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Alogliptin

Also known as: Nesina

Route: Oral

2 interactions on record

Alogliptin has 2 known drug interactions based on U.S. FDA drug labeling data. Notable interactions include combinations with Insulin Human, Sulfonylurea. Patients taking Alogliptin should inform their healthcare provider of all current medications — including over-the-counter drugs and supplements — to avoid potentially harmful combinations. Data sourced from OpenFDA and the NIH National Library of Medicine.

Total: 2
Moderate: 2

Moderate (2)

Alogliptin + Insulin Human— Coadministration may increase hypoglycemia risk. Lower dosages of insulin may be required when used with alogliptin.
Alogliptin + Sulfonylurea— Coadministration may increase hypoglycemia risk. Lower dosages of sulfonylurea may be required when used with alogliptin…

Alogliptin + Insulin Human🟡Moderate

Coadministration may increase hypoglycemia risk. Lower dosages of insulin may be required when used with alogliptin.

Alogliptin + Sulfonylurea🟡Moderate

Coadministration may increase hypoglycemia risk. Lower dosages of sulfonylurea may be required when used with alogliptin.

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 )

Pregnancy & Breastfeeding

8.1 Pregnancy Risk Summary Limited data with NESINA in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriage. There are risks to the mother and fetus associated with poorly controlled diabetes mellitus in pregnancy [see Clinical Considerations ] . No adverse developmental effects were observed when alogliptin was administered to pregnant rats and rabbits during organogenesis at exposures 180- and 149-times the 25 mg clinical dose, respectively, based on plasma drug exposure (AUC) [see Data ] . The estimated background risk of major birth defects is 6-10% in women with pre-gestational diabetes mellitus with a HbA1c >7 and has been reported to be as high as 20-25% in women with HbA1c >10. The estimated background risk of miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Clinical Considerations Disease-associated Maternal and/or Embryo/Fetal Risk Poorly controlled diabetes mellitus in pregnancy increases the maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery, and delivery complications. Poorly controlled diabetes mellitus increases the fetal risk for major birth defects, still birth, and macrosomia related morbidity. Data Animal Data Alogliptin administered to pregnant rabbits and rats during the period of organogenesis did not cause adverse developmental effects at doses of up to 200 mg/kg and 500 mg/kg, or 149 times and 180 times, the 25 mg clinical dose, respectively, based on plasma drug exposure (AUC). Placental transfer of alogliptin into the fetus was observed following oral dosing to pregnant rats. No adverse developmental outcomes were observed in offspring when alogliptin was administered to pregnant rats during gestation and lactation at doses up to 250 mg/kg (~95 times the 25 mg clinical

Data sourced from U.S. FDA drug labeling via openFDA and the NIH National Library of Medicine. For informational purposes only. Always consult your pharmacist or physician.