alogliptin

alogliptin

(al-oh-glip-tin) ,

Nisena

(trade name)

Classification

Therapeutic: antidiabetics
Pharmacologic: dipeptidyl peptidase4 ddp4 inhibitors
Pregnancy Category: B

Indications

Adjunct with diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Action

Acts as a competitive inhibitor of dipeptidyl peptidase-4 (DDP-4) which slows the inactivation of incretin hormones, thereby increasing their concentrations and reducing fasting and postprandial glucose concentrations.

Therapeutic effects

Improved control of blood glucose.

Pharmacokinetics

Absorption: Completely absorbed following oral administration (100%).
Distribution: Well distributed into tissues.
Metabolism and Excretion: Not extensively metabolized, 76% excreted unchanged in urine.
Half-life: 21 hr.

Time/action profile (inhibition of DDP-4)

ROUTEONSETPEAK†DURATION
POunknown1–2 hr24 hr
†Multiple dosing.

Contraindications/Precautions

Contraindicated in: Type 1 diabetes;Diabetic ketoacidosis;Previous severe hypersensitivity reactions.
Use Cautiously in: Liver disease; Geriatric: Elderly patients may have ↑ sensitivity to effects; Lactation: Use cautiously; Obstetric: Use during pregnancy only if clearly needed; Pediatric: Safe and effective use has not been established.

Adverse Reactions/Side Effects

Central nervous system

  • headache

Gastrointestinal

  • hepatotoxicity (life-threatening)
  • pancreatitis (life-threatening)
  • ↑ liver enzymes

Miscellaneous

  • hypersensitivity reactions including anaphylaxis, angioedema, severe cutaneous reactions including stevens-johnson syndrome

Interactions

Drug-Drug interaction

↑ risk of hypoglycemia with sulfonylureas and insulin, dose adjustments may be necessary

Route/Dosage

Oral (Adults) 25 mg once daily.

Renal Impairment

Oral (Adults) CCr ≥30 mL/min–<60 mL/min—12.5 once daily; CCr <30 mL/min–6.25 once daily.

Availability

Tablets: 6.25 mg, 12.5 mg, 25 mg
In combination with: metformin (Kazano), pioglitazone (Oseni).

Nursing implications

Nursing assessment

  • Observe for signs and symptoms of hypoglycemic reactions (abdominal pain, sweating, hunger, weakness, dizziness, headache, tremor, tachycardia, anxiety).
  • Monitor for signs of pancreatitis (nausea, vomiting, anorexia, persistent severe abdominal pain, sometimes radiating to the back) during therapy. If pancreatitis occurs, discontinue alogliptin and monitor serum and urine amylase, amylase/creatinine clearance ratio, electrolytes, serum calcium, glucose, and lipase.
  • Assess for rash periodically during therapy. May cause Stevens-Johnson syndrome. Discontinue therapy if severe or if accompanied with fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis, hepatitis and/or eosinophilia.
  • Lab Test Considerations: Monitor hemoglobin A1C prior to and periodically during therapy.
    • Monitor renal function prior to and periodically during therapy.

Potential Nursing Diagnoses

Imbalanced nutrition: more than body requirements (Indications)
Noncompliance (Patient/Family Teaching)

Implementation

  • Patients stabilized on a diabetic regimen who are exposed to stress, fever, trauma, infection, or surgery may require administration of insulin.
  • Oral: May be administered without regard to food.

Patient/Family Teaching

  • Instruct patient to take alogliptin as directed. Take missed doses as soon as remembered, unless it is almost time for next dose; do not double doses. Advise patient to read Medication Guide before starting and with each Rx refill in case of changes.
  • Explain to patient that alogliptin helps control hyperglycemia but does not cure diabetes. Therapy is usually long term.
  • Instruct patient not to share this medication with others, even if they have the same symptoms; it may harm them.
  • Encourage patient to follow prescribed diet, medication, and exercise regimen to prevent hyperglycemic or hypoglycemic episodes.
  • Review signs of hypoglycemia and hyperglycemia with patient. If hypoglycemia occurs, advise patient to take a glass of orange juice or 2–3 tsp of sugar, honey, or corn syrup dissolved in water, and notify health care professional.
  • Instruct patient in proper testing of blood glucose and urine ketones. These tests should be monitored closely during periods of stress or illness and health care professional notified if significant changes occur.
  • Advise patient to stop taking alogliptin and notify health care professional promptly if symptoms of hypersensitivity reactions (rash; hives; swelling of face, lips, tongue, and throat; difficulty in breathing or swallowing) or pancreatitis occur.
  • Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
  • Advise patient to notify health care professional if pregnancy is planned or suspected or if breast feeding.

Evaluation/Desired Outcomes

  • Improved hemoglobin A1C, fasting plasma glucose and 2-hr post-prandial glucose levels.
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References in periodicals archive ?
There has been some breakthrough in the management and treatment of this diabetes such as the use of glimepiride, acarbose, alogliptin, canagliflozin, glipizide, glimepiride, empagliflozin, dapagliflozin, colesevelam and sometimes a combination of medication.
Sitagliptin (Januvia), saxagliptin (Onglyza), linagliptin (Tradjenta) and alogliptin (Nesina) are inhibitors of DDP-4, an enzyme responsible for breakdown of incretin hormones.
M2 PHARMA-August 17, 2017-Hikma expands licensing agreement for Alogliptin, Azilsartan, Dexlansoprozole and Lornoxicam for MENA
There are four drugs in this subclass: alogliptin (Nesina), linagliptin (Tradjenta), saxagliptin (Onglyza), and sitagliptin (Januvia).
He referred to findings that alogliptin and sitagliptin did not reduce cardiovascular events compared with placebo in the EXAMINE trial (N EnglJ Med.
However, the 2015 EXAMINE (Examination of Cardiovascular Outcomes with Alogliptin vs Standard of Care) (53) trial and the 2015 TECOS (Trial Evaluating Cardiovascular Outcomes with Sitagliptin) (54) trial evaluated heart failure and mortality outcomes in patients with alogliptin and sitagliptin, respectively, compared to placebo, and did not show a relationship to heart failure.
16] While multiple studies with linagliptin and sitagliptin have found no such detrimental effects, the FDA recommends discontinuation of saxagliptin and alogliptin in patients of heart failure.
Combining a dipeptidyl peptidase-4 inhibitor, alogliptin, with pioglitazone improves glycaemic control, lipid profiles and beta-cell function in db/db mice.
Takeda Pharmaceutical Company Limited today announced that Takeda has obtained the New Drug Application Approval from the Ministry of Health, Labour and Welfare for the Inisync Combination Tablets, a fixed-dose combination of Nesina (generic name: alogliptin benzoate) and metformin hydrochloride (hereinafter metformin) for the treatment of type 2 diabetes.
Experts also discuss the positive cardiovascular safety data published for Victoza in the LEADER trial, and shed light on the recent US-FDA issued warnings about heart failure risk to the labels of T2DM medicines containing saxagliptin (Onglyza) and alogliptin (Nesina).
sitagliptin [Januvia[R]], saxagliptin [Onglyza[R]], linagliptin [Tradjenta[R]], and alogliptin [Nesina[R]]) delay degradation of endogenous GLP-1 and GIP.
Of the 33 cases of severe arthralgia found in the FDA adverse events reporting database, 28 were associated with the use of sitagliptin (Januvia), with some cases also reported with saxagliptin (Onglyza), linagliptin (Tradjenta), alogliptin (Nesina), and vildagliptin (Galvus).