US2016243190A1PendingUtilityA1
Doses and methods for administering telavancin
Assignee: THERAVANCE BIOPHARMA ANTIBIOTICS IP LLCPriority: Feb 23, 2015Filed: Feb 18, 2016Published: Aug 25, 2016
Est. expiryFeb 23, 2035(~8.6 yrs left)· nominal 20-yr term from priority
A61K 38/12A61P 9/00A61P 7/00A61P 31/04A61P 29/00A61P 31/00A61K 38/14A61K 9/0019A61P 19/08A61P 11/00A61K 47/40A61P 19/02A61P 19/00
34
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Claims
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.
Claims
exact text as granted — not AI-modifiedWhat is claimed is:
1 . 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.
2 . The dose of claim 1 , wherein the patient has a creatinine clearance greater than about 50 mL/minute.
3 . The dose of claim 1 , wherein the patient has a creatinine clearance between about 30 mL/minute and about 50 mL/minute.
4 . The dose of claim 1 , wherein the patient has a creatinine clearance less than about 30 mL/minute.
5 . The dose of claim 1 , wherein the patient has a creatinine clearance between about 10 mL/minute and less than about 30 mL/minute.
6 . The dose of claim 1 , wherein the patient has bacteremia.
7 . The dose of claim 1 , wherein the patient has pneumonia.
8 . The dose of claim 1 , wherein the patient has endocarditis.
9 . The dose of claim 1 , wherein the patient has osteomyelitis.
10 . The dose of claim 1 , wherein the patient has a prosthetic joint infection.
11 . The dose of claim 1 , wherein the dose is administered intravenously.
12 . The dose of claim 1 , wherein the Staphylococcus aureus is methicillin-resistant Staphylococcus aureus.
13 . The dose of claim 1 , wherein the telavancin is administered as a hydrochloride salt.
14 . The dose of claim 1 , wherein telavancin or a pharmaceutically-acceptable salt thereof is administered in combination with 2-hydroxypropyl-β-cyclodextrin.
15 . A method for administering telavancin to a human patient having bacteremia, pneumonia, endocarditis, osteomyelitis, or a prosthetic joint infection caused by Staphylococcus aureus , the method comprising administering a dose of telavancin or a pharmaceutically-acceptable salt thereof to the patient about once every 24 hours; wherein the dose of telavancin administered to the patient is selected from claim 1 .
16 . A method for treating bacteremia, pneumonia, endocarditis, osteomyelitis, or a prosthetic joint infection caused by Staphylococcus aureus in a human patient, the method comprising administering a dose of telavancin or a pharmaceutically-acceptable salt thereof to the patient about once every 24 hours; wherein the dose of telavancin administered to the patient is selected from claim 1 .
17 . The method of claim 16 , wherein the patient has bacteremia.
18 . The method of claim 16 , wherein the patient has pneumonia.
19 . The method of claim 16 , wherein the patient has endocarditis.
20 . The method of claim 16 , wherein the patient has osteomyelitis.
21 . The method of claim 16 , wherein the patient has a prosthetic joint infection.
22 . 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.
23 . The dose of claim 22 , wherein the patient has a creatinine clearance between about 30 mL/minute and about 50 mL/minute.
24 . The dose of claim 22 , wherein the patient has a creatinine clearance less than about 30 mL/minute.
25 . The dose of claim 22 , wherein the patient has a creatinine clearance between about 10 mL/minute and less than about 30 mL/minute.
26 . The dose of claim 22 , wherein the dose is administered intravenously.
27 . The dose of claim 22 , wherein the Staphylococcus aureus is methicillin-resistant Staphylococcus aureus.
28 . The dose of claim 22 , wherein the telavancin is administered as a hydrochloride salt.
29 . The dose of claim 22 , wherein telavancin or a pharmaceutically-acceptable salt thereof is administered in combination with 2-hydroxypropyl-β-cyclodextrin.
30 . A method for administering telavancin to a human 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 method comprising administering a dose of telavancin or a pharmaceutically-acceptable salt thereof to the patient about once every 24 hours; wherein the dose of telavancin administered to the patient is selected from claim 22 .
31 . A method for treating complicated skin and skin structure infections caused by Staphylococcus aureus in a human patient having a creatinine clearance less than about 50 mL/minute, the method comprising administering a dose of telavancin or a pharmaceutically-acceptable salt thereof to the patient about once every 24 hours for about 7 to about 14 days; wherein the dose of telavancin administered to the patient is selected from claim 22 .
32 . 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)=AUC target *1.15*(WT/77) 0.352 *(CrCl/99) 0.454 ±5.0 (I)
wherein:
AUC target 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.
33 . The dose of claim 32 , wherein the dose is rounded to the nearest 10 mg.
34 . The dose of claim 32 , wherein the AUC target is 600 μg*hr/mL.
35 . The dose of claim 32 , wherein the infection is selected from bacteremia, pneumonia, endocarditis, osteomyelitis, a prosthetic joint infection or a complicated skin and skin structure infection.
36 . The dose of claim 32 , wherein the dose is administered intravenously.
37 . The dose of claim 32 , wherein the Staphylococcus aureus is methicillin-resistant Staphylococcus aureus.
38 . The dose of claim 32 , wherein the telavancin is administered as a hydrochloride salt.
39 . The dose of claim 32 , wherein telavancin or a pharmaceutically-acceptable salt thereof is administered in combination with 2-hydroxypropyl-β-cyclodextrin.
40 . A method for administering telavancin to a human patient having an infection caused by Staphylococcus aureus , the method comprising administering a dose of telavancin or a pharmaceutically-acceptable salt thereof to the patient about once every 24 hours; wherein the dose comprises an amount of telavancin (free base equivalents) in the range defined by claim 32 .
41 . A method for treating an infection caused by Staphylococcus aureus in a human patient, the method comprising administering a dose of telavancin or a pharmaceutically-acceptable salt thereof to the patient about once every 24 hours; wherein the dose comprises an amount of telavancin (free base equivalents) in the range defined by claim 32 .
42 . The method of claim 41 , wherein the infection is bacteremia.
43 . The method of claim 41 , wherein the infection is pneumonia.
44 . The method of claim 41 , wherein the infection is endocarditis.
45 . The method of claim 41 , wherein the infection is osteomyelitis.
46 . The method of claim 41 , wherein the infection is a prosthetic joint infection.
47 . The method of claim 41 , wherein the infection is a complicated skin and skin structure infection.
48 . 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)=AUC target *1.15*(WT/77) 0.352 *(CrCl/99) 0.454 ±5.0 (I)
wherein:
AUC target 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.
49 . The dose of claim 48 , wherein the dose is rounded to the nearest 10 mg.
50 . The dose of claim 48 , wherein the AUC target is 600 μg*hr/mL.
51 . The dose of claim 48 , wherein the infection is selected from bacteremia, pneumonia, endocarditis, osteomyelitis, a prosthetic joint infection or a complicated skin and skin structure infection.
52 . The dose of claim 48 , wherein the dose is administered intravenously.
53 . The dose of claim 48 , wherein the Staphylococcus aureus is methicillin-resistant Staphylococcus aureus.
54 . The dose of claim 48 , wherein the telavancin is administered as a hydrochloride salt.
55 . The dose of claim 48 , wherein telavancin or a pharmaceutically-acceptable salt thereof is administered in combination with 2-hydroxypropyl-β-cyclodextrin.
56 . A method for administering telavancin to a human patient having an infection caused by Staphylococcus aureus , the method comprising administering a dose of telavancin or a pharmaceutically-acceptable salt thereof to the patient about once every 24 hours; wherein the dose comprises an amount of telavancin (free base equivalents) defined by claim 48 .
57 . A method for treating an infection caused by Staphylococcus aureus in a human patient, the method comprising administering a dose of telavancin or a pharmaceutically-acceptable salt thereof to the patient about once every 24 hours; wherein the dose comprises an amount of telavancin (free base equivalents) defined by claim 48 .
58 . The method of claim 57 , wherein the infection is bacteremia.
59 . The method of claim 57 , wherein the infection is pneumonia.
60 . The method of claim 57 , wherein the infection is endocarditis.
61 . The method of claim 57 , wherein the infection is osteomyelitis.
62 . The method of claim 57 , wherein the infection is a prosthetic joint infection.
63 . The method of claim 57 , wherein the infection is a complicated skin and skin structure infection.
64 . 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).
65 . The dose of claim 64 , wherein the infection is selected from bacteremia, pneumonia, endocarditis, osteomyelitis, a prosthetic joint infection or a complicated skin and skin structure infection.
66 . The dose of claim 64 , wherein the Staphylococcus aureus is methicillin-resistant Staphylococcus aureus.
67 . The dose of claim 64 , wherein the telavancin is administered as a hydrochloride salt.
68 . The dose of claim 64 , wherein telavancin or a pharmaceutically-acceptable salt thereof is administered in combination with 2-hydroxypropyl-β-cyclodextrin.
69 . A method for administering telavancin to a human patient having an infection caused by Staphylococcus aureus , the method comprising administering a dose of telavancin or a pharmaceutically-acceptable salt thereof to the patient about once every 24 hours; wherein the dose comprises an amount of telavancin (free base equivalents) defined by claim 64 .
70 . A method for treating an infection caused by Staphylococcus aureus in a human patient, the method comprising administering a dose of telavancin or a pharmaceutically-acceptable salt thereof to the patient about once every 24 hours; wherein the dose comprises an amount of telavancin (free base equivalents) defined by claim 64 .
71 . The method of claim 70 , wherein the infection is bacteremia.
72 . The method of claim 70 , wherein the infection is pneumonia.
73 . The method of claim 70 , wherein the infection is endocarditis.
74 . The method of claim 70 , wherein the infection is osteomyelitis.
75 . The method of claim 70 , wherein the infection is a prosthetic joint infection.
76 . The method of claim 70 , wherein the infection is a complicated skin and skin structure infection.Join the waitlist — get patent alerts
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