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Ryzodeg is a brand name for Insulin Degludec. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Treatment of diabetes mellitus in adults, adolescents and children from the age of 2 years.
Verbatim from this product's EMA label. Tap a section to expand.
Posology This medicinal product is a soluble insulin product consisting of the basal insulin degludec and the rapid-acting prandial insulin aspart. The potency of insulin analogues, including Ryzodeg, is expressed in units. One (1) unit of this insulin corresponds to 1 international unit of human insulin, 1 unit of insulin glargine, 1 unit of insulin detemir or 1 unit of biphasic insulin aspart.
3 Ryzodeg is to be dosed in accordance with the individual patient’s needs. Dose-adjustments are recommended to be based on fasting plasma glucose measurements. Adjustment of dose may be necessary if patients undertake increased physical activity, change their usual diet or during concomitant illness.
1). g. to avoid hypoglycaemia. Split the dose based on individual patient’s needs and administer with main meals. Patients with type 1 diabetes mellitus Ryzodeg can be administered once daily at mealtime in combination with short-/rapid-acting insulin at the remaining meals.
Flexibility in dosing time Ryzodeg allows for flexibility in the timing of insulin administration as long as it is dosed with the main meal(s). If a dose of this medicinal product is missed, the patient can take the missed dose with the next main meal of that day and thereafter resume the usual dosing schedule.
Patients should not take an extra dose to make up for a missed dose. Initiation Patients with type 2 diabetes mellitus The recommended total daily starting dose is 10 units with meal(s) followed by individual dosage adjustments. Patients with type 1 diabetes mellitus The recommended starting dose of Ryzodeg is 60–70% of the total daily insulin requirements.
This medicinal product is to be used once daily at mealtime in combination with short-/rapid-acting insulin at the remaining meals followed by individual dosage adjustments. Transfer from other insulin medicinal products Close glucose monitoring is recommended during the transfer and in the following weeks.
Doses and timing of concurrent rapid-acting or short-acting insulin products or other concomitant antidiabetic treatment may need to be adjusted. Patients with type 2 diabetes mellitus Patients switching from once-daily basal or premix insulin therapy can be converted unit-to-unit to once- or twice-daily Ryzodeg at the same total insulin dose as the patient’s previous total daily insulin dose.
Summary of the safety profile The most frequently reported adverse reaction during treatment is hypoglycaemia (see section ‘Description of selected adverse reactions’ below). Tabulated list of adverse reactions Adverse reactions listed below are based on clinical trial data and classified according to MedDRA System Organ Class.
Frequency categories are defined according to the following convention:
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) and not known (cannot be estimated from the available data). System organ class Frequency Adverse reaction Immune system disorders Rare Hypersensitivity Urticaria Metabolism and nutrition disorders Very common Hypoglycaemia Skin and subcutaneous tissue disorders Not known Lipodystrophy Cutaneous amyloidosis† General disorders and administration site conditions Common Injection site reactions Uncommon Peripheral oedema † ADR from postmarketing sources.
Description of selected adverse reactions Immune system disorders With insulin preparations, allergic reactions may occur. Immediate-type allergic reactions to either insulin itself or the excipients may potentially be life-threatening.
8 With Ryzodeg, hypersensitivity (manifested with swelling of tongue and lips, diarrhoea, nausea, tiredness and itching) and urticaria were reported rarely. Hypoglycaemia Hypoglycaemia may occur if the insulin dose is too high in relation to the insulin requirement.
Severe hypoglycaemia may lead to unconsciousness and/or convulsions and may result in temporary or permanent impairment of brain function or even death. The symptoms of hypoglycaemia usually occur suddenly. They may include cold sweats, cool pale skin, fatigue, nervousness or tremor, anxiousness, unusual tiredness or weakness, confusion, difficulty in concentration, drowsiness, excessive hunger, vision changes, headache, nausea and palpitation.
Hypoglycaemia Omission of a meal or unplanned strenuous physical exercise may lead to hypoglycaemia. 9). In children, extra care should be taken to match insulin doses with food intake and physical activities in order to minimise the risk of hypoglycaemia.
1). For this age group, Ryzodeg should be considered on an individual basis. g. by intensified insulin therapy) may experience a change in their usual warning symptoms of hypoglycaemia and must be advised accordingly. Usual warning symptoms may disappear in patients with long-standing diabetes.
Concomitant illness, especially infections and fever, usually increases the patient's insulin requirement. Concomitant diseases in the kidney, liver or diseases affecting the adrenal, pituitary or thyroid gland may require changes in the insulin dose.
As with other basal insulin products or insulin products with a basal component, the prolonged effect of Ryzodeg may delay recovery from hypoglycaemia. Hyperglycaemia Administration of rapid-acting insulin is recommended in situations with severe hyperglycaemia.
Inadequate dosing and/or discontinuation of treatment in patients requiring insulin may lead to hyperglycaemia and potentially to diabetic ketoacidosis. Furthermore, concomitant illness, especially infections, may lead to hyperglycaemia and thereby cause an increased insulin requirement.
Usually, the first symptoms of hyperglycaemia develop gradually over a period of hours or days. They include thirst, increased frequency of urination, nausea, vomiting, drowsiness, flushed dry skin, dry mouth, and loss of appetite as well as acetone odour of breath.
In type 1 diabetes mellitus, untreated hyperglycaemic events eventually lead to diabetic ketoacidosis, which is potentially lethal. Skin and subcutaneous tissue disorders Patients must be instructed to perform continuous rotation of the injection site to reduce the risk of developing lipodystrophy and cutaneous amyloidosis.
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Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Patients switching from more than once-daily basal or premix insulin therapy can be converted unit-to-unit to once- or twice-daily Ryzodeg at the same total insulin dose as the patient’s previous total daily insulin dose. Patients switching from basal/bolus insulin therapy to Ryzodeg will need to convert their dose based on individual needs.
In general, patients are initiated on the same number of basal units. Patients with type 1 diabetes mellitus The recommended starting dose of Ryzodeg is 60–70% of the total daily insulin requirements in combination with short-/rapid-acting insulin at the remaining meals followed by individual dosage adjustments.
4 Special populations Elderly (≥ 65 years old) Ryzodeg can be used in the elderly. 2). Renal and hepatic impairment Ryzodeg can be used in renal and hepatic impaired patients. 2). Paediatric population There is no clinical experience with the use of this medicinal product in children below the age of 2 years.
1). 4). 1). Method of administration Subcutaneous use only. This medicinal product must not be administered intravenously as it may result in severe hypoglycaemia. This medicinal product must not be administered intramuscularly as it may change the absorption.
This medicinal product must not be used in insulin infusion pumps. 4). Ryzodeg is administered subcutaneously by injection in the abdominal wall, the upper arm or the 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). Ryzodeg 100 units/mL FlexTouch solution for injection in pre-filled pen Ryzodeg comes in a pre-filled pen designed to be used with NovoFine or NovoTwist injection needles.
The pre-filled pen delivers 1–80 units in steps of 1 unit. Ryzodeg 100 units/mL FlexPen solution for injection in pre-filled pen Ryzodeg comes in a pre-filled pen designed to be used with NovoFine or NovoTwist injection needles. The pre-filled pen delivers 1–60 units in steps of 1 unit.
Ryzodeg 100 units/mL Penfill solution for injection in cartridge Ryzodeg comes in a […]
Skin and subcutaneous tissue disorders Lipodystrophy (including lipohypertrophy, lipoatrophy) and cutaneous amyloidosis may occur at the injection site and delay local insulin absorption. 4). Injection site reactions Injection site reactions (including injection site haematoma, pain, haemorrhage, erythema, nodules, swelling, discolouration, pruritus, warmth and injection site mass) occurred in patients treated with Ryzodeg.
These reactions are usually mild and transitory and they normally disappear during continued treatment. 2). Safety and efficacy have been demonstrated in a trial in children aged 2 to less than 18 years. 1). Other special populations Based on results from clinical trials, the frequency, type and severity of adverse reactions observed in the elderly and in patients with renal or hepatic impairment do not indicate any differences to the broader experience in the general population.
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.
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 from an affected to an unaffected area, and dose adjustment of antidiabetic medications may be considered. Transfer from other insulin medicinal products Transferring a patient to another type, brand or manufacturer of insulin must be done under medical supervision and may result in the need for a change in dosage.
Combination of pioglitazone and insulin medicinal products Cases of cardiac failure have been reported when pioglitazone was used in combination with insulin, especially in patients with risk factors for development of cardiac failure.
This should be kept in mind if treatment with the combination of pioglitazone and Ryzodeg is considered. If the combination is used, patients should be observed for signs and symptoms of heart failure, weight gain and oedema. Pioglitazone should be discontinued if any deterioration in cardiac symptoms occurs.
6 Eye disorder Intensification of insulin therapy with abrupt improvement in glycaemic control may be associated with temporary worsening of diabetic retinopathy, while long-term improved glycaemic control decreases the risk of progression of diabetic retinopathy.
Avoidance of accidental mix-ups Patients must be instructed to always check the insulin label before each injection to avoid accidental mix-ups between Ryzodeg and other insulin products. Patients must visually verify the dialled units on the dose counter of the pen.
Therefore, the requirement for patients to self-inject is that they can read the dose counter on the pen. Patients who are blind or have poor vision must be instructed to always get help/assistance from another person who has good vision and is trained in using the insulin device.
To avoid dosing errors and potential overdose, patients and healthcare professionals should never use a syringe to draw the medicinal product from the cartridge in the pre-filled pen. 6). Insulin antibodies Insulin administration may cause insulin antibodies to form.
In rare cases, the presence of such insulin antibodies may necessitate adjustment of the insulin dose in order to correct a tendency to hyper- or hypoglycaemia. e. it is essentially ‘sodium-free’. 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.