Suliqua 100/50, 100/33

/ Sanofi

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.
For the starting dose of this formulation  is based on previous anti-diabetic treatment, and in order not to exceed the recommended lixisenatide starting dose of 10 mcg: See prescribing information for full details. The maximum daily dose is 60 units insulin glargine and 20 mcg lixisenatide corresponding to 60 dose steps. The drug  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: This formulation is to be dosed in accordance with the individual patient’s need for insulin. See prescribing information for full details.
Special population
Elderly (≥65 years old): This formulation 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 this formulation in patients ≥75 years of age is limited.
Renal impairment: The drug 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 this drug, frequent glucose monitoring and dose adjustment may be necessary.
Hepatic impairment: No dose adjustment of lixisenatide is needed in patients with hepatic impairment. 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 this drug in patients with hepatic impairment.

Indicated in combination with metformin for the treatment of adults with type 2 diabetes mellitus to improve glycemic control when this has not been provided by metformin alone or metformin combined with another oral glucose lowering medicinal product or with basal insulin.

Hypersensitivity to the active substances or to any of the excipients.

This formulation should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
Hypoglycaemia: Hypoglycaemia was the most frequently reported observed adverse reaction during treatment with this formulation. Hypoglycaemia may occur if the dose of this formulation is higher than required. Factors increasing the susceptibility to hypoglycaemia require particularly close monitoring and may necessitate dose adjustment. These factors include: Change in the injection area, Improved insulin sensitivity (e.g. by removal of stress factors), Unaccustomed, increased or prolonged physical activity, Intercurrent illness (e.g. vomiting, diarrhoea), Inadequate food intake, Missed meals, Alcohol consumption, Certain uncompensated endocrine disorders, (e.g. in hypothyroidism and in anterior pituitary or adrenocortical insufficiency), Concomitant treatment with certain other medicinal products.
Lixisenatide and/or insulin in combination with a sulfonylurea may result in an increased risk of hypoglycaemia. Therefore this formulation should not be given in combination with a sulfonylurea. The dose of this formulation must be individualised based on clinical response and is titrated based on the patient’s need for insulin.
Acute pancreatitis: Use of glucagon-like peptide-1 (GLP-1) receptor agonists has been associated with a risk of developing acute pancreatitis. There have been few reported events of acute pancreatitis with lixisenatide although a causal relationship has not been established. Patients should be informed of the characteristic symptoms of acute pancreatitis: persistent, severe abdominal pain. If pancreatitis is suspected, this formulation should be discontinued; if acute pancreatitis is confirmed, lixisenatide should not be restarted. Caution should be exercised in patients with a history of pancreatitis.
Severe gastrointestinal disease: Use of GLP-1 receptor agonists may be associated with gastrointestinal adverse reactions. This formulation has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis and therefore, the use of this formulation is not recommended in these patients.
Severe renal impairment: There is no therapeutic experience in patients with severe renal impairment (creatinine clearance less than 30 ml/min) or end-stage renal disease. Use is not recommended in patients with severe renal impairment or end-stage renal disease.
Concomitant medicinal products: The delay of gastric emptying with lixisenatide may reduce the rate of absorption of orally administered medicinal products. This formulation should be used with caution in patients receiving oral medicinal products that require rapid gastrointestinal absorption, require careful clinical monitoring or have a narrow therapeutic ratio.
Dehydration: Patients treated with this formulation should be advised of the potential risk of dehydration in relation to gastrointestinal adverse reactions and take precautions to avoid fluid depletion.
Antibody formation: Administration of this formulation may cause formation of antibodies against insulin glargine and/or lixisenatide. In rare cases, the presence of such antibodies may necessitate adjustment of the this formulation dose in order to correct a tendency for hyperglycaemia or hypoglycaemia.
Avoidance of medication errors: Patients must be instructed to always check the pen label before each injection to avoid accidental mix-ups between the two different strengths of this formulation and mix-ups with other injectable diabetes medicinal products. To avoid dosing errors and potential overdose, neither the patients nor healthcare professionals should ever use a syringe to draw the medicinal product from the cartridge in the pre-filled pen into a syringe.
Populations not studied: Switch from GLP-1 receptor agonist has not been studied. This formulation has not been studied in combination with DPP-4 inhibitors, sulfonylureas, glinides, pioglitazone and SGLT-2 inhibitors.
See prescribing information for full details.

Hypoglycemia, nausea, vomiting, diarrhea.
See prescribing information for full details.

No interaction studies with this drug have been performed.
See prescribing information for full details.

Pregnancy: This formulation is not recommended in women of childbearing potential not using contraception. There is no clinical data on exposed pregnancies from controlled clinical studies with use of this formulation, insulin glargine, or lixisenatide.
Lactation: It is unknown whether insulin glargine or lixisenatide is excreted in human milk. Suliqua should not be used during breast-feeding.           
See prescribing information for full details.

Hypoglycaemia and gastrointestinal adverse reactions may develop if a patient is dosed with more this formulation 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.

Not in-use pens.
Storage: 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.