Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: AstraZeneca AB, SE-151 85 Sodertalje, Sweden
Byetta is indicated for treatment of type 2 diabetes mellitus in combination with:
in adults who have not achieved adequate glycaemic control on maximally tolerated doses of these oral therapies.
Byetta is also indicated as adjunctive therapy to basal insulin with or without metformin and/or pioglitazone in adults who have not achieved adequate glycaemic control with these medicinal products.
Immediate-release exenatide (Byetta) therapy should be initiated at 5 mcg exenatide per dose administered twice daily (BID) for at least one month in order to improve tolerability. The dose of exenatide can then be increased to 10 mcg BID to further improve glycaemic control. Doses higher than 10 mcg BID are not recommended.
Immediate-release exenatide is available as either a 5 mcg or a 10 mcg exenatide per dose pre-filled pen.
Immediate-release exenatide can be administered at any time within the 60-minute period before the morning and evening meal (or two main meals of the day, approximately 6 hours or more apart). Immediate-release exenatide should not be administered after a meal. If an injection is missed, the treatment should be continued with the next scheduled dose.
Immediate-release exenatide is recommended for use in patients with type 2 diabetes mellitus who are already receiving metformin, a sulphonylurea, pioglitazone and/or a basal insulin. Immediate-release exenatide use can be continued when a basal insulin is added to existing therapy. When immediate-release exenatide is added to existing metformin and/or pioglitazone therapy, the current dose of metformin and/or pioglitazone can be continued as no increased risk of hypoglycaemia is anticipated, compared to metformin or pioglitazone alone. When immediate-release exenatide is added to sulphonylurea therapy, a reduction in the dose of sulphonylurea should be considered to reduce the risk of hypoglycaemia (see section 4.4.). When immediate-release exenatide is used in combination with basal insulin, the dose of basal insulin should be evaluated. In patients at increased risk of hypoglycaemia reducing the dose of basal insulin should be considered (see section 4.8).
The dose of immediate-release exenatide does not need to be adjusted on a day-by-day basis depending on self-monitored glycaemia. Blood glucose self-monitoring is necessary to adjust the dose of sulphonylurea or insulin, particularly when Byetta therapy is started and insulin is reduced. A stepwise approach to insulin dose reduction is recommended.
Immediate-release exenatide should be used with caution and dose escalation from 5 mcg to 10 mcg should proceed conservatively in patients >70 years. The clinical experience in patients >75 years is very limited.
No dosage adjustment is necessary in patients with mild renal impairment (creatinine clearance 50-80 ml/min).
In patients with moderate renal impairment (creatinine clearance 30-50 ml/min), dose escalation from 5 mcg to 10 mcg should proceed conservatively (see section 5.2).
Exenatide is not recommended for use in patients with end-stage renal disease or severe renal impairment (creatinine clearance <30 ml/min) (see section 4.4).
No dosage adjustment is necessary in patients with hepatic impairment (see section 5.2).
The safety and efficacy of exenatide in children and adolescents under 18 years of age have not been established (see section 5.2).
Currently available data are described in section 5.2 but no recommendation on a posology can be made.
Each dose should be administered as a subcutaneous injection in the thigh, abdomen, or upper arm. Immediate-release exenatide and basal insulin must be administered as two separate injections.
For instructions for using the pen, see section 6.6 and the user manual included with the leaflet.
Signs and symptoms of overdose may include severe nausea, severe vomiting and rapidly declining blood glucose concentrations. In the event of overdose, appropriate supportive treatment (possibly given parenterally) should be initiated according to the patient’s clinical signs and symptoms.
3 years.
In use pen: 30 days.
Store in a refrigerator (2°C-8°C). Do not freeze.
In use pen: Store below 25°C.
The pen must not be stored with the needle attached. Replace cap on pen in order to protect from light.
Type I glass cartridge with a (bromobutyl) rubber plunger, rubber disc, and aluminium seal. Each cartridge is assembled into a disposable pen-injector (pen).
5 mcg: Each pre-filled pen contains 60 doses (approximately 1.2 ml of solution).
10 mcg: Each pre-filled pen contains 60 doses (approximately 2.4 ml of solution).
Pack size of 1 and 3 pens. Not all pack sizes may be marketed.
Injection needles are not included.
Becton, Dickinson and Company needles are suitable to use with the Byetta pen.
The patient should be instructed to discard the needle after each injection.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Byetta is for use by one person only.
The instructions for using the pen, included with the leaflet, must be followed carefully. The pen must not be stored with the needle attached.
Byetta should not be used if particles appear or if the solution is cloudy and/or coloured. Do not use Byetta if it has been frozen.
© 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.
