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Authoritative Clinical Reference
Schedule H
Subcutaneous injection
Formulation Strength
Prefilled pen injection 10 mcg/0.2 mL
Prefilled pen injection 20 mcg/0.2 mL
INDICATIONS + DOSING — FOR CLINICIAN USE ONLY
Primary Indications (Approved / Standard in India)
Type 2 Diabetes Mellitus
(As adjunct to metformin, sulfonylurea, basal insulin, or combination therapy when glycaemic control is inadequate)
Parameter Recommendation
Starting dose 10 mcg SC once daily for 14 days
Titration Increase to 20 mcg SC once daily from Day 15
Usual maintenance dose 20 mcg SC once daily
Maximum dose 20 mcg per day
Administration Notes:
Secondary Indications — Adults Only (Off-label, if any)
Indication Dose Duration Notes Evidence
Weight management in obese T2DM patients Same as diabetes dosing (10 mcg → 20 mcg) ≥12 weeks with diet and lifestyle modification OFF-LABEL; Specialist only Supported by meta-analyses; not formally approved in India for this indication
PAEDIATRIC DOSING (Specialist Only)
Primary Indications
Not applicable.
Secondary Indications — Paediatric Doses (Off-label, if any)
Not applicable.
Safety Statement:
| eGFR (ml/min/1.73m²) | Recommendation |
|---|
Mild impairment 60–89 No dose adjustment required
Moderate impairment 30–59 No dose adjustment required; monitor for GI tolerance
Severe impairment <30 Use with caution; limited data; increased risk of GI adverse effects leading to dehydration
End-stage renal disease / Dialysis — Not recommended due to insufficient data and elevated risk of volume depletion
| Severity | Recommendation |
|---|---|
| Mild impairment (Child-Pugh A) | No dose adjustment required |
| Moderate impairment (Child-Pugh B) | No dose adjustment required |
| Severe impairment (Child-Pugh C) | Use with caution; limited clinical data available |
Parameter Recommendation
Risk statement Safety in human pregnancy not established; animal studies show potential risk
Preferred alternatives Insulin is the preferred agent for glycaemic control during pregnancy
When to use Only if potential benefit clearly justifies risk; initiate under specialist supervision
Monitoring Fetal growth (ultrasound), maternal glycaemic control, signs of hypoglycaemia
Parameter Recommendation
Compatibility Unknown whether excreted in human breast milk
Recommendation Breastfeeding not recommended during treatment
Preferred alternatives Insulin or metformin (safer options during lactation)
Infant monitoring If inadvertently exposed — monitor for feeding difficulties, GI symptoms, weight gain
Parameter Recommendation
Starting dose 10 mcg SC once daily (same as adults)
Titration May consider slower titration in patients ≥75 years
Special risks Increased sensitivity to GI side-effects; higher risk of dehydration and hypoglycaemia (particularly if on sulfonylurea/insulin)
Monitoring Regular assessment of renal function; hydration status; blood glucose
Interacting Drug Effect Management
Sulfonylureas (glimepiride, gliclazide) Increased risk of hypoglycaemia Reduce sulfonylurea dose when initiating lixisenatide
Basal insulin Increased risk of hypoglycaemia Consider reducing insulin dose by 10–20% at initiation
Levothyroxine Delayed absorption due to slowed gastric emptying Administer levothyroxine at least 1 hour before lixisenatide
Warfarin Potential alteration in absorption kinetics Monitor INR closely; administer warfarin 1 hour before lixisenatide
Other GLP-1 receptor agonists Additive effects; no therapeutic benefit Concurrent use contraindicated
Interacting Drug Effect Management
Paracetamol Delayed time to peak concentration (Tmax) Generally not clinically significant
Oral antibiotics (e.g., amoxicillin) Delayed absorption Clinical significance usually low
Oral contraceptives Slight reduction in peak plasma levels Administer OCP at least 1 hour before or 11 hours after lixisenatide
Statins Minor delay in absorption Separate timing if possible; usually not clinically relevant
Digoxin Delayed Tmax and reduced Cmax Monitor digoxin levels; space administration
GI adverse effects typically decrease over first 2–4 weeks of therapy
Adverse Effect Action Required
Acute pancreatitis Discontinue immediately; do not rechallenge
Acute kidney injury (secondary to volume depletion from GI effects) Discontinue; supportive management; fluid resuscitation
Severe hypoglycaemia (particularly with insulin/SUs) Reduce concomitant therapy; glucose rescue
Anaphylaxis or angioedema Discontinue permanently; emergency management
Thyroid C-cell tumours Observed in animal studies; human relevance uncertain; monitor thyroid if risk factors present
Phase Parameters
Baseline Fasting plasma glucose, HbA1c, renal function (serum creatinine, eGFR), lipase/amylase (if pancreatitis risk), thyroid examination if indicated
After initiation / dose change GI tolerance assessment (first 2–4 weeks); blood glucose monitoring (especially if on SU/insulin)
Long-term HbA1c every 3–6 months; body weight; renal function annually; periodic thyroid examination if risk factors present
| Formulation | Approximate Price (per tablet) |
|---|---|
| Prefilled pen (10 mcg or 20 mcg) | ₹1,700–2,500 per pen (14–28 doses depending on titration phase) |
Notes:
lixisenatide; type 2 diabetes; GLP-1 receptor agonist; antidiabetic injection; subcutaneous; renal caution; GI adverse effects; weight management; pregnancy-avoid; schedule H; India formulary
RxIndia v0.4 — 10 Jun 2025
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