RYZODEG FLEXTOUCH 100/UNITS/ML 5×3ML/PENFILL @

Indications

Approved Uses

Improve glycemic control in patients 1 year of age and older with diabetes mellitus.

Dosage & Administration

Dosing by Condition

Type 2 diabetes (insulin-naïve): start 10 units SC once daily with the main meal, then titrate to targets; Type 1 diabetes: use as part of a basal-bolus regimen-typically give Ryzodeg once daily with a main meal to provide basal plus that meal’s prandial insulin, and add rapid-acting insulin at the other meals (dose individualized; often a defined proportion of total daily insulin is allocated to Ryzodeg per specialist plan).

Initial Dose

Type 2 diabetes (insulin-naive): 10 units once daily with the main meal. Type 1 diabetes: approximately one-third to one-half of the total daily insulin dose.

Maintenance Dose

Individualized; titrate dose every 3-4 days based on fasting blood glucose levels (target fasting glucose 4-7 mmol/L). Typical range: 0.2-1.0 units/kg/day

Maximum Dose

No defined maximum dose; dose is individualized and titrated to glycemic targets.

Children's Dosage

Approved for children aged 1 year and older. Dose reduction should be considered when switching from other insulins to minimize hypoglycemia risk.

Dose Adjustment Notes

Individualize and titrate based on glucose monitoring; when switching from other insulin regimens, use close glucose monitoring and expect dose adjustment; adjust dose with changes in meals/physical activity, intercurrent illness, and with renal or hepatic impairment; review interacting drugs that may increase or decrease insulin requirements.

How to Take

Subcutaneous injection only (abdomen, thigh, or upper arm); inject once daily with the main meal (or twice daily with main meals if prescribed), at the same meal(s) each day; rotate injection sites within the same region; do NOT give IV/IM or via insulin pump; do NOT mix with other insulins; use the FlexTouch pen with a new needle each time, perform a safety/flow check per pen instructions, inject the dialed dose and keep the needle under the skin for at least 6 seconds.

How to Prepare

Inspect the solution-must be clear and colorless; do not use if cloudy/colored/with particles. If refrigerated, allow pen to reach room temperature before injection. Prime/perform a flow check (typically 2 units) before first use and when needed per pen instructions.

Side Effects

Common Side Effects

Hypoglycemia, injection site reactions (pain, redness, swelling, itching), lipodystrophy (thickening or hollowing of the skin at the injection site), weight gain.

Safety & Warnings

Contraindications

During episodes of hypoglycemia, Hypersensitivity to insulin degludec, insulin aspart, or any of the excipients.

Warnings & Precautions

Key warnings/precautions: hypoglycemia risk (may be severe); do not share pens/needles; regimen changes only with medical supervision; subcutaneous use only (not IV/IM, not for pumps); rotate injection sites to reduce lipodystrophy; monitor/consider hypokalemia risk; hypersensitivity possible; and heart failure risk with concomitant TZDs.

Age Restriction

Approved for adults and pediatric patients ≥1 year (type 1 or type 2 diabetes), per current product labeling; not recommended for pediatric patients requiring less than 5 units.

Drug Interactions

Drug Interactions

Both are broadly correct; key clinically relevant interactions include: agents that increase hypoglycemia risk (other antidiabetics, ACE inhibitors, MAOIs, salicylates, sulfonamide antibiotics, some antidepressants e.g., fluoxetine), agents that reduce glucose-lowering effect (corticosteroids, thiazide/loop diuretics, thyroid hormones, sympathomimetics, growth hormone, danazol, oral contraceptives), beta-blockers (mask hypoglycemia), alcohol (may increase or decrease effect), and TZDs (pioglitazone/rosiglitazone) increasing fluid retention/heart failure risk when combined with insulin.

Food Interaction

Administer with a main meal (inject at the same main meal each day); do not inject and then skip/delay the meal due to hypoglycemia risk.

Special Populations

Pregnancy

Consult Doctor

Breastfeeding

Consult Doctor

Children

Approved for children aged 1 year and older. Dose reduction should be considered when switching from other insulins to minimize hypoglycemia risk.

Elderly

Use with caution; hypoglycemia risk is increased. Start at lower doses, titrate slowly, and monitor blood glucose frequently. Individualize dosing based on renal function and overall health status.

Kidney Impairment

No fixed dose adjustment; use with intensified glucose monitoring and individual titration-renal impairment often lowers insulin requirements and increases hypoglycemia risk.

Liver Impairment

No fixed dose adjustment; use with intensified glucose monitoring and individual titration-hepatic impairment may reduce insulin requirements.

Storage & Patient Advice

Preparation Instructions

Inspect the solution-must be clear and colorless; do not use if cloudy/colored/with particles. If refrigerated, allow pen to reach room temperature before injection. Prime/perform a flow check (typically 2 units) before first use and when needed per pen instructions.

Stopping the Medicine

Do not stop or change Ryzodeg abruptly; any changes must be under medical supervision to avoid severe hyperglycemia and possible diabetic ketoacidosis.

Overdose

Overdose primarily causes hypoglycemia (may be severe/prolonged): treat with oral fast-acting carbohydrate if conscious; severe cases require glucagon IM/SC or IV dextrose with medical monitoring (and consider hypokalemia monitoring).

Patient Counseling

Inject subcutaneously with a main meal and do not skip that meal; rotate sites; use a new needle each time and do not share the pen; check the label before each injection; recognize and treat hypoglycemia and carry fast-acting carbohydrate; store unopened pens refrigerated (2-8°C per SFDA) and do not freeze; once in use, follow local labeling for in-use storage/expiry and protect from heat/light; use caution with driving/operating machinery if hypoglycemia occurs.

Monitoring Requirements

Self-monitoring/CGM-guided glucose monitoring (fasting and postprandial as clinically needed) and periodic HbA1c; monitor for hypoglycemia, weight, and injection-site lipodystrophy; check serum potassium in at-risk patients and assess renal/hepatic function when clinically indicated (e.g., dose changes, comorbidity, frailty).

Pharmacology

Mechanism of Action

Insulin receptor agonism: increases peripheral glucose uptake and decreases hepatic glucose output; insulin degludec forms multi-hexamers in SC tissue creating a depot with slow continuous release (flat basal profile), while insulin aspart is rapidly absorbed to control postprandial glucose excursions.

Onset of Action

Prandial onset is rapid due to insulin aspart (approximately 10-20 minutes; measurable appearance ~10-15 minutes); the degludec basal component has a gradual onset and reaches steady state after ~2-3 days of once-daily dosing.

Duration of Effect

Overall glucose-lowering effect lasts beyond 24 hours; the degludec basal component has an ultra-long duration (up to ~42 hours) while the aspart component provides mealtime coverage for several hours.

Half-Life

Insulin degludec: ~25 hours (terminal half-life at steady state); insulin aspart: ~1-1.5 hours.

Bioavailability

After subcutaneous administration, systemic exposure is high; absolute bioavailability is not routinely stated for the co-formulation in many labels and should be treated as not reliably specified (do not cite precise percentages without the product’s official SmPC/label).

Metabolism

Both components are metabolized like endogenous human insulin-degraded by proteolytic enzymes to inactive peptides/amino acids; no CYP-mediated hepatic metabolism.

Excretion

Insulins are primarily cleared by proteolytic degradation to inactive metabolites (mainly in liver, kidney, and muscle) rather than excreted unchanged; metabolites are eliminated via normal metabolic pathways with minimal unchanged renal excretion.

Protein Binding

Insulin degludec: >99% bound to plasma albumin; insulin aspart: negligible/low protein binding (commonly cited as <10%).

Product Information

Available Dosage Forms

Solution for injection in a 3 mL pre-filled pen (FlexTouch).

Composition per Dose

Each 1 ml: Insulin degludec 70 units (70%) + Insulin aspart 30 units (30%); total 100 units/ml. Each 3 ml pen cartridge contains 300 units total (210 units insulin degludec + 90 units insulin aspart)

Generic Availability

No

OTC Alternatives

No OTC alternative

Diabetes Type

Both

Insulin Type

Pre-mixed

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