CLEXANE 60/MG/0.6/ML 2/PREF.SYR

Indications

Approved Uses

Prevention of venous thromboembolic disease in surgical patients, prevention of VTE in medical patients with restricted mobility, treatment of deep vein thrombosis (DVT) with or without pulmonary embolism, treatment of unstable angina and non-ST-elevation myocardial infarction (NSTEMI), treatment of ST-elevation myocardial infarction (STEMI) managed medically or with percutaneous coronary intervention (PCI), prevention of thrombus formation in extracorporeal circulation during hemodialysis

Off-Label Uses

Antiphospholipid syndrome thromboprophylaxis, cancer-associated thrombosis, thromboprophylaxis during pregnancy in high-risk patients, bridging anticoagulation therapy

Dosage & Administration

Dosing by Condition

DVT prophylaxis (surgical, moderate risk): 20mg SC once daily; DVT prophylaxis (surgical, high risk/orthopedic): 40mg SC once daily; DVT prophylaxis (medical patients): 40mg SC once daily; DVT treatment: 1mg/kg SC every 12 hours or 1.5mg/kg SC once daily; NSTEMI/Unstable angina: 1mg/kg SC every 12 hours with aspirin; STEMI: 30mg IV bolus + 1mg/kg SC, then 1mg/kg SC every 12 hours; Hemodialysis: 1mg/kg intra-arterial into dialysis circuit

Initial Dose

40 mg SC once daily (abdominal/medical prophylaxis) or 30 mg SC every 12 hours (hip/knee replacement prophylaxis) or 1 mg/kg SC every 12 hours (treatment)

Maintenance Dose

1 mg/kg SC every 12 hours or 1.5 mg/kg SC once daily (treatment); 40 mg SC once daily (abdominal/medical prophylaxis) or 30 mg SC every 12 hours (hip/knee replacement prophylaxis)

Maximum Dose

180mg per day (treatment doses); single dose not to exceed 100mg for the first two doses in STEMI

Children's Dosage

Not approved for routine use in children; limited data available - use only under specialist supervision with anti-Xa monitoring

Dose Adjustment Notes

Reduce dose in severe renal impairment (CrCl <30 ml/min); no dose adjustment for mild-moderate renal impairment; weight-based dosing required for treatment indications; obese patients (>100kg) may require anti-Xa monitoring

How to Take

Administer by deep subcutaneous injection into the anterolateral or posterolateral abdominal wall; alternate injection sites; do not expel the air bubble from the prefilled syringe before injection; do not rub the injection site after administration; for IV bolus (STEMI loading dose), administer through an IV line; do not administer intramuscularly

How to Prepare

N/A - ready-to-use prefilled syringe; no reconstitution required

Side Effects

Common Side Effects

Injection site reactions (pain, bruising, hematoma, erythema), bleeding (minor), thrombocytopenia (mild, transient), elevated liver enzymes (AST, ALT), anemia

Side Effect Frequency

Very common (>10%): injection site hematoma, bleeding complications (minor). Common (1-10%): thrombocytopenia (mild), elevated AST/ALT, anemia, injection site pain and erythema. Uncommon (<1%): immune-mediated HIT with thrombosis, major hemorrhage, hyperkalemia, skin necrosis at injection site, osteoporosis (with prolonged use), anaphylaxis

Safety & Warnings

Contraindications

Active major bleeding, hypersensitivity to enoxaparin sodium or heparin or pork-derived products, history of immune-mediated heparin-induced thrombocytopenia (HIT) within the past 100 days or in the presence of circulating antibodies, acute bacterial endocarditis, thrombocytopenia with positive in vitro platelet aggregation test in the presence of enoxaparin

Warnings & Precautions

Risk of spinal/epidural hematoma with neuraxial anesthesia or spinal puncture - monitor for neurological impairment; use with extreme caution in patients with history of HIT; monitor platelet counts in patients receiving >5 days of therapy; use with caution in patients with renal impairment, low body weight (<45kg women, <57kg men), elderly patients, recent surgery, peptic ulcer disease, or hemorrhagic stroke; not interchangeable unit-for-unit with unfractionated heparin or other LMWHs; contains benzyl alcohol in multidose vials - avoid in neonates

Age Restriction

No strict minimum age, but safety and efficacy not established in pediatric patients; use with caution

Driving Warning

Safe

Drug Interactions

Drug Interactions

Anticoagulants and antiplatelets (warfarin, aspirin, clopidogrel, ticagrelor, prasugrel - increased bleeding risk), NSAIDs (increased bleeding risk), thrombolytics (increased hemorrhagic risk), dextran (enhanced anticoagulant effect), systemic corticosteroids (increased risk of bleeding), SSRIs (additive bleeding risk)

Interaction Severity

MAJOR: Warfarin (additive anticoagulation, increased major bleeding risk - monitor INR closely); Thrombolytics such as alteplase/streptokinase (synergistic hemorrhagic risk); Other anticoagulants including fondaparinux, dabigatran, rivaroxaban (additive bleeding risk). MODERATE: Aspirin and NSAIDs (increased bleeding risk - use with caution); Clopidogrel, ticagrelor, prasugrel (additive antiplatelet and anticoagulant effect); SSRIs/SNRIs (increased bleeding risk via platelet inhibition); Systemic corticosteroids (increased GI bleeding risk). MINOR: Dextran (mild enhancement of anticoagulant effect); Vitamin C in high doses (may affect anticoagulant response)

Food Interaction

No restriction

Special Populations

Pregnancy

Caution

Children

Not approved for routine use in children; limited data available - use only under specialist supervision with anti-Xa monitoring

Elderly

Patients ≥75 years with STEMI: omit IV loading dose, use 0.75mg/kg SC every 12 hours (max 75mg for first two doses); for other indications, standard dosing applies but monitor renal function closely as age-related decline in renal function increases drug accumulation risk

Kidney Impairment

CrCl ≥30 ml/min: no dose adjustment required; CrCl <30 ml/min (treatment): 1mg/kg SC once daily; CrCl <30 ml/min (prophylaxis): 30mg SC once daily; CrCl <30 ml/min (STEMI): 1mg/kg SC once daily

Storage & Patient Advice

Storage Conditions

Store below 25°C. Do not freeze. Keep in original packaging. No reconstitution required.

Preparation Instructions

N/A - ready-to-use prefilled syringe; no reconstitution required

Missed Dose

Administer as soon as remembered; do not double the next dose to make up for a missed dose; maintain the regular dosing schedule

Stopping the Medicine

Safe to stop when clinically indicated; abrupt discontinuation does not cause rebound effect, but underlying thrombotic risk must be managed; transition to oral anticoagulants should be planned with physician guidance

Overdose

Symptoms: hemorrhagic complications. Treatment: protamine sulfate IV neutralizes enoxaparin (1mg protamine per 1mg enoxaparin for doses given within 8 hours; 0.5mg protamine per 1mg enoxaparin if >8 hours since dose); protamine neutralizes approximately 60% of anti-Xa activity; seek immediate medical attention

Patient Counseling

Inject into the fatty tissue of the abdomen as instructed; alternate injection sites to minimize bruising; do not rub the injection site after injection; report any unusual bleeding (prolonged bleeding from cuts, blood in urine or stool, unusual bruising, coughing up blood); report any back pain, numbness, tingling, or weakness in legs immediately if you have had spinal anesthesia or a spinal tap; inform all healthcare providers including dentists that you are taking this medication before any procedure; store below 25°C and do not freeze; this medication requires a prescription and regular monitoring by your doctor; do not stop or change your dose without consulting your doctor

Monitoring Requirements

Platelet count before and during therapy (especially days 5-10); anti-Xa levels in special populations (renal impairment, obesity, pregnancy, extremes of weight); renal function (serum creatinine/CrCl) before and during therapy; signs and symptoms of bleeding; neurological status if neuraxial anesthesia used

Pharmacology

Mechanism of Action

Binds to and potentiates antithrombin III, selectively inhibiting Factor Xa and, to a lesser extent, thrombin (Factor IIa), thereby preventing fibrin clot formation and thrombus propagation

Onset of Action

Anti-Xa activity peaks within 3-5 hours after subcutaneous injection

Half-Life

4.5 hours after single SC dose; approximately 7 hours after repeated dosing

Bioavailability

Approximately 100% after subcutaneous injection

Excretion

Primarily renal; approximately 40% of dose excreted in urine (10% as active fragments)

Product Information

Available Dosage Forms

Solution for injection in prefilled syringe, solution for injection in multidose vial

Composition per Dose

Each 0.6ml prefilled syringe: 60mg enoxaparin sodium (equivalent to approximately 6,000 IU anti-Xa activity)

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Cv Drug Class

Anticoagulant

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