Lupinox Injection (Enoxaparin Sodium)

Lupinox is Lupin Pharmaceuticals' brand of enoxaparin sodium - a Low Molecular Weight Heparin (LMWH) used as a parenteral anticoagulant.

Drug Class & Mechanism

Enoxaparin is produced by cleaving unfractionated heparin (UFH) into shorter fragments (mean molecular weight ~4,000 Da, ~15 saccharide units). It acts via antithrombin (AT) to selectively inhibit Factor Xa (and partially Factor IIa/thrombin). Compared to UFH:

More specific and predictable anticoagulation
Longer half-life - allows once or twice daily SC dosing
Does NOT usually require routine laboratory monitoring (aPTT not affected)
Anti-Factor Xa levels may be needed in renal failure, pregnancy, extremes of body weight (<50 kg or >80 kg)

(Miller's Anesthesia, 10e; Fuster & Hurst's The Heart, 15e)

Available Strengths

Concentration	Presentations
100 mg/mL	20 mg/0.2 mL, 40 mg/0.4 mL, 60 mg/0.6 mL, 80 mg/0.8 mL, 100 mg/1 mL prefilled syringes
150 mg/mL	120 mg/0.8 mL, 150 mg/1 mL prefilled syringes
Multidose vial	300 mg/3 mL (contains benzyl alcohol as preservative)

Lupinox is available in India typically as 20 mg, 40 mg, 60 mg, 80 mg prefilled syringes.

Indications & Dosing

Indication	Dose
DVT prophylaxis - abdominal surgery	40 mg SC once daily (start 2 hrs pre-op), 7-10 days
DVT prophylaxis - hip/knee replacement	30 mg SC every 12 hrs OR 40 mg SC once daily, up to 14 days
DVT prophylaxis - medical/acutely ill	40 mg SC once daily, 6-14 days
Treatment of DVT ± PE (inpatient)	1 mg/kg SC every 12 hrs OR 1.5 mg/kg SC once daily
Treatment of DVT without PE (outpatient)	1 mg/kg SC every 12 hrs
Unstable angina / NSTEMI	1 mg/kg SC every 12 hrs + aspirin, 2-8 days
STEMI (with fibrinolysis, age <75)	30 mg IV bolus + 1 mg/kg SC every 12 hrs
STEMI (age ≥75)	0.75 mg/kg SC every 12 hrs (no IV bolus)

Pharmacokinetics

Route: Subcutaneous (SC); IV bolus for STEMI
Bioavailability: ~100% after SC injection
Half-life: ~4.5 hours (longer than UFH)
Excretion: Primarily renal - dose adjustment needed in CrCl <30 mL/min

Renal impairment dose (CrCl <30 mL/min):

All prophylaxis indications: 30 mg SC once daily
Treatment of DVT/PE: 1 mg/kg SC once daily

Contraindications

Active major bleeding
History of immune-mediated heparin-induced thrombocytopenia (HIT) within past 100 days or with circulating antibodies
Hypersensitivity to enoxaparin, heparin, or pork products
Hypersensitivity to benzyl alcohol (multidose vials)

Key Warnings & Precautions

Spinal/epidural hematoma: Risk increases with neuraxial anesthesia, spinal puncture, indwelling epidural catheters - can cause permanent paralysis
Hemorrhage: Monitor for bleeding; avoid in uncontrolled bleeding
Thrombocytopenia: Monitor platelet counts; discontinue if significant drop
Pregnancy: Use with caution; not recommended with mechanical prosthetic heart valves (risk of valve thrombosis)
Obese patients: Use actual body weight for dosing

Reversal

Protamine sulfate partially reverses enoxaparin:

1 mg protamine neutralizes ~1 mg enoxaparin
Only partially effective - protamine neutralizes the higher MW fractions (those with ≥14 saccharide units) but does NOT completely abolish anti-Xa activity
Give protamine within 8 hours of last enoxaparin dose

(The Harriet Lane Handbook, 23e; Miller's Anesthesia, 10e)

Drug Interactions

NSAIDs, aspirin, clopidogrel, other anticoagulants: Additive bleeding risk
Thrombolytics: Increased hemorrhage risk
SSRIs: Mild increased bleeding risk

Monitoring

Routine aPTT monitoring is not required. Anti-Factor Xa levels should be checked in:

Renal impairment
Pregnancy
Extremes of body weight
Patients not responding as expected

Target anti-Xa level (therapeutic): 0.5-1.0 IU/mL (BID dosing), 1.0-2.0 IU/mL (once daily dosing)

Clinical Evidence

Clinical trials (ESSENCE, ExTRACT-TIMI 25) have shown enoxaparin produces a 15-20% reduction in death or MI at 4-6 weeks versus UFH in NSTE-ACS managed medically, with a small excess in minor bleeding. For STEMI patients receiving fibrinolysis, enoxaparin vs UFH trials showed improved outcomes. (Fuster & Hurst's The Heart, 15e)

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