ENDOSA 6000 IU ENOXAPARIN PRE‑FILLED SYRINGESX2

Indications

Approved Uses

Prevention of venous thromboembolism (VTE) in surgical patients (including orthopedic and general surgery) and in acutely ill medical patients with restricted mobility; treatment of deep vein thrombosis (DVT) with or without pulmonary embolism (PE); prevention of ischemic complications in unstable angina and non-Q-wave myocardial infarction (NSTEMI); treatment of acute ST-elevation myocardial infarction (STEMI).

Off-Label Uses

Common off-label uses include anticoagulation in pregnancy (VTE treatment/prophylaxis), antiphospholipid syndrome management (often with/without aspirin depending on scenario), peri-procedural bridging anticoagulation, and treatment/prophylaxis of cancer-associated thrombosis in selected settings.

Dosage & Administration

Dosing by Condition

DVT Prophylaxis (Abdominal Surgery): 40mg SC once daily. DVT Prophylaxis (Knee/Hip Surgery): 30mg SC every 12 hours. DVT/PE Treatment: 1mg/kg SC every 12 hours or 1.5mg/kg SC once daily. Unstable Angina/NSTEMI: 1mg/kg SC every 12 hours with aspirin. STEMI (<75 years): 30mg IV bolus plus 1mg/kg SC, then 1mg/kg SC every 12 hours.

Initial Dose

1mg/kg SC every 12 hours (treatment) or 40mg SC once daily (prophylaxis)

Maintenance Dose

For DVT treatment: 1mg/kg subcutaneously every 12 hours or 1.5mg/kg once daily.

Maximum Dose

For this 60 mg/0.6 mL pre-filled syringe (subcutaneous): do not exceed the prescribed regimen. Typical maximum treatment dosing is 1 mg/kg subcutaneously every 12 hours OR 1.5 mg/kg subcutaneously once daily (use actual body weight; avoid exceeding weight-based dosing).

Dose Adjustment Notes

Dose adjustment is required in severe renal impairment (CrCl <30 mL/min) for both prophylaxis and treatment regimens; in mild-moderate renal impairment, routine adjustment is generally not required but bleeding risk is higher and clinical monitoring is advised. Consider anti-Xa monitoring in special populations (pregnancy, extremes of body weight, severe renal impairment) when clinically indicated.

How to Take

For subcutaneous use only (per SFDA route). Inject into the anterolateral or posterolateral abdominal wall; alternate left/right sites. Do not expel the air bubble from the pre-filled syringe. Insert the full needle length at 90° into a pinched skin fold; keep the skin fold throughout injection. Do not rub the injection site after injection. Do not administer intramuscularly.

How to Prepare

Ready-to-use pre-filled syringe for subcutaneous injection; visually inspect solution for particulate matter/discoloration and do not use if present.

Side Effects

Common Side Effects

Bleeding (including minor bleeding), injection-site reactions (pain, bruising, hematoma/erythema), thrombocytopenia (including risk of HIT), anemia, and transient elevations in liver aminotransferases (AST/ALT); nausea can occur.

Safety & Warnings

Contraindications

Active major bleeding; hypersensitivity to enoxaparin/heparin/pork products; history of immune-mediated HIT within the past 100 days or presence of circulating anti-platelet antibodies (HIT); (formulation-specific) hypersensitivity to benzyl alcohol only if the product contains it (typically multi-dose vials, not pre-filled syringes).

Warnings & Precautions

Bleeding risk; boxed warning for spinal/epidural hematoma with neuraxial anesthesia/spinal puncture; monitor platelets for HIT; caution in renal impairment/elderly/extremes of body weight and perioperative patients; not interchangeable unit-for-unit with other heparins/LMWHs; consider hyperkalemia risk; benzyl alcohol warning only if present in the formulation (typically multi-dose vials).

Age Restriction

No specific age restriction; enoxaparin is used in pediatrics (including neonates) with weight-based dosing, but this pre-filled syringe is not pediatric-friendly and benzyl alcohol warning applies only to multi-dose vials/preservative-containing products (not typical for pre-filled syringes).

Drug Interactions

Drug Interactions

Additive bleeding risk with other anticoagulants (warfarin, DOACs, UFH), antiplatelets (aspirin, clopidogrel), NSAIDs, thrombolytics; also increased bleeding risk reported with SSRIs/SNRIs and other agents affecting hemostasis.

Interaction Severity

MAJOR: Concomitant anticoagulants (e.g., warfarin, DOACs, other heparins) and thrombolytics (e.g., alteplase) due to markedly increased bleeding risk. MODERATE: Antiplatelet agents (e.g., aspirin, clopidogrel) and NSAIDs (e.g., ibuprofen/diclofenac) due to increased bleeding risk; SSRIs/SNRIs may also increase bleeding risk. (Avoid/limit combinations unless clearly indicated and closely monitored.)

Special Populations

Kidney Impairment

CrCl <30 mL/min: reduce to 1 mg/kg SC once daily for treatment indications; prophylaxis commonly reduced (e.g., 30 mg SC once daily for general prophylaxis; some orthopedic regimens use 30 mg once daily); STEMI regimens also require modification (no IV bolus in severe renal impairment and adjusted maintenance per labeling).

Storage & Patient Advice

Preparation Instructions

Ready-to-use pre-filled syringe for subcutaneous injection; visually inspect solution for particulate matter/discoloration and do not use if present.

Missed Dose

Take/administer the missed dose as soon as remembered; if it is close to the time of the next scheduled dose, skip the missed dose and resume the regular schedule. Do not double doses.

Stopping the Medicine

Do not stop without prescriber direction; stopping early increases thrombosis risk, and any transition to another anticoagulant should be planned.

Overdose

Primary risk is major bleeding; management includes stopping enoxaparin, supportive measures, and protamine sulfate (partial reversal of anti-Xa activity; ~1 mg protamine per 1 mg enoxaparin if recent, with reduced dosing if time elapsed) with urgent medical evaluation.

Patient Counseling

Use exactly as prescribed (prescription-only per SFDA). Inject subcutaneously in the abdomen as instructed; rotate sites; do not expel the air bubble; do not rub after injection; never inject into muscle. Seek urgent care for signs of bleeding (e.g., black/tarry stools, blood in urine, prolonged bleeding, coughing/vomiting blood) or neurologic symptoms after spinal/epidural procedures (back pain, numbness/weakness). Tell all healthcare providers/dentists you are on enoxaparin before procedures and avoid new NSAIDs/antiplatelets unless advised. Store below 30°C and do not freeze (per SFDA storage).

Monitoring Requirements

Routine anti-Xa monitoring is not required for most patients. Monitor for bleeding clinically; check platelet count at baseline and periodically during therapy to detect HIT; assess renal function (SCr/CrCl) especially in older adults or renal impairment; consider anti-Xa levels in selected patients (severe renal impairment, pregnancy, extremes of body weight) when results will change management; monitor neurologic status if neuraxial anesthesia/spinal puncture is used; consider potassium monitoring in at-risk patients (e.g., diabetes, renal impairment, prolonged therapy).

Pharmacology

Mechanism of Action

Enoxaparin potentiates antithrombin (ATIII) activity, leading to preferential inhibition of factor Xa and lesser inhibition of thrombin (factor IIa), thereby reducing fibrin formation and thrombus propagation.

Onset of Action

After subcutaneous administration, peak anti-factor Xa activity occurs about 3-5 hours (approximately 4 hours).

Duration of Effect

Anti-factor Xa activity after subcutaneous dosing is typically detectable for about 12 hours (supporting q12h regimens), with clinically meaningful activity persisting longer with once-daily regimens.

Half-Life

Elimination half-life after SC dosing is ~4.5 hours after a single dose and ~7 hours at steady state (after repeated dosing).

Bioavailability

Approximately 90% bioavailability after subcutaneous administration (based on anti-Xa activity).

Metabolism

Enoxaparin is primarily excreted unchanged by the kidneys via glomerular filtration.

Excretion

Primarily renal elimination; a substantial fraction of anti-Xa activity/metabolites is recovered in urine, and clearance is reduced in renal impairment.

Protein Binding

Lower, non-specific plasma protein binding than unfractionated heparin; binds specifically to antithrombin (AT) to exert anti-Xa activity (a single fixed % such as '80%' is not a reliable/standard label value).

Product Information

Available Dosage Forms

Solution for injection in a pre-filled syringe.

Composition per Dose

Each pre-filled syringe (0.6ml): Enoxaparin sodium 60mg (6000 IU anti-Xa activity)

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Cv Drug Class

Anticoagulant

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