TENKASI (oritavancin)

TENKASI (oritavancin) could be a solution for those hard-to-reach adult patients with ABSSSI²

Learn more

Learn more

Learn more

*In vitro activity does not necessarily infer clinical effectiveness.

Single-dose TENKASI (oritavancin) can help spare hospital and OPAT resources^3,4

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 treatment^2,7
  
  
• 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.

Contact Us

*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 vancomycin^6,7

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 hours^6,7
  
  
• Early clinical response was comparable to vancomycin, regardless of baseline pathogen^6,7
  
  
• Efficacy rates were similar to vancomycin regardless of patient demographics such as BMI^6,7
  

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

Product indications (refer to local SmPC for full details - details may vary between GB and NI):

QUOFENIX^®(delafloxacin) is indicated for the treatment of the following infections in adults: (1) acute bacterial skin and skin structure infections (ABSSSI) (2) community-acquired pneumonia (CAP). Only prescribe when other antibiotics that are commonly recommended for these infections are inappropriate. [Refer to local SmPC for full indication details including risk of prolonged, disabling and potentially irreversible serious adverse drug reactions].¹

VABOREM^®(meropenem/vaborbactam) is indicated for use in adults for the treatment of: complicated urinary tract infection (cUTI) including pyelonephritis; complicated intra-abdominal infection (cIAI); hospital-acquired pneumonia (HAP) including ventilator-associated pneumonia (VAP); bacteraemia that occurs in association with, or is suspected to be associated with, any of these previously listed infections; infections due to aerobic Gram-negative organisms in adults with limited treatment options.²⁴

TENKASI^® (oritavancin) is indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults and paediatric patients aged 3 months and older.

 

References:

1. TENKASI 400 mg powder for concentrate for solution for infusion SmPC (GB).
2. Nathwani D, Dryden M, Garau J. Int J Antimicrob Agents 2016; 48: 127–136.
3. Wu C et al. Value Health 2015; 18: A233 [abstract no. PIN32].
4. Tirupathi R et al. J Community Hosp Intern Med Perspect 2019; 9: 310–313.
5. Brade KD et al. Infect Dis Ther 2016; 5: 1–15.
6. Corey GR et al. N Engl J Med 2014; 370: 2180–2190.
7. Corey GR et al. Clin Infec Dis 2015; 60: 254–262.
8. Garcia-Robles AA et al. Farm Hosp 2018; 42: 73–81.
9. Crotty MP et al. J Clin Microbiol 2016; 54(9): 2225–2232.
10. Roberts KD et al. Pharmacotherapy 2015; 35(10): 935–948.
11. Saravolatz LD, Stein GE. Clin Infect Dis 2015; 61(4): 627–632.
12. Corey GR et al. Int J Antimicrob Agents 2016; 48(5): 528–534.
13. Corey GR et al. Antimicrob Agents Chemother 2018; 62: e01919–17.
14. QUOFENIX 300 mg powder for concentrate for solution for infusion SmPC.
15. QUOFENIX 450 mg tablets SmPC.
16. Giordano PA et al. Clin Infect Dis 2019; 68(Suppl 3): S223–S232.
17. VABOREM 1 g/1 g powder for concentrate for solution for infusion SmPC.
18. Hecker SJ et al. J Med Chem 2015; 58: 3682–3692.
19. Dhillon S. Drugs 2018; 78: 1259–1270.
20. Toussaint KA et al. Ann Pharmacother 2015; 49: 86–98.
21. Pogue JM et al. Clin Infect Dis 2019; 68: 519–524.