NESINA (alogliptin) tablet, film coated
[Takeda Pharmaceuticals America, Inc.]
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use NESINA safely and effectively. See full prescribing information for NESINA.
NESINA (alogliptin) tablets
Initial U.S. Approval: 2013
INDICATIONS AND USAGE
NESINA is a dipeptidyl peptidase-4 (DPP-4) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. (1.1, 14)
Limitation of Use: Not for treatment of type 1 diabetes or diabetic ketoacidosis. (1.2)
DOSAGE AND ADMINISTRATION
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The recommended dose in patients with normal renal function or mild renal impairment is 25 mg once daily. (2.1)
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Can be taken with or without food. (2.1)
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Adjust dose if moderate or severe renal impairment or end-stage renal disease (ESRD). (2.2)
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Degree of Renal Impairment
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Creatinine Clearance (mL/min)
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Recommended Dosing
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Moderate
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≥30 to <60
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12.5 mg once daily
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Severe/ESRD
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<30
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6.25 mg once daily
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DOSAGE FORMS AND STRENGTHS
Tablets: 25 mg, 12.5 mg and 6.25 mg (3)
CONTRAINDICATIONS
History of a serious hypersensitivity reaction to alogliptin-containing products, such as anaphylaxis, angioedema or severe cutaneous adverse reactions. (4)
WARNINGS AND PRECAUTIONS
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Acute pancreatitis: There have been postmarketing reports of acute pancreatitis. If pancreatitis is suspected, promptly discontinue NESINA. (5.1)
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Hypersensitivity: There have been postmarketing reports of serious hypersensitivity reactions in patients treated with NESINA such as anaphylaxis, angioedema and severe cutaneous adverse reactions. In such cases, promptly discontinue NESINA, assess for other potential causes, institute appropriate monitoring and treatment and initiate alternative treatment for diabetes. (5.2)
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Hepatic effects: Postmarketing reports of hepatic failure, sometimes fatal. Causality cannot be excluded. If liver injury is detected, promptly interrupt NESINA and assess patient for probable cause, then treat cause if possible, to resolution or stabilization. Do not restart NESINA if liver injury is confirmed and no alternative etiology can be found. (5.3)
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Hypoglycemia: When an insulin secretagogue (e.g., sulfonylurea) or insulin is used in combination with NESINA, a lower dose of the insulin secretagogue or insulin may be required to minimize the risk of hypoglycemia. (5.4)
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Macrovascular outcomes: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with NESINA or any other antidiabetic drug. (5.5)
ADVERSE REACTIONS
Common adverse reactions (reported in ≥4% of patients treated with NESINA 25 mg and more frequently than in patients who received placebo) are: nasopharyngitis, headache and upper respiratory tract infection. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals at 1-877-TAKEDA-7 (1-877-825-3327) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
Revised: 06/2013
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
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25 mg tablets are light red, oval, biconvex, film-coated, with "TAK ALG-25" printed on one side.
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12.5 mg tablets are yellow, oval, biconvex, film-coated, with "TAK ALG-12.5" printed on one side.
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6.25 mg tablets are light pink, oval, biconvex, film-coated, with "TAK ALG-6.25" printed on one side.
4 CONTRAINDICATIONS
History of a serious hypersensitivity reaction to alogliptin-containing products, such as anaphylaxis, angioedema or severe cutaneous adverse reactions.
5 WARNINGS AND PRECAUTIONS
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