Nesina

Nesina (alogliptin) is an anti-diabetic drug used as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Nesina should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. Common side effects of Nesina include:

• cold symptoms (stuffy nose, sore throat, sinus infection, sinus pain), or
• headache.

Tell your doctor if you have serious side effects of Nesina including:

• severe pain in your upper stomach spreading to your back,
• nausea and vomiting,
• loss of appetite,
• fast heart rate,
• itching,
• dark urine,
• clay-colored stools,
• jaundice (yellowing of the skin or eyes), or
• a severe skin reaction.

The recommended dose of Nesina is 25 mg once daily. Nesina may interact with other drugs. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant before taking Nesina. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Our Nesina (alogliptin) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Nesina Consumer Information

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Stop taking alogliptin and call your doctor right away if you have symptoms of pancreatitis: severe pain in your upper stomach spreading to your back, nausea and vomiting, loss of appetite, or fast heartbeats.

Call your doctor at once if you have:

• severe or ongoing pain in your joints;
• heart problems--shortness of breath (even while lying down), rapid weight gain, swelling (especially in your feet, legs, or midsection);
• liver problems--nausea, upper stomach pain, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
• a severe autoimmune reaction--itching, blisters, breakdown of the outer layer of skin.

Common side effects may include:

• headache; or
• cold symptoms such as stuffy nose, sinus pain, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Nesina (Alogliptin Tablets)

 

Nesina Professional Information

SIDE EFFECTS

The following serious adverse reactions are described below or elsewhere in the prescribing information:

• Pancreatitis [see WARNINGS AND PRECAUTIONS]
• Heart Failure [see WARNINGS AND PRECAUTIONS]
• Hypersensitivity Reactions [see WARNINGS AND PRECAUTIONS]
• Hepatic Effects [see WARNINGS AND PRECAUTIONS]
• Severe and Disabling Arthralgia [see WARNINGS AND PRECAUTIONS]
• Bullous Pemphigoid [see WARNINGS AND PRECAUTIONS]

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 participated in 14 randomized, double-blind, controlled clinical trials of whom 9052 subjects were treated with NESINA, 3469 subjects were treated with placebo and 2257 were treated with an active comparator. The mean duration of diabetes was seven years, the mean body mass index (BMI) was 31 kg/m (49% of patients had a BMI ≥30 kg/m ), and the mean age was 58 years (26% of patients ≥65 years of age). The mean exposure to NESINA was 49 weeks with 3348 subjects treated for more than one year.

In a pooled analysis of these 14 controlled clinical trials, the overall incidence of adverse reactions was 73% in patients treated with NESINA 25 mg compared to 75% with placebo and 70% with active comparator. Overall discontinuation of therapy due to adverse reactions was 6.8% with NESINA 25 mg compared to 8.4% with placebo or 6.2% with active comparator.

Adverse reactions reported in ≥4% of patients treated with NESINA 25 mg and more frequently than in patients who received placebo are summarized in Table 1.

Table 1: Adverse Reactions Reported in ≥4% Patients Treated with NESINA 25 mg and More Frequently Than in Patients Given Placebo in Pooled Studies

	Number of Patients (%)
	NESINA 25 mg N=6447	Placebo N=3469	Active Comparator N=2257
Nasopharyngitis	309 (4.8)	152 (4.4)	113 (5.0)
Upper Respiratory Tract Infection	287 (4.5)	121 (3.5)	113 (5.0)
Headache	278 (4.3)	101 (2.9)	121 (5.4)

Hypoglycemia

Hypoglycemic events were documented based upon a blood glucose value and/or clinical signs and symptoms of hypoglycemia.

In the monotherapy study, the incidence of hypoglycemia was 1.5% in patients treated with NESINA compared to 1.6% with placebo. The use of NESINA as add-on therapy to glyburide or insulin did not increase the incidence of hypoglycemia compared to placebo. In a monotherapy study comparing NESINA to a sulfonylurea in elderly patients, the incidence of hypoglycemia was 5.4% with NESINA compared to 26% with glipizide (Table 2).

Table 2: Incidence and Rate of Hypoglycemia* in Placebo and Active-Controlled Studies when NESINA Was Used as Add-On Therapy to Glyburide, Insulin, Metformin, Pioglitazone or Compared to Glipizide or Metformin

Add-On to Glyburide (26 Weeks)	NESINA 25 mg N=198	Placebo N=99
Overall (%)	19 (9.6)	11 (11.1)
Severe (%)†	0	1 (1)
Add-On to Insulin (± Metformin) (26 Weeks)	NESINA 25 mg	Placebo
	N=129	N=129
Overall (%)	35 (27)	31 (24)
Severe (%)+	1 (0.8)	2 (1.6)
Add-On to Metformin (26 Weeks)	NESINA 25 mg	Placebo
	N=207	N=104
Overall (%)	0	3 (2.9)
Severe (%)+	0	0
Add-On to Pioglitazone (± Metformin or Sulfonylurea) (26 Weeks)	NESINA 25 mg	Placebo
	N=199	N=97
Overall (%)	14 (7.0)	5 (5.2)
Severe (%)†	0	1 (1)
Compared to Glipizide (52 Weeks)	NESINA 25 mg	Glipizide
	N=222	N=219
Overall (%)	12 (5.4)	57 (26)
Severe (%)†	0	3 (1.4)
Compared to Metformin (26 Weeks)	NESINA 25 mg	Metformin 500 mg twice daily
	N=112	N=109
Overall (%)	2 (1.8)	2 (1.8)
Severe (%)†	0	0
Add-On to Metformin Compared to Glipizide (52 Weeks)	NESINA 25 mg	Glipizide
	N=877	N=869
Overall (%)	12 (1.4)	207 (23.8)
Severe (%)†	0	4 (0.5)
*Adverse reactions of hypoglycemia were based on all reports of symptomatic and asymptomatic hypoglycemia; a concurrent glucose measurement was not required; intent-to-treat population. †Severe events of hypoglycemia were defined as those events requiring medical assistance or exhibiting depressed level or loss of consciousness or seizure.

In the EXAMINE trial, the incidence of investigator reported hypoglycemia was 6.7% in patients receiving NESINA and 6.5% in patients receiving placebo. Serious adverse reactions of hypoglycemia were reported in 0.8% of patients treated with NESINA and in 0.6% of patients treated with placebo.

Renal Impairment

In glycemic control trials in patients with type 2 diabetes, 3.4% of patients treated with NESINA and 1.3% of patients treated with placebo had renal function adverse reactions. The most commonly reported adverse reactions were renal impairment (0.5% for NESINA and 0.1% for active comparators or placebo), decreased creatinine clearance (1.6% for NESINA and 0.5% for active comparators or placebo) and increased blood creatinine (0.5% for NESINA and 0.3% for active comparators or placebo) [see Use In Specific Populations].

In the EXAMINE trial of high CV risk type 2 diabetes patients, 23% of patients treated with NESINA and 21% of patients treated with placebo had an investigator reported renal impairment adverse reaction. The most commonly reported adverse reactions were renal impairment (7.7% for NESINA and 6.7% for placebo), decreased glomerular filtration rate (4.9% for NESINA and 4.3% for placebo) and decreased renal clearance (2.2% for NESINA and 1.8% for placebo). Laboratory measures of renal function were also assessed. Estimated glomerular filtration rate decreased by 25% or more in 21.1% of patients treated with NESINA and 18.7% of patients treated with placebo. Worsening of chronic kidney disease stage was seen in 16.8% of patients treated with NESINA and in 15.5% of patients treated with placebo.

Postmarketing Experience

The following adverse reactions have been identified during the postmarketing use of NESINA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Acute pancreatitis, hypersensitivity reactions including anaphylaxis, angioedema, rash, urticaria and severe cutaneous adverse reactions, including Stevens-Johnson syndrome, hepatic enzyme elevations, fulminant hepatic failure, severe and disabling arthralgia, bullous pemphigoid, and diarrhea, constipation, nausea, and ileus [see WARNINGS AND PRECAUTIONS].

Read the entire FDA prescribing information for Nesina (Alogliptin Tablets)

&Copy; Nesina Patient Information is supplied by Cerner Multum, Inc. and Nesina Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.