Vildagliptin

ATC code

A10BH02

Therapeutic class

Drugs used in diabetes, blood glucose lowering drugs, excl. insulins · Dipeptidyl peptidase 4 (DPP-4) inhibitor

Forms

oral tablet

Brand names

Galvus (ES) · Jalra (EU)

Overall confidence

high

Regulatory sources consulted

Indicated as monotherapy in patients in whom metformin is inappropriate due to contraindications or intolerance, as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus.
Indicated in combination with other medicinal products for the treatment of diabetes, including insulin, when these do not provide adequate glycaemic control.

Hypersensitivity to the active substance or to any of the excipients.
Hepatic impairment, including patients with pre-treatment alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 times the upper limit of normal (ULN).

Major warning · Acute pancreatitis: Postmarketing cases of acute pancreatitis have been observed. If pancreatitis is suspected, vildagliptin should be discontinued. — EMA
Angioedema: An increased risk of angioedema has been reported in combination with ACE inhibitors. Use with caution and monitor. — EMA
Major warning · Liver function: Liver function tests are recommended prior to initiation of treatment, at three-monthly intervals during the first year and periodically thereafter. If elevated transaminases are detected, treatment should be discontinued. — EMA

ModerateACE inhibitorsC09A
Mechanism: Increased risk of angioedema, possibly due to additive inhibition of the degradation of vasoactive peptides (e.g., substance P) by DPP-4 and ACE.
Recommendation: Use with caution and monitor closely for signs and symptoms of angioedema, especially at treatment initiation.
EMA SPC
LowThiazidesC03A
Mechanism: The intrinsic hyperglycemic effect of thiazides may counteract the glucose-lowering effect of vildagliptin.
Recommendation: Monitor glycaemic control when initiating, stopping, or changing the dose of the thiazide diuretic.
EMA SPC

dizziness · headache · arthralgia · constipation · peripheral oedema

acute pancreatitis · hepatitis · angioedema · bullous pemphigoid

Should not be used during pregnancy. It is unknown whether it is excreted in human milk, therefore it should not be used during breast-feeding.