Drugplain

Nesina 12.5 mg/1

alogliptin · TABLET, FILM COATED · Takeda Pharmaceuticals America, Inc.

No Recall History
Plain English

Nesina is a tablet, film coated containing alogliptin at 12.5 mg/1, taken oral. Manufactured by Takeda Pharmaceuticals America, Inc..

Key Facts

Brand Name
Nesina
Generic Name
alogliptin
NDC Code (Product)
64764-125
Manufacturer
Takeda Pharmaceuticals America, Inc.
Strength
12.5 mg/1
Dosage Form
TABLET, FILM COATED
Route
ORAL
Marketing Status
Application #
NDA022271
Marketing Start
01/25/2013

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

diarrhoea132 reports
nausea121 reports
vomiting108 reports
acute kidney injury102 reports
pemphigoid101 reports
rash95 reports
malaise92 reports
dyspnoea86 reports
blood glucose increased84 reports
pneumonia83 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE NESINA ® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. 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 ) Limitations of Use: Should not be used in patients with type 1 diabetes mellitus. ( 1 ) Limitations of Use NESINA is not recommended for use in patients with type 1 diabetes mellitus.

Dosage & Administration

2 DOSAGE AND ADMINISTRATION The recommended dosage in patients with normal renal function or mild renal impairment is 25 mg orally once daily. ( 2.1 ) Can be taken with or without food. ( 2.1 ) Adjust dosage if moderate or severe renal impairment or end-stage renal disease (ESRD). ( 2.2 ) Degree of Renal Impairment Creatinine Clearance (mL/min) Recommended Dosage Moderate ≥30 to <60 12.5 mg once daily Severe/ESRD <30 6.25 mg once daily 2.1 Recommended Dosage The recommended dosage of NESINA is 25 mg taken orally once daily. Do not split tablets. NESINA may be taken with or without food [see Clinical Pharmacology (12.3) ] . Instruct patients if a dose is missed, not to double their next dose. 2.2 Patients with Renal Impairment Assess renal function prior to initiation of NESINA and periodically thereafter [see Use in Specific Populations (8.6) ] . 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…

Contraindications

4 CONTRAINDICATIONS NESINA is contraindicated in patients with a history of serious hypersensitivity to alogliptin or any of the excipients in NESINA. Reactions such as anaphylaxis, angioedema and severe cutaneous adverse reactions have been reported [see Warnings and Precautions (5.3) , Adverse Reactions (6.2) ] . History of serious hypersensitivity to alogliptin or any of the excipients in NESINA. ( 4 )

Drug Interactions

7 DRUG INTERACTIONS 7.1 Insulin Secretagogues and Insulin Insulin and insulin secretagogues are known to cause hypoglycemia. Coadministration of NESINA with an insulin secretagogue (e.g., sulfonylurea) or insulin may require lower dosages of the insulin secretagogue and insulin to reduce the risk of hypoglycemia [see Warnings and Precautions (5.5) ] .

Adverse Reactions

6 ADVERSE REACTIONS The following serious adverse reactions are described below or elsewhere in the prescribing information: Pancreatitis [see Warnings and Precautions (5.1) ] Heart Failure [see Warnings and Precautions (5.2) ] Hypersensitivity Reactions [see Warnings and Precautions (5.3) ] Hepatic Effects [see Warnings and Precautions (5.4) ] Severe and Disabling Arthralgia [see Warnings and Precautions (5.6) ] Bullous Pemphigoid [see Warnings and Precautions (5.7) ] Most common adverse reactions (incidence ≥4%) are nasopharyngitis, headache and upper respiratory tract infection. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals America, Inc. at 1-877-TAKEDA-7 (1-877-825-3327) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. A total of 14,778 patients with type 2 diabetes mellitus participated in 14 randomized, double-blind, controlled clinical trials of whom 9,…

Frequently Asked Questions

What is Nesina used for?

Nesina contains alogliptin. It is a tablet, film coated taken oral. Consult your doctor for specific uses.

Is Nesina a controlled substance?

Nesina is not classified as a controlled substance by the DEA.

What is the generic name for Nesina?

The generic name for Nesina is alogliptin. There are 9 other brand versions of alogliptin.

What is the NDC code for Nesina 12.5 mg/1?

The NDC (National Drug Code) for Nesina 12.5 mg/1 is 64764-125, listed by Takeda Pharmaceuticals America, Inc..

Product NDC

64764-125

Package NDC

64764-125-02

Other Alogliptin Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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