SOLIQUA Solution for injection in pre-filled pen (SoloStar) Ref.[50623] Active ingredients: Insulin glargine Lixisenatide

Suliqua is available in two pre-filled pens, providing different dosing options, i.e. Suliqua (10-40) pen, Suliqua (30-60) pen respectively. The differentiation between the pen strengths is based on the dose range of the pen.

• Suliqua 100 units/ml + 50 micrograms/ml pre-filled pen delivers dose steps from 10-40 units of insulin glargine in combination with 5-20 mcg of lixisenatide (Suliqua (10-40) pen).
• Suliqua 100 units/ml + 33 micrograms/ml pre-filled pen delivers dose steps from 30-60 units of insulin glargine in combination with 10-20 mcg of lixisenatide (Suliqua (30-60) pen).

To avoid medication errors, the prescriber must make sure that the correct strength and number of dose steps is stated in the prescription (see section 4.4).

Posology

The dose must be individualised based on clinical response and is titrated based on the patient’s need for insulin. The lixisenatide dose is increased or decreased along with insulin glargine dose and also depends on which pen is used.

Starting dose

Therapy with basal insulin or glucagon-like peptide-1 (GLP-1) receptor agonist or oral glucose lowering medicinal product other than metformin and SGLT-2 inhibitors should be discontinued prior to initiation of Suliqua.

The starting dose of Suliqua is based on previous anti-diabetic treatment, and in order not to exceed the recommended lixisenatide starting dose of 10 mcg:

^* Units insulin glargine (100 units/ml)/mcg lixisenatide

Patients on less than 20 units of insulin glargine may be considered similar to insulin naive patients.

^** If a different basal insulin was used:

• For twice daily basal insulin or insulin glargine (300 units/ml), the total daily dose previously used should be reduced by 20% to choose the Suliqua starting dose.
• For any other basal insulin the same rule as for insulin glargine (100 units/ml) should be applied The maximum daily dose is 60 units insulin glargine and 20 mcg lixisenatide corresponding to 60 dose steps.

Suliqua should be injected once a day within one hour prior to a meal. It is preferable that the prandial injection is performed before the same meal every day, when the most convenient meal has been chosen.

Dose titration

Suliqua is to be dosed in accordance with the individual patient’s need for insulin. It is recommended to optimise glycaemic control via dose adjustment based on fasting plasma glucose (see section 5.1). Close glucose monitoring is recommended during the transfer and in the following weeks.

• If the patient starts with the Suliqua (10-40) pen, the dose may be titrated up to 40 dose steps with this pen.
• For doses >40 dose steps/day titration must be continued with Suliqua (30-60) pen.
• If the patient starts with the Suliqua (30-60) pen, the dose may be titrated up to 60 dose steps with this pen.
• For total daily doses >60 dose steps/day, Suliqua must not be used.

Patients adjusting the amount or timing of dosing should only do so under medical supervision with appropriate glucose monitoring (see section 4.4).

Missed dose

If a dose of Suliqua is missed, it should be injected within the hour prior to the next meal.

Special population

Elderly

Suliqua can be used in elderly patients. The dose should be adjusted on an individual basis, based on glucose monitoring. In the elderly, progressive deterioration of renal function may lead to a steady decrease in insulin requirements. For lixisenatide no dose adjustment is required based on age. The therapeutic experience of Suliqua in patients ≥75 years of age is limited.

Renal impairment

Suliqua is not recommended in patients with severe renal impairment and end-stage renal disease as there is no sufficient therapeutic experience with use of lixisenatide.

No dose adjustment is required for lixisenatide in patients with mild or moderate renal impairment.

In patients with renal impairment, insulin requirements may be diminished due to reduced insulin metabolism.

In patients with mild to moderate renal impairment using Suliqua, frequent glucose monitoring and dose adjustment may be necessary.

Hepatic impairment

No dose adjustment of lixisenatide is needed in patients with hepatic impairment (see section 5.2). In patients with hepatic impairment, insulin requirements may be diminished due to reduced capacity for gluconeogenesis and reduced insulin metabolism. Frequent glucose monitoring and dose adjustment may be necessary for Suliqua in patients with hepatic impairment.

Paediatric population

There is no relevant use of Suliqua in the paediatric population.

Method of administration

Suliqua is to be injected subcutaneously in the abdomen, deltoid, or thigh.

The injection sites should be rotated within the same region (abdomen, deltoid, or thigh) from one injection to the next in order to reduce the risk of lipodystrophy and cutaneous amyloidosis (see section 4.4 and 4.8).

Patients should be instructed to always use a new needle. The re-use of insulin pen needles increases the risk of blocked needles, which may cause under- or overdosing. In the event of blocked needles, patients must follow the instructions described in the Instructions for Use accompanying the package leaflet (see section 6.6).

Suliqua must not be drawn from the cartridge of the pre-filled pen into a syringe to avoid dosing errors and potential overdose (see section 4.4).

Hypoglycaemia and gastrointestinal adverse reactions may develop if a patient is dosed with more Suliqua than required.

Mild episodes of hypoglycaemia can usually be treated with oral carbohydrates. Adjustments in dose of the medicinal product, meal patterns, or physical activity may be needed.

More severe episodes of hypoglycaemia with coma, seizure, or neurologic impairment may be treated with intramuscular/subcutaneous glucagon or concentrated intravenous glucose. Sustained carbohydrate intake and observation may be necessary because hypoglycaemia may recur after apparent clinical recovery.

In case of gastrointestinal adverse reactions, appropriate supportive treatment should be initiated according to the patient’s clinical signs and symptoms.

Before first use: 3 years.

After first use: 28 days.

After first use: Store below 25°C. Do not refrigerate. Do not freeze.

Do not store with attached needle.

Store pen away from direct heat or direct light. The pen cap must be put back on the pen after each injection in order to protect from light.

Store in a refrigerator (2°C-8°C).

Do not freeze or place next to the freezer compartment or a freezer pack.

Keep the pre-filled pen in the outer carton in order to protect from light.

For storage conditions after first opening of the medicinal product, see section 6.3.

Type I colourless glass cartridge with a black plunger (bromobutyl rubber) and a flanged cap (aluminium) with inserted laminated sealing disks (bromobutyl rubber on the medicinal product side and polyisoprene on the outside) containing 3 ml of solution. Each cartridge is assembled into a disposable pen.

Packs of 3, 5 and 10 pre-filled pens.

Not all pack sizes may be marketed.

Before first use, the pen must be taken out of the refrigerator and stored below 25°C for 1 to 2 hours.

The cartridge should be inspected before use. It must only be used if the solution is clear, colourless, with no solid particles visible, and if it is of water-like consistency.

Suliqua must not be mixed with any other insulin or diluted. Mixing or diluting can change its time/action profile and mixing can cause precipitation.

A new needle must always be attached before each use. Needles must not be re-used. The patient should discard the needle after each injection. Needles are not included in the pack.

In the event of blocked needles patients must follow the instructions described in the “Instructions for Use” accompanying the package leaflet.

Empty pens must never be reused and must be properly discarded. To prevent the possible transmission of disease, each pen must be used by one patient only.

The label must always be checked before each injection to avoid medication errors between Suliqua and other injectable anti-diabetic medicinal products, including the 2 different pens of Suliqua (see section 4.4).

Before using Suliqua, the instructions for use included in the package leaflet must be read carefully.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.