"The US Food and Drug Administration (FDA) has approved a new type 2 diabetes drug that combines the sodium glucose cotransporter 2 (SGLT2) inhibitor empagliflozin with metformin hydrochloride (Synjardy, Boehringer Ingelheim and Eli Lilly"...
Monotherapy and Combination Therapy
Limitation of Use
DOSAGE AND ADMINISTRATION
The recommended dose of NESINA is 25 mg once daily.
NESINA may be taken with or without food.
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].
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.
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.
Storage And Handling
NESINA tablets are available as film-coated tablets containing 25 mg, 12.5 mg or 6.25 mg of alogliptin as follows:
25 mg tablet: light red, oval, biconvex, film-coated, with “TAK ALG-25” printed on one side, available in:
NDC 64764-250-30 Bottles of 30 tablets
NDC 64764-250-90 Bottles of 90 tablets
NDC 64764-250-50 Bottles of 500 tablets
12.5 mg tablet: yellow, oval, biconvex, film-coated, with “TAK ALG-12.5” printed on one side, available in:
NDC 64764-125-30 Bottles of 30 tablets
NDC 64764-125-90 Bottles of 90 tablets
NDC 64764-125-50 Bottles of 500 tablets
6.25 mg tablet: light pink, oval, biconvex, film-coated, with “TAK ALG-6.25” printed on one side, available in:
NDC 64764-625-30 Bottles of 30 tablets
NDC 64764-625-90 Bottles of 90 tablets
Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
Distributed by: Takeda Pharmaceuticals America, Inc., Deerfield, IL 60015. Revised: January 2013
Last reviewed on RxList: 2/11/2013
This monograph has been modified to include the generic and brand name in many instances.
Additional Nesina Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.