NIPRO JMI Pharma Limited
Lijenta is indicated for Type 2 Diabetes Mellitus
Precautions and warnings
Concomitant use w/ sulphonylureas which are known to cause hypoglycemia; dose reduction of sulphonylureas may be considered. May affect ability to drive or operate machinery. Childn. Elderly >75 yr. Pregnancy & lactation.
Hypoglycaemia. Uncommonly, nasopharyngitis, hypersensitivity, cough.
Hypoglycemia was more commonly reported in patients treated with the combination and sulfonylurea compared with those treated with the combination of placebo and sulfonylurea
Decreased steady-state AUC & Cmax w/ rifampicin.
Patients with a history of a hypersensitivity reaction to linagliptin, such as urticaria, angioedema, or bronchial hyperreactivity. Type 1 DM. Treatment of diabetic ketoacidosis.
Mode of actions
Dipeptidyl peptidase 4 (DPP-4) inhibitor; increases and prolongs incretin hormone activity which is inactivated by DPP-4 enzyme.
Incretins regulate glucose homeostasis by increasing insulin synthesis and release from pancreatic beta cells and reducing glucagon secretion from pancreatic alpha cells .
Dosage & Administration
Adults: Recommended Dose: 5 mg once daily.
When linagliptin is added to metformin, the dose of metformin should be maintained and linagliptin administered concomitantly.
When linagliptin is used in combination with a sulphonylurea, a lower dose of the sulphonylurea may be considered to reduce the risk of hypoglycaemia.
Special Population: Renal Impairment: No dose adjustment.
Hepatic Impairment: Pharmacokinetics studies suggest that no dose adjustment is required for patients with hepatic impairment.
Elderly: No dose adjustment is necessary based on age. However, clinical experience in patients >75 years is limited.
Children: The safety and efficacy of linagliptin in paediatric population has not yet been established. No data are available.
Administration:It can be taken with or without a meal at any time of the day.
Pregnancy & Lactation
Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women OR Animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester.