Source: Health Products Regulatory Authority (ZA) Revision Year: 2022 Publisher: Novartis South Africa (Pty) Ltd., Magwa Crescent West, Waterfall City, Jukskei View, Johannesburg, 2090
For patients with Type 2 diabetes mellitus (T2DM):
JALRAMET is indicated as an adjunct to diet and exercise in patients who are already stabilised with the combination of vildagliptin and metformin hydrochloride at the same dosages, as separate tablets.
JALRAMET is indicated as add-on to insulin as an adjunct to diet and exercise in patients on a stable dose of insulin plus vildagliptin and metformin hydrochloride.
JALRAMET is indicated as an add-on to insulin at the same dosages as the separate tablets of vildagliptin and metformin hydrochloride.
JALRAMET is indicated in combination with sulphonylurea (SU) (i.e. triple combination therapy) as an adjunct to diet and exercise in patients stabilised on vildagliptin, metformin hydrochloride and a sulphonylurea.
JALRAMET can be used to replace the vildagliptin and metformin hydrochloride at the same dosages as the separate tablets.
In using JALRAMET do not exceed the maximum daily dose of vildagliptin (100 mg).
The recommended starting dose of JALRAMET should be based on the patient’s current regimen of vildagliptin and/or metformin hydrochloride. JALRAMET should be given with meals to reduce the gastrointestinal side effects associated with metformin hydrochloride.
The dose of JALRAMET should provide vildagliptin dosed as 50 mg twice daily (100 mg total daily dose) and a dose of metformin similar to the dose already being taken.
A GFR should be assessed before initiation of treatment with metformin-containing products (such as JALRAMET) and at least annually thereafter. In patients at increased risk of further progression of renal impairment and in the elderly, renal function should be assessed more frequently, e.g. every 3 to 6 months. The maximum daily dose of metformin should preferably be divided into 2 to 3 daily doses. Factors that may increase the risk of lactic acidosis (see section 4.4) should be reviewed before considering initiation of metformin-containing products (such as JALRAMET) in patients with GFR <60 ml/min. JALRAMET is contraindicated in patients with GFR <30 ml/min because of its metformin component (see section 4.3).
The following dosing recommendations apply to metformin and vildagliptin, used separately or in combination, in patients with renal impairment. If no adequate strength of JALRAMET is available, individual components should be used instead of the fixed dose combination.
Dose adjustments in patients with renal impairment:
| GFR ml/min | Metformin | Vildagliptin |
|---|---|---|
| 60-89 | Maximum daily dose is 3000 mg*. Dose reduction may be considered if renal function declines. | Maximal daily dose is 100 mg. |
| 45-59 | Starting dose should not be more than 1000 mg with a maximum daily dose of 2000 mg*. | Maximal daily dose is 50 mg. |
| 30-44 | Starting dose should not be more than 500 mg with a maximum daily dose of 1000 mg. | |
| <30 | Metformin is contraindicated. |
* If metformin doses higher than those achievable with JALRAMET alone are considered necessary.
JALRAMET is not recommended in patients with clinical or laboratory evidence of hepatic impairment including patients with a pre-treatment ALT or AST >2,5 x the ULN (see section 4.4).
As metformin is excreted via the kidneys, and elderly patients tend to exhibit decreased renal function, elderly patients taking metformin-containing products (such as JALRAMET) should have their renal function monitored regularly. The dosage of JALRAMET for elderly patients should be adjusted based on renal function (see section 4.3 “Renal disease” and section 4.4 “Monitoring of renal function”).
Safety and efficacy of JALRAMET in paediatric patients have not been established. Therefore, JALRAMET is not recommended for use in children below 18 years of age.
Reports include muscle pain, paraesthesia, fever and oedema. Increases in lipase levels (2 x ULN), creatine phosphokinase (CPK) levels, aspartate aminotransferase (AST), C-reactive protein, and myoglobin may occur. Vildagliptin is not dialysable, however the major hydrolysis metabolite (LAY151) can be removed by haemodialysis.
Hypoglycaemia may develop and should be monitored for. Lactic acidosis has been reported in approximately 32% of metformin hydrochloride overdose cases. Metformin hydrochloride is dialysable with a clearance of up to 170 mL/min under good haemodynamic conditions. Therefore, haemodialysis may be useful for removal of accumulated medicine from patients in whom metformin hydrochloride overdosage is suspected.
In the event of overdosage, appropriate supportive treatment should be initiated according to the patient’s clinical signs and symptoms.
18 Months.
Store at or below 30°C in the original package. Protect from moisture.
Do not remove blister from carton until required for use.
10, 30, 60, 120, 180 or 360’s tablets in PA / AI / PVC (polyamide / aluminium / polyvinylchloride) blisters with an aluminium foil backing.
Not all pack sizes may be marketed.
Not Applicable.
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