Schedule H

Subcutaneous injection

Form Strengths Available

Injection (lyophilized powder for reconstitution) 5 mg per vial

Note: Available in India only via special import authorization; no domestic manufacturing currently approved by CDSCO.

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Short Bowel Syndrome (SBS) — Parenteral Support Dependent

For adult and paediatric patients aged ≥1 year who require parenteral support (parenteral nutrition or IV fluids)

Parameter Details

Starting dose 0.05 mg/kg subcutaneously once daily

Titration Not routinely required; dose is weight-based

Usual maintenance dose 0.05 mg/kg subcutaneously once daily

Maximum dose 0.05 mg/kg/day

Duration Evaluate clinical benefit after 6 months; continue long-term only if sustained reduction in parenteral support achieved

Clinical Notes:

• Inject subcutaneously into abdomen, thigh, or upper arm; rotate injection sites daily

• Reconstitute lyophilized powder with provided diluent before use

• Reduce parenteral nutrition volume based on clinical response (fluid balance, urine output, weight, nutritional intake)

• Close multidisciplinary monitoring (gastroenterology, nutrition, nursing) is essential

• Not a standalone therapy — use alongside optimized enteral nutrition and medical management

Secondary Indications — Adults (Off-label)

Not applicable. No off-label indications established or used in Indian practice.

PAEDIATRIC DOSING (Specialist Only)

Primary Indications (Approved / Standard in India)

Short Bowel Syndrome (SBS) — Children ≥1 Year

Parameter Details

Starting dose 0.05 mg/kg subcutaneously once daily

Titration Not routinely required

Usual maintenance dose 0.05 mg/kg subcutaneously once daily

Maximum dose 0.05 mg/kg/day

Weight-Based Dosing Reference:

Body Weight (kg) Daily Dose (mg) Approximate Volume (after reconstitution)

10 kg 0.5 mg 0.1 mL

20 kg 1.0 mg 0.2 mL

30 kg 1.5 mg 0.3 mL

40 kg 2.0 mg 0.4 mL

≥50 kg 2.5 mg 0.5 mL

Safety Monitoring — Paediatrics:

• Monitor growth velocity (height, weight) regularly

• Assess hydration status and parenteral support requirements weekly during initiation

• Watch for signs of intestinal obstruction or fluid overload

• Paediatric gastroenterologist supervision mandatory

Minimum Age Statement

⚠️ Not recommended in children <1 year of age except under paediatric gastroenterologist supervision in exceptional circumstances. Safety and efficacy not established below this age.

Secondary Indications — Paediatrics (Off-label)

Not applicable. No off-label paediatric indications supported in India.

Clinical Notes:

• Monitor for fluid overload and electrolyte disturbances

• More frequent renal function monitoring recommended during treatment

• Known or suspected malignancy of the gastrointestinal tract, pancreas, or hepatobiliary system

• Active gastrointestinal malignancy

• History of gastrointestinal polyps (adenomatous or other non-hyperplastic polyps) unless adequately treated and polyp-free on recent colonoscopy

• Hypersensitivity to teduglutide or any excipient in the formulation

• History of colonic polyps — Perform colonoscopy before initiation; exclude active polyps

• Cardiovascular disease or heart failure — Risk of fluid overload; monitor weight and cardiac status

• Renal impairment — Increased risk of volume-related complications

• Risk of intestinal obstruction — Monitor for new or worsening abdominal symptoms

• Pancreatic disease — May elevate pancreatic enzymes

• Gallbladder/biliary disease — Monitor hepatobiliary function; abdominal ultrasound if symptomatic

• Concurrent neoplasm surveillance — Enhanced vigilance for malignancy development

Aspect Details

Overall Safety No adequate human data; Animal studies show increased fetal mortality at supratherapeutic doses

Risk Category Avoid unless benefit clearly outweighs risk

Preferred Alternatives Optimized nutritional support (enteral/parenteral), surgical options

When May Be Used Only if no alternatives and under specialist supervision

Monitoring Fetal growth parameters; Maternal volume status and electrolytes

Aspect Details

Compatible with Breastfeeding Not recommended; Limited human data

Drug Levels in Milk Unknown; Presumed low based on molecular weight and peptide nature

Preferred Alternatives Continue optimized parenteral/enteral nutritional support

Infant Monitoring If unavoidable use: GI disturbances (diarrhoea, vomiting), feeding difficulties

Aspect Recommendation

Starting dose 0.05 mg/kg/day (same as younger adults)

Titration Not applicable (fixed weight-based dosing)

Special Considerations Slower clinical response may be observed

Extra Risks Increased susceptibility to fluid overload; Cardiac decompensation risk; Reduced renal reserve

Monitoring Daily weight; Signs of heart failure; Electrolytes; Renal function

Dose Adjustment Reduce to 0.025 mg/kg/day if eGFR <30 mL/min

Interacting Drug Mechanism/Effect Management

Oral drugs with narrow therapeutic index (digoxin, phenytoin, cyclosporine) Enhanced intestinal absorption due to mucosal trophic effect → Increased plasma levels Monitor drug levels closely; May require dose reduction of interacting drug

Loop diuretics (furosemide, torsemide) Altered fluid balance → Risk of dehydration or volume overload Monitor fluid status, electrolytes, and blood pressure closely

Antihypertensives Altered fluid dynamics may affect blood pressure control Adjust antihypertensive doses based on BP monitoring

Interacting Drug Effect Management

Fat-soluble vitamins (A, D, E, K) Enhanced intestinal absorption Monitor serum vitamin levels in long-term use; Adjust supplementation

Warfarin Variable absorption → INR fluctuations Monitor INR more frequently (weekly initially)

Oral contraceptives Potentially altered absorption Consider backup contraception during therapy initiation

Levothyroxine Enhanced absorption possible Monitor TSH; May require dose adjustment

• Abdominal pain/distension

• Nausea, vomiting

• Injection site reactions (erythema, pain, bruising)

• Headache

• Upper respiratory tract infections

• Peripheral oedema/fluid retention

• Abdominal distension

• Flatulence

Adverse Effect Clinical Action

Intestinal obstruction Urgently evaluate new/worsening abdominal pain, distension, vomiting — May require hospitalization and surgical consultation

Biliary/pancreatic disease (elevated LFTs, pancreatitis) Monitor amylase/lipase; Discontinue if pancreatitis confirmed

Colonic polyps Requires colonoscopy for biopsy/polypectomy; Consider discontinuation if adenomatous polyps found

Hypersensitivity reactions (rash, urticaria, dyspnoea) Discontinue immediately; Provide supportive care

Congestive heart failure exacerbation Fluid restriction; Diuretics; May require treatment discontinuation

Gastrointestinal malignancy Immediate discontinuation; Oncology referral

After Initiation (First 3 Months) Weekly: Body weight, parenteral nutrition volume, fluid balance; Monthly: LFTs, renal function, amylase, lipase, electrolytes

Long-term Monitoring Colonoscopy every 5 years (more frequently if polyps detected); Annual gallbladder ultrasound (if biliary symptoms); Regular nutritional assessment; Monitor for signs of malignancy

Brand Name Manufacturer Notes

Gattex Takeda (imported) Available via special import authorization

Revestive Takeda (imported) Available via special import authorization

Note: No Indian generic currently approved by CDSCO. Access typically through hospital import programs or compassionate use schemes.

NLEM Status: NOT included in NLEM; No NPPA price control

Access: Available primarily through tertiary care centres with special import license; Some government hospital programs may provide access

1. Strict indication: Reserve only for SBS patients with confirmed long-term parenteral nutrition dependence — Not for acute intestinal failure

1. Colonoscopy mandatory: Always perform colonoscopy within 6 months prior to initiation; Exclude polyps and malignancy; Repeat every 5 years during treatment

1. Expect gradual response: Clinical benefit (reduction in parenteral nutrition) typically observed over weeks to months — Evaluate formally at 6 months; Discontinue if no meaningful reduction achieved

1. Fluid balance vigilance: Risk of both dehydration (as parenteral nutrition reduced) and fluid overload — Monitor daily weights; Adjust parenteral volumes cautiously

1. Multidisciplinary approach essential: Requires coordination between gastroenterologist, nutrition team, nursing, and pharmacy — Not suitable for use outside specialized centres

1. Cost consideration: Extremely high treatment cost; Discuss financial sustainability with patient/family before initiation; Explore institutional or pharmaceutical company access programs

teduglutide; short bowel syndrome; SBS; intestinal failure; GLP-2 analogue; parenteral nutrition; specialist drug; paediatric use; high-cost therapy; import-only

RxIndia v1.0 — 28 Apr 2025

• CDSCO Import Registry

• Indian Pharmacopoeia (no monograph; import status referenced)

• API Textbook of Medicine, 11th edition

• AIIMS Gastroenterology Department Protocols

• Goodman & Gilman's The Pharmacological Basis of Therapeutics

• Harrison's Principles of Internal Medicine

• International regulatory labels (FDA/EMA) — Used only for supplementary safety information where Indian data unavailable