Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands
Treatment of diabetes mellitus in adults.
Lyumjev is a mealtime insulin for subcutaneous injection and should be administered zero to two minutes before the start of the meal, with the option to administer up to 20 minutes after starting the meal (see section 5.1).
Lyumjev 100 units/mL is suitable for continuous subcutaneous insulin infusion (CSII) and is used for both the bolus and basal insulin requirement.
The initial dosage should take into account the type of diabetes, weight of the patient and their blood glucose levels.
The early onset of action must be considered when prescribing Lyumjev (see section 5.1). Continued adjustment of the dose of Lyumjev should be based on the patient’s metabolic needs, blood glucose monitoring results, and glycaemic control goal. Dose adjustments may be needed, when switching from another insulin, with changes in physical activity, changes in concomitant medicinal products, changes in meal patterns (i.e., amount and type of food, timing of food intake), changes in renal or hepatic function or during acute illness to minimize the risk of hypoglycaemia or hyperglycaemia (see sections 4.4 and 4.5).
If converting from another mealtime insulin to Lyumjev, the change can be done on a unit-to-unit basis. The potency of insulin analogues, including Lyumjev, is expressed in units. One (1) unit of Lyumjev corresponds to 1 international unit (IU) of human insulin or 1 unit of other fast-acting insulin analogues.
Patients who forget a mealtime dose should monitor their blood glucose level to decide if an insulin dose is needed, and to resume their usual dosing schedule at the next meal.
The safety and efficacy of Lyumjev has been established in elderly patients aged 65 to 75 years. Close glucose monitoring is recommended and the insulin dose should be adjusted on an individual basis (see sections 4.8, 5.1 and 5.2). The therapeutic experience in patients ≥75 years of age is limited.
Insulin requirements may be reduced in the presence of renal impairment. In patients with renal impairment, glucose monitoring should be intensified and the dose adjusted on an individual basis.
Insulin requirements may be reduced in patients with hepatic impairment due to reduced capacity for gluconeogenesis and reduced insulin breakdown. In patients with hepatic impairment, glucose monitoring should be intensified and the dose adjusted on an individual basis.
The safety and efficacy of Lyumjev in children and adolescents below 18 years of age have not yet been established. No data are available.
Patients should be trained on proper use and injection technique before initiating Lyumjev. Patients should be told to:
Lyumjev should be injected subcutaneously into the abdomen, upper arm, thigh or buttocks (see section 5.2).
Lyumjev should generally be used in combination with an intermediate or long-acting insulin. A different injection site should be used if injecting at the same time as another insulin.
When injecting a blood vessel should not be entered.
Devices should be discarded if any part looks broken or damaged.
The needle should be discarded after each injection.
If subcutaneous administration by syringe is necessary, a vial should be used.
The syringe must have 100 units/mL markings.
Patients using vials must never share needles or syringes.
Lyumjev in cartridges is only suitable for subcutaneous injections from a Lilly reusable pen.
Lyumjev cartridges should not be used with any other reusable pen as the dosing accuracy has not been established with other pens.
The instructions with each individual pen must be followed for loading the cartridge, attaching the needle and administering the insulin injection.
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.
The KwikPen and Junior KwikPen are only suitable for subcutaneous injections.
Lyumjev is available in two concentrations: Lyumjev 100 units/mL KwikPen and Lyumjev 200 units/mL KwikPen. See the separate SmPC for Lyumjev 200 units/mL KwikPen. The KwikPen delivers 1-60 units in steps of 1 unit in a single injection. The Lyumjev 100 units/mL Junior KwikPen delivers 0.5-30 units in steps of 0.5 units in a single injection. The number of insulin units is shown in the dose window of the pen regardless of concentration and no dose conversion should be done when transferring a patient to a new concentration or to a pen with a different dose step.
Lyumjev 100 units/mL Junior KwikPen is suitable for patients who may benefit from finer insulin dose adjustments.
For detailed user instructions, please refer to the instructions for use provided with the package leaflet.
To prevent the possible transmission of disease, each pen must be used by one patient only, even if the needle is changed.
Use a pump suitable for insulin infusion. Fill the pump reservoir from a Lyumjev 100 units/mL vial.
Patients using a pump should follow the instructions provided with the pump and infusion set. Use the correct reservoir and catheter for the pump.
When filling the pump reservoir avoid damaging it by using the correct needle length on the filling system. The infusion set (tubing and cannula) should be changed in accordance with the instructions in the product information supplied with the infusion set.
A pump malfunction or obstruction of the infusion set can result in a rapid rise in glucose levels (see section 4.4).
Lyumjev 100 units/mL is available in vials if administration of intravenous injection is necessary. This medicinal product must not be mixed with any other insulin or any other medicinal product except those mentioned in section 6.6.
For instructions on dilution of the medicinal product before administration, see section 6.6.
Intravenous administration of Lyumjev 100 units/mL must be performed under medical supervision.
Overdose causes hypoglycaemia with accompanying symptoms that include listlessness, confusion, palpitations, sweating, vomiting, and headache.
Hypoglycaemia may occur as a result of an excess of insulin lispro relative to food intake, energy expenditure, or both. Mild episodes of hypoglycaemia usually can be treated with oral glucose. More severe episodes with coma, seizure, or neurologic impairment may be treated with glucagon or concentrated intravenous glucose. Sustained carbohydrate intake and observation may be necessary because hypoglycaemia may recur after apparent clinical recovery. Adjustments in drug dosage, meal patterns, or exercise may be needed.
Before use: 2 years.
After first use: 28 days.
Lyumjev 100 units/mL solution for injection in vial:
When the vial is diluted for intravenous use:
Chemical, physical in-use stability has been demonstrated for 14 days at 2–8°C and 20 hours at 20-25°C when protected from light. From a microbiological point of view, the medicinal product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would not normally be longer than 24 hours at 2-8°C, unless dilution has taken place in controlled and validated aseptic conditions (see section 6.6).
Store in the refrigerator (2°C-8°C).
Do not freeze.
Store in the original package in order to protect from light
Do not store above 30°C.
Do not freeze.
Lyumjev 100 units/mL solution for injection in vial:
Store in the original package in order to protect from light.
Lyumjev 100 units/mL solution for injection in cartridge:
Do not refrigerate.
Keep the cap on the pen once cartridge inserted, in order to protect from light.
Lyumjev 100 units/mL KwikPen solution for injection in pre-filled pen:
Do not refrigerate.
Keep the cap on the pen in order to protect from light.
Lyumjev 100 units/mL Junior KwikPen solution for injection in pre-filled pen:
Do not refrigerate.
Keep the cap on the pen in order to protect from light.
Lyumjev 100 units/mL solution for injection in vial:
Type I clear glass vials, sealed with halobutyl stoppers and secured with aluminium seals.
10 mL vial: Packs of 1 or 2 vials or 5 (5 packs of 1) vials.
Lyumjev 100 units/mL solution for injection in cartridge:
Type I clear glass cartridges, sealed with disc seals secured with aluminium seals and halobutyl plungers.
3 mL cartridge: Packs of 2, 5 or 10 cartridges.
Lyumjev 100 units/mL KwikPen solution for injection in pre-filled pen:
Type I clear glass cartridges, sealed with disc seals secured with aluminium seals and halobutyl plungers.
The 3 mL cartridges are sealed in a disposable pen injector KwikPen
The medicinal product is packed in a white carton with dark blue bands and an image of the pen. The KwikPen is taupe, the dose knob is blue with raised edges.
3 mL KwikPen: Packs of 2 pre-filled pens, 5 pre-filled pens or a multipack of 10 (2 packs of 5) prefilled pens.
Lyumjev 100 units/mL Junior KwikPen solution for injection in pre-filled pen:
Type I clear glass cartridges, sealed with disc seals secured with aluminium seals and halobutyl plungers.
The 3 mL cartridges are sealed in a disposable pen injector Junior KwikPen .
The medicinal product is packed in a white carton with stripes of peach, light blue and dark blue bands and an image of the pen. The Junior KwikPen is taupe, the dose knob is peach with raised edges.
3 mL Junior KwikPen: Packs of 2 pre-filled pens, 5 pre-filled pens or a multipack of 10 (2 packs of 5) pre-filled pens.
Not all pack sizes may be marketed.
Lyumjev should look clear and colourless. It should not be used if it is cloudy, coloured, or has particles or clumps in it.
Lyumjev should not be used if it has been frozen.
A new needle must always be attached before each use. Needles must not be re-used. Needles are not included.
Lyumjev 100 units/mL vial can be diluted to concentrations of 0.1 to 1.0 unit/mL in 5% glucose solution for injection or sodium chloride 9 mg/mL (0.9%) solution for injection for intravenous use. Compatibility has been demonstrated in ethylene-propylene copolymer and polyolefin with polyvinyl chloride bags.
It is recommended that the system is primed before starting the infusion to the patient.
Lyumjev 100 units/mL vial can be used to fill a continuous insulin infusion pump for a maximum of 9 days. Tubings in which the inner surface materials are made of polyethylene or polyolefin have been evaluated and found compatible with pump use.
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.
