Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Takeda Pharma A/S, Delta Park 45, 2665 Vallensbaek Strand, Denmark
Incresync is indicated as a second or third line treatment in adult patients aged 18 years and older with type 2 diabetes mellitus:
In addition, Incresync can be used to replace separate tablets of alogliptin and pioglitazone in those adult patients aged 18 years and older with type 2 diabetes mellitus already being treated with this combination.
After initiation of therapy with Incresync, patients should be reviewed after 3 to 6 months to assess adequacy of response to treatment (e.g. reduction in HbA1c). In patients who fail to show an adequate response, Incresync should be discontinued. In light of potential risks with prolonged pioglitazone therapy, prescribers should confirm at subsequent routine reviews that the benefit of Incresync is maintained (see section 4.4).
For the different dose regimens Incresync is available in strengths of 25 mg/30 mg, 25 mg/45 mg and 12.5 mg/30 mg film-coated tablets.
The dose should be individualised on the basis of the patient’s current treatment regimen.
For patients intolerant to metformin or for whom metformin is contraindicated, inadequately controlled on pioglitazone alone, the recommended dose of Incresync is one tablet of 25 mg/30 mg or 25 mg/45 mg once daily, depending on the dose of pioglitazone already being taken.
For patients inadequately controlled on dual therapy with pioglitazone and a maximally tolerated dose of metformin, the dose of metformin should be maintained, and Incresync administered concomitantly. The recommended dose is one tablet of 25 mg/30 mg or 25 mg/45 mg once daily, depending on the dose of pioglitazone already being taken.
Caution should be exercised when alogliptin is used in combination with metformin and a thiazolidinedione as an increased risk of hypoglycaemia has been observed with this triple therapy (see section 4.4). In case of hypoglycaemia, a lower dose of the thiazolidinedione or metformin may be considered.
For patients switching from separate tablets of alogliptin and pioglitazone, both alogliptin and pioglitazone should be dosed at the daily dose already being taken.
The maximum recommended daily dose of 25 mg alogliptin and 45 mg pioglitazone should not be exceeded.
No dose adjustment is necessary based on age (see section 4.4). However, dosing of alogliptin should be conservative in patients with advanced age due to the potential for decreased renal function in this population.
For patients with mild renal impairment (creatinine clearance (CrCl) >50 to ≤80 mL/min), no dose adjustment of Incresync is necessary (see section 5.2).
For patients with moderate renal impairment (CrCl ≥30 to ≤50 mL/min), one-half of the recommended dose of alogliptin should be administered. Therefore, one tablet of 12.5 mg/30 mg once daily is recommended in patients with moderate renal impairment (see section 5.2).
Incresync is not recommended for patients with severe renal impairment (CrCl <30 mL/min) or end-stage renal disease requiring dialysis.
Appropriate assessment of renal function is recommended prior to initiation of Incresync and periodically thereafter (see section 4.4).
Incresync must not be used in patients with hepatic impairment (see sections 4.3, 4.4 and 5.2).
The safety and efficacy of Incresync in children and adolescents <18 years old have not been established. No data are available.
Oral use.
Incresync should be taken once daily with or without food. The tablets should be swallowed whole with water.
If a dose is missed, it should be taken as soon as the patient remembers. A double dose should not be taken on the same day.
No data are available with regard to overdose of Incresync.
The highest doses of alogliptin administered in clinical studies were single doses of 800 mg to healthy subjects and doses of 400 mg once daily for 14 days to patients with type 2 diabetes mellitus (equivalent to 32 times and 16 times the recommended daily dose of 25 mg alogliptin, respectively).
In clinical studies, patients have taken pioglitazone at higher than the recommended highest dose of 45 mg daily. The maximum reported dose of 120 mg/day for four days, then 180 mg/day for seven days was not associated with any symptoms.
Hypoglycaemia may occur in combination with sulphonylureas or insulin.
In the event of an overdose, appropriate supportive measures should be employed as dictated by the patient’s clinical status.
Minimal quantities of alogliptin are removed by haemodialysis (approximately 7% of the substance was removed during a 3-hour haemodialysis session). Therefore, haemodialysis is of little clinical benefit in overdose. It is not known if alogliptin is removed by peritoneal dialysis.
4 years.
This medicinal product does not require any special temperature storage conditions. Store in the original package in order to protect from moisture.
Nylon/aluminium/polyvinyl chloride (PVC) blisters with push through aluminium lidding foil. Pack sizes of 10, 14, 28, 30, 56, 60, 90, 98 or 100 film-coated tablets.
Not all pack sizes may be marketed.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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