Soliqua

Soliqua Dosage/Direction for Use

insulin glargine + lixisenatide

Manufacturer:

sanofi-aventis

Distributor:

DKSH
Full Prescribing Info
Dosage/Direction for Use
Soliqua is available in two pens, providing different dosing options, i.e. Soliqua Solostar (10-40) pen, Soliqua Solostar (30-60) pen respectively. The differentiation between the pen strengths is based on the dose range of the pen.
Soliqua Solostar 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 lixisenatide (Soliqua (10-40) pen).
Soliqua Solostar 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 lixisenatide (Soliqua (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 Precautions).
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 oral glucose lowering medicinal product other than metformin should be discontinued prior to initiation of Soliqua.
The starting dose of Soliqua is based on previous anti-diabetic treatment, and in order not to exceed the recommended lixisenatide starting dose of 10 mcg: (See Table 4.)

Click on icon to see table/diagram/image

The maximum daily dose is 60 units insulin glargine and 20 mcg lixisenatide corresponding to 60 dose steps.
Soliqua 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.
Dosage titration: Soliqua 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 Pharmacology: Pharmacodynamics under Actions). Close glucose monitoring is recommended during the transfer and in the following weeks.
If the patient starts with the Soliqua Solostar (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 Soliqua Solostar (30-60) pen.
If the patient starts with the Soliqua Solostar (30-60) pen, the dose may be titrated up to 60 dose steps with this pen.
For total daily doses >60 dose steps/day, Soliqua must not be used.
Patients adjusting the amount or timing of dosing should only do so under medical supervision with appropriate glucose monitoring (see Precautions).
Special population: Elderly (≥65 years old): Soliqua 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 Soliqua in patients ≥75 years of age is limited.
Renal impairment: Soliqua 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 Soliqua, frequent glucose monitoring and dose adjustment may be necessary.
Hepatic impairment: No dose adjustment of lixisenatide is needed in patients with hepatic impairment (see Pharmacology: Pharmacokinetics under Actions). 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 Soliqua in patients with hepatic impairment.
Paediatric population: There is no relevant use of Soliqua in the paediatric population.
Method of administration: Soliqua 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 to reduce the risk of lipodystrophy and cutaneous amyloidosis (see Precautions and Adverse Reactions).
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 Special precautions for disposal and other handling under Cautions for Usage).
Soliqua must not be drawn from the cartridge of the pre-filled pen into a syringe to avoid dosing errors and potential overdose (see Precautions).
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