Doses and methods for administering telavancin
AssigneeTheravance Biopharma Antibiotics IP, LLC
InventorsSteven L. Barriere, Arthur Lo, Mathai Mammen, Philip Worboys
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Abstract
Doses and methods for administering telavancin or a pharmaceutically-acceptable salt thereof to a human patient having an infection caused by Staphylococcus aureus, such as bacteremia, pneumonia, endocarditis, osteomyelitis, a prosthetic joint infection or a complicated skin and skin structure infection, are disclosed. Also disclosed are methods for treating an infection caused by Staphylococcus aureus in a human patient using telavancin or a pharmaceutically-acceptable salt thereof. The dose of telavancin administered to the patient is determined, in part, by the weight and creatinine clearance of the patient.
Claims76
A once-daily dose of telavancin for administration to a human patient having bacteremia, pneumonia, endocarditis, osteomyelitis, or a prosthetic joint infection caused by Staphylococcus aureus, the dose comprising telavancin or a pharmaceutically-acceptable salt thereof in an amount selected from:
- (a) about 7.5 mg/kg of telavancin (free base equivalents) if the patient has a creatinine clearance greater than about 50 mL/minute, provided that the total dose does not exceed about 750 mg/day;
- (b) about 5.6 mg/kg of telavancin (free base equivalents) if the patient has a creatinine clearance between about 30 mL/minute and about 50 mL/minute, provided that the total dose does not exceed about 560 mg/day;
- and
- (c) about 3.8 mg/kg of telavancin (free base equivalents) if the patient has a creatinine clearance less than about 30 mL/minute, provided that the total dose does not exceed about 380 mg/day.
A once-daily dose of telavancin for administration to a patient having a creatinine clearance less than about 50 mL/minute and having a complicated skin and skin structure infection caused by Staphylococcus aureus, the dose comprising telavancin or a pharmaceutically-acceptable salt thereof in an amount selected from:
- (a) about 5.6 mg/kg of telavancin (free base equivalents) if the patient has a creatinine clearance between about 30 mL/minute and about 50 mL/minute, provided that the total dose does not exceed about 560 mg/day;
- and
- (b) about 3.8 mg/kg of telavancin (free base equivalents) if the patient has a creatinine clearance less than about 30 mL/minute, provided that the total dose does not exceed about 380 mg/day.
A once-daily dose of telavancin for administration to a human patient having an infection caused by Staphylococcus aureus, the dose comprising an amount of telavancin (free base equivalents) in the range defined by formula (I):
- Dose(mg)=AUCtarget*1.15*(WT/77)0.352*(CrCl/99)0.454±5.0 (I)
- wherein:
- AUCtarget is a target area under the concentration curve selected from the range of about 220 to about 730 μg*hr/mL;
- WT is the weight of the patient in kilograms;
- and
- CrCl is the creatinine clearance of the patient in mL/minute.
A once-daily dose of telavancin for administration to a human patient having an infection caused by Staphylococcus aureus, the dose comprising an amount of telavancin (free base equivalents) selected from a nomogram wherein each value in the nomogram is in the range defined by formula (I):
- Dose(mg)=AUCtarget*1.15*(WT/77)0.352*(CrCl/99)0.454±5.0 (I)
- wherein:
- AUCtarget is a target area under the concentration curve selected from the range of about 220 to about 730 μg*hr/mL;
- WT is the weight of the patient in kilograms;
- and
- CrCl is the creatinine clearance of the patient in mL/minute.
A once-daily dose of telavancin for administration to a human patient having an infection caused by Staphylococcus aureus, the dose comprising an amount of telavancin (free base equivalents) selected from a nomogram comprising the values:
- CrCl
- mg
- 10
- 20
- 30
- 40
- 50
- 70
- 90
- 120
- 150
- WT
- 50
- 210
- 290
- 340
- 390
- 430
- 510
- 570
- 650
- 720
- 60
- 220
- 310
- 370
- 420
- 460
- 540
- 610
- 690
- 760
- 70
- 240
- 320
- 390
- 440
- 490
- 570
- 640
- 730
- 810
- 90
- 260
- 350
- 420
- 480
- 530
- 620
- 700
- 800
- 880
- 110
- 280
- 380
- 450
- 520
- 570
- 670
- 750
- 850
- 940
- 130
- 290
- 400
- 480
- 550
- 610
- 710
- 790
- 910
- 1000
- 150
- 310
- 420
- 510
- 580
- 640
- 750
- 840
- 950
- 1050
- wherein:
- WT is the weight of the patient in kilograms (rounded to the nearest value in the nomogram);
- and
- CrCl is the creatinine clearance of the patient in mL/minute (rounded to the nearest value in the nomogram).
Dependencies are inferred from the claim text.