RYZODEG FLEXTOUCH Insulin Degludec / Insulin Aspart 100units / mL (70% Insulin Degludec / 30% Insulin Aspart) Solution for SC Injection 3mL 1's
RXDRUG-BR-1178-1-1pc
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Features
Brand
Ryzodeg Flextouch
Full Details
Dosage Strength
100 Units / ml (70% Insulin Degludec / 30% Insulin Aspart)
Drug Ingredients
- Insulin Aspart
- Insulin Degludec
Drug Packaging
Solution for Injection (S.C.) 3ml x 1's
Generic Name
Insulin Degludec / Insulin Aspart
Dosage Form
Solution For Injection (S.C.)
Registration Number
BR-1178
Drug Classification
Prescription Drug (RX)
Description
Indications/Uses
Treatment of diabetes mellitus in adults.
Dosage/Direction for Use
Ryzodeg is a soluble insulin product consisting of the basal insulin degludec and the rapid-acting prandial insulin aspart. Ryzodeg can be administered once or twice daily with the main meal(s). When needed, the patient can change the time of administration as long as Ryzodeg is dosed with the largest meal when taken once daily.
The potency of insulin analogues, including Ryzodeg, is expressed in units (U). One (1) unit (U) of Ryzodeg corresponds to 1 international unit (IU) of human insulin, 1 unit of insulin glargine, 1 unit of insulin detemir or 1 unit of biphasic insulin aspart.
In patients with type 2 diabetes mellitus, Ryzodeg can be administered alone, in combination with oral anti-diabetic medicinal products, and in combination with bolus insulin (see Pharmacological properties: Pharmacodynamic properties under Actions).
In type 1 diabetes mellitus, Ryzodeg is combined with short-/rapid-acting insulin at the remaining meals.
Ryzodeg is to be dosed in accordance with the individual patient's needs. Dose-adjustments are recommended to be primarily based on fasting plasma glucose measurements. As with all insulin products adjustment of dose may be necessary if patients undertake increased physical activity, change their usual diet or during concomitant illness.
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 Ryzodeg 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. Ryzodeg is to be used once daily at meal-time 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-daily Ryzodeg at the same total insulin dose as the patient's previous total daily insulin dose.
Patients switching from more than once-daily basal or premix insulin therapy can be converted unit-to-unit to 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.
Special populations: Elderly (≥ 65 years old): Ryzodeg can be used in elderly patients. Glucose monitoring is to be intensified and the insulin dose adjusted on an individual basis (see Pharmacological properties: Pharmacokinetic properties under Actions).
Renal and hepatic impairment: Ryzodeg can be used in renal and hepatic impaired patients. Glucose monitoring is to be intensified and the insulin dose adjusted on an individual basis (see Pharmacological properties: Pharmacokinetic properties under Actions).
Pediatric population: The safety and efficacy of Ryzodeg in children and adolescents below 18 years of age have not been established. Currently available data are described in Pharmacokinetic properties under Actions, but no recommendation on a posology can be made.
Method of administration: Ryzodeg is for subcutaneous use only.
Ryzodeg must not be administered intravenously as it may result in severe hypoglycemia.
Ryzodeg must not be administered intramuscularly as it may change the absorption.
Ryzodeg must not be used in insulin infusion pumps.
Ryzodeg is administered subcutaneously by injection in the abdominal wall, the upper arm or the thigh. Injection sites are always to be rotated within the same region in order to reduce the risk of lipodystrophy.
Ryzodeg comes in a pre-filled pen (FlexTouch) designed to be used with NovoFine or NovoTwist injection needles. The pre-filled pen delivers 1-80 units in steps of 1 unit.
The potency of insulin analogues, including Ryzodeg, is expressed in units (U). One (1) unit (U) of Ryzodeg corresponds to 1 international unit (IU) of human insulin, 1 unit of insulin glargine, 1 unit of insulin detemir or 1 unit of biphasic insulin aspart.
In patients with type 2 diabetes mellitus, Ryzodeg can be administered alone, in combination with oral anti-diabetic medicinal products, and in combination with bolus insulin (see Pharmacological properties: Pharmacodynamic properties under Actions).
In type 1 diabetes mellitus, Ryzodeg is combined with short-/rapid-acting insulin at the remaining meals.
Ryzodeg is to be dosed in accordance with the individual patient's needs. Dose-adjustments are recommended to be primarily based on fasting plasma glucose measurements. As with all insulin products adjustment of dose may be necessary if patients undertake increased physical activity, change their usual diet or during concomitant illness.
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 Ryzodeg 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. Ryzodeg is to be used once daily at meal-time 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-daily Ryzodeg at the same total insulin dose as the patient's previous total daily insulin dose.
Patients switching from more than once-daily basal or premix insulin therapy can be converted unit-to-unit to 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.
Special populations: Elderly (≥ 65 years old): Ryzodeg can be used in elderly patients. Glucose monitoring is to be intensified and the insulin dose adjusted on an individual basis (see Pharmacological properties: Pharmacokinetic properties under Actions).
Renal and hepatic impairment: Ryzodeg can be used in renal and hepatic impaired patients. Glucose monitoring is to be intensified and the insulin dose adjusted on an individual basis (see Pharmacological properties: Pharmacokinetic properties under Actions).
Pediatric population: The safety and efficacy of Ryzodeg in children and adolescents below 18 years of age have not been established. Currently available data are described in Pharmacokinetic properties under Actions, but no recommendation on a posology can be made.
Method of administration: Ryzodeg is for subcutaneous use only.
Ryzodeg must not be administered intravenously as it may result in severe hypoglycemia.
Ryzodeg must not be administered intramuscularly as it may change the absorption.
Ryzodeg must not be used in insulin infusion pumps.
Ryzodeg is administered subcutaneously by injection in the abdominal wall, the upper arm or the thigh. Injection sites are always to be rotated within the same region in order to reduce the risk of lipodystrophy.
Ryzodeg comes in a pre-filled pen (FlexTouch) designed to be used with NovoFine or NovoTwist injection needles. The pre-filled pen delivers 1-80 units in steps of 1 unit.
Overdosage
A specific overdose for insulin cannot be defined. However, hypoglycemia may develop over sequential stages if a patient is dosed with more insulin than required.
Mild hypoglycemic episodes can be treated by oral administration of glucose or other products containing sugar. It is therefore recommended that the patient always carries glucose-containing products.
Severe hypoglycemic episodes, where the patient is not able to treat himself, can be treated with glucagon (0.5 to 1 mg) given intramuscularly or subcutaneously by a trained person, or with glucose given intravenously by a healthcare professional. Glucose must be given intravenously if the patient does not respond to glucagon within 10 to 15 minutes. Upon regaining consciousness, administration of oral carbohydrates is recommended for the patient in order to prevent a relapse.
Mild hypoglycemic episodes can be treated by oral administration of glucose or other products containing sugar. It is therefore recommended that the patient always carries glucose-containing products.
Severe hypoglycemic episodes, where the patient is not able to treat himself, can be treated with glucagon (0.5 to 1 mg) given intramuscularly or subcutaneously by a trained person, or with glucose given intravenously by a healthcare professional. Glucose must be given intravenously if the patient does not respond to glucagon within 10 to 15 minutes. Upon regaining consciousness, administration of oral carbohydrates is recommended for the patient in order to prevent a relapse.
Administration
Should be taken with food: OD: Taken w/ the largest meal. BID: Taken w/ main meals.
Contraindications
Hypersensitivity to the active substances or to any of the excipients listed in Description.
Special Precautions
Hypoglycemia: Omission of a meal or unplanned strenuous physical exercise may lead to hypoglycemia.
Hypoglycemia may occur if the insulin dose is too high in relation to the insulin requirement.
Patients whose blood glucose control is greatly improved (e.g. by intensified insulin therapy) may experience a change in their usual warning symptoms of hypoglycemia 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 hypoglycemia.
Hyperglycemia: Administration of rapid-acting insulin is recommended in situations with severe hyperglycemia.
Inadequate dosing and/or discontinuation of treatment in patients requiring insulin may lead to hyperglycemia and potentially to diabetic ketoacidosis. Furthermore, concomitant illness, especially infections, may lead to hyperglycemia and thereby cause an increased insulin requirement.
Usually, the first symptoms of hyperglycemia 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 odor of breath. In type 1 diabetes mellitus, untreated hyperglycemic events eventually lead to diabetic ketoacidosis, which is potentially lethal.
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 thiazolidinediones and insulin medicinal products: Cases of cardiac failure have been reported when thiazolidinediones were 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 thiazolidinediones and Ryzodeg is considered. If the combination is used, patients should be observed for signs and symptoms of heart failure, weight gain and edema. Thiazolidinediones should be discontinued if any deterioration in cardiac symptoms occurs.
Eye disorder: Intensification of insulin therapy with abrupt improvement in glycemic control may be associated with temporary worsening of diabetic retinopathy, while long-term improved glycemic 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 dialed 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.
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 hypoglycemia.
Effects on ability to drive and use machines: The patient's ability to concentrate and react may be impaired as a result of hypoglycemia. This may constitute a risk in situations where these abilities are of special importance (e.g. driving a car or using machines).
Patients must be advised to take precautions to avoid hypoglycemia while driving. This is particularly important in those who have reduced or absent awareness of the warning signs of hypoglycemia or have frequent episodes of hypoglycemia. The advisability of driving should be considered in these circumstances.
Hypoglycemia may occur if the insulin dose is too high in relation to the insulin requirement.
Patients whose blood glucose control is greatly improved (e.g. by intensified insulin therapy) may experience a change in their usual warning symptoms of hypoglycemia 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 hypoglycemia.
Hyperglycemia: Administration of rapid-acting insulin is recommended in situations with severe hyperglycemia.
Inadequate dosing and/or discontinuation of treatment in patients requiring insulin may lead to hyperglycemia and potentially to diabetic ketoacidosis. Furthermore, concomitant illness, especially infections, may lead to hyperglycemia and thereby cause an increased insulin requirement.
Usually, the first symptoms of hyperglycemia 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 odor of breath. In type 1 diabetes mellitus, untreated hyperglycemic events eventually lead to diabetic ketoacidosis, which is potentially lethal.
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 thiazolidinediones and insulin medicinal products: Cases of cardiac failure have been reported when thiazolidinediones were 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 thiazolidinediones and Ryzodeg is considered. If the combination is used, patients should be observed for signs and symptoms of heart failure, weight gain and edema. Thiazolidinediones should be discontinued if any deterioration in cardiac symptoms occurs.
Eye disorder: Intensification of insulin therapy with abrupt improvement in glycemic control may be associated with temporary worsening of diabetic retinopathy, while long-term improved glycemic 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 dialed 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.
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 hypoglycemia.
Effects on ability to drive and use machines: The patient's ability to concentrate and react may be impaired as a result of hypoglycemia. This may constitute a risk in situations where these abilities are of special importance (e.g. driving a car or using machines).
Patients must be advised to take precautions to avoid hypoglycemia while driving. This is particularly important in those who have reduced or absent awareness of the warning signs of hypoglycemia or have frequent episodes of hypoglycemia. The advisability of driving should be considered in these circumstances.
Use In Pregnancy & Lactation
Pregnancy: There is no clinical experience with use of Ryzodeg in pregnant women.
Animal reproduction studies have not revealed any difference between insulin degludec and human insulin regarding embryotoxicity and teratogenicity.
In general, intensified blood glucose control and monitoring of pregnant women with diabetes are recommended throughout pregnancy and when contemplating pregnancy.
Insulin requirements usually decrease in the first trimester and increase subsequently during the second and third trimesters. After delivery, insulin requirements usually return rapidly to pre-pregnancy values.
Breast-feeding: There is no clinical experience with Ryzodeg during breast-feeding. In rats, insulin degludec was secreted in milk; the concentration in milk was lower than in plasma.
It is unknown whether insulin degludec/insulin aspart is excreted in human milk. No metabolic effects are anticipated in the breast-fed newborn/infant.
Fertility: Animal reproduction studies with insulin degludec have not revealed any adverse effects on fertility.
Animal reproduction studies have not revealed any difference between insulin degludec and human insulin regarding embryotoxicity and teratogenicity.
In general, intensified blood glucose control and monitoring of pregnant women with diabetes are recommended throughout pregnancy and when contemplating pregnancy.
Insulin requirements usually decrease in the first trimester and increase subsequently during the second and third trimesters. After delivery, insulin requirements usually return rapidly to pre-pregnancy values.
Breast-feeding: There is no clinical experience with Ryzodeg during breast-feeding. In rats, insulin degludec was secreted in milk; the concentration in milk was lower than in plasma.
It is unknown whether insulin degludec/insulin aspart is excreted in human milk. No metabolic effects are anticipated in the breast-fed newborn/infant.
Fertility: Animal reproduction studies with insulin degludec have not revealed any adverse effects on fertility.
Adverse Reactions
Summary of the safety profile: The most frequently reported adverse reaction during treatment is hypoglycemia (see Description of selected adverse reactions as follows).
Tabulated list of adverse reactions: Adverse reactions listed as follows 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).
Tabulated list of adverse reactions: Adverse reactions listed as follows 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).
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.
With Ryzodeg, hypersensitivity (manifested with swelling of tongue and lips, diarrhea, nausea, tiredness and itching) and urticaria were reported rarely.
Hypoglycemia: Hypoglycemia may occur if the insulin dose is too high in relation to the insulin requirement. Severe hypoglycemia may lead to unconsciousness and/or convulsions and may result in temporary or permanent impairment of brain function or even death. The symptoms of hypoglycemia 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.
Lipodystrophy: Lipodystrophy (including lipohypertrophy, lipoatrophy) may occur at the injection site. Continuous rotation of the injection site within the particular injection area may help to reduce the risk of developing these reactions.
Injection site reactions: Injection site reactions (including injection site hematoma, pain, hemorrhage, erythema, nodules, swelling, discoloration, 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.
Pediatric population: Ryzodeg has been administered to children and adolescents up to 18 years of age for the investigation of pharmacokinetic properties (see Pharmacological properties: Pharmacokinetic properties under Actions). Safety and efficacy have not been investigated in children and adolescents.
Other special populations: Based on results from clinical trials, the frequency, type and severity of adverse reactions observed in elderly patients and in patients with renal or hepatic impairment do not indicate any differences to the broader experience in the general population.
Immediate-type allergic reactions to either insulin itself or the excipients may potentially be life-threatening.
With Ryzodeg, hypersensitivity (manifested with swelling of tongue and lips, diarrhea, nausea, tiredness and itching) and urticaria were reported rarely.
Hypoglycemia: Hypoglycemia may occur if the insulin dose is too high in relation to the insulin requirement. Severe hypoglycemia may lead to unconsciousness and/or convulsions and may result in temporary or permanent impairment of brain function or even death. The symptoms of hypoglycemia 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.
Lipodystrophy: Lipodystrophy (including lipohypertrophy, lipoatrophy) may occur at the injection site. Continuous rotation of the injection site within the particular injection area may help to reduce the risk of developing these reactions.
Injection site reactions: Injection site reactions (including injection site hematoma, pain, hemorrhage, erythema, nodules, swelling, discoloration, 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.
Pediatric population: Ryzodeg has been administered to children and adolescents up to 18 years of age for the investigation of pharmacokinetic properties (see Pharmacological properties: Pharmacokinetic properties under Actions). Safety and efficacy have not been investigated in children and adolescents.
Other special populations: Based on results from clinical trials, the frequency, type and severity of adverse reactions observed in elderly patients and in patients with renal or hepatic impairment do not indicate any differences to the broader experience in the general population.
Drug Interactions
A number of medicinal products are known to interact with glucose metabolism.
The following substances may reduce the insulin requirement: Oral antidiabetic medicinal products, GLP-1 receptor agonists, monoamine oxidase inhibitors (MAOI), beta-blockers, angiotensin converting enzyme (ACE) inhibitors, salicylates, anabolic steroids and sulfonamides.
The following substances may increase the insulin requirement: Oral contraceptives, thiazides, glucocorticoids, thyroid hormones, sympathomimetics, growth hormone and danazol.
Beta-blockers may mask the symptoms of hypoglycemia.
Octreotide/lanreotide may either increase or decrease the insulin requirement.
Alcohol may intensify or reduce the hypoglycemic effect of insulin.
The following substances may reduce the insulin requirement: Oral antidiabetic medicinal products, GLP-1 receptor agonists, monoamine oxidase inhibitors (MAOI), beta-blockers, angiotensin converting enzyme (ACE) inhibitors, salicylates, anabolic steroids and sulfonamides.
The following substances may increase the insulin requirement: Oral contraceptives, thiazides, glucocorticoids, thyroid hormones, sympathomimetics, growth hormone and danazol.
Beta-blockers may mask the symptoms of hypoglycemia.
Octreotide/lanreotide may either increase or decrease the insulin requirement.
Alcohol may intensify or reduce the hypoglycemic effect of insulin.
Caution For Usage
Incompatibilities: Substances added to Ryzodeg may cause degradation of insulin degludec and/or insulin aspart.
Ryzodeg must not be added to infusion fluids.
This medicinal product must not be mixed with any other product.
Special precautions for disposal and other handling: The pre-filled pen (FlexTouch) is designed to be used with NovoFine or NovoTwist injection needles up to a length of 8 mm. It delivers 1-80 units in steps of 1 unit.
The pre-filled pen (FlexTouch) is for use by one person only.
The pre-filled pen must not be refilled.
Ryzodeg must not be used if the solution does not appear clear and colorless.
Ryzodeg which has been frozen must not be used.
The patient should discard the needle after each injection.
Any waste material should be disposed of in accordance with local requirements.
Instructions for the patient on how to use Ryzodeg 100 units/mL solution for injection in pre-filled pen (FlexTouch): If the instructions are not followed carefully, there can be a little or too much insulin, which can lead to too high or too low blood sugar level.
Do not use the pen without proper training from the doctor or nurse.
Start by checking the pen to make sure that it contains Ryzodeg 100 units/mL.
If the patient is blind or have poor eyesight and cannot read the dose counter on the pen, do not use this pen without help. Get help from a person with good eyesight who is trained to use the FlexTouch pre-filled pen.
The pen is a pre-filled dial-a-dose insulin pen containing 300 units of insulin. A maximum of 80 units per dose can be selected, in steps of 1 unit. The pen is designed to be used with NovoTwist or NovoFine single-use disposable needles up to a length of 8 mm. Needles are not included in the pack.
1. Prepare the pen. Check the name and strength on the label of the pen, to make sure that it contains Ryzodeg 100 units/mL. This is especially important if the patient takes more than one type of insulin. If the patient takes a wrong type of insulin, his/her blood sugar level may get too high or too low.
Pull off the pen cap.
Check that the insulin in the pen is clear and colorless. Look through the insulin window. If the insulin looks cloudy, do not use the pen.
Take a new needle and tear off the paper tab.
Push the needle straight onto the pen. Turn until it is on tight.
Pull off the outer needle cap and keep it for later. This will be needed after the injection, to correctly remove the needle from the pen.
Pull off the inner needle cap and throw it away. If trying to put it back on, the patient may accidentally stick him/herself with the needle.
A drop of insulin may appear at the needle tip. This is normal, but the patient must still check the insulin flow.
Always use a new needle for each injection. This reduces the risk of contamination, infection, leakage of insulin, blocked needles and inaccurate dosing.
Never use a bent or damaged needle.
2. Check the insulin flow. Always check the insulin flow before starting. This helps to ensure that the patient will get full insulin dose. Turn the dose selector to select 2 units. Make sure the dose counter shows 2.
Hold the pen with the needle pointing up. Tap the top of the pen gently a few times to let any air bubbles rise to the top.
Press and hold in the dose button until the dose counter returns to 0. The 0 must line up with the dose pointer.
A drop of insulin should appear at the needle tip.
A small air bubble may remain at the needle tip, but it will not be injected. If no drop appears, repeat steps 2A to 2C up to 6 times. If there is still no drop, change the needle and repeat steps 2A to 2C once more.
If a drop of insulin still does not appear, dispose of the pen and use a new one.
Always make sure that a drop appears at the needle tip before injecting. This makes sure that the insulin flows.
If no drop appears, the patient will not inject any insulin, even though the dose counter may move.
This may indicate a blocked or damaged needle.
Always check the flow before injecting. If patient does not check the flow, the patient may get too little insulin or no insulin at all. This may lead to too high blood sugar level.
3. Selecting the dose. Make sure the dose counter shows 0 before starting. The 0 must line up with the dose pointer.
Turn the dose selector to select the dose needed, as directed by the doctor or nurse.
If a wrong dose is selected, turn the dose selector forwards or backwards to the correct dose.
The pen can dial up to a maximum of 80 units.
The dose selector changes the number of units. Only the dose counter and dose pointer will show how many units is selected per dose.
The patient can select up to 80 units per dose. When the pen contains less than 80 units, the dose counter stops at the number of units left.
The dose selector clicks differently when turned forwards, backwards or past the number of units left. Do not count the pen clicks.
Always use the dose counter and the dose pointer to see how many units the patient has selected before injecting the insulin.
Do not count the pen clicks. If the wrong dose is selected and injected, the blood sugar level may get too high or too low. Do not use the insulin scale, it only shows approximately how much insulin is left in the pen.
4. Injecting the dose. Insert the needle into the skin as the doctor or nurse has shown the patient.
Make sure the patient can see the dose counter. Do not touch the dose counter with the fingers. This could interrupt the injection.
Press and hold down the dose button until the dose counter returns to 0. The 0 must line up with the dose pointer. The patient may then hear or feel a click.
Leave the needle under the skin for at least 6 seconds to make sure the patient gets full dose.
Pull the needle and pen straight up from the skin.
If blood appears at the injection site, press lightly with a cotton swab. Do not rub the area.
The patient may see a drop of insulin at the needle tip after injecting. This is normal and does not affect the dose.
Always watch the dose counter to know how many units injected.
The dose counter will show the exact number of units. Do not count the pen clicks.
Hold the dose button down until the dose counter returns to 0 after the injection. If the dose counter stops before it returns to 0, the full dose has not been delivered, which may result in too high blood sugar level.
5. After the injection. Lead the needle tip into the outer needle cap on a flat surface without touching the needle or the outer cap.
Once the needle is covered, carefully push the outer needle cap completely on.
Unscrew the needle and dispose of it carefully.
Put the pen cap on the pen after each use to protect the insulin from light.
Always dispose of the needle after each injection. This reduces the risk of contamination, infection, leakage of insulin, blocked needles and inaccurate dosing. If the needle is blocked, any insulin cannot be injected.
When the pen is empty, throw it away without a needle on as instructed by the doctor, nurse, pharmacist or local authorities.
Never try to put the inner needle cap back on the needle. The patient may stick the needle.
Always remove the needle after each injection and store the pen without the needle attached.
This reduces the risk of contamination, infection, leakage of insulin, blocked needles and inaccurate dosing.
6. How much insulin is left. The insulin scale shows approximately how much insulin is left in the pen.
To see precisely how much insulin is left, use the dose counter: Turn the dose selector until the dose counter stops. If it shows 80, at least 80 units are left in the pen.
If it shows less than 80, the number shown is the number of units left in the pen.
Turn the dose selector back until the dose counter shows 0.
If more insulin is needed than the units left in the pen, split the dose between two pens.
Be very careful to calculate correctly if splitting the dose.
If in doubt, take the full dose with a new pen. If the patient splits the dose wrong, the patient will inject too little or too much insulin, which can lead to too high or too low blood sugar level.
Further important information: Always keep the pen with the patient.
Always carry an extra pen and new needles with the patient, in case of loss or damage.
Always keep the pen and needles out of sight and reach of others, especially children.
Never share the pen or the needles with other people. It might lead to cross-infection.
Never share the pen with other people. The medicine might be harmful to their health.
Caregivers must be very careful when handling used needles - to reduce the risk of needle injury and cross-infection.
Caring for the pen: Treat the pen with care. Rough handling or misuse may cause inaccurate dosing, which can lead to too high or too low blood sugar level.
Do not leave the pen in a car or other place where it can get too hot or too cold.
Do not expose the pen to dust, dirt or liquid.
Do not wash, soak or lubricate the pen. If necessary, clean it with mild detergent on a moistened cloth.
Do not drop the pen or knock it against hard surfaces.
If the pen is dropped or suspected a problem, attach a new needle and check the insulin flow before injecting.
Do not try to refill the pen. Once empty, it must be disposed of.
Do not try to repair the pen or pull it apart.
Ryzodeg must not be added to infusion fluids.
This medicinal product must not be mixed with any other product.
Special precautions for disposal and other handling: The pre-filled pen (FlexTouch) is designed to be used with NovoFine or NovoTwist injection needles up to a length of 8 mm. It delivers 1-80 units in steps of 1 unit.
The pre-filled pen (FlexTouch) is for use by one person only.
The pre-filled pen must not be refilled.
Ryzodeg must not be used if the solution does not appear clear and colorless.
Ryzodeg which has been frozen must not be used.
The patient should discard the needle after each injection.
Any waste material should be disposed of in accordance with local requirements.
Instructions for the patient on how to use Ryzodeg 100 units/mL solution for injection in pre-filled pen (FlexTouch): If the instructions are not followed carefully, there can be a little or too much insulin, which can lead to too high or too low blood sugar level.
Do not use the pen without proper training from the doctor or nurse.
Start by checking the pen to make sure that it contains Ryzodeg 100 units/mL.
If the patient is blind or have poor eyesight and cannot read the dose counter on the pen, do not use this pen without help. Get help from a person with good eyesight who is trained to use the FlexTouch pre-filled pen.
The pen is a pre-filled dial-a-dose insulin pen containing 300 units of insulin. A maximum of 80 units per dose can be selected, in steps of 1 unit. The pen is designed to be used with NovoTwist or NovoFine single-use disposable needles up to a length of 8 mm. Needles are not included in the pack.
1. Prepare the pen. Check the name and strength on the label of the pen, to make sure that it contains Ryzodeg 100 units/mL. This is especially important if the patient takes more than one type of insulin. If the patient takes a wrong type of insulin, his/her blood sugar level may get too high or too low.
Pull off the pen cap.
Check that the insulin in the pen is clear and colorless. Look through the insulin window. If the insulin looks cloudy, do not use the pen.
Take a new needle and tear off the paper tab.
Push the needle straight onto the pen. Turn until it is on tight.
Pull off the outer needle cap and keep it for later. This will be needed after the injection, to correctly remove the needle from the pen.
Pull off the inner needle cap and throw it away. If trying to put it back on, the patient may accidentally stick him/herself with the needle.
A drop of insulin may appear at the needle tip. This is normal, but the patient must still check the insulin flow.
Always use a new needle for each injection. This reduces the risk of contamination, infection, leakage of insulin, blocked needles and inaccurate dosing.
Never use a bent or damaged needle.
2. Check the insulin flow. Always check the insulin flow before starting. This helps to ensure that the patient will get full insulin dose. Turn the dose selector to select 2 units. Make sure the dose counter shows 2.
Hold the pen with the needle pointing up. Tap the top of the pen gently a few times to let any air bubbles rise to the top.
Press and hold in the dose button until the dose counter returns to 0. The 0 must line up with the dose pointer.
A drop of insulin should appear at the needle tip.
A small air bubble may remain at the needle tip, but it will not be injected. If no drop appears, repeat steps 2A to 2C up to 6 times. If there is still no drop, change the needle and repeat steps 2A to 2C once more.
If a drop of insulin still does not appear, dispose of the pen and use a new one.
Always make sure that a drop appears at the needle tip before injecting. This makes sure that the insulin flows.
If no drop appears, the patient will not inject any insulin, even though the dose counter may move.
This may indicate a blocked or damaged needle.
Always check the flow before injecting. If patient does not check the flow, the patient may get too little insulin or no insulin at all. This may lead to too high blood sugar level.
3. Selecting the dose. Make sure the dose counter shows 0 before starting. The 0 must line up with the dose pointer.
Turn the dose selector to select the dose needed, as directed by the doctor or nurse.
If a wrong dose is selected, turn the dose selector forwards or backwards to the correct dose.
The pen can dial up to a maximum of 80 units.
The dose selector changes the number of units. Only the dose counter and dose pointer will show how many units is selected per dose.
The patient can select up to 80 units per dose. When the pen contains less than 80 units, the dose counter stops at the number of units left.
The dose selector clicks differently when turned forwards, backwards or past the number of units left. Do not count the pen clicks.
Always use the dose counter and the dose pointer to see how many units the patient has selected before injecting the insulin.
Do not count the pen clicks. If the wrong dose is selected and injected, the blood sugar level may get too high or too low. Do not use the insulin scale, it only shows approximately how much insulin is left in the pen.
4. Injecting the dose. Insert the needle into the skin as the doctor or nurse has shown the patient.
Make sure the patient can see the dose counter. Do not touch the dose counter with the fingers. This could interrupt the injection.
Press and hold down the dose button until the dose counter returns to 0. The 0 must line up with the dose pointer. The patient may then hear or feel a click.
Leave the needle under the skin for at least 6 seconds to make sure the patient gets full dose.
Pull the needle and pen straight up from the skin.
If blood appears at the injection site, press lightly with a cotton swab. Do not rub the area.
The patient may see a drop of insulin at the needle tip after injecting. This is normal and does not affect the dose.
Always watch the dose counter to know how many units injected.
The dose counter will show the exact number of units. Do not count the pen clicks.
Hold the dose button down until the dose counter returns to 0 after the injection. If the dose counter stops before it returns to 0, the full dose has not been delivered, which may result in too high blood sugar level.
5. After the injection. Lead the needle tip into the outer needle cap on a flat surface without touching the needle or the outer cap.
Once the needle is covered, carefully push the outer needle cap completely on.
Unscrew the needle and dispose of it carefully.
Put the pen cap on the pen after each use to protect the insulin from light.
Always dispose of the needle after each injection. This reduces the risk of contamination, infection, leakage of insulin, blocked needles and inaccurate dosing. If the needle is blocked, any insulin cannot be injected.
When the pen is empty, throw it away without a needle on as instructed by the doctor, nurse, pharmacist or local authorities.
Never try to put the inner needle cap back on the needle. The patient may stick the needle.
Always remove the needle after each injection and store the pen without the needle attached.
This reduces the risk of contamination, infection, leakage of insulin, blocked needles and inaccurate dosing.
6. How much insulin is left. The insulin scale shows approximately how much insulin is left in the pen.
To see precisely how much insulin is left, use the dose counter: Turn the dose selector until the dose counter stops. If it shows 80, at least 80 units are left in the pen.
If it shows less than 80, the number shown is the number of units left in the pen.
Turn the dose selector back until the dose counter shows 0.
If more insulin is needed than the units left in the pen, split the dose between two pens.
Be very careful to calculate correctly if splitting the dose.
If in doubt, take the full dose with a new pen. If the patient splits the dose wrong, the patient will inject too little or too much insulin, which can lead to too high or too low blood sugar level.
Further important information: Always keep the pen with the patient.
Always carry an extra pen and new needles with the patient, in case of loss or damage.
Always keep the pen and needles out of sight and reach of others, especially children.
Never share the pen or the needles with other people. It might lead to cross-infection.
Never share the pen with other people. The medicine might be harmful to their health.
Caregivers must be very careful when handling used needles - to reduce the risk of needle injury and cross-infection.
Caring for the pen: Treat the pen with care. Rough handling or misuse may cause inaccurate dosing, which can lead to too high or too low blood sugar level.
Do not leave the pen in a car or other place where it can get too hot or too cold.
Do not expose the pen to dust, dirt or liquid.
Do not wash, soak or lubricate the pen. If necessary, clean it with mild detergent on a moistened cloth.
Do not drop the pen or knock it against hard surfaces.
If the pen is dropped or suspected a problem, attach a new needle and check the insulin flow before injecting.
Do not try to refill the pen. Once empty, it must be disposed of.
Do not try to repair the pen or pull it apart.
Storage
Before first use: Store in a refrigerator (2°C-8°C). Keep away from the freezing element.
Do not freeze.
Keep the cap on the pen in order to protect from light.
After first opening or carried as a spare: The product may be stored for a maximum of 4 weeks. Do not store above 30°C. Can be stored in a refrigerator (2°C-8°C). Keep the cap on the pen in order to protect from light.
Shelf-life: 30 months.
Do not freeze.
Keep the cap on the pen in order to protect from light.
After first opening or carried as a spare: The product may be stored for a maximum of 4 weeks. Do not store above 30°C. Can be stored in a refrigerator (2°C-8°C). Keep the cap on the pen in order to protect from light.
Shelf-life: 30 months.
Action
Pharmacotherapeutic group: Drugs used in diabetes. Insulins and analogues for injection, intermediate- or long-acting combined with fast-acting. ATC code: A10AD06.
Pharmacological properties: Pharmacodynamic properties: Mechanism of action: Insulin degludec and insulin aspart binds specifically to the human insulin receptor and results in the same pharmacological effects as human insulin.
The blood glucose-lowering effect of insulin is due to the facilitated uptake of glucose following the binding of insulin to receptors on muscle and fat cells and to the simultaneous inhibition of glucose output from the liver.
Pharmacodynamic effects: The pharmacodynamic effect of Ryzodeg is distinctively separated for the two components (see figure), and the resulting action profile reflects the individual components, the rapid-acting insulin aspart and the basal component insulin degludec.
The basal component of Ryzodeg (insulin degludec) forms soluble multi-hexamers upon subcutaneous injection, resulting in a depot from which insulin degludec is continuously and slowly absorbed into the circulation leading to a flat and stable glucose-lowering effect. This effect is maintained in the co-formulation with insulin aspart and does not interfere with the rapid-acting insulin aspart monomers.
Ryzodeg has a rapid onset of action occurring soon after injection providing meal time coverage while the basal component has a flat and stable action profile providing continuous coverage of the basal insulin requirements. The duration of action of a single-dose of Ryzodeg is beyond 24 hours.
Pharmacological properties: Pharmacodynamic properties: Mechanism of action: Insulin degludec and insulin aspart binds specifically to the human insulin receptor and results in the same pharmacological effects as human insulin.
The blood glucose-lowering effect of insulin is due to the facilitated uptake of glucose following the binding of insulin to receptors on muscle and fat cells and to the simultaneous inhibition of glucose output from the liver.
Pharmacodynamic effects: The pharmacodynamic effect of Ryzodeg is distinctively separated for the two components (see figure), and the resulting action profile reflects the individual components, the rapid-acting insulin aspart and the basal component insulin degludec.
The basal component of Ryzodeg (insulin degludec) forms soluble multi-hexamers upon subcutaneous injection, resulting in a depot from which insulin degludec is continuously and slowly absorbed into the circulation leading to a flat and stable glucose-lowering effect. This effect is maintained in the co-formulation with insulin aspart and does not interfere with the rapid-acting insulin aspart monomers.
Ryzodeg has a rapid onset of action occurring soon after injection providing meal time coverage while the basal component has a flat and stable action profile providing continuous coverage of the basal insulin requirements. The duration of action of a single-dose of Ryzodeg is beyond 24 hours.
The total and maximum-glucose-lowering effects of Ryzodeg increase linearly with increasing doses. Steady state will occur after 2-3 days of dose administration.
There is no difference in the pharmacodynamic effect of Ryzodeg between elderly and younger patients.
Clinical efficacy and safety: Five multi-national, randomised, controlled, open-label, treat-to-target clinical studies of 26 weeks' and 52 weeks' duration were conducted exposing a total of 1,360 patients with diabetes mellitus (362 patients in type 1 diabetes mellitus and 998 patients in type 2 diabetes mellitus) to Ryzodeg. Ryzodeg administered once daily (o.d.) plus Oral Antidiabetic Drugs (OADs) was compared to insulin glargine (IGlar) (o.d.) plus OADs in two trials in type 2 diabetes mellitus (Table 1). Ryzodeg b.i.d. plus OADs was compared to biphasic insulin aspart 30 (BIAsp 30) b.i.d. plus OADs in two trials in type 2 diabetes mellitus (Table 2). Ryzodeg o.d. plus insulin aspart (IAsp) was also compared to once-daily (o.d.) or twice-daily insulin detemir (IDet) plus IAsp in type 1 diabetes mellitus (Table 3).
Non-inferiority in HbA1c change from baseline to end-of-trial was confirmed in all studies against all comparators when treating patients to target.
In two trials combining insulin and OAD treatment in both insulin-naïve (insulin initiation) and insulin-using (insulin intensification) patients with type 2 diabetes mellitus, Ryzodeg o.d. demonstrated similar glycemic control (HbA1c) compared to IGlar (administered according to label) (Table 1). As Ryzodeg contains a rapid-acting meal-time insulin (insulin aspart), prandial glycemic control at the dosing meal is improved relative to administering basal insulin only; see trial results in Table 1. A lower rate of nocturnal hypoglycemia (defined as episodes between midnight and 6 a.m. confirmed by plasma glucose <3.1 mmol/L or by patient needing third party assistance) was observed with Ryzodeg relative to IGlar (Table 1).
Ryzodeg b.i.d. demonstrated similar glycemic control (HbA1c) compared with BIAsp 30 b.i.d. in patients with type 2 diabetes mellitus. It demonstrates superior improvements in fasting plasma glucose levels compared to patients treated with BIAsp 30. Ryzodeg causes a lower rate of overall and nocturnal hypoglycemia (Table 2).
In patients with type 1 diabetes mellitus, treatment with Ryzodeg o.d. plus IAsp for the remaining meals demonstrated similar glycemic control (HbA1c and fasting plasma glucose) with a lower rate of nocturnal hypoglycemia compared to a basal/bolus regimen with IDet plus IAsp at all meals (Table 3).
There is no clinically relevant development of insulin antibodies after long-term treatment of Ryzodeg.
There is no difference in the pharmacodynamic effect of Ryzodeg between elderly and younger patients.
Clinical efficacy and safety: Five multi-national, randomised, controlled, open-label, treat-to-target clinical studies of 26 weeks' and 52 weeks' duration were conducted exposing a total of 1,360 patients with diabetes mellitus (362 patients in type 1 diabetes mellitus and 998 patients in type 2 diabetes mellitus) to Ryzodeg. Ryzodeg administered once daily (o.d.) plus Oral Antidiabetic Drugs (OADs) was compared to insulin glargine (IGlar) (o.d.) plus OADs in two trials in type 2 diabetes mellitus (Table 1). Ryzodeg b.i.d. plus OADs was compared to biphasic insulin aspart 30 (BIAsp 30) b.i.d. plus OADs in two trials in type 2 diabetes mellitus (Table 2). Ryzodeg o.d. plus insulin aspart (IAsp) was also compared to once-daily (o.d.) or twice-daily insulin detemir (IDet) plus IAsp in type 1 diabetes mellitus (Table 3).
Non-inferiority in HbA1c change from baseline to end-of-trial was confirmed in all studies against all comparators when treating patients to target.
In two trials combining insulin and OAD treatment in both insulin-naïve (insulin initiation) and insulin-using (insulin intensification) patients with type 2 diabetes mellitus, Ryzodeg o.d. demonstrated similar glycemic control (HbA1c) compared to IGlar (administered according to label) (Table 1). As Ryzodeg contains a rapid-acting meal-time insulin (insulin aspart), prandial glycemic control at the dosing meal is improved relative to administering basal insulin only; see trial results in Table 1. A lower rate of nocturnal hypoglycemia (defined as episodes between midnight and 6 a.m. confirmed by plasma glucose <3.1 mmol/L or by patient needing third party assistance) was observed with Ryzodeg relative to IGlar (Table 1).
Ryzodeg b.i.d. demonstrated similar glycemic control (HbA1c) compared with BIAsp 30 b.i.d. in patients with type 2 diabetes mellitus. It demonstrates superior improvements in fasting plasma glucose levels compared to patients treated with BIAsp 30. Ryzodeg causes a lower rate of overall and nocturnal hypoglycemia (Table 2).
In patients with type 1 diabetes mellitus, treatment with Ryzodeg o.d. plus IAsp for the remaining meals demonstrated similar glycemic control (HbA1c and fasting plasma glucose) with a lower rate of nocturnal hypoglycemia compared to a basal/bolus regimen with IDet plus IAsp at all meals (Table 3).
There is no clinically relevant development of insulin antibodies after long-term treatment of Ryzodeg.
Pharmacokinetic properties: Absorption: After subcutaneous injection, soluble and stable multi-hexamers of insulin degludec are formed creating a depot of insulin in the subcutaneous tissue, while not interfering with the rapid release of insulin aspart monomers into the circulation. Insulin degludec monomers gradually separate from the multi-hexamers thus resulting in a slow and continuous delivery of insulin degludec into the circulation. Steady state serum concentration of the basal component (insulin degludec) is reached after 2-3 days of daily Ryzodeg administration.
The rapid absorption characteristics of the well-established insulin aspart are maintained by Ryzodeg. The pharmacokinetic profile for insulin aspart appears 14 minutes after injection with a peak concentration after 72 minutes.
Distribution: The affinity of insulin degludec to serum albumin corresponds to a plasma protein binding of >99% in human plasma. Insulin aspart has a low binding to plasma proteins (<10%), similar to that seen with regular human insulin.
Biotransformation: Degradation of insulin degludec and insulin aspart is similar to that of human insulin; all metabolites formed are inactive.
Elimination: The half-life after subcutaneous administration of Ryzodeg is determined by the rate of absorption from the subcutaneous tissue. The half-life of the basal component (insulin degludec) at steady state is 25 hours independent of dose.
Linearity: Total exposure with Ryzodeg increases proportionally with increasing dose of the basal component (insulin degludec) and the meal-time component (insulin aspart) in type 1 and type 2 diabetes mellitus.
Gender: There is no gender difference in the pharmacokinetic properties of Ryzodeg.
Elderly, race, renal and hepatic impairment: There are no clinically relevant differences in the pharmacokinetics of Ryzodeg between elderly and younger adult patients, between races or between healthy subjects and patients with renal or hepatic impairment.
Pediatric population: The pharmacokinetic properties of Ryzodeg in type 1 diabetes mellitus were investigated in children (6-11 years) and adolescents (12-18 years) and compared to adults after single dose administration.
Total exposure and peak concentration of insulin aspart are higher in children than in adults and are similar for adolescents and adults.
The pharmacokinetic properties of insulin degludec in children and adolescents were comparable to those observed in adults with type 1 diabetes mellitus. Total exposure of insulin degludec after single dose administration is, however, higher in children and adolescents than in adults with type 1 diabetes mellitus.
Toxicology: Preclinical safety data: Non-clinical data reveal no safety concerns for humans based on studies of safety pharmacology, repeated dose toxicity, carcinogenic potential, and toxicity to reproduction.
The ratio of mitogenic relative to metabolic potency for insulin degludec is comparable to that of human insulin.
The rapid absorption characteristics of the well-established insulin aspart are maintained by Ryzodeg. The pharmacokinetic profile for insulin aspart appears 14 minutes after injection with a peak concentration after 72 minutes.
Distribution: The affinity of insulin degludec to serum albumin corresponds to a plasma protein binding of >99% in human plasma. Insulin aspart has a low binding to plasma proteins (<10%), similar to that seen with regular human insulin.
Biotransformation: Degradation of insulin degludec and insulin aspart is similar to that of human insulin; all metabolites formed are inactive.
Elimination: The half-life after subcutaneous administration of Ryzodeg is determined by the rate of absorption from the subcutaneous tissue. The half-life of the basal component (insulin degludec) at steady state is 25 hours independent of dose.
Linearity: Total exposure with Ryzodeg increases proportionally with increasing dose of the basal component (insulin degludec) and the meal-time component (insulin aspart) in type 1 and type 2 diabetes mellitus.
Gender: There is no gender difference in the pharmacokinetic properties of Ryzodeg.
Elderly, race, renal and hepatic impairment: There are no clinically relevant differences in the pharmacokinetics of Ryzodeg between elderly and younger adult patients, between races or between healthy subjects and patients with renal or hepatic impairment.
Pediatric population: The pharmacokinetic properties of Ryzodeg in type 1 diabetes mellitus were investigated in children (6-11 years) and adolescents (12-18 years) and compared to adults after single dose administration.
Total exposure and peak concentration of insulin aspart are higher in children than in adults and are similar for adolescents and adults.
The pharmacokinetic properties of insulin degludec in children and adolescents were comparable to those observed in adults with type 1 diabetes mellitus. Total exposure of insulin degludec after single dose administration is, however, higher in children and adolescents than in adults with type 1 diabetes mellitus.
Toxicology: Preclinical safety data: Non-clinical data reveal no safety concerns for humans based on studies of safety pharmacology, repeated dose toxicity, carcinogenic potential, and toxicity to reproduction.
The ratio of mitogenic relative to metabolic potency for insulin degludec is comparable to that of human insulin.
MedsGo Class
Insulin Preparations
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