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Suliqua is a brand name for Insulin Glargine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Suliqua 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 sodium-glucose co-transporter-2 (SGLT-2) inhibitors. For study results with respect to effect on glycaemic…
Verbatim from this product's EMA label. Tap a section to expand.
, Suliqua (10-40) pen, Suliqua (30-60) pen respectively. The differentiation between the pen strengths is based on the dose range of the pen. 3 • 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). 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: Previous therapy Insulin naïve patients (oral anti-diabetic treatment or GLP-1 receptor agonist) Insulin glargine (100 units/ml)** ≥20 to <30 units Insulin glargine (100 units/ml)** ≥30 to ≤60 units Starting dose and pen Suliqua (10-40) pen 10 dose steps (10 units/5 mcg)* 20 dose steps (20 units/10 mcg)* Suliqua (30-60) pen 30 dose steps (30 units/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.
Summary of the safety profile The most frequently reported adverse reactions during treatment with Suliqua were hypoglycaemia and gastrointestinal adverse reactions (see section 'Description of selected adverse reactions' below). 10 Tabulated list of adverse reactions The following related adverse reactions from clinical investigations are listed below by system organ class and in order of decreasing frequency (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; not known: cannot be estimated from the available data).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. 9 mmol/L) and severe hypoglycaemia for both Suliqua and the comparator***. 9 mmol/L. ** Severe symptomatic hypoglycaemia was an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.
*** Liraglutide, exenatide BID (twice in a day) or extended release, dulaglutide or albiglutide Gastrointestinal disorders Gastrointestinal adverse reactions (nausea, vomiting and diarrhoea) were frequently reported adverse reactions during the treatment period.
2%, respectively. Gastrointestinal adverse reactions were mostly mild and transient in nature. 3% of patients. Cases of generalised allergic reaction including anaphylactic reaction and angioedema have been reported during marketed use of insulin glargine and lixisenatide.
Immunogenicity Administration of Suliqua may cause formation of antibodies against insulin glargine and/or lixisenatide. 2%. In approximately 93% of the patients, anti-insulin glargine antibodies showed cross-reactivity to human insulin.
The incidence of formation of anti-lixisenatide antibodies was approximately 43%. Neither status for anti- insulin glargine antibodies nor for anti-lixisenatide antibodies had a clinically relevant impact on safety or efficacy. Skin and subcutaneous tissue disorders Lipodystrophy and cutaneous amyloidosis may occur at the injection site of insulins and delay local insulin absorption.
Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Type 1 diabetes mellitus Suliqua should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
Rotation of the injection site 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 medicinal product may be considered.
8). Hypoglycaemia may occur if the dose of Suliqua is higher than required. Factors increasing the susceptibility to hypoglycaemia require particularly close monitoring and may necessitate dose adjustment. 5). - lixisenatide and/or insulin in combination with a sulfonylurea may result in an increased risk of hypoglycaemia.
Therefore, Suliqua should not be given in combination with a sulfonylurea. 2). 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.
Patients should be informed of the characteristic symptoms of acute pancreatitis: persistent, severe abdominal pain. If pancreatitis is suspected, Suliqua should be discontinued; if acute pancreatitis is confirmed, lixisenatide should not be restarted.
Caution should be exercised in patients with a history of pancreatitis. 8). Suliqua has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis and therefore, the use of Suliqua is not recommended in these patients.
1.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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1). Close glucose monitoring is recommended during the transfer and in the following weeks. 4 • 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. 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.
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. 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. 6). 4). 5
4). 7%) patients using insulin containing therapy, including Suliqua have experienced erythema, local oedema, and pruritus at the site of injection. Heart rate Increase in heart rate has been reported with GLP-1 receptor agonist use and a transient increase was also observed in some studies with lixisenatide.
No increase in mean heart rate was seen in all phase 3 studies with Suliqua. 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.
Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
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. 2). Concomitant medicinal products The delay of gastric emptying with lixisenatide may reduce the rate of absorption of orally administered medicinal products.
Suliqua 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. Specific recommendations regarding intake of such medicinal products are given in section