Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: AstraZeneca AB, SE-151 85, Södertälje, Sweden
Onglyza is indicated in adult patients with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control:
The recommended dose of Onglyza is 5 mg once daily. When Onglyza is used in combination with insulin or a sulphonylurea, a lower dose of the insulin or sulphonylurea may be required to reduce the risk of hypoglycaemia (see section 4.4).
The safety and efficacy of saxagliptin as triple oral therapy in combination with metformin and a thiazolidinedione have not been established.
No dose adjustment is recommended based solely on age (see also sections 5.1 and 5.2).
No dose adjustment is recommended for patients with mild renal impairment or in patients with moderate renal impairment that have GFR ≥45 mL/min.
The dose should be reduced to 2.5 mg once daily in patients with moderate renal impairment that have GFR <45 mL/min and in patients with severe renal impairment.
Onglyza is not recommended for patients with end-stage renal disease (ESRD) requiring haemodialysis (see section 4.4).
Because the dose should be limited to 2.5 mg based upon renal function, assessment of renal function is recommended prior to initiation of treatment, and, in keeping with routine care, renal assessment should be done periodically thereafter (see sections 4.4 and 5.2).
No dose adjustment is necessary for patients with mild or moderate hepatic impairment (see section 5.2). Saxagliptin should be used with caution in patients with moderate hepatic impairment, and is not recommended for use in patients with severe hepatic impairment (see section 4.4).
The safety and efficacy of Onglyza in children aged birth to < 18 years have not yet been established. No data are available.
The tablets can be taken with or without a meal at any time of the day. Tablets must not be split or cut.
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.
Onglyza had no clinically meaningful effect on QTc interval or heart rate at oral doses up to 400 mg daily for 2 weeks (80 times the recommended dose). In the event of an overdose, appropriate supportive treatment should be initiated as dictated by the patient’s clinical status. Saxagliptin and its major metabolite can be removed by haemodialysis (23% of dose over 4 hours).
3 years.
This medicinal product does not require any special storage conditions.
Alu/Alu blister.
Onglyza 2.5 mg film-coated tablets:
Pack sizes of 14, 28, and 98 film-coated tablets in non-perforated calendar blisters.
Pack sizes of 30x1 and 90x1 film-coated tablets in perforated unit dose blisters.
Not all pack sizes may be marketed.
Onglyza 5 mg film-coated tablets:
Pack sizes of 14, 28, 56 and 98 film-coated tablets in non-perforated blisters.
Pack sizes of 14, 28, 56 and 98 film-coated tablets in non-perforated calendar blisters.
Pack sizes of 30x1 and 90x1 film-coated tablets in perforated unit dose blisters.
Not all pack sizes may be marketed.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
