in or