Aloglip Tablet

Aloglip Tablet is used for: Type 2 diabetes mellitus

Oral Type 2 diabetes mellitus Adult: 25 mg once daily.

Renal impairment Mild (CrCl >60mL/min): No dosage adjustment is required Moderate (CrCl >30 to <60 mL/min): Decrease dose to 12.5 mg PO qDay Severe (CrCl >15 to <30 mL/min) or ESRD (CrCl <15 mL/min) or requiring hemodialysis: 6.25 mg PO qDay May administer without regard to the timing of dialysis Peritoneal dialysis: Not studied

May be taken with or without food.

Type 1 diabetes mellitus or diabetic ketoacidosis. Hypersensitivity to alogliptin, including anaphylaxis, angioedema, or severe cutaneous adverse reactions including Stevens-Johnson syndrome

Acute pancreatitis: There have been postmarketing reports of acute pancreatitis. If pancreatitis is suspected, promptly discontinue Alogliptin. Heart failure: Consider the risks and benefits of Alogliptin prior to initiating treatment in patients at risk for heart failure. If heart failure develops, evaluate and manage according to current standards of care and consider discontinuation of Alogliptin. Hypersensitivity: There have been postmarketing reports of serious hypersensitivity reactions in patients treated with Alogliptin such as anaphylaxis, angioedema and severe cutaneous adverse reactions, including Stevens-Johnson syndrome. In such cases, promptly discontinue Alogliptin, assess for other potential causes, institute appropriate monitoring and treatment and initiate alternative treatment for diabetes. Hepatic effects: Postmarketing reports of hepatic failure, sometimes fatal. Causality cannot be excluded. If liver injury is detected, promptly interrupt NESINA and assess patient for probable cause, then treat cause if possible, to resolution or stabilization. Do not restart Alogliptin if liver injury is confirmed and no alternative etiology can be found. Hypoglycemia: When an insulin secretagogue (e.g., sulfonylurea) or insulin is used in combination with Alogliptin, a lower dose of the insulin secretagogue or insulin may be required to minimize the risk of hypoglycemia. Arthralgia: Severe and disabling arthralgia has been reported in patients taking DPP-4 inhibitors. Consider as a possible cause for severe joint pain and discontinue drug if appropriate. Bullous pemphigoid: There have been postmarketing reports of bullous pemphigoid requiring hospitalization in patients taking DPP-4 inhibitors. Tell patients to report development of blisters or erosions. If bullous pemphigoid is suspected, discontinue Alogliptin. Macrovascular outcomes: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Alogliptin or any other antidiabetic drug.

Pregnancy Risk Summary Limited data with Alogliptin 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 in pregnancy. 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). The estimated background risk of major birth defects is 6-10% in women with pre-gestational diabetes 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 in pregnancy increases the maternal risk for diabetic ketoacidosis, preeclampsia, spontaneous abortions, preterm delivery, still birth and delivery complications. Poorly controlled diabetes 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 dose, based on AUC). Lactation Risk Summary There is no information regarding the presence of alogliptin in human milk, the effects on the breastfed infant, or the effects on milk production. Alogliptin is present in rat milk: however, due to species specific differences in lactation physiology, animal lactation data may not reliably predict levels in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for NESINA and any potential adverse effects on the breastfed infant from Alogliptin or from the underlying maternal condition.

Increased risk of hypoglycaemia with sulfonylurea (e.g. metformin), thiazolidinedione (e.g. pioglitazone) and insulin.

Side effects of Alogliptin : >10% Hypoglycemia (1.5-35%); higher when added to insulin 1-10% Nasopharyngitis (4.4%) Headache (4.2%) Upper respiratory tract infection (4.2%) <1% Hypersensitivity (0.6%) Pancreatitis (0.2%)

Alogliptin inhibits dipeptidylpeptidase-4 (DPP-4), an enzyme that inactivates incretin hormones. Inhibition of DPP-4 result in an increase in the levels of hormones [e.g. GLP-1 (glucagon-like peptide-1) and GIP (glucose-dependent insulinotrophic polypeptide)] which regulate glucose homeostasis by increasing insulin synthesis and release from pancreatic β-cells and decreasing glucagon secretion from the pancreatic α-cells, leading to reduced hepatic glucose production.

Aloglip 12.5mg Tablet manufactured by Navana Pharmaceuticals Ltd.. Its generic name is Alogliptin. Aloglip is availble in Bangladesh. Farmaco BD drug index information on Aloglip Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.