Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: sanofi-aventis groupe, 54, rue La Boétie, F 75008 Paris, France
Truvelog Mix 30 is indicated for treatment of diabetes mellitus in adults, adolescents and children aged 10 years and above.
The potency of insulin analogues, including insulin aspart, is expressed in units, whereas the potency of human insulin is expressed in international units.
Truvelog Mix 30 dosing is individual and determined in accordance with the needs of the patient. Blood glucose monitoring and insulin dose adjustments are recommended to achieve optimal glycaemic control.
In patients with type 2 diabetes, Truvelog Mix 30 can be given as monotherapy. Truvelog Mix 30 can also be given in combination with oral antidiabetic medicinal products and/or GLP-1 receptor agonists. For patients with type 2 diabetes, the recommended starting dose of Truvelog Mix 30 is 6 units at breakfast and 6 units at dinner (evening meal). Truvelog Mix 30 can also be initiated once daily with 12 units at dinner (evening meal). When using Truvelog Mix 30 once daily, it is generally recommended to move to twice daily when reaching 30 units by splitting the dose into equal breakfast and dinner doses. If twice daily dosing with Truvelog Mix 30 results in recurrent daytime hypoglycaemic episodes, the morning dose can be split into morning and lunchtime doses (thrice daily dosing).
The following titration guideline is recommended for dose adjustments:
| Pre-meal blood glucose level | Truvelog Mix 30 dose adjustment | |
|---|---|---|
| <4.4 mmol/L | <80 mg/dL | -2 units |
| 4.4–6.1 mmol/L | 80–110 mg/dL | 0 |
| 6.2–7.8 mmol/L | 111–140 mg/dL | +2 units |
| 7.9–10 mmol/L | 141–180 mg/dL | +4 units |
| >10 mmol/L | >180 mg/dL | +6 units |
The lowest of the three previous days' pre-meal blood glucose levels should be used. The dose should not be increased if hypoglycaemia occurred within these days. Dose adjustments can be made once a week until target HbA1c is reached. Pre-meal blood glucose levels should be used to evaluate the adequacy of the preceding dose.
In patients with type 2 diabetes, a dose reduction of 20% is recommended for patients with an HbA1c less than 8% when a GLP-1 receptor agonist is added to Truvelog Mix 30, to minimise the risk of hypoglycaemia. For patients with an HbA1c higher than 8% a dose reduction should be considered. Subsequently, dose should be adjusted individually. In patients with type 1 diabetes, the individual insulin requirement is usually between 0.5 and 1 unit/kg/day. Truvelog Mix 30 may fully or partially meet this requirement.
Adjustment of dose may be necessary if patients undertake increased physical activity, change their usual diet or during concomitant illness.
When transferring a patient from a treatment regimen with another premix insulin therapy with the same ratio as Truvelog Mix 30, the switch of the insulin should be done on a unit to unit (1:1) basis (no conversion needed) under strict medical supervision with titration according to individual needs (see the titration guideline in the table above).
Close glucose monitoring is recommended during the transfer and in the initial weeks thereafter (see section 4.4).
Truvelog Mix 30 can be used in elderly patients; however there is limited experience with the use of Truvelog Mix 30 in combination with oral antidiabetic medicinal products in patients older than 75 years.
In elderly patients, glucose monitoring should be intensified and the insulin aspart dose adjusted on an individual basis.
Renal impairment may reduce the patient’s insulin requirements. In patients with renal impairment, glucose monitoring should be intensified and the insulin aspart dose adjusted on an individual basis.
Hepatic impairment may reduce the patient’s insulin requirements. In patients with hepatic impairment, glucose monitoring should be intensified and the insulin aspart dose adjusted on an individual basis.
Truvelog Mix 30 can be used in adolescents and children aged 10 years and above when premixed insulin is preferred. There is limited clinical experience with Truvelog Mix 30 in children aged 6-9 years (see section 5.1).
No data are available for Truvelog Mix 30 in children below 6 years of age.
Truvelog Mix 30 is a biphasic suspension of the insulin analogue, insulin aspart. The suspension contains rapid-acting and intermediate-acting insulin aspart in the ratio 30/70.
Truvelog Mix 30 is for subcutaneous administration only.
Before every injection with Truvelog Mix 30,the insulin must be mixed by rolling and moving the pen until the liquid appears uniformly white and cloudy.
Truvelog Mix 30 is administered subcutaneously by injection in the thigh or in the abdominal wall. If convenient, the gluteal or deltoid region may be used. Injection sites should always be rotated within the same region in order to reduce the risk of lipodystrophy and cutaneous amyloidosis (see sections 4.4 and 4.8). The influence of different injection sites on the absorption of Truvelog Mix 30 has not been investigated. The duration of action will vary according to the dose, injection site, blood flow, temperature and level of physical activity.
Truvelog Mix 30 has a faster onset of action than biphasic human insulin and should generally be given immediately before a meal. When necessary, Truvelog Mix 30 can be given soon after a meal.
Truvelog Mix 30 must not be administered intravenously, as it may result in severe hypoglycaemia. Intramuscular administration should be avoided. Truvelog Mix 30 is not to be used in insulin infusion pumps.
Truvelog Mix 30 in cartridges is only suitable for subcutaneous injections from a reusable pen (see section 4.4). Truvelog Mix 30 in cartridges is designated to be used in the following pens (see section 6.6):
Truvelog Mix 30 in pre-filled pen is only suitable for subcutaneous injections. If administration by syringe is necessary, another insulin medicinal product offering a vial should be used (see section 4.4). Truvelog Mix 30 in pre-filled pen delivers 1-80 units of insulin aspart per injection in increments of 1 unit.
Patients must visually verify the dialled units on the dose counter of the pen. Therefore, the requirement for patients to self-inject is that they can read the dose counter on the pen. Patients who are blind or have poor vision must be instructed to always get help/assistance from another person who has good vision and is trained in using the insulin device.
For detailed user instructions, please refer to the package leaflet.
A specific overdose for insulin cannot be defined, however, hypoglycaemia may develop over sequential stages if too high doses relative to the patient’s requirement are administered:
Before opening for first use: 2 years.
After first use: 4 weeks.
Store below 30°C. Do not refrigerate. Do not freeze. Keep the pen cap on the pen in order to protect from light.
Truvelog Mix 30 100 units/mL suspension for injection in cartridge:
Store in a refrigerator (2°C–8°C). Do not freeze.
Keep the cartridge in the outer carton in order to protect from light.
Truvelog Mix 30 100 units/mL suspension for injection in pre-filled pen:
Store in a refrigerator (2°C–8°C). Do not freeze.
Keep the pre-filled pen in the outer carton in order to protect from light.
For storage conditions after first use of the medicinal product, see section 6.3.
Type 1 colourless glass cartridge with a grey plunger (bromobutyl rubber) and a flanged cap (aluminium) with a sealing disk (laminate of isoprene and bromobutyl rubber). Each cartridge contains 3 mL of suspension. The cartridge contains steel balls to facilitate resuspension.
Pack sizes: 5 or 10 cartridges. Not all pack sizes may be marketed.
Type 1 colourless glass cartridge with a grey plunger (bromobutyl rubber) and a flanged cap (aluminium) with a sealing disk (laminate of isoprene and bromobutyl rubber) sealed in a disposable pen injector (SoloStar). The cartridge contains steel balls to facilitate resuspension.
Each pre-filled pen contains 3 mL of suspension.
Pack sizes: 1, 5 or 10 pre-filled pens. Not all pack sizes may be marketed.
After removing Truvelog Mix 30 from the refrigerator, it is recommended to allow Truvelog Mix 30 to reach room temperature for 1 to 2 hours before resuspending the insulin as instructed for first time use. This medicinal product must not be used if the resuspended liquid is not uniformly white and cloudy. The necessity of resuspending the Truvelog Mix 30 suspension immediately before use is to be stressed to the patient. Truvelog Mix 30 which has been frozen must not be used. Always use a new needle for each injection.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
To prevent the possible transmission of disease, each cartridge must be used by one patient only, even if the needle on the delivery device is changed.
Truvelog Mix 30 in cartridges are to be used with AllStar or AllStar PRO pens as recommended (see section 4.2 and 4.4).
The manufacturer’s instructions with each individual pen must be followed for loading the cartridge, attaching the needle and administering the insulin injection.
The pen with the inserted cartridge should not be stored with the needle attached.
The cartridge must not be refilled.
To prevent the possible transmission of disease, each pen must be used by one patient only, even if the needle is changed.
The pre-filled pen should not be stored with the needle attached.
Needles are not included in the pack.
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