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.
Mentioned in ?
References in periodicals archive ?
A New Drug Application (NDA) for alogliptin was approved in April 2010 by the Japanese Ministry of Health, Labour and Welfare for the treatment of type 2 diabetes, and the therapy is currently available under the brand name NESINA[R] in this market.
After several years of reviews and rejections, the peptidase IV inhibitor alogliptin has finally been approved by the Food and Drug Administration.
received confirmation on the acceptance of the submission of a Marketing Authorization Application, or MAA, from the European Medicines Agency for alogliptin, a selective dipeptidyl peptidase IV, or DPP-4, inhibitor for the treatment of type 2 diabetes.
These data, published in the New England Journal of Medicine(NEJM) and also presented at the ESC Congress 2013, demonstrate that alogliptin does not increase CV risk in Type 2 diabetes patients at high-risk for major adverse cardiac events (MACE) due to a recent acute coronary syndrome (ACS).
Nineteen DPP-4 inhibitor trials involved sitagliptin, 10 involved saxagliptin, 7 vildagliptin, and 6 alogliptin.
chairman of Furiex, "While the complete response letter from the FDA regarding alogliptin and the fixed-dose combination alogliptin and pioglitazone was disappointing, the alogliptin program remains on track in the other global markets, and we remain optimistic Takeda will be able to address the agency's requests.
Mannucci and his colleagues examined 42 phase III trials completed through March 2011 that included one of four DPP-4 inhibitors: saxagliptin, sitagliptin, alogliptin, and vildagliptin.
Food and Drug Administration (FDA) regarding its new drug applications (NDAs) for alogliptin, and the fixed-dose combination therapy alogliptin and pioglitazone.
TGRD Europe") received confirmation of the acceptance of submissions of Marketing Authorisation Applications (MAAs) from the European Medicines Agency (EMA) for alogliptin and pioglitazone, which combines alogliptin with pioglitazone in a single tablet, and alogliptin and metformin, which combines alogliptin with metformin in a single tablet.
Currently, Furiex receives royalty payments from Takeda for the sale of alogliptin products, trade names Nesina[R] and Liovel[R], in Japan.
TGRD Europe") received confirmation of the acceptance of the submission of a Marketing Authorisation Application (MAA) from the European Medicines Agency (EMA) for alogliptin, a selective dipeptidyl peptidase IV inhibitor (DPP-4i) for the treatment of type 2 diabetes.