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MEDICINE MONOGRAPH CODE: [4.23] ID: TIP-MED-000067 ⚠️ HIGH-ALERT / SPECIALIST SUPERVISION

Insulin Degludec (Ultra-Long Basal U-100 & Co-Formulation IDegAsp)

Active Ingredient / Scientific Identity: Insulin Degludec • Class: Ultra-Long-Acting Basal Insulin Analogue & Soluble Rapid+Basal Co-Formulation (Schedule H | HIGH-ALERT)

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THE INDIAN PHARMACIST — Educational Reference Sheet
Profile: Insulin Degludec (Ultra-Long Basal U-100 & Co-Formulation IDegAsp) ([4.23] | ID: TIP-MED-000067) • Last Reviewed: 2026-11-10
Source URL: https://theindianpharmacist.com/medicine/4-23-insulin-degludec-ultra-long-basal-u-100-co-formulation-idegasp/
Generic / Entity NameInsulin Degludec (Ultra-Long Basal U-100 & Co-Formulation IDegAsp) ([4.23])
Verified Indian Brands / RefGeneric Compendial Entry (No Commercial Brand Claimed)
Pharmacological ClassUltra-Long-Acting Basal Insulin Analogue & Soluble Rapid+Basal Co-Formulation (Schedule H
Available Dosage Forms100 IU/mL Pre-Filled FlexTouch Pen & 3 mL Penfill Cartridges (Clear, colourless solution for BOTH Tresiba and
Regulatory ClassificationSchedule H & Schedule G Prescription Drug ('Caution: It is dangerous to take this pre
Key Warning & Review DateRenal & Hepatic: Insulin clearance decreases in CKD Stage 3–5 and cirrhosis — titrate cautiously based on SMBG to avoid hypog
Reviewed: 2026-11-10
Safety Matrix:⚖️ Legal Status: Schedule H & Schedule G Prescription Drug ('Caution:🚨 Clinically High-Alert: Independent Dose & Route Verification Required

1. Clinical & Scientific Overview

Insulin Degludec (Ultra-Long Basal U-100 & Co-Formulation IDegAsp) (TIP-MED-000067, Reference Code [4.23]) is classified under Antidiabetic Medicines, Insulins & GLP-1 Agonists (Ch 04) as a Ultra-Long-Acting Basal Insulin Analogue & Soluble Rapid+Basal Co-Formulation (Schedule H | HIGH-ALERT). Within the Indian regulatory and compendial framework, it is governed under Schedule H & Schedule G Prescription Drug ('Caution: It is dangerous to take this preparation except under medical supervision' — Drugs Rules 1945).

Verified Indian Market Examples / Compendial Status:
Representative Indian Market Examples (Edition 2.7 Ch 04 [4.23], p. 56): Insulin Degludec: Tresiba FlexTouch (Novo Nordisk). Insulin Degludec 70% + Insulin Aspart 30%: Ryzodeg FlexTouch / Penfill (Novo Nordisk) — Strengths & Dosage Forms: 100 IU/mL Pre-Filled FlexTouch Pen & 3 mL Penfill Cartridges (Clear, colourless solution for BOTH Tresiba and Ryzodeg!)
Representative Indian Market Examples (Edition 2.7 Ch 04 [4.23], p. 56): Insulin Degludec: Tresiba FlexTouch (Novo Nordisk). Insulin Degludec 70% + Insulin Aspart 30%: Ryzodeg FlexTouch / Penfill (Novo Nordisk) — Strengths & Dosage Forms: 100 IU/mL Pre-Filled FlexTouch Pen & 3 mL Penfill Cartridges (Clear, colourless solution for BOTH Tresiba and Ryzodeg!)
Dosage Forms & Available Strengths:
100 IU/mL Pre-Filled FlexTouch Pen & 3 mL Penfill Cartridges (Clear, colourless solution for BOTH Tresiba and Ryzodeg!)
Routes: Oral / Parenteral / Topical as specified by formulation

3. Mechanism of Action & Pharmacodynamics

Ultra-Long-Acting Basal Insulin Analogue & Soluble Rapid+Basal Co-Formulation (Schedule H | HIGH-ALERT) acting on target receptor/enzyme pathways in Antidiabetic Medicines, Insulins & GLP-1 Agonists (Ch 04): clinical efficacy is mediated via Ultra-Long-Acting Basal Insulin Analogue & Soluble Rapid+Basal Co-Formulation (Schedule H | HIGH-ALERT) for Diabetes Mellitus (Type 1 and Type 2) requiring basal insulin (Tresiba) or basal + prandial coverage with fewer injections and lower nocturnal hypoglycaemia (Ryzodeg).

4. Therapeutic Indications & Evidence-Supported Uses

  • Diabetes Mellitus (Type 1 and Type 2) requiring basal insulin (Tresiba) or basal + prandial coverage with fewer injections and lower nocturnal hypoglycaemia (Ryzodeg)

🇮🇳 Jurisdiction & Indication Note: Indications and schedules reflect Indian compendial and regulatory records (CDSCO / Indian Pharmacopoeia & NFI / NLEM 2022). Where international reference labels (US FDA DailyMed / NCBI StatPearls) are cited for pharmacokinetic or mechanistic parameters, international approvals do not automatically imply CDSCO approval in India.

5. Educational Dosage Context, Formulations & Administration

Educational Dosing & Regimen Summary: Tresiba: Start 10 Units SC Once Daily (or 0.1–0.2 U/kg/d); titrate every 3–4 days (after steady state) to fasting target 80–130 mg/dL. Ryzodeg: Inject Once or Twice Daily with the main meal(s)

Administration & Meal Timing: Tresiba (Basal): Inject Once Daily at any time (flexible 8–40h window if needed). Ryzodeg (70/30 Co-Formulation): MUST be injected WITH the main meal(s) because 30% is rapid-acting Insulin Aspart! | Tresiba: Fixed daily time. Ryzodeg: Immediately before the largest meal (OD) or before Breakfast & Dinner (BD)

6. Pharmacokinetics, Metabolism & Renal/Hepatic Adjustment

Absorption & Disposition:
Absorption, distribution, metabolism, and excretion follow class pharmacokinetic profile; verify patient renal/hepatic function.
Metabolism & Biotransformation:
Renal & Hepatic: Insulin clearance decreases in CKD Stage 3–5 and cirrhosis — titrate cautiously based on SMBG to avoid hypoglycaemia
Elimination & Renal Adjustment:
Renal & Hepatic: Insulin clearance decreases in CKD Stage 3–5 and cirrhosis — titrate cautiously based on SMBG to avoid hypoglycaemia
Hepatic Impairment Considerations:
Renal & Hepatic: Insulin clearance decreases in CKD Stage 3–5 and cirrhosis — titrate cautiously based on SMBG to avoid hypoglycaemia

7. Contraindications, Precautions & High-Risk Warnings

Contraindications & Red-Flag Precautions:
  • HIGH-ALERT LASA & FORMULATION RULE: Unlike cloudy Mixtard 30/70 or NovoMix 30, Ryzodeg 70/30 is a CRYSTAL-CLEAR solution (do NOT roll/resuspend, and NEVER confuse Ryzodeg with pure basal Tresiba or Glargine — Ryzodeg must be taken with a meal!). Never administer IV

Key Clinical Precautions: Renal & Hepatic: Insulin clearance decreases in CKD Stage 3–5 and cirrhosis — titrate cautiously based on SMBG to avoid hypoglycaemia

8. Adverse Effects Profile

Common & Mechanism-Related Adverse Effects:
  • Hypoglycaemia (40% lower nocturnal severe hypoglycaemia on Tresiba compared with Glargine U-100), lipohypertrophy, mild weight gain
  • Severe hypoglycaemia, hypokalaemia, severe allergic reaction
Serious / Dose-Limiting Adverse Effects:
  • Monitor for severe hypersensitivity, organ toxicity, or dose-limiting adverse events.

9. Major Drug–Drug, Drug–Food & Drug–Herb Interactions

  • Beta-blockers mask hypoglycaemic tremors/palpitations; Pioglitazone + Insulin increases fluid retention/HF risk; Corticosteroids and Thiazides antagonise insulin

10. Clinical Monitoring, Patient Counselling & Storage

Clinical & Laboratory Monitoring: Monitor clinical response, baseline renal/hepatic parameters, and relevant serum biomarkers.

Pharmacist Patient Counselling Points:

  • Patient Counselling Checklist: Verify whether the prescription is Tresiba (pure basal, any time) or Ryzodeg (70% basal + 30% mealtime Aspart — MUST eat a meal immediately after injecting!); both are clear liquids; rotate abdominal sites and hold pen button for 10 seconds
  • Meal & Clock Timing Instruction: Tresiba (Basal): Inject Once Daily at any time (flexible 8–40h window if needed). Ryzodeg (70/30 Co-Formulation): MUST be injected WITH the main meal(s) because 30% is rapid-acting Insulin Aspart! (Tresiba: Fixed daily time. Ryzodeg: Immediately before the largest meal (OD) or before Breakfast & Dinner (BD))
  • Missed Dose Protocol: Tresiba: If forgotten, inject upon discovery, ensuring >=8 hours before the next daily Tresiba dose. Ryzodeg: If forgotten at mealtime, take with the next main meal of that day
  • Geriatric Dispensing Pearl: Tresiba is the preferred basal analogue in frail elderly patients due to its flexible >=8h dosing window and low nocturnal hypoglycaemia

Storage, Stability & Dispensing Safeguards: COLD CHAIN MANDATORY (2°C–8°C): Store in a pharmaceutical refrigerator between 2°C and 8°C; DO NOT FREEZE. Protect from light and heat during dispensing.

11. Visual Pharmacology & Mechanism Diagram (svg-v339-01-adme-12-step-journey)

THE 12-STEP ORAL DRUG JOURNEY THROUGH THE HUMAN BODY (LADME) Note: IV bolus enters Step 6 directly (F = 100%); Sublingual & Transdermal routes bypass Step 4–5 Portal First-Pass Metabolism 1. Oral Administration • Tablet / Capsule swallowed • Gastric emptying to duodenum pH 1.5–3.5 (Stomach) 2. Disintegration & Dissolution • Tablet breaks into granules • API dissolves in GI fluid Noyes-Whitney Dissolution Rate 3. GI Epithelial Absorption • Crosses intestinal villi • Passive / Active / P-gp efflux Small Intestine (Large Surface Area) 4. Portal Circulation • Mesenteric veins → Portal vein • Delivers blood to liver sinusoids Pre-systemic Venous Conduit 5. First-Pass Metabolism • Gut & hepatic CYP450 extraction • High: GTN, Propranolol, Morphine Determines Bioavailability (F = f_a × (1-E_H)) 6. Systemic Circulation • Hepatic vein → IVC → Heart • Unbound vs Albumin-bound drug Only FREE drug is active 7–8. Tissue Distribution (Vd) • Capillary permeation to organs • Blood-Brain & Placental barriers Vd = Dose / C_0 (L or L/kg) 9. Target Site of Action • Receptors (GPCR, Ion channel) • Enzymes & Carrier Transporters Pharmacodynamic Effect (E_max, EC50) 10. Hepatic Biotransformation • Phase I (CYP450 Oxidation/Hydrolysis) • Phase II (Glucuronidation/Sulfation) Converts lipophilic drug → hydrophilic metabolite 11. Renal & Biliary Elimination • Nephron: Filtration + Secretion − Reabsorption • Biliary excretion & Enterohepatic recycling Total Clearance CL_tot = CL_renal + CL_hepatic 12. Excretion from the Body • Urine (Primary polar metabolite route) • Bile/Faeces, Expired Air, Sweat, Milk Elimination Half-Life t1/2 = (0.693 × Vd) / CL
svg-v339-01-adme-12-step-journey — 8.1 Complete 12-Step Journey of an Orally Administered Drug (ADME): Figure 8.1: The 12-step physiological journey of a typical orally administered solid dosage form through Liberation, Absorption, Distribution, Metabolism, and Excretion (LADME). Note: Parenteral (IV), sublingual, and inhalational routes bypass gastrointestinal absorption and/or hepatic first-pass metabolism.

12. Authoritative References, Regulatory Sources & Editorial Disclaimer

Primary Compendial & Guideline Reference: Indian Pharmacist Desk Reference — Professional Edition 2.7 (2026–27) • Ch 04 [4.23] (p. 56)

Official Verification Portals: Indian Pharmacopoeia Commission (IPC) & National Formulary of India (NFI) • Central Drugs Standard Control Organization (CDSCO) • Ministry of Health & Family Welfare — NLEM 2022 • NCBI Bookshelf / StatPearls Pharmacology Reference • DailyMed (US FDA Official Prescribing Reference)

Last Medically & Pharmaceutically Reviewed: 2026-11-10 • Verification Status: HANDBOOK_SOURCE_CONTENT

Educational & Clinical Disclaimer: This reference profile is published solely for pharmacy education, academic study, and professional clinical reference. It does not substitute for patient-specific clinical judgement, qualified specialist oncology/medical supervision, or official CDSCO/IP prescribing information. Never self-medicate with prescription, Schedule H/H1/X, NDPS, or oncology medicines.

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Educational Reference Notice: This printout from THE INDIAN PHARMACIST (https://theindianpharmacist.com/medicine/4-23-insulin-degludec-ultra-long-basal-u-100-co-formulation-idegasp/, Last Reviewed: 2026-11-10) is an educational reference sheet for students and healthcare learners. It is NOT an official prescribing guideline or patient-specific treatment order.