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MEDICINE MONOGRAPH CODE: [4.22]-C18 ID: TIP-MED-000288

Dulaglutide

Active Ingredient / Scientific Identity: Dulaglutide • Class: Subcutaneous GLP-1 Receptor Agonists (Schedule H | 2°C–8°C Cold Chain)

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THE INDIAN PHARMACIST — Educational Reference Sheet
Profile: Dulaglutide ([4.22]-C18 | ID: TIP-MED-000288) • Last Reviewed: 2026-11-10
Source URL: https://theindianpharmacist.com/medicine/4-22-c18-dulaglutide/
Generic / Entity NameDulaglutide ([4.22]-C18)
Verified Indian Brands / RefGeneric Compendial Entry (No Commercial Brand Claimed)
Pharmacological ClassSubcutaneous GLP-1 Receptor Agonists (Schedule H | 2°C–8°C Cold Chain)
Available Dosage FormsLiraglutide Multi-Dose Pen: 6 mg/mL (3 mL pen delivering 0.6 mg, 1.2 mg, or 1.8 mg daily). Dulaglutide Single-
Regulatory ClassificationSchedule H & Schedule G Prescription Drug ('Caution: It is dangerous to take this pre
Key Warning & Review DateRenal & Hepatic: No dose adjustment required in mild, moderate, or severe CKD (eGFR >=15 mL/min) or hepatic impairment; monit
Reviewed: 2026-11-10
Safety Matrix:⚖️ Legal Status: Schedule H & Schedule G Prescription Drug ('Caution:✔️ Standard Clinical Dispensing Precautions

1. Clinical & Scientific Overview

Dulaglutide (TIP-MED-000288, Reference Code [4.22]-C18) is classified under Antidiabetic Medicines, Insulins & GLP-1 Agonists (Ch 04) as a Subcutaneous GLP-1 Receptor Agonists (Schedule H | 2°C–8°C Cold Chain). 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:
Co-indexed constituent under primary monograph [4.22] (Liraglutide & Dulaglutide (Injectable GLP-1 Receptor Agonists)). Representative Indian Market Examples (Edition 2.7 Ch 04 [4.22], p. 55): Liraglutide: Victoza (Novo Nordisk), Lirafit (Glenmark — Indian biosimilar). Dulaglutide: Trulicity (Eli Lilly) — Strengths & Dosage Forms: Liraglutide Multi-Dose Pen: 6 mg/mL (3 mL pen delivering 0.6 mg, 1.2 mg, or 1.8 mg daily). Dulaglutide Single-Dose Auto-Injector Pen: 0.75 mg/0.5mL, 1.5 mg/0.5mL Weekly
Co-indexed constituent under primary monograph [4.22] (Liraglutide & Dulaglutide (Injectable GLP-1 Receptor Agonists)). Representative Indian Market Examples (Edition 2.7 Ch 04 [4.22], p. 55): Liraglutide: Victoza (Novo Nordisk), Lirafit (Glenmark — Indian biosimilar). Dulaglutide: Trulicity (Eli Lilly) — Strengths & Dosage Forms: Liraglutide Multi-Dose Pen: 6 mg/mL (3 mL pen delivering 0.6 mg, 1.2 mg, or 1.8 mg daily). Dulaglutide Single-Dose Auto-Injector Pen: 0.75 mg/0.5mL, 1.5 mg/0.5mL Weekly
Dosage Forms & Available Strengths:
Liraglutide Multi-Dose Pen: 6 mg/mL (3 mL pen delivering 0.6 mg, 1.2 mg, or 1.8 mg daily). Dulaglutide Single-Dose Auto-Injector Pen: 0.75 mg/0.5mL, 1.5 mg/0.5mL Weekly
Routes: Oral / Parenteral / Topical per formulation

3. Mechanism of Action & Pharmacodynamics

Subcutaneous GLP-1 Receptor Agonists (Schedule H | 2°C–8°C Cold Chain) acting on target receptor/enzyme pathways in Antidiabetic Medicines, Insulins & GLP-1 Agonists (Ch 04): clinical efficacy is mediated via Subcutaneous GLP-1 Receptor Agonists (Schedule H | 2°C–8°C Cold Chain) for Type 2 Diabetes Mellitus with established atherosclerotic cardiovascular disease (LEADER & REWIND trials), CKD, or obesity.

4. Therapeutic Indications & Evidence-Supported Uses

  • Type 2 Diabetes Mellitus with established atherosclerotic cardiovascular disease (LEADER & REWIND trials), CKD, or obesity

🇮🇳 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: Liraglutide: Start 0.6 mg SC Once Daily x 1 week, then increase to 1.2 mg OD (max 1.8 mg OD). Dulaglutide: Start 0.75 mg SC Once Weekly, increase to 1.5 mg Once Weekly

Administration & Meal Timing: Inject subcutaneously into abdomen, thigh, or upper arm at any time of day, independent of meals | Liraglutide: Fixed hour Once Daily. Dulaglutide: Fixed day Once Weekly

6. Pharmacokinetics, Metabolism & Renal/Hepatic Adjustment

Absorption & Disposition:
Follows class pharmacokinetic profile detailed in parent monograph [4.22].
Metabolism & Biotransformation:
Renal & Hepatic: No dose adjustment required in mild, moderate, or severe CKD (eGFR >=15 mL/min) or hepatic impairment; monitor hydration if vomiting occurs
Elimination & Renal Adjustment:
Renal & Hepatic: No dose adjustment required in mild, moderate, or severe CKD (eGFR >=15 mL/min) or hepatic impairment; monitor hydration if vomiting occurs
Hepatic Impairment Considerations:
Renal & Hepatic: No dose adjustment required in mild, moderate, or severe CKD (eGFR >=15 mL/min) or hepatic impairment; monitor hydration if vomiting occurs

7. Contraindications, Precautions & High-Risk Warnings

Contraindications & Red-Flag Precautions:
  • Contraindicated in personal/family history of Medullary Thyroid Carcinoma (MTC), MEN 2, acute pancreatitis, severe gastroparesis, pregnancy, and Type 1 DM

Key Clinical Precautions: Renal & Hepatic: No dose adjustment required in mild, moderate, or severe CKD (eGFR >=15 mL/min) or hepatic impairment; monitor hydration if vomiting occurs

8. Adverse Effects Profile

Common & Mechanism-Related Adverse Effects:
  • Nausea, vomiting, diarrhoea, dyspepsia, anorexia, mild injection-site erythema, 2–3 bpm increase in resting heart rate
  • Acute necrotising pancreatitis, acute cholecystitis, dehydration-induced AKI, aspiration risk under anaesthesia/sedation
Serious / Dose-Limiting Adverse Effects:

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

    • Reduce concomitant Sulfonylurea (Glimepiride) or Basal Insulin dose by 20–25% on initiation to prevent hypoglycaemia; delays oral drug Tmax slightly

    10. Clinical Monitoring, Patient Counselling & Storage

    Clinical & Laboratory Monitoring: Monitor clinical parameters per parent monograph [4.22].

    Pharmacist Patient Counselling Points:

    • Patient Counselling Checklist: Store unopened pens in refrigerator (2°C–8°C; NEVER freeze!); in-use Liraglutide pen may be kept at <30°C for 30 days (Dulaglutide up to 14 days at <30°C); stop and seek emergency care if severe persistent upper stomach pain occurs
    • Meal & Clock Timing Instruction: Inject subcutaneously into abdomen, thigh, or upper arm at any time of day, independent of meals (Liraglutide: Fixed hour Once Daily. Dulaglutide: Fixed day Once Weekly)
    • Missed Dose Protocol: Liraglutide: If >12h late, skip and take next day. Dulaglutide: If >=3 days (72h) remain before next weekly dose, inject immediately; otherwise skip
    • Geriatric Dispensing Pearl: Effective CV risk reduction in older adults; monitor for unintended excessive weight loss or dehydration

    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 Pharmacopoeia (IP 2022) • NFI • CDSCO

    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: VERIFIED_EDUCATIONAL_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/4-22-c18-dulaglutide/, 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.