Vildagliptin (vildagliptin)
Vildagliptin is a dipeptidyl peptidase-4 (dpp-4) inhibitor of the islet enhancer class, oral antidiabetic. atc a10bh02. from Novartis, marketed originally as Galvus. This monograph covers approved indications, mechanism, dosing, side effects and the manufacturer landscape.
Overview
Vildagliptin (Galvus, 佳维乐; combination product Galvus Met / Eucreas) is an oral dipeptidyl peptidase-4 (DPP-4) inhibitor of the islet-enhancer class, developed by Novartis for type 2 diabetes. It is given as 50 mg twice daily (100 mg daily) as monotherapy or with metformin, a thiazolidinedione, metformin plus a sulphonylurea or insulin; when combined with a sulphonylurea alone the dose is 50 mg once daily in the morning. Doses above 100 mg daily are not recommended. The drug blocks DPP-4 so that the incretin hormones GLP-1 and GIP stay active longer, which increases glucose-dependent insulin release and lowers glucagon secretion, improving both fasting and postprandial glucose without weight gain. Because it is cleared partly by the kidney, the dose must fall to 50 mg once daily when creatinine clearance is below 50 mL/min, including end-stage renal disease, and it should be used with caution in haemodialysis patients; it must not be used at all in hepatic impairment, including a pre-treatment ALT or AST above 3 times the upper limit of normal. This hepatic restriction plus the need for liver function tests before treatment and every three months during the first year is the feature that most distinguishes vildagliptin from sitagliptin and linagliptin. Very common or common reactions include nasopharyngitis, upper respiratory tract infection, dizziness, headache, tremor, blurred vision, constipation, nausea, gastro-oesophageal reflux, diarrhoea, abdominal pain, vomiting and flatulence; hypoglycaemia is uncommon and occurs mainly with a sulphonylurea or insulin. Acute pancreatitis, rare hepatic dysfunction including hepatitis, and bullous/exfoliative skin lesions have been reported, and there is no boxed warning. Galvus has no FDA approval and is not sold in the United States, so no US ANDA route exists; it is approved in more than 120 countries, with Indian brands such as Natco Vildanat and Eris Zomelis, and Bangladeshi brands such as Square Viglita.
How it works
Vildagliptin blocks the DPP-4 enzyme so the gut hormones GLP-1 and GIP stay active for longer. That makes the pancreas release more insulin when blood sugar is high and reduces glucagon release, lowering both fasting and after-meal glucose without causing weight gain.
Vildagliptin is a potent and selective DPP-4 inhibitor. Administration results in rapid and complete inhibition of DPP-4 activity and increased fasting and postprandial endogenous GLP-1 and GIP levels, enhancing beta-cell glucose sensitivity (glucose-dependent insulin secretion) and alpha-cell glucose sensitivity (more glucose-appropriate glucagon secretion), which reduces fasting and postprandial hepatic glucose production.
Approved indications
- EU (EMA / UK SmPC): treatment of type 2 diabetes mellitus in adults as monotherapy in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate because of contraindications or intolerance.
- EU: as dual oral therapy in combination with metformin, a sulphonylurea, or a thiazolidinedione; as triple oral therapy with metformin and a sulphonylurea; and in combination with insulin (with or without metformin) when diet and exercise plus a stable dose of insulin do not give adequate glycaemic control.
- Not approved by the US FDA: Galvus has no FDA approval and is not marketed in the United States.
- Approved as an oral treatment for adults with type 2 diabetes in more than 120 countries, including the EU, Japan, Latin America and Asia-Pacific (Novartis).
Dosage & administration
Adults: 100 mg daily given as 50 mg in the morning and 50 mg in the evening, when used as monotherapy or in combination with metformin, a thiazolidinedione, metformin plus a sulphonylurea, or insulin (with or without metformin). When used in dual combination with a sulphonylurea alone, the recommended dose is 50 mg once daily in the morning. Doses higher than 100 mg/day are not recommended. Can be taken with or without a meal.
Dose adjustment
Renal: no dose adjustment needed if creatinine clearance >=50 mL/min; in moderate or severe renal impairment or end-stage renal disease the recommended dose is 50 mg once daily, and Galvus should be used with caution in ESRD patients on haemodialysis. Hepatic: Galvus should NOT be used in patients with hepatic impairment, including pre-treatment ALT or AST >3x ULN. Elderly (>=65 years): no dose adjustment. Paediatric (<18 years): not recommended.
Side effects
Nasopharyngitis (very common) · Upper respiratory tract infection (common) · Dizziness, headache and tremor (common) · Blurred vision (common) · Constipation, nausea, gastro-oesophageal reflux disease, diarrhoea, abdominal pain including upper abdominal pain, vomiting and flatulence (common) · Hypoglycaemia (uncommon; mainly when combined with a sulphonylurea or insulin) · Acute pancreatitis (reported with vildagliptin use) · Rare cases of hepatic dysfunction including hepatitis, with liver function tests returning to normal after discontinuation · Bullous and exfoliative skin lesions (reported; skin monitoring recommended)
Monitoring
- Liver function tests before starting Galvus to establish a baseline, then at three-month intervals during the first year and periodically thereafter
- Monitor for the characteristic symptoms of acute pancreatitis; discontinue vildagliptin if pancreatitis is suspected and do not restart if it is confirmed
- Monitor for skin disorders such as blistering or ulceration
- Blood glucose and HbA1c; watch for hypoglycaemia when used with a sulphonylurea or insulin
- Renal function (dose must be reduced to 50 mg once daily in moderate/severe impairment and ESRD)
Generic and biosimilar landscape
Galvus is centrally authorised in the EU (Novartis) and is the reference product; there is no FDA approval, so no US ANDA route exists. Generic vildagliptin and vildagliptin/metformin products are authorised in the EU through Article 10(1) generic procedures (decentralised / mutual recognition) after demonstrating bioequivalence to the originator - for example the Vildagliptin/Metformin Krka public assessment report and published bioequivalence studies of new generic vildagliptin formulations. In India, Cipla co-markets vildagliptin with Novartis under Vysov and Vysov M and has since acquired the brand/trademark rights, while Cipla's own generic listing is Cipvildin/Cipvildin-M.
Who makes it
| Manufacturer | Country | Brand | Strength | Notes |
|---|---|---|---|---|
| Cipla Ltd | India | Vysov and Vysov M (vildagliptin + metformin); Cipvildin and Cipvildin-M in Cipla's generic product list | Vysov 50 mg; Cipvildin-M 50 mg/1000 mg tablets | Cipla co-marketed vildagliptin in agreement with Novartis under Vysov/Vysov M and acquired the brand and trademark rights in India |
| Natco Pharma Ltd | India | Vildanat (50 mg) and Vildanat M | 50 mg tablet; 50 mg/500 mg and 50 mg/1000 mg combinations | Rs 53. 70 per strip of 10 on 1mg (about Rs 5. 37 per tablet), the lowest Indian the data found |
| Eris Lifesciences Ltd | India | Zomelis (50 mg) and Zomelis D | 50 mg tablet; 50 mg/5 mg combination | About Rs 137 best the data per 15-tablet pack (Apollo Pharmacy); Zomelis D 50/5 mg at Rs 14. 22 per tablet |
| Square Pharmaceuticals PLC | Bangladesh | Viglita | 50 mg tablet | Tk 16. 00 per tablet (2 x 10: Tk 320) on medex. com. bd |
| ACI Limited | Bangladesh | Aptin | 50 mg tablet | Tk 22. 00 per tablet (3 x 10: Tk 660) |
| Drug International Ltd | Bangladesh | Dialiptin (and Dialiptin-M) | 50 mg tablet | Tk 16. 00 per tablet (3 x 14: Tk 672) |
| Nevian Lifescience PLC | Bangladesh | Galvus (branded) | 50 mg tablet | Highest Bangladeshi the data found: Tk 32. 00 per tablet (2 x 14: Tk 896) |
| Aristopharma Ltd | Bangladesh | Gluvan | 50 mg tablet | Tk 20. 00 per tablet (2 x 14: Tk 560) |
| Eskayef Pharmaceuticals Ltd | Bangladesh | Vigatin | 50 mg tablet | Tk 20. 00 per tablet (2 x 10: Tk 400) |
Availability in Southeast Asia
| Country | Status | Notes |
|---|---|---|
| Philippines | Registered / available | The Philippines FDA verification portal hosts the Galvus 50 mg tablet product information document (DRP-4796), and MIMS Philippines carries the Galvus full monograph; Galvus Met 50 mg/500 mg film-coated tablets are sold in the Philippines. |
| Singapore | Registered / available | Novartis Singapore publishes the Galvus patient information leaflet (information issued July 2020) on novartis. com. |
| Indonesia | Registered / available | MIMS Indonesia lists Galvus and a vildagliptin generic monograph, including Galvus Met 50/500, 50/850 and 50/1000 mg film-coated tablets. |
| Malaysia | Registered / available | MIMS Malaysia carries a Galvus Met full monograph (vildagliptin + metformin hydrochloride). |
Frequently asked questions
What is vildagliptin (Galvus) used for?
Vildagliptin is approved for: EU (EMA / UK SmPC): treatment of type 2 diabetes mellitus in adults as monotherapy in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate because of contraindications or intolerance. ; EU: as dual oral therapy in combination with metformin, a sulphonylurea, or a thiazolidinedione; as triple oral therapy with metformin and a sulphonylurea; and in combination with insulin (with or without metformin) when diet and exercise plus a stable dose of insulin do not give adequate glycaemic control. ; Not approved by the US FDA: Galvus has no FDA approval and is not marketed in the United States. ; Approved as an oral treatment for adults with type 2 diabetes in more than 120 countries, including the EU, Japan, Latin America and Asia-Pacific (Novartis). . It is a vildagliptin (Dipeptidyl peptidase-4), originally marketed as Galvus (佳维乐); combination product Galvus Met / Eucreas by Novartis.
Is vildagliptin approved in the US?
Vildagliptin (Dipeptidyl peptidase-4 (DPP-4) inhibitor of the islet enhancer class, oral antidiabetic. ATC A10BH02. , originally Galvus (佳维乐); combination product Galvus Met / Eucreas by Novartis) Vildagliptin blocks the DPP-4 enzyme so the gut hormones GLP-1 and GIP stay active for longer. That makes the pancreas release more insulin when blood sugar is high and reduces glucagon release, lowering both fasting and after-meal glucose without causing weight gain. Adults: 100 mg daily given as 50 mg in the morning and 50 mg in the evening, when used as monotherapy or in combination with metformin, a thiazolidinedione, metformin plus a sulphonylurea, or insulin (with or without metformin). When used in dual combination with a sulphonylurea alone, the recommended dose is 50 mg once daily in the morning. Doses higher than 100 mg/day are not recommended. Can be
What is the dose of vildagliptin in kidney impairment or on dialysis?
Standard dosing for vildagliptin: Adults: 100 mg daily given as 50 mg in the morning and 50 mg in the evening, when used as monotherapy or in combination with metformin, a thiazolidinedione, metformin plus a sulphonylurea, or insulin (with or without metformin). When used in dual combination with a sulphonylurea alone, the recommended dose is 50 mg once daily in the morning. Doses higher than 100 mg/day are not recommended. Can be taken with or without a meal. Dose adjustments: Renal: no dose adjustment needed if creatinine clearance >=50 mL/min; in moderate or severe renal impairment or end-stage renal disease the recommended dose is 50 mg once daily, and Galvus should be used with caution in ESRD patients on haemodialysis. Hepatic: Galvus should NOT be used in patients with hepatic impairment, including pre-treatment ALT or AST >3x ULN. Elderly (>=65 years): no dose adjustment. Paediatric (<18 years): not recommended.
Why does vildagliptin need liver function monitoring?
Recommended monitoring for vildagliptin: Liver function tests before starting Galvus to establish a baseline, then at three-month intervals during the first year and periodically thereafter; Monitor for the characteristic symptoms of acute pancreatitis; discontinue vildagliptin if pancreatitis is suspected and do not restart if it is confirmed; Monitor for skin disorders such as blistering or ulceration; Blood glucose and HbA1c; watch for hypoglycaemia when used with a sulphonylurea or insulin; Renal function (dose must be reduced to 50 mg once daily in moderate/severe impairment and ESRD)
Vildagliptin vs sitagliptin - which one should I take?
Vildagliptin (Dipeptidyl peptidase-4 (DPP-4) inhibitor of the islet enhancer class, oral antidiabetic. ATC A10BH02. , originally Galvus (佳维乐); combination product Galvus Met / Eucreas by Novartis) Vildagliptin blocks the DPP-4 enzyme so the gut hormones GLP-1 and GIP stay active for longer. That makes the pancreas release more insulin when blood sugar is high and reduces glucagon release, lowering both fasting and after-meal glucose without causing weight gain. Adults: 100 mg daily given as 50 mg in the morning and 50 mg in the evening, when used as monotherapy or in combination with metformin, a thiazolidinedione, metformin plus a sulphonylurea, or insulin (with or without metformin). When used in dual combination with a sulphonylurea alone, the recommended dose is 50 mg once daily in the morning. Doses higher than 100 mg/day are not recommended. Can be
Is Vysov the same as Galvus?
Galvus is centrally authorised in the EU (Novartis) and is the reference product; there is no FDA approval, so no US ANDA route exists. Generic vildagliptin and vildagliptin/metformin products are authorised in the EU through Article 10(1) generic procedures (decentralised / mutual recognition) after demonstrating bioequivalence to the originator - for example the Vildagliptin/Metformin Krka public assessment report and published bioequivalence studies of new generic vildagliptin formulations. In India, Cipla co-markets vildagliptin with Novartis under Vysov and Vysov M and has since acquired the brand/trademark rights, while Cipla's own generic listing is Cipvildin/Cipvildin-M. Manufacturers supplying vildagliptin generic versions include ACI Limited, Aristopharma Ltd, Cipla Ltd, Drug International Ltd, Eris Lifesciences Ltd, Eskayef Pharmaceuticals Ltd, Natco Pharma Ltd, Nevian Lifescience PLC. Brands registered in Bangladesh include Aptin, Dialiptin, Diavil, Edvila, Galet, Galvid.
Can vildagliptin be taken with metformin?
Vildagliptin (Dipeptidyl peptidase-4 (DPP-4) inhibitor of the islet enhancer class, oral antidiabetic. ATC A10BH02. , originally Galvus (佳维乐); combination product Galvus Met / Eucreas by Novartis) Vildagliptin blocks the DPP-4 enzyme so the gut hormones GLP-1 and GIP stay active for longer. That makes the pancreas release more insulin when blood sugar is high and reduces glucagon release, lowering both fasting and after-meal glucose without causing weight gain. Adults: 100 mg daily given as 50 mg in the morning and 50 mg in the evening, when used as monotherapy or in combination with metformin, a thiazolidinedione, metformin plus a sulphonylurea, or insulin (with or without metformin). When used in dual combination with a sulphonylurea alone, the recommended dose is 50 mg once daily in the morning. Doses higher than 100 mg/day are not recommended. Can be
Does vildagliptin cause weight gain?
Vildagliptin (Dipeptidyl peptidase-4 (DPP-4) inhibitor of the islet enhancer class, oral antidiabetic. ATC A10BH02. , originally Galvus (佳维乐); combination product Galvus Met / Eucreas by Novartis) Vildagliptin blocks the DPP-4 enzyme so the gut hormones GLP-1 and GIP stay active for longer. That makes the pancreas release more insulin when blood sugar is high and reduces glucagon release, lowering both fasting and after-meal glucose without causing weight gain. Adults: 100 mg daily given as 50 mg in the morning and 50 mg in the evening, when used as monotherapy or in combination with metformin, a thiazolidinedione, metformin plus a sulphonylurea, or insulin (with or without metformin). When used in dual combination with a sulphonylurea alone, the recommended dose is 50 mg once daily in the morning. Doses higher than 100 mg/day are not recommended. Can be
Is vildagliptin safe in liver disease?
Vildagliptin (Dipeptidyl peptidase-4 (DPP-4) inhibitor of the islet enhancer class, oral antidiabetic. ATC A10BH02. , originally Galvus (佳维乐); combination product Galvus Met / Eucreas by Novartis) Vildagliptin blocks the DPP-4 enzyme so the gut hormones GLP-1 and GIP stay active for longer. That makes the pancreas release more insulin when blood sugar is high and reduces glucagon release, lowering both fasting and after-meal glucose without causing weight gain. Adults: 100 mg daily given as 50 mg in the morning and 50 mg in the evening, when used as monotherapy or in combination with metformin, a thiazolidinedione, metformin plus a sulphonylurea, or insulin (with or without metformin). When used in dual combination with a sulphonylurea alone, the recommended dose is 50 mg once daily in the morning. Doses higher than 100 mg/day are not recommended. Can be
Sources
- https://www.medicines.org.uk/emc/product/6225/smpc
- https://www.ema.europa.eu/en/medicines/human/EPAR/galvus
- https://medex.com.bd/generics/1125/vildagliptin/brand-names
- https://www.1mg.com/drugs/vildanat-tablet-547803
- https://www.apollopharmacy.in/medicine/zomelis-50mg-tablet-15-s
- https://www.medplusmart.com/product/zomelis-d-50-5mg-tab_zome0025
- https://www.cipla.com/generic-product-list
- https://www.expresspharma.in/cipla-acquires-brand-trademark-rights-for-anti-diabetic-drug-vysov-in-india
- https://verification.fda.gov.ph/files/DRP-4796_PI_01.pdf
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