NESINA TABLET 25 MG

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

ALOGLIPTIN BENZOATE 34MG EQV ALOGLIPTIN

Available from:

TAKEDA PHARMACEUTICALS (ASIA PACIFIC) PTE. LTD.

ATC code:

A10BH04

Pharmaceutical form:

TABLET, FILM COATED

Composition:

ALOGLIPTIN BENZOATE 34MG EQV ALOGLIPTIN 25MG

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

Takeda Ireland Ltd.

Authorization status:

ACTIVE

Authorization date:

2015-07-16

Summary of Product characteristics

Page 1 of 28
FULL PRESCRIBING INFORMATION
1
INDICATIONS AND USAGE
1.1
MONOTHERAPY AND COMBINATION THERAPY
NESINA is indicated as an adjunct to diet and exercise to improve
glycemic control in
adults with type 2 diabetes mellitus in multiple clinical settings
_[see Clinical Studies _
_(14)]._
1.2
LIMITATION OF USE
NESINA should not be used in patients with type 1 diabetes mellitus or
for the treatment
of diabetic ketoacidosis, as it would not be effective in these
settings.
2
DOSAGE AND ADMINISTRATION
2.1
RECOMMENDED DOSING
The recommended dose of NESINA is 25 mg once daily.
NESINA may be taken with or without food.
2.2
PATIENTS WITH RENAL IMPAIRMENT
No dose adjustment of NESINA is necessary for patients with mild renal
impairment
(creatinine clearance [CrCl] ≥60 mL/min).
The dose of NESINA is 12.5 mg once daily for patients with moderate
renal impairment
(CrCl ≥30 to <60 mL/min).
The dose of NESINA is 6.25 mg once daily for patients with severe
renal impairment
(CrCl ≥15 to <30 mL/min) or with end-stage renal disease (ESRD)
(CrCl <15 mL/min or
requiring hemodialysis). NESINA may be administered without regard to
the timing of
dialysis. NESINA has not been studied in patients undergoing
peritoneal dialysis _[see _
_Clinical Pharmacology (12.3)]. _
Because there is a need for dose adjustment based upon renal function,
assessment of
renal function is recommended prior to initiation of NESINA therapy
and periodically
thereafter.
3
DOSAGE FORMS AND STRENGTHS
•
25 mg tablets are light red, oval, biconvex, film-coated, with “TAK
ALG-25” printed
on one side.
•
12.5 mg tablets are yellow, oval, biconvex, film-coated, with “TAK
ALG-12.5”
printed on one side.
•
6.25 mg tablets are light pink, oval, biconvex, film-coated, with
“TAK ALG-6.25”
printed on one side.
Note: The 6.25 mg tablets should not be used in multiples to achieve
higher daily doses.
Page 2 of 28
4
CONTRAINDICATIONS
History of a serious hypersensitivity reaction to
alogliptin-containing products, such as
anaphylaxis, angioedema or seve