LYUMJEV

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 dose should take into account the type of diabetes, weight of the patient and their blood glucose levels.

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. 5). Switching from another mealtime insulin medicinal product 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. Missed doses 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.

Special populations Elderly The safety and efficacy of Lyumjev has been established in elderly patients aged 65 to 75 years. 2). The therapeutic experience in patients ≥ 75 years of age is limited. Renal impairment 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. Hepatic impairment 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. 1). There is no clinical experience with the use of Lyumjev in children below the age of 3 years. Similar to adults, dosage should be adjusted individually.

Lyumjev is recommended to 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 when needed. Method of administration Patients should be trained on proper use and injection technique before initiating Lyumjev.

Patients should be told to: • Always check insulin labels before administration. • Inspect Lyumjev visually before use and discard for particulate matter or discolouration. 8). • Carry a spare or alternative administration method in case their delivery system breaks.

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. Lyumjev vials 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 cartridges 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.

Lyumjev KwikPens and Lyumjev Tempo Pen The KwikPen, Junior KwikPen and Tempo Pen are only suitable for subcutaneous injections.

Lyumjev KwikPens are 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. 5 units in a single injection. The Lyumjev 100 units/ml Tempo Pen delivers 1 – 60 units in steps of 1 unit 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.

6). As with any insulin injection, when using the Tempo Pen, Tempo Smart Button and the mobile application, the patient should be instructed to check their blood sugar levels when considering or making decisions about another injection if they are […]

9). The following related adverse reactions from clinical trials are listed below as MedDRA preferred term by system organ class and in order of decreasing incidence (very common: ≥ 1/10; common: ≥ 1/100 to < 1/10; uncommon: ≥ 1/1 000 to < 1/100; rare: ≥ 1/10 000 to < 1/1 000; very rare: < 1/10 000) and not known (cannot be estimated from the available data).

Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. Table 1. 8 Description of selected adverse reactions cReported in PRONTO-T1D, PRONTO-T2D and PRONTO-Peds Description of selected adverse reactions Hypoglycaemia Hypoglycaemia is the most commonly observed adverse reaction in patients using insulin.

9% in patients with type 2 diabetes (see tables 2 and 3). 7% of paediatric patients treated with Lyumjev. The symptoms of hypoglycaemia usually occur suddenly. They may include listlessness, confusion, palpitations, sweating, vomiting, and headache.

There were no clinically significant differences in the frequency of hypoglycaemia with administration of Lyumjev or the comparator (another medicinal product containing insulin lispro) across all studies. In studies where Lyumjev and the comparator were administered at different times relative to meals, there were no clinically relevant differences in the frequency of hypoglycaemia.

Hypoglycaemia may occur earlier after an injection/infusion of Lyumjev compared to other mealtime insulins due to the earlier onset of action. Allergic reactions Severe, life-threatening, generalized allergy, including anaphylaxis, generalized skin reactions, angioedema, bronchospasm, hypotension, and shock may occur with any insulin, including Lyumjev.

Injection/Infusion site reactions As with other insulin therapy, patients may experience rash, redness, inflammation, pain, bruising or itching at the site of Lyumjev injection or infusion. 7% of adult patients treated with Lyumjev.

These reactions were usually mild and normally disappeared during continued treatment. 1%). 2% of paediatric patients treated with Lyumjev. These events were mild or moderate. 5%). In study PRONTO-Pump-2, infusion site reactions were reported in 38% of patients treated with Lyumjev.

The majority of these events were mild. 3%). Immunogenicity Administration of insulin can cause formation of insulin antibodies. The presence of anti-drug antibodies did not have a clinically meaningful effect on the pharmacokinetics, efficacy, or safety of Lyumjev.

Skin and subcutaneous tissue disorders Lipodystrophy and cutaneous amyloidosis may occur at the injection site and delay local insulin absorption. 4). Oedema Cases of oedema have been reported with insulin therapy, particularly if previous poor metabolic control is improved by intensified insulin therapy.

Paediatric population Safety and efficacy have been investigated in a therapeutic confirmatory trial in children with type 1 diabetes aged 3 to < 18 years. In the trial, 418 patients were treated with Lyumjev. The frequency, type and severity of adverse reactions observed in the paediatric population is consistent with the safety profile in adult patients.

Other special populations Based on results from clinical trials with insulin lispro in general, the frequency, type and severity of adverse reactions observed in elderly patients and in patients with renal or hepatic impairment do not indicate any differences to the broader experience in the general population.

1). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered medicinal product should be clearly recorded. 8). The timing of hypoglycaemia usually reflects the time-action profile of the administered insulin formulations.

1). Hypoglycaemia can happen suddenly and symptoms may differ in each individual and change over time in the same individual. Severe hypoglycaemia can cause seizures, may lead to unconsciousness, may be life-threatening, or cause death.

Symptomatic awareness of hypoglycaemia may be less pronounced in patients with longstanding diabetes. Hyperglycaemia The use of inadequate doses or discontinuation of treatment, may lead to hyperglycaemia and diabetic ketoacidosis; conditions which are potentially lethal.

Patients should be educated to recognize the signs and symptoms of ketoacidosis and to get immediate help when ketoacidosis is suspected. Injection technique Patients must be instructed to perform continuous rotation of the injection site to reduce the risk of developing lipodystrophy and cutaneous amyloidosis.

There is a potential risk of delayed insulin absorption and worsened glycaemic control following insulin injections at sites with these reactions. A sudden change in the injection site to an unaffected area has been reported to result in hypoglycaemia.

Blood glucose monitoring is recommended after the change in the injection site, and dose adjustment of antidiabetic medications may be considered. Insulin requirements and dose adjustments Changes in insulin, insulin concentration, manufacturer, type, or method of administration may affect glycaemic control and predispose to hypoglycaemia or hyperglycaemia.

These changes should be made cautiously under close medical supervision and the frequency of glucose monitoring should be increased. 5). 2). Insulin requirements may be increased during illness or emotional disturbances. Adjustment of dose may also be necessary if patients undertake increased physical activity or change their usual diet.

Exercise taken immediately after a meal may increase the risk of hypoglycaemia. Hyperglycaemia and ketoacidosis due to insulin pump device malfunction Malfunction of the insulin pump or insulin infusion set can rapidly lead to hyperglycaemia and ketoacidosis.

Prompt identification and correction of the cause of hyperglycaemia or ketosis is necessary. Interim subcutaneous injections with Lyumjev may be required. Thiazolidinediones (TZDs) used in combination with insulin TZDs can cause dose-related fluid retention, particularly when used in combination with insulin.

Fluid retention may lead to or exacerbate heart failure. Patients treated with insulin and a TZD should be observed for signs and symptoms of heart failure. If heart failure develops, consider discontinuation of the TZD. 8). If hypersensitivity reactions occur, discontinue Lyumjev.

Medication errors Lyumjev should not be used by patients with visual impairment without help of a trained person. To avoid medication errors between Lyumjev and other insulins, patients need to always check the insulin label before each injection.

Patients should always use a new needle for each injection to prevent infections and a blocked needle. In the event of a blocked needle it should be replaced with a new needle. 5) that may interfere with the functions of an implantable electronic medical device, such as a pacemaker.

5 cm. Excipients This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially “sodium-free”.

Hypoglycaemia. 1