Just a little something to make us grin ear to ear
Post# of 72445
(Total Views: 515)
Posted On: 03/01/2018 9:46:58 PM
Just a little something to make us grin ear to ear. IPIXers, enjoy. Just one example of how strong we really are, DD pays off, handsomely. Go IPIX/Leo......
Dalvance (dalbavancin) for injection
IMPORTANT SAFETY INFORMATION
FULL PRESCRIBING INFORMATION
Change the ABSSSI Treatment Journey
Dalvance (dalbavancin) for injection
DALVANCE provides a full course of ABSSSI treatment in just one 30-minute IV infusion
Dear Hospital Administrator,
DALVANCE® (dalbavancin) is indicated for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) due to designated susceptible Gram-positive bacteria as described below. DALVANCE is contraindicated in patients with known hypersensitivity to dalbavancin. See additional Important Safety Information below.
Daily IV antibiotics send patients in all directions. DALVANCE can help you change the ABSSSI treatment journey. Effective treatment is a key consideration when treating your patients with ABSSSI. DALVANCE has been shown in clinical trials to be effective against common ABSSSI pathogens including MRSA.1
Early clinical response at 48 to 72 hours1
1 dose DALVANCE demonstrated similar response rates as the 2 dose regimen at 48 to 72 hours (ITT population)
Primary endpoint: ≥20% reduction in lesion area*
Dalvance (dalbavancin) for injection
CI=confidence interval.
• 1 dose DALVANCE was shown to be noninferior to the 2 dose regimen
* Primary endpoint1: Clinical response defined as patients who had at least a 20% decrease from baseline in lesion area 48 to 72 hours after randomization without receiving any rescue antibiotic treatment.
Clinical success rates at Days 26 to 301
1 dose DALVANCE provided comparable clinical success rates at Days 26 to 30 vs the 2 dose regimen (ITT population)
Secondary endpoint: ≥90% reduction in lesion size, stable temperature, absent or mild and improved local signs†
Dalvance (dalbavancin) for injection
Comparison of clinical success at Days 26 to 30 cannot be used to establish noninferiority‡1
† Secondary endpoint1: Clinical success rate at follow-up visit (Days 26 to 30) was defined as having at least a 90% decrease from baseline in lesion size, a temperature of 37.6°C or lower, and meeting prespecified criteria for local signs: purulent discharge and drainage absent or mild and improved from baseline (for patients with wound infections), heat/warmth and fluctuance absent, swelling/induration and tenderness to palpation absent or mild.
‡ There are insufficient historical data to establish the magnitude of drug effect for antibacterial drugs compared with placebo at the follow-up visit.
Study Design:
Phase 3, randomized, double-blind, noninferiority trial that evaluated the efficacy and safety of 1 dose DALVANCE (1500 mg IV) vs 2 dose DALVANCE regimen (1000 mg IV followed 1 week later by 500 mg IV).1 The ITT population included 698 randomized adult patients§ with documented ABSSSI.1 Patient selection criteria included patients with cellulitis, abscess, or wound infection with a lesion size ≥75 cm2 and at least one systemic sign of disease at baseline, defined as2: Temperature ≥38°C, WBC count >12,000 cells/mm3, or ≥10% band forms on WBC differential.
§ Patients with creatinine clearance <30 mL/min had their dose adjusted. Approximately 5% of patients also received a protocol-specified empiric course of treatment with intravenous aztreonam for coverage of Gram-negative pathogens.
EOT=end of treatment; ITT=intent to treat; WBC=white blood cell.
1 Dose Efficacy
1 Dose 30 Minute Infusion
DALVANCE—The only 1 dose, 30-minute IV antibiotic that provides a full course of outpatient treatment for appropriate ABSSSI patients.
Learn More
INDICATION AND USAGE
DALVANCE® (dalbavancin) for injection is indicated for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of the following Gram-positive microorganisms: Staphylococcus aureus (including methicillin-susceptible and methicillin-resistant strains), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae, Streptococcus anginosus group (including S. anginosus, S. intermedius, S. constellatus) and Enterococcus faecalis (vancomycin-susceptible strains).
To reduce the development of drug-resistant bacteria and maintain the effectiveness of DALVANCE and other antibacterial agents, DALVANCE should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria.
IMPORTANT SAFETY INFORMATION
Contraindications
DALVANCE is contraindicated in patients with known hypersensitivity to dalbavancin.
Warnings and Precautions
HYPERSENSITIVITY REACTIONS
Serious hypersensitivity (anaphylactic) and skin reactions have been reported with glycopeptide antibacterial agents, including DALVANCE. Exercise caution in patients with known hypersensitivity to glycopeptides due to the possibility of cross-sensitivity. If an allergic reaction occurs, treatment with DALVANCE should be discontinued.
INFUSION-RELATED REACTIONS
Rapid intravenous infusion of DALVANCE can cause reactions, including flushing of the upper body, urticaria, pruritus, and rash.
HEPATIC EFFECTS
ALT elevations with DALVANCE treatment were reported in clinical trials.
CLOSTRIDIUM DIFFICILE-ASSOCIATED DIARRHEA
Clostridium difficile-associated diarrhea (CDAD) has been reported with nearly all systemic antibacterial agents, including DALVANCE, with severity ranging from mild diarrhea to fatal colitis. Evaluate if diarrhea occurs.
DEVELOPMENT OF DRUG-RESISTANT BACTERIA
Prescribing DALVANCE in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
Adverse Reactions
The most common adverse reactions in patients treated with DALVANCE were nausea (4.7%), headache (3.8%), and diarrhea (3.4%).
Use in Specific Populations
• There have been no adequate and well-controlled studies with DALVANCE in pregnant or nursing women. DALVANCE should only be used if the potential benefit justifies the potential risk in these populations.
• In patients with renal impairment whose known creatinine clearance is less than 30 mL/min and who are not receiving regularly scheduled hemodialysis, the recommended regimen of 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.
• 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.
Please see Full Prescribing Information.
REFERENCES: 1. DALVANCE® (dalbavancin) [prescribing information]. Parsippany, NJ: Durata Therapeutics U.S. Limited; 2016. 2. Dunne MW, Puttagunta S, Giord
Dalvance (dalbavancin) for injection
IMPORTANT SAFETY INFORMATION
FULL PRESCRIBING INFORMATION
Change the ABSSSI Treatment Journey
Dalvance (dalbavancin) for injection
DALVANCE provides a full course of ABSSSI treatment in just one 30-minute IV infusion
Dear Hospital Administrator,
DALVANCE® (dalbavancin) is indicated for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) due to designated susceptible Gram-positive bacteria as described below. DALVANCE is contraindicated in patients with known hypersensitivity to dalbavancin. See additional Important Safety Information below.
Daily IV antibiotics send patients in all directions. DALVANCE can help you change the ABSSSI treatment journey. Effective treatment is a key consideration when treating your patients with ABSSSI. DALVANCE has been shown in clinical trials to be effective against common ABSSSI pathogens including MRSA.1
Early clinical response at 48 to 72 hours1
1 dose DALVANCE demonstrated similar response rates as the 2 dose regimen at 48 to 72 hours (ITT population)
Primary endpoint: ≥20% reduction in lesion area*
Dalvance (dalbavancin) for injection
CI=confidence interval.
• 1 dose DALVANCE was shown to be noninferior to the 2 dose regimen
* Primary endpoint1: Clinical response defined as patients who had at least a 20% decrease from baseline in lesion area 48 to 72 hours after randomization without receiving any rescue antibiotic treatment.
Clinical success rates at Days 26 to 301
1 dose DALVANCE provided comparable clinical success rates at Days 26 to 30 vs the 2 dose regimen (ITT population)
Secondary endpoint: ≥90% reduction in lesion size, stable temperature, absent or mild and improved local signs†
Dalvance (dalbavancin) for injection
Comparison of clinical success at Days 26 to 30 cannot be used to establish noninferiority‡1
† Secondary endpoint1: Clinical success rate at follow-up visit (Days 26 to 30) was defined as having at least a 90% decrease from baseline in lesion size, a temperature of 37.6°C or lower, and meeting prespecified criteria for local signs: purulent discharge and drainage absent or mild and improved from baseline (for patients with wound infections), heat/warmth and fluctuance absent, swelling/induration and tenderness to palpation absent or mild.
‡ There are insufficient historical data to establish the magnitude of drug effect for antibacterial drugs compared with placebo at the follow-up visit.
Study Design:
Phase 3, randomized, double-blind, noninferiority trial that evaluated the efficacy and safety of 1 dose DALVANCE (1500 mg IV) vs 2 dose DALVANCE regimen (1000 mg IV followed 1 week later by 500 mg IV).1 The ITT population included 698 randomized adult patients§ with documented ABSSSI.1 Patient selection criteria included patients with cellulitis, abscess, or wound infection with a lesion size ≥75 cm2 and at least one systemic sign of disease at baseline, defined as2: Temperature ≥38°C, WBC count >12,000 cells/mm3, or ≥10% band forms on WBC differential.
§ Patients with creatinine clearance <30 mL/min had their dose adjusted. Approximately 5% of patients also received a protocol-specified empiric course of treatment with intravenous aztreonam for coverage of Gram-negative pathogens.
EOT=end of treatment; ITT=intent to treat; WBC=white blood cell.
1 Dose Efficacy
1 Dose 30 Minute Infusion
DALVANCE—The only 1 dose, 30-minute IV antibiotic that provides a full course of outpatient treatment for appropriate ABSSSI patients.
Learn More
INDICATION AND USAGE
DALVANCE® (dalbavancin) for injection is indicated for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of the following Gram-positive microorganisms: Staphylococcus aureus (including methicillin-susceptible and methicillin-resistant strains), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae, Streptococcus anginosus group (including S. anginosus, S. intermedius, S. constellatus) and Enterococcus faecalis (vancomycin-susceptible strains).
To reduce the development of drug-resistant bacteria and maintain the effectiveness of DALVANCE and other antibacterial agents, DALVANCE should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria.
IMPORTANT SAFETY INFORMATION
Contraindications
DALVANCE is contraindicated in patients with known hypersensitivity to dalbavancin.
Warnings and Precautions
HYPERSENSITIVITY REACTIONS
Serious hypersensitivity (anaphylactic) and skin reactions have been reported with glycopeptide antibacterial agents, including DALVANCE. Exercise caution in patients with known hypersensitivity to glycopeptides due to the possibility of cross-sensitivity. If an allergic reaction occurs, treatment with DALVANCE should be discontinued.
INFUSION-RELATED REACTIONS
Rapid intravenous infusion of DALVANCE can cause reactions, including flushing of the upper body, urticaria, pruritus, and rash.
HEPATIC EFFECTS
ALT elevations with DALVANCE treatment were reported in clinical trials.
CLOSTRIDIUM DIFFICILE-ASSOCIATED DIARRHEA
Clostridium difficile-associated diarrhea (CDAD) has been reported with nearly all systemic antibacterial agents, including DALVANCE, with severity ranging from mild diarrhea to fatal colitis. Evaluate if diarrhea occurs.
DEVELOPMENT OF DRUG-RESISTANT BACTERIA
Prescribing DALVANCE in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
Adverse Reactions
The most common adverse reactions in patients treated with DALVANCE were nausea (4.7%), headache (3.8%), and diarrhea (3.4%).
Use in Specific Populations
• There have been no adequate and well-controlled studies with DALVANCE in pregnant or nursing women. DALVANCE should only be used if the potential benefit justifies the potential risk in these populations.
• In patients with renal impairment whose known creatinine clearance is less than 30 mL/min and who are not receiving regularly scheduled hemodialysis, the recommended regimen of 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.
• 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.
Please see Full Prescribing Information.
REFERENCES: 1. DALVANCE® (dalbavancin) [prescribing information]. Parsippany, NJ: Durata Therapeutics U.S. Limited; 2016. 2. Dunne MW, Puttagunta S, Giord
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