TENKASI (oritavancin) could be a solution for those hard-to-reach
adult patients with ABSSSI2
*In vitro activity does not necessarily infer clinical effectiveness.
Single-dose TENKASI (oritavancin) can help spare hospital and OPAT
resources3,4
When services are stretched and capacity challenged, TENKASI (oritavancin):2
- Can be delivered at the point of discharge without the need for hospitalisation*
- Can be delivered without OPAT services
TENKASI (oritavancin) may be beneficial:
- As an alternative to a course of standard IV treatment2,7
- When compliance is a concern with oral antibiotics2
- For the treatment of hard-to-reach or chaotic patients such as IVDUs2
Get in touch to discuss the Budget Impact Model and see how TENKASI (oritavancin) could help spare resources in your hospital.
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*Subject to periodic review of efficacy and adverse events. Please refer to the SmPC.
TENKASI (oritavancin) for potent in vitro activity against Gram-positive
bacteria, including MRSA and VRE*5,9
*In vitro data shown. In vitro activity does not necessarily infer clinical effectiveness.
†The susceptibility breakpoint for oritavancin with S. aureus and E. faecalis (vancomycin-susceptible isolates only) is 0.12 μg/mL (susceptible); with streptococci, it is 0.25 μg/mL, with no intermediate or resistant breakpoints established. The susceptibility breakpoints for linezolid with S. aureus are 4 μg/mL for susceptible and 8 μg/mL for resistant; against enterococci, 2 μg/mL is susceptible, 4 μg/mL is intermediate, and 8 μg/mL is resistant. The susceptibility breakpoint for dalbavancin with S. aureus and most streptococci is 0.12 μg/mL; with Streptococcus pneumoniae, it is 0.03 μg/mL, with no intermediate or resistant breakpoints established. The susceptibility breakpoints for vancomycin with S. aureus are 2 μg/mL for susceptible, 4 to 8 μg/mL is intermediate, and 16 μg/mL is resistant; against enterococci, 4 μg/mL is susceptible, 8 to 16 μg/mL is intermediate, and 32 μg/mL is resistant.
‡Shown as MIC range (MIC90 not available due to limited number of isolates).
§Shown as MIC90 (vanB, vanA) for vancomycin-resistant organisms.
¶Shown as MIC90 (penicillin-susceptible, penicillin non-susceptible) for viridans group Streptococcus.
Adapted from Crotty et al., 2016.9
TENKASI (oritavancin) is the only lipoglycopeptide to retain potent in
vitro activity against both VanA and VanB VRE*5,10,11
*In vitro data shown. In vitro activity does not necessarily infer clinical effectiveness.
Adapted from Saravolatz LD, Stein GE. 2015.11
Single-dose TENKASI (oritavancin) is non-inferior to multiple doses and
days of vancomycin6,7
In SOLO I and SOLO II (click here for study design):
- In adults, non-inferiority was demonstrated for the primary composite endpoint of cessation of spreading or a reduction in the size of the baseline lesion, the absence of fever, and no need for rescue antibiotic; the secondary endpoint of investigator-assessed clinical cure 7–14 days after the end of treatment; and a ≥20% reduction in lesion area at 48–72 hours6,7
- Early clinical response was comparable to vancomycin, regardless of baseline pathogen6,7
- Efficacy rates were similar to vancomycin regardless of patient demographics such as BMI6,7
EMA endpoint: Investigator-assessed clinical cure 7–14 days after end of
treatment (mITT population)*6,7
*Data are presented as comparator % (n/N), modified intention-to-treat populations (randomised and received any study drug). No significant difference between treatment groups was observed. In the two major trials in ABSSSI the types of infections treated were confined to cellulitis, abscesses and wound infections only. Other types of infections have not been studied.
Adapted from Corey GR et al. 20146 and Corey GR et al. 2015.7
Single-dose TENKASI (oritavancin) showed comparable efficacy in
the treatment of MSSA and MRSA in adults with ABSSSI12
Response by baseline pathogen (MicroITT population, pooled SOLO studies)12
*Clinical success was defined as the patient experienced a complete or nearly complete resolution of baseline signs and symptoms at days 14–24.12
MicroITT = the subset of patients within the mITT population with baseline Gram-positive pathogen(s) known to cause ABSSSI
Adapted from Corey GR et al. 20167
TENKASI (oritavancin) is generally well tolerated13
Please refer to the TENKASI Summary of Product Characteristics for more information on the safety profile.
In SOLO I and SOLO II studies of adults:
- TENKASI (oritavancin) was generally well-tolerated13
- The frequency, distribution and severity of adverse events were similar for single-dose TENKASI (oritavancin) and vancomycin13
- >90% of treatment-emergent adverse events with TENKASI (oritavancin) were mild or moderate in severity13
TENKASI (oritavancin) safety profile1
The table below is from the TENKASI (oritavancin) SmPC (GB) and lists adverse reactions (by system organ class) from pooled Phase 3 ABSSSI clinical trials.1 [SmPC information can vary by UK region - refer to your local SmPC for more detail].
*These reactions may be infusion-related.
TENKASI (oritavancin) may simplify patient management8
The single dose allows adult patients to be discharged with no requirement for therapeutic drug monitoring or repeat dosing, subject to periodic review of efficacy and adverse events.8