Schedule H

Subcutaneous (SC)

• Prefilled Syringe: 2.5 mg/0.5 mL

• Prefilled Syringe: 5 mg/0.4 mL

• Prefilled Syringe: 7.5 mg/0.6 mL

• Prefilled Syringe: 10 mg/0.8 mL

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Prophylaxis of Venous Thromboembolism (VTE) — Post-Major Orthopaedic or Abdominal Surgery

Parameter Recommendation

Starting dose 2.5 mg SC once daily

Timing of initiation 6–8 hours postoperatively, only after haemostasis achieved

Titration Not applicable — fixed prophylactic dose

Usual maintenance dose 2.5 mg SC once daily

Maximum dose 2.5 mg/day

Clinical Notes:

• Duration: 5–9 days for general surgery; may extend up to 24–32 days post-hip fracture or hip replacement surgery

• Do not initiate if surgical haemostasis not achieved

• Not recommended for prophylaxis in patients weighing <50 kg (increased bleeding risk)

1. Treatment of Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE)

Weight-Based Dosing:

Body Weight Dose (SC once daily)

<50 kg 5 mg

50–100 kg 7.5 mg

100 kg 10 mg

Parameter Recommendation

Starting dose Weight-based as above

Titration Not applicable — fixed weight-based dosing

Usual maintenance dose As per weight category

Maximum dose 10 mg/day

Clinical Notes:

• Initiate as soon as diagnosis confirmed

• Initial treatment duration: 5–7 days minimum

• Overlap with warfarin for at least 5 days AND until INR ≥2.0 for ≥24 hours before discontinuing fondaparinux

• If transitioning to DOACs: follow specific DOAC switching protocols

1. VTE Prophylaxis in Medically Ill Patients with High Thromboembolic Risk

Parameter Recommendation

Starting dose 2.5 mg SC once daily

Titration Not applicable

Usual maintenance dose 2.5 mg SC once daily

Maximum dose 2.5 mg/day

Clinical Notes:

• Duration: 6–14 days based on clinical risk assessment and mobility status

• Suitable for immobilised medical patients with acute illness (heart failure, respiratory disease, infection)

Secondary Indications — Adults (Off-label)

Indication Dose Duration Notes

Non-ST Elevation Acute Coronary Syndrome (NSTE-ACS) (OFF-LABEL) 2.5 mg SC once daily Up to 8 days or until hospital discharge Specialist only; preferred when bleeding risk is high; evidence from OASIS-5 trial; accepted in Indian cardiology practice

STEMI — Conservatively Managed (OFF-LABEL) 2.5 mg SC once daily (after initial heparin if thrombolysis given) Up to 8 days or until revascularisation Specialist only; NOT to be used alone in patients undergoing primary PCI (catheter thrombosis risk); evidence from OASIS-6 trial

PAEDIATRIC DOSING (Specialist Only)

Primary Indications

Not approved for paediatric use in India. No established primary paediatric indications.

Secondary Indications — Paediatrics (Off-label)

Treatment of Venous Thromboembolism — OFF-LABEL

Paediatric Haematologist Input Mandatory

Body Weight Dose (SC once daily)

<17 kg 0.1 mg/kg

17–50 kg 2.5 mg

50–100 kg 5 mg

100 kg 7.5–10 mg

Clinical Notes:

• Duration: 5–7 days initial treatment, followed by transition to oral anticoagulant

• Evidence basis: Limited paediatric pharmacokinetic studies; tertiary hospital protocols

• Specialist only

Monitoring Required:

• Anti-Xa levels (target peak: 0.5–1.0 mg/L, 3 hours post-dose)

• Complete blood count including platelets

• Clinical assessment for bleeding

Age Restriction: Not recommended below 1 year of age except under specialist paediatric haematologist supervision.

Dialysis Notes:

• Haemodialysis: Contraindicated — fondaparinux is not dialyzable; accumulates

• Peritoneal dialysis: Contraindicated

• Severe renal impairment (CrCl <30 mL/min)

• Active clinically significant bleeding

• Acute bacterial endocarditis

• Thrombocytopenia with positive in-vitro test for anti-platelet antibodies in presence of fondaparinux

• History of heparin-induced thrombocytopenia (HIT) with positive anti-PF4 antibody cross-reactivity (rare)

• Hypersensitivity to fondaparinux or any excipient

• Body weight <50 kg for prophylactic indications

• Recent surgery or invasive procedures — increased bleeding risk

• Neuraxial anaesthesia (spinal/epidural) — risk of spinal/epidural haematoma; timing of catheter placement/removal critical

• Concomitant use of anticoagulants or antiplatelets — additive bleeding risk

• Elderly patients (>75 years) — increased bleeding tendency

• Low body weight (<50 kg) for treatment indications — monitor closely

• Recent gastrointestinal ulceration or bleeding

• Diabetic retinopathy

• Uncontrolled severe hypertension

• Recent intracranial haemorrhage

Aspect Details

Safety Category Limited human data; does not cross placenta significantly; no teratogenicity reported in animal studies

Preferred Alternatives Low molecular weight heparin (LMWH) — enoxaparin, dalteparin — preferred in Indian obstetric practice

When to Use Reserved for patients with documented HIT requiring anticoagulation; specialist input essential

Monitoring Anti-Xa levels; clinical bleeding assessment; fetal monitoring as per obstetric protocol

Aspect Details

Compatibility Likely compatible — minimal oral bioavailability in infant

Drug Levels in Milk Expected to be low (large molecular weight, poor oral absorption)

Preferred Alternatives LMWH (enoxaparin) preferred due to more extensive safety data

Infant Monitoring Observe for unusual bruising or bleeding (unlikely)

Aspect Recommendation

Starting dose Same as adult dosing (weight-based for treatment; 2.5 mg for prophylaxis)

Titration Not applicable

Special Risks Increased bleeding risk; age-related decline in renal function (even with normal serum creatinine); falls risk

Monitoring Calculate eGFR before each prescription; more frequent clinical assessment for bleeding

Interacting Drug Effect/Risk Management

Other anticoagulants (warfarin, DOACs, UFH, LMWH) Significant additive bleeding risk Avoid concurrent use except during planned transition; overlap with warfarin only as per protocol

NSAIDs (ibuprofen, diclofenac, naproxen) Increased gastrointestinal and systemic bleeding Avoid combination; if essential, use shortest duration with gastroprotection

Antiplatelet agents (aspirin, clopidogrel, prasugrel, ticagrelor) Additive bleeding risk Use with caution in ACS; monitor closely for bleeding

Neuraxial anaesthesia Risk of spinal/epidural haematoma → paralysis Avoid fondaparinux for at least 36–42 hours before catheter placement; delay next dose until 6–12 hours after catheter removal

Interacting Drug Effect/Risk Management

SSRIs/SNRIs (fluoxetine, sertraline, venlafaxine) Increased bleeding tendency (impaired platelet function) Monitor for clinical bleeding

Systemic corticosteroids Increased gastrointestinal bleeding risk Gastroprotection; clinical vigilance

Dextran Additive bleeding Avoid concurrent use if possible

Herbal supplements (ginkgo, garlic, ginger in high doses) May potentiate bleeding Counsel patients to avoid

• Injection site reactions (pain, bruising, erythema, induration)

• Minor bleeding (epistaxis, gum bleeding, haematuria, ecchymosis)

• Anaemia

• Mild thrombocytopenia

• Transient elevation of hepatic transaminases

• Headache

• Nausea

Adverse Effect Clinical Features Action Required

Major haemorrhage Intracranial, gastrointestinal, retroperitoneal, or surgical site bleeding Immediate discontinuation; supportive care; recombinant Factor VIIa may be considered (no specific antidote)

Spinal/Epidural haematoma Back pain, sensory/motor deficits, bowel/bladder dysfunction Urgent neurosurgical consultation; imaging

Severe thrombocytopenia Platelet count <50,000/µL Discontinue; evaluate for alternative causes

Hypersensitivity reactions Angioedema, urticaria, anaphylaxis (rare) Discontinue permanently

Note: No specific antidote available for fondaparinux. Protamine does NOT reverse its effect.

During treatment Platelet count twice weekly for first 2 weeks; clinical assessment for bleeding; renal function if prolonged therapy

Anti-Xa monitoring Not routinely required in adults; indicated in renal impairment (eGFR 30–50), extremes of body weight, paediatric use, pregnancy

If transitioning to warfarin Daily INR until stable ≥2.0 for 24 hours

• Arixtra (GlaxoSmithKline)

• Fondared (Reddy's)

• Fondazest (Zest Pharma)

• Fondinex (Intas)

• Fondawell (Wellona Pharma)

• Fonda (Glenmark)

2.5 mg prefilled syringe ₹250–700 per syringe

5 mg prefilled syringe ₹300–750 per syringe

7.5 mg prefilled syringe ₹350–800 per syringe

10 mg prefilled syringe ₹400–900 per syringe

Note: Not under NPPA/NLEM price control. Primarily available in tertiary care hospitals and specialty pharmacies. Government supply limited.

1. HIT-safe alternative: Fondaparinux is a preferred parenteral anticoagulant in patients with confirmed or suspected heparin-induced thrombocytopenia (HIT) — no cross-reactivity with HIT antibodies in most cases.

1. Not interchangeable with LMWH: Dosing is distinct from enoxaparin; always use fondaparinux-specific weight-based protocols for treatment.

1. Renal function is critical: Always calculate eGFR before prescribing — contraindicated if CrCl <30 mL/min. Even borderline renal impairment increases bleeding risk.

1. Neuraxial anaesthesia timing: Allow at least 36–42 hours after last fondaparinux dose before spinal/epidural catheter placement; wait 6–12 hours after catheter removal before next dose.

1. No reversal agent: Unlike heparin (protamine) or DOACs (specific reversal agents), there is no approved antidote for fondaparinux. Recombinant Factor VIIa may be considered in life-threatening bleeding.

1. Prophylaxis weight restriction: Avoid 2.5 mg prophylactic dose in patients <50 kg — increased bleeding risk without dose reduction option.

Fondaparinux; anticoagulant; Factor Xa inhibitor; VTE prophylaxis; DVT treatment; PE treatment; HIT-safe; renal-contraindicated; surgery prophylaxis; injectable anticoagulant

RxIndia v1.0 — 02 Apr 2025

• CDSCO approved product inserts

• Indian Pharmacopoeia (IP)

• API Textbook of Medicine

• AIIMS Hospital Formulary and Anticoagulation Protocol

• ICMR/National Guidelines for VTE prevention in surgical patients

• Harrison's Principles of Internal Medicine

• Goodman & Gilman's The Pharmacological Basis of Therapeutics

• OASIS-5 and OASIS-6 RCTs (for off-label ACS indications)

• WHO EML (supportive paediatric dosing reference)