GALVUS MET 50/850/MG TAB 60/TAB

Indications

Approved Uses

Type 2 diabetes mellitus in adults as an adjunct to diet and exercise: (a) Galvus (vildagliptin) can be used as monotherapy when metformin is inappropriate, or as add-on/combination therapy with other glucose-lowering agents; (b) Galvus Met (vildagliptin/metformin) is indicated in patients inadequately controlled on metformin alone or already treated with vildagliptin + metformin as separate tablets.

Dosage & Administration

Dosing by Condition

Type 2 diabetes: Galvus (vildagliptin) 50 mg once daily (with a sulfonylurea or in moderate/severe renal impairment) or 50 mg twice daily (monotherapy or with metformin/TZD/insulin), max 100 mg/day; Galvus Met 50/850 mg: typically 1 tablet twice daily with meals (individualize based on prior metformin dose/tolerability), max vildagliptin 100 mg/day.

Initial Dose

For patients inadequately controlled on metformin monotherapy, the starting dose should provide 50mg of vildagliptin twice daily plus the dose of metformin already being taken. For treatment-naïve patients, treatment may be initiated at 50mg/500mg once daily and titrated upwards.

Maintenance Dose

50 mg twice daily (100 mg/day total vildagliptin)

Maximum Dose

The maximum recommended daily dose is 100mg of vildagliptin. The maximum daily dose of metformin is typically 2000mg to 3000mg, depending on renal function. [2, 5, 9]

Children's Dosage

Not recommended for use in children and adolescents under 18 years of age as safety and efficacy have not been established. [1, 9]

Dose Adjustment Notes

Renal: Galvus (vildagliptin) requires dose reduction to 50 mg once daily in moderate or severe renal impairment; Galvus Met is not recommended/contraindicated at low eGFR per metformin restrictions and requires eGFR-based assessment before initiation and periodically. Hepatic: avoid/use is not recommended in hepatic impairment; monitor LFTs.

Side Effects

Common Side Effects

Common: gastrointestinal upset (nausea, diarrhea, abdominal pain, decreased appetite), headache, dizziness; nasopharyngitis/URTI; and hypoglycemia mainly when combined with insulin or a sulfonylurea; peripheral edema can occur (more with TZD combinations).

Safety & Warnings

Contraindications

Hypersensitivity to vildagliptin (and to metformin/excipients if using the combination); severe renal impairment (eGFR <30 mL/min/1.73 m²) and acute/chronic metabolic acidosis (incl. DKA) are contraindications for metformin-containing products; hepatic impairment/active liver disease is a contraindication/strong precaution (avoid) for vildagliptin/metformin; type 1 diabetes is not indicated; temporarily stop/avoid in acute conditions predisposing to hypoxia or renal deterioration (e.g., dehydration, severe infection, shock).

Warnings & Precautions

Monitor renal function before and during metformin therapy; counsel on lactic acidosis risk and avoid excess alcohol; withhold metformin around iodinated contrast and major surgery per risk-based guidance; obtain baseline LFTs and monitor periodically and discontinue if persistent ALT/AST elevations or clinical hepatitis; warn about pancreatitis symptoms and stop if suspected; hypoglycemia risk increases when combined with insulin/sulfonylureas-consider dose reduction of the secretagogue.

Age Restriction

Not approved under 18 years. [1, 9]

Drug Interactions

Drug Interactions

Key interactions/precautions: alcohol (↑ lactic acidosis risk with metformin), iodinated contrast (hold metformin around procedures in at-risk patients), drugs that reduce renal function or compete for renal tubular secretion (e.g., NSAIDs, diuretics, ACEi/ARBs; cimetidine) may ↑ metformin exposure; insulin/sulfonylureas ↑ hypoglycemia risk when combined; beta-blockers may mask hypoglycemia symptoms.

Interaction Severity

MAJOR: Iodinated contrast media (temporarily withhold metformin around procedures per eGFR/risk), excessive alcohol (increases lactic acidosis risk with metformin). MODERATE: Drugs that raise metformin exposure (e.g., cimetidine/other OCT2/MATE inhibitors), insulin/sulfonylureas (hypoglycemia risk), diuretics/corticosteroids (worsen glycemia), ACE inhibitors (may enhance glucose-lowering; rare angioedema reported with DPP-4 inhibitors).

Alcohol Interaction

Dangerous

Special Populations

Children

Not recommended for use in children and adolescents under 18 years of age as safety and efficacy have not been established. [1, 9]

Elderly

Use with caution. Monitor renal function regularly as elderly patients are more likely to have decreased renal function. Dose adjustments should be based on renal function. [5, 9]

Kidney Impairment

eGFR ≥45: usual dosing may be used (metformin per standard max doses; vildagliptin typically 50 mg BID if monotherapy/combination allows); eGFR 30-44: do not initiate metformin and if already on metformin, reduce total metformin dose (commonly ≤1000 mg/day) and monitor closely; vildagliptin dose should be reduced to 50 mg once daily in moderate/severe renal impairment; eGFR <30: metformin is contraindicated (therefore the fixed-dose combination is contraindicated).

Storage & Patient Advice

Patient Counseling

Take with meals (do not double doses if missed); limit/avoid excessive alcohol; recognize and seek urgent care for lactic acidosis symptoms (unexplained fatigue, muscle pain, abdominal pain, rapid breathing) and for liver injury symptoms (jaundice, dark urine, persistent nausea); check glucose as directed and be aware of hypoglycemia risk if also using insulin/sulfonylurea; inform providers before iodinated-contrast imaging/surgery; consider periodic vitamin B12 monitoring with long-term use.

Monitoring Requirements

Monitor HbA1c about every 3 months until at goal then every ~6 months; renal function (eGFR) before initiation and at least annually (more often if elderly/at risk); liver function tests before initiation and every 3 months for the first year then periodically; monitor for hypoglycemia if used with insulin/SU; consider vitamin B12 periodically with long-term metformin; monitor for symptoms of lactic acidosis.

Pharmacology

Mechanism of Action

Vildagliptin inhibits DPP-4, increasing endogenous incretins (GLP-1, GIP) to enhance glucose-dependent insulin secretion and suppress glucagon; metformin decreases hepatic gluconeogenesis, reduces intestinal glucose absorption, and improves peripheral insulin sensitivity.

Onset of Action

Pharmacodynamic DPP-4 inhibition occurs within hours of dosing; clinically meaningful glucose lowering is seen within days to 1-2 weeks, with HbA1c effect assessed over ~12 weeks.

Duration of Effect

Approximately 24-hour glycemic coverage with recommended dosing; DPP-4 inhibition is sustained over the dosing interval (often requiring BID dosing for full-day effect in many regimens).

Half-Life

Vildagliptin: ~3 hours (plasma terminal half-life). Metformin: ~6.2-6.5 hours (plasma elimination half-life; longer in erythrocytes).

Metabolism

Vildagliptin: mainly metabolized by non-CYP hydrolysis to inactive metabolites (major pathway ~69%). Metformin: not metabolized.

Excretion

Vildagliptin: primarily renal elimination (~85% of dose recovered in urine; remainder in feces).

Product Information

Available Dosage Forms

Film-coated oral tablet (vildagliptin 50 mg); and, separately, film-coated fixed-dose combination oral tablets (vildagliptin/metformin) marketed as Galvus Met.

Composition per Dose

Each tablet: 50mg vildagliptin + 850mg metformin hydrochloride.

OTC Alternatives

No OTC alternative

Diabetes Type

Type 2

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