Ryzodeg Insulin Degludec and Insulin Aspart Injection

1. Indications and Usage
This combination is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 1 or type 2 diabetes mellitus. It is not intended for the treatment of diabetic ketoacidosis.
2. Dosage and Administration
Recommended Dosage: The dosage must be individualized. The recommended starting dose is approximately 50% of the total daily insulin requirement previously taken by the patient. The remainder of the total daily dose should be divided so that 50% is administered as this fixed-ratio combination and 50% as separate rapid-acting or long-acting insulin.
Administration: Administer subcutaneously once daily at the same time each day, preferably immediately before the largest meal of the day. The injection site should be varied within the intended area.
Dose Adjustments: Dosage must be titrated based on individual glycemic response. Regular blood glucose monitoring is essential to determine the appropriate dose.
3. Mechanism of Action
Insulin Degludec: A long-acting insulin analog that forms multi-hexamers upon subcutaneous injection, creating a soluble depot that gradually dissociates to provide a duration of action extending beyond 42 hours with a flat pharmacodynamic profile.
Insulin Aspart: A rapid-acting insulin analog that is absorbed quickly into the bloodstream, providing rapid onset and short duration of action to control postprandial glucose excursions.
4. Safety and Warnings
Hypoglycemia: The most common adverse reaction. Risk increases with missed meals, increased physical activity, or dose mismatches.
Hypersensitivity: Severe allergic reactions (anaphylaxis, angioedema) and injection site reactions (lipodystrophy, pruritus, erythema) may occur.
Hyperkalemia: All insulins can cause shifts in serum potassium, potentially leading to hyperkalemia.
Weight Gain: Weight gain is a common adverse reaction associated with insulin therapy and occurs alongside glycemic control.
5. Adverse Reactions and Clinical Research
Common Adverse Reactions: The most frequently reported adverse reactions include hypoglycemia, injection site reactions, hypersensitivity, weight gain, and pruritus.
Clinical Research: Clinical trials have demonstrated that this fixed-ratio combination effectively reduces both fasting and postprandial glucose levels with a low risk of hypoglycemia compared to separate administration of basal and bolus insulins.
6. Drug Interactions
Medications Affecting Glucose Metabolism: Corticosteroids, thiazides, and sympathomimetics may increase blood glucose.
Medications Affecting Insulin Sensitivity: ACE inhibitors, alcohol, beta-blockers, and salicylates may increase the risk of hypoglycemia.
CYP3A4 Inhibitors/Inducers: May affect the pharmacokinetics of insulin aspart.
7. Pharmaceutical Information
Composition: This is a fixed-ratio combination containing 100 units/mL of insulin degludec and 25 units/mL of insulin aspart.
Appearance: The solution is clear and colorless.
Storage: Store in a refrigerator between 2°C and 8°C. Do not freeze. Once in use, it can be stored at room temperature below 30°C for up to 56 days.