THERAPEUTIC INDICATION

Soliqua is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus to improve glycaemic control as an adjunct to diet and exercise in addition to metformin with or without SGLT2 inhibitors, when this has not been provided by metformin alone or metformin combined with another oral glucose lowering medicinal product or with basal insulin or with a GLP-1RA.

POSOLOGY AND METHOD OF ADMINISTRATION

Posology

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

Soliqua 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 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).

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 from one injection to the next in order to reduce the risk of lipodystrophy and cutaneous amyloidosis.

CONTRA-INDICATIONS

Hypersensitivity to the active substances or to any of the excipients

SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE

Soliqua should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.

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

Hypoglycaemia

Hypoglycaemia was the most frequently reported observed adverse reaction during treatment with Soliqua. Hypoglycaemia may occur if the dose of Soliqua is higher than required. The dose of Soliqua must be individualised based on clinical response and is titrated based on the patient’s need for insulin.

Acute pancreatitis

Use of 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.

Severe gastrointestinal disease

Use of GLP-1 receptor agonists may be associated with gastrointestinal adverse reactions.

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. Soliqua 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 Soliqua 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 Soliqua may cause formation of antibodies against insulin glargine and/or lixisenatide. In rare cases, the presence of such antibodies may necessitate adjustment of the Soliqua dose in order to correct a tendency for hyperglycaemia or hypoglycaemia.

Hypokalemia

All insulin-containing products, including Soliqua, cause a sshift in potassium from the extracellular to intracellular space, possibly leading to hypokalemia.

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 Soliqua 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.

Fluid Retention and Heart Failure with Concomitant Use of PPAR-gamma Agonist Thiazolidinediones (TZDs), which are peroxisome proliferator-activated receptor (PPAR) gamma agonists, can cause dose-related fluid retention, particularly when used in combination with insulin containing products, including Soliqua. Fluid retention may lead to or exacerbate heart failure.

Populations not studied

Soliqua has not been studied in combination with dipeptidyl peptidase-4 (DPP-4) inhibitors, sulfonylureas, glinides, and pioglitazone.

Excipients

This medicinal product contains less than 1 mmol (23 mg) sodium per dose, i.e. it is essentially 'sodium-free'.

This medicinal product contains metacresol, which may cause allergic reactions.

INTERACTIONS

No interaction studies with Soliqua have been performed.

PREGNANCY AND LACTATIONS

Women of childbearing potential

Soliqua is not recommended in women of childbearing potential not using contraception.

Pregnancy

There is no clinical data on exposed pregnancies from controlled clinical studies with use of Soliqua, insulin glargine, or lixisenatide.

Breast-feeding

It is unknown whether insulin glargine or lixisenatide is excreted in human milk. Soliqua should not be used during breast-feeding.

Fertility

Animal studies with lixisenatide or insulin glargine do not indicate direct harmful effects with respect to fertility.

UNDESIRABLE EFFECTS

Very common : Hypoglycaemia

Common : Dizziness, Nausea, Diarrhoea, Vomiting, Injection site reactions

Uncommon : Nasopharyngitis, Upper respiratory tract infection, Urticaria, Headache, Dyspepsia, Abdominal pain, Fatigue,

Not Known : Cutaneous amyloidosis, Lipodystrophy

OVERDOSE

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

PHARMACODYNAMIC PROPERTIES

Pharmacotherapeutic group: Drugs used in diabetes, insulins and analogues for injection, long-acting. ATC Code: A10AE54.

Presentation:

Insulin glargine 100 U/ml & lixisenatide 33 mcg/ml,

• Box, 3 prefilled pen @ 3 mL, Reg. No. DKI1959203043A1

Insulin glargine 100 U/ml & lixisenatide 50 mcg/ml,

• Box, 3 prefilled pen @ 3 mL, Reg. No. DKI1959203043B1

BPOM approval: 03-Jan-2022

This information is intended for Health Care Professional only. See local product information for full details information

SOLIQUA