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NESINA is a brand name for Alogliptin, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Monotherapy: NESINA (alogliptin as alogliptin benzoate) is indicated for use as an adjunct to diet and exercise to improve glycemic control in adult patients with type 2 diabetes mellitus (T2DM) for whom metformin is inappropriate due to contraindications or intolerance. Add-on combination: NESINA (alogliptin as…
Verbatim from this product's HC label. Tap a section to expand.
, 7 WARNINGS AND PRECAUTIONS, and 10 CLINICAL PHARMACOLOGY. 2 CONTRAINDICATIONS NESINA is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing, see
Driving and Operating Machinery Patients should be warned about driving or operating a vehicle or potentially dangerous machinery under conditions where a risk of hypoglycemia is present (see 7 WARNINGS AND PRECAUTIONS, Hypoglycemia).
When NESINA is used in combination with metformin and a sulfonylurea or in combination with insulin (with or without metformin) patients should be advised to take precautions to avoid hypoglycemia while driving or operating a vehicle or potentially dangerous machinery.
Endocrine and Metabolism Hypoglycemia:
As sulfonylureas and insulin are each known to cause hypoglycemia, a lower dose of sulfonylurea or insulin may be considered to reduce the risk of hypoglycemia when these drugs are used in combination with NESINA. See 4 DOSAGE AND ADMINISTRATION.
Caution should be exercised when NESINA is used in combination with metformin and pioglitazone, as an increased risk of hypoglycemia has been observed with this regimen. NESINA® alogliptin (as alogliptin benzoate) Page 8 of 52 Hepatic/Biliary/Pancreatic Hepatic: There have been post-marketing reports of fatal and non-fatal hepatic failure in patients taking NESINA, although some of the reports contain insufficient information necessary to establish the probable cause.
See 8 ADVERSE REACTIONS. Patients with type 2 diabetes may have fatty liver disease which may cause liver test abnormalities, and they may also have other forms of liver disease, many of which can be treated or managed. Therefore, obtaining a liver test panel and assessing the patient before initiating NESINA therapy is recommended.
In patients with abnormal live r tests, NESINA should be initiated with caution. Measure liver tests promptly in patients who report symptoms that may indicate liver injury, including fatigue, anorexia, right upper abdominal discomfort, dark urine or jaundice.
, Driving and Operating Machinery 02/2022 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES............................................................................................
2 TABLE OF CONTENTS .............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION .....................................................................
4 1 INDICATIONS .............................................................................................................. 1 Pediatrics ..........................................................................................................
2 Geriatrics........................................................................................................... 4 2 CONTRAINDICATIONS .................................................................................................
4 4 DOSAGE AND ADMINISTRATION................................................................................. 1 Dosing Considerations ....................................................................................... 2 Recommended Dose and Dosage Adjustment.....................................................
4 Administration................................................................................................... 5 Missed Dose ......................................................................................................
6 5 OVERDOSAGE ............................................................................................................. 6 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................. 6 7 WARNINGS AND PRECAUTIONS ..................................................................................
NESINA is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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In this clinical context, if the patient is found to have clinically significant liver enzyme elevations and if abnormal liver tests persist or worsen, NESINA should be interrupted and investigation done to establish the probable cause.
NESINA has not been studied in patients with severe hepatic impairment (Child-Pugh score > 9) and is therefore, not recommended for use in such patients. See 4 DOSAGE AND ADMINISTRATION and 10 CLINICAL PHARMACOLOGY.
Pancreatitis:
Events of acute pancreatitis have been reported with NESINA in clinical trials and in post- marketing reports. Reports of acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, were noted in patients taking NESINA and other members of this class.
After initiation of NESINA, patients should be observed carefully for signs and symptoms of pancreatitis. If pancreatitis is suspected, NESINA should be promptly discontinued and appropriate management should be initiated. See 8 ADVERSE REACTIONS.
Immune Hypersensitivity Reactions:
Post-marketing events of serious hypersensitivity reactions in patients treated with NESINA such as anaphylaxis, angioedema, and severe cutaneous adverse reactions including Stevens - Johnson syndrome have been reported and have been associated with other DPP -4 inhibitors.
A single event of serum sickness was observed with NESINA treatment in a clinical trial. If a hypersensitivity reaction is suspected, discontinue NESINA, assess for other potential causes for the event, and institute alternative treatment for diabetes.
See 2 CONTRAINDICATIONS and 8 ADVERSE REACTIONS. Use caution in a patient with a history of angioedema with another DPP-4 inhibitor, since it is unknown whether such patients will be predisposed to angioedema with NESINA.
Immunocompromised Patients:
A dose-related mean decrease in absolute lymphocyte count was observed with other dipeptidyl peptidase 4 (DPP-4) inhibitors. When clinically indicated, such as in settings of NESINA® alogliptin (as alogliptin benzoate) Page 9 of 52 unusual or prolonged infection, lymphocyte count should be measured.
g. human immunodeficiency virus) is unknown. Immunocompromised patients, such as patients who have undergone organ transplantation or patients diagnosed with human immunodeficiency syndrome have not been studied in the alogliptin clinical program.
Therefore, the efficacy and safety profile of alogliptin in these patients has not been established.
Monitoring and Laboratory Tests Blood Glucose and HbA1c:
Response to all diabetic therapies should be monitored by periodic measurements of blood glucose and HbA1c levels, with a goal of decreasing these levels towards the normal range. HbA1c is especially useful for evaluating long-term glycemic control.
Renal Function:
Because there is a need for dose adjustment based upon re nal function, assessment of renal function is recommended prior to initiation of NESINA therapy and periodically thereafter.
Hepatic Function:
Patients with type 2 diabetes may have fatty liver disease which may cause liver test abnormalities, and they may also have other forms of liver disease, many of which can be treated or managed. Therefore, obtaining a liver test panel and assessing the patient before initiating NESINA therapy is recommended.
In patients with abnormal liver tests, NESINA should be initiated with caution. Renal As there is a need for dose adjustment in patients with moderate or severe renal impairment, or End-Stage Renal Disease (ESRD) requiring dialysis, assessment of renal function is recommended prior to initiation of NESINA and periodically thereafter.
See 4 DOSAGE AND ADMINISTRATION. Experience in patients with severe renal impairment or ESRD requiring dialysis is limited and NESINA should be used with caution in such patients. See 4 DOSAGE AND ADMINISTRATION and 10 CLINICAL PHARMACOLOGY.
Skin Bullous pemphigoid:
Post-marketing cases of bullous pemphigoid requiring hospitalization have been reported with the use of NESINA and other DPP-4 inhibitors. In reported […]
1 Special Populations .......................................................................................... 1 Pregnant Women ....................................................................................... 2 Breast-feeding............................................................................................
3 Pediatrics ................................................................................................... 4 Geriatrics ................................................................................................... 10 8 ADVERSE REACTIONS ................................................................................................
1 Adverse Reaction Overview.............................................................................. 2 Clinical Trial Adverse Reactions ........................................................................ 3 Less Common Clinical Trial Adverse Reactions ..................................................
4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data ...................................................................................................... 5 Post-Market Adverse Reactions........................................................................
15 9 DRUG INTERACTIONS................................................................................................ 2 Drug Interactions Overview.............................................................................. 3 Drug-Behavioural Interactions..........................................................................
4 Drug-Drug Interactions .................................................................................... 5 Drug-Food Interactions .................................................................................... 6 Drug-Herb Interactions ....................................................................................
7 Drug-Laboratory Test Interactions .................................................................... 20 10 CLINICAL PHARMACOLOGY ....................................................................................... 1 Mechanism of Action..................................................................................
2 Pharmacodynamics .................................................................................... 3 Pharmacokinetics....................................................................................... 21 11 STORAGE, STABILITY AND DISPOSAL .........................................................................
24 12 SPECIAL HANDLING INSTRUCTIONS........................................................................... 24 PART II: SCIENTIFIC INFORMATION ......................................................................................
25 13 PHARMACEUTICAL INFORMATION............................................................................ 25 14 CLINICAL TRIALS........................................................................................................
1 Clinical Trials by Indication.......................................................................... 26 15 MICROBIOLOGY ........................................................................................................ 44 16 NON-CLINICAL TOXICOLOGY .....................................................................................
44 PATIENT MEDICATION INFORMATION ................................................................................. 47 NESINA® alogliptin (as alogliptin benzoate) Page 4 of 52 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS Monotherapy: NESINA (alogliptin as alogliptin benzoate) is indicated for use as an adjunct to diet and exercise to improve glycemic control in adult patients with type 2 diabetes mellitus (T2DM) for whom metformin is inappropriate due to contraindications or intolerance.
Add-on combination: […]