TRESIBA FLEX TOUCH 100/UNITS/ML 5×3ML/PENFILL @

Indications

Approved Uses

To improve glycemic control in adults and pediatric patients ≥1 year of age with diabetes mellitus (Type 1 or Type 2).

Dosage & Administration

Dosing by Condition

Type 1 diabetes: start at ~1/3 to 1/2 of the total daily insulin requirement as once-daily basal insulin degludec, with the remainder as prandial rapid-acting insulin; titrate to fasting glucose targets. Type 2 diabetes (insulin-naïve): start 10 units SC once daily and titrate (e.g., by 2 units every 3-4 days or per protocol) to fasting glucose targets; if switching from another basal insulin, generally convert unit-to-unit with monitoring.

Initial Dose

Type 2 diabetes: 10 units once daily. Type 1 diabetes: approximately one-third to one-half of the total daily insulin requirement once daily.

Maintenance Dose

Individually titrated based on blood glucose monitoring results. Dose adjustments are typically made every 3 to 4 days.

Maximum Dose

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

Children's Dosage

Approved for children 1 year of age and older. In pediatric patients, it should be administered at the same time every day. When switching from another basal insulin, the recommended starting dose is 80% of the previous basal insulin dose.

Dose Adjustment Notes

Adjust/titrate based on glucose monitoring (primarily fasting plasma glucose) and individual targets; when switching from another basal insulin, a 1:1 unit conversion is commonly used in adults, with close monitoring and possible dose reduction in those at higher hypoglycemia risk. Dose adjustments may be needed with changes in diet/activity, intercurrent illness, and in renal/hepatic impairment.

How to Take

For subcutaneous use only: Inject insulin degludec (Tresiba) under the skin once daily at the same time each day (or at any time of day, but consistently), into the abdomen, thigh, or upper arm; rotate injection sites within the same region. Do NOT administer intravenously or intramuscularly and do NOT mix with other insulins in the same syringe/infusion. Use a new needle for each injection and do not share the pen.

How to Prepare

No reconstitution needed; ready-to-use solution-inspect before use and use only if clear, colorless, and particle-free

Side Effects

Common Side Effects

Hypoglycemia; injection-site reactions (pain, erythema, swelling, pruritus) and lipodystrophy; weight gain; peripheral edema; (less commonly) upper respiratory tract infection/nasopharyngitis and headache.

Side Effect Frequency

Hypoglycemia (very common); injection site reactions, weight gain (common); peripheral edema, lipodystrophy (uncommon); hypersensitivity reactions including anaphylaxis (rare).

Safety & Warnings

Contraindications

Contraindicated during episodes of hypoglycemia and in patients with hypersensitivity to insulin degludec or any excipients.

Warnings & Precautions

Major warnings/precautions: hypoglycemia risk (may be life-threatening); do not share pens/cartridges; do not administer IV/IM; rotate injection sites to reduce lipodystrophy/skin amyloidosis; monitor/treat hypokalemia risk; regimen changes only under medical supervision; insulin needs may change with illness/stress/surgery and in renal/hepatic impairment; beta-blockers/clonidine may mask hypoglycemia; monitor for fluid retention/heart failure with TZDs.

Age Restriction

Approved for patients ≥1 year of age for diabetes mellitus (Type 1 and Type 2).

Driving Warning

Patients should be advised to take precautions to avoid hypoglycemia while driving; may impair concentration and reaction time.

Drug Interactions

Drug Interactions

Key interactions: (1) Drugs increasing hypoglycemia risk (e.g., other antidiabetics, ACE inhibitors, salicylates, MAOIs, fibrates, SSRIs such as fluoxetine, alcohol); (2) Drugs decreasing glucose-lowering effect (e.g., corticosteroids, thiazide/loop diuretics, sympathomimetics, thyroid hormones, growth hormone, glucagon, some antipsychotics); (3) Drugs masking hypoglycemia symptoms (e.g., beta-blockers, clonidine); (4) Thiazolidinediones + insulin: fluid retention/heart failure risk.

Interaction Severity

MAJOR/clinically significant: Thiazolidinediones (pioglitazone/rosiglitazone) with insulin may cause fluid retention and precipitate/worsen heart failure. MODERATE: Agents that increase hypoglycemia risk (other antidiabetics, ACE inhibitors/ARBs, MAOIs, salicylates, fibrates, fluoxetine, some antibiotics) and agents that reduce insulin effect (corticosteroids, thiazide/loop diuretics, sympathomimetics, thyroid hormones, atypical antipsychotics). Beta-blockers/clonidine and alcohol: may mask hypoglycemia symptoms and alcohol may increase or decrease glucose with increased hypoglycemia risk.

Food Interaction

No food restriction: can be administered without regard to meals; administer once daily and, if changing dosing time, ensure at least 8 hours between doses.

Special Populations

Pregnancy

Risk Summary: Available data from published studies and postmarketing reports with insulin degludec use in pregnant women have not established a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes.

Breastfeeding

Consult Doctor

Children

Approved for children 1 year of age and older. In pediatric patients, it should be administered at the same time every day. When switching from another basal insulin, the recommended starting dose is 80% of the previous basal insulin dose.

Elderly

No specific dose restriction; however, hypoglycemia risk is higher in elderly patients - initiate at lower doses, titrate cautiously, and monitor blood glucose frequently

Kidney Impairment

No fixed dose adjustment; use close glucose monitoring and titrate-insulin requirements may be reduced in renal impairment.

Liver Impairment

No fixed dose adjustment; use close glucose monitoring and titrate-insulin requirements may be reduced in hepatic impairment.

Storage & Patient Advice

Storage Conditions

store in a refrigerator (2°c - 8°c)

Preparation Instructions

No reconstitution needed; ready-to-use solution-inspect before use and use only if clear, colorless, and particle-free

Missed Dose

If a dose is missed, take it as soon as remembered, then continue once daily; ensure at least 8 hours between doses and do not double. In pediatric patients, caregivers should follow the prescriber’s instructions/plan for missed doses.

Stopping the Medicine

Do not discontinue or change dose abruptly; any changes should be under medical supervision to avoid hyperglycemia and (especially in Type 1) diabetic ketoacidosis.

Overdose

Overdose causes potentially severe/prolonged hypoglycemia; treat with oral carbohydrates if mild, and for severe episodes give IV dextrose (with ongoing infusion as needed) and/or IM/SC glucagon, with urgent medical care and monitoring.

Patient Counseling

Inject SC once daily (abdomen/thigh/upper arm) and rotate sites; do not share the pen and use a new needle each time. Recognize and treat hypoglycemia and monitor glucose as directed. Store unopened pens refrigerated (2-8°C per SFDA data); once in use, store per local label (often room temperature) and discard after the in-use period specified on the pack; keep away from heat/light and do not freeze.

Monitoring Requirements

Monitor blood glucose regularly (fasting and as clinically indicated) and HbA1c about every 3 months until controlled then at least twice yearly; monitor for hypoglycemia and injection-site/lipodystrophy. Check serum potassium in at-risk patients and assess renal/hepatic function when clinically indicated (e.g., dose changes, comorbidity).

Pharmacology

Mechanism of Action

Insulin degludec lowers blood glucose by increasing peripheral glucose uptake (muscle/fat) and decreasing hepatic glucose production; after SC injection it forms multi-hexamers creating a subcutaneous depot with slow, continuous monomer release, producing a flat, stable basal effect.

Onset of Action

Onset is approximately 1 hour after subcutaneous injection (with steady state reached after ~2-3 days of once-daily dosing).

Duration of Effect

At least 42 hours (ultra-long duration).

Half-Life

Approximately 25 hours

Bioavailability

Not clinically established/meaningful (subcutaneous insulin degludec has high systemic availability; no definitive % in major labels)

Metabolism

Degraded by proteolytic enzymes similar to human insulin; metabolites are inactive

Excretion

Not specifically characterized; cleared via proteolytic degradation like endogenous insulin (no meaningful unchanged renal excretion)

Protein Binding

>99% (primarily albumin binding)

Product Information

Available Dosage Forms

Solution for injection in pre-filled FlexTouch pen (3 mL); multiple dose vial (10 mL).

Composition per Dose

Each 1 ml solution: insulin degludec 100 IU; each 3 ml cartridge/pen: insulin degludec 300 IU

Generic Availability

No

OTC Alternatives

No OTC alternative

Diabetes Type

Both

Insulin Type

Long-acting

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