INHIXA 6000 IU 60MG/0.6ML

Indications

Approved Uses

Treatment of acute deep vein thrombosis (DVT) with or without pulmonary embolism (PE); prophylaxis of venous thromboembolism (VTE) in surgical patients (e.g., abdominal and orthopedic surgery) and in acutely ill medical patients with restricted mobility; management of unstable angina and non-ST-elevation myocardial infarction (UA/NSTEMI); treatment of acute ST-elevation myocardial infarction (STEMI) including patients managed medically and those undergoing PCI; prevention of clotting in extracorporeal circulation during hemodialysis.

Dosage & Administration

Dosing by Condition

DVT/PE treatment: 1 mg/kg SC every 12 hours OR 1.5 mg/kg SC once daily (selected patients). UA/NSTEMI: 1 mg/kg SC every 12 hours with antiplatelet therapy. STEMI (<75 years): 30 mg IV bolus then 1 mg/kg SC, followed by 1 mg/kg SC every 12 hours; STEMI (≥75 years): no IV bolus, 0.75 mg/kg SC every 12 hours (dose caps for first doses per protocol). VTE prophylaxis: commonly 40 mg SC once daily for abdominal surgery/medical patients; orthopedic prophylaxis regimens vary by region/protocol (e.g., 30 mg SC every 12 hours or 40 mg SC once daily). Hemodialysis (extracorporeal circuit): typically ~1 mg/kg into the arterial line at start of session (protocol-dependent).

Initial Dose

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

Maintenance Dose

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

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

Severe renal impairment (CrCl <30 mL/min): dose reduction is required (e.g., treatment 1 mg/kg SC once daily; prophylaxis regimens reduced per indication/product labeling); consider anti‑Xa monitoring in renal impairment and in extremes of body weight/pregnancy when clinically indicated. STEMI age ≥75 years: omit the initial IV bolus and use 0.75 mg/kg SC every 12 hours (with dose caps for the first doses per protocol).

How to Take

Subcutaneous (SC): Inject deep SC into the anterolateral or posterolateral abdominal wall (or thigh if needed), alternating left/right sites; administer with the patient lying down; do NOT expel the air bubble from the prefilled syringe; do NOT rub the injection site after injection; do NOT administer intramuscularly. Intravenous (IV): Use only when specifically indicated per protocol (e.g., IV bolus); administer as an IV bolus through an IV line per protocol.

How to Prepare

Ready‑to‑use pre‑filled syringe (0.6 mL); no reconstitution or dilution required-administer as supplied via SC (or IV for specific indications) per protocol.

Side Effects

Common Side Effects

Bleeding; injection-site hematoma/pain/ecchymosis; anemia; thrombocytopenia (including risk of HIT); transient elevations in liver enzymes (AST/ALT).

Side Effect Frequency

Very common (>10%): bleeding/hemorrhage; injection‑site hematoma/bruising; transient elevations of AST/ALT. Common (1-10%): anemia; thrombocytopenia (non‑HIT); injection‑site pain/erythema; nausea. Uncommon (<1%): major bleeding; heparin‑induced thrombocytopenia (HIT) ± thrombosis; hypersensitivity reactions; hyperkalemia; spinal/epidural hematoma; osteoporosis with prolonged use.

Safety & Warnings

Contraindications

Contraindications: active major bleeding; hypersensitivity to enoxaparin/heparin (including pork products) or history of severe hypersensitivity; history of immune-mediated HIT within the past 100 days or with circulating antibodies.

Warnings & Precautions

Key warnings/precautions: boxed warning for spinal/epidural hematoma with neuraxial anesthesia/spinal puncture (monitor neurologic signs); increased bleeding risk (elderly, renal impairment, low body weight, recent surgery/ulcer/hemorrhagic stroke); monitor platelets for HIT; not interchangeable unit-for-unit with UFH/other LMWHs; consider anti-Xa monitoring in special populations; pregnancy with mechanical/prosthetic valves requires specialist management.

Driving Warning

Safe

Drug Interactions

Drug Interactions

Additive bleeding risk with other anticoagulants (warfarin, DOACs, UFH), antiplatelets (aspirin, clopidogrel, etc.), NSAIDs, thrombolytics; use caution with other agents affecting hemostasis (e.g., SSRIs/SNRIs, systemic corticosteroids).

Interaction Severity

MAJOR: concomitant anticoagulants (warfarin, DOACs, heparins) and thrombolytics (e.g., alteplase/tenecteplase) due to major bleeding risk; neuraxial anesthesia/analgesia or spinal puncture (risk of spinal/epidural hematoma). MODERATE: antiplatelet agents (aspirin, clopidogrel, ticagrelor) and NSAIDs (additive bleeding), and other drugs that increase bleeding risk (e.g., SSRIs/SNRIs).

Food Interaction

No restriction

Special Populations

Pregnancy

Consult Doctor

Children

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

Elderly

Patients ≥75 years: standard dosing for prophylaxis; for STEMI, omit IV bolus and reduce to 0.75 mg/kg SC every 12 hours (max 75 mg for first two doses); monitor renal function and signs of bleeding closely

Kidney Impairment

CrCl <30 mL/min: treatment 1 mg/kg SC once daily; prophylaxis 30 mg SC once daily (typical medical/surgical prophylaxis). CrCl ≥30 mL/min: usual dosing; consider monitoring in extremes/high risk.

Storage & Patient Advice

Storage Conditions

Store below 30°C. Do not freeze. Keep in original packaging. No reconstitution required.

Preparation Instructions

Ready‑to‑use pre‑filled syringe (0.6 mL); no reconstitution or dilution required-administer as supplied via SC (or IV for specific indications) per protocol.

Missed Dose

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

Stopping the Medicine

Do not stop or interrupt without prescriber direction; if discontinuing, ensure an appropriate anticoagulation plan/transition to avoid thrombosis.

Overdose

Overdose primarily causes hemorrhage; manage with supportive care and consider protamine sulfate (partial reversal): if <8 hours since last dose give 1 mg protamine per 1 mg enoxaparin, if 8-12 hours give 0.5 mg per 1 mg; anti-Xa activity is only partially neutralized-seek urgent medical care.

Patient Counseling

Use only as prescribed; inject deep SC into abdominal fatty tissue (alternate sites) and do not rub afterward; do not expel the air bubble; avoid IM injections. Seek urgent care for signs of serious bleeding (black/tarry stools, blood in urine, vomiting blood), severe headache/weakness, or after falls/head injury. Tell all clinicians/dentists you are on enoxaparin, especially before surgery or spinal/epidural procedures. Avoid starting aspirin/NSAIDs or other blood thinners unless instructed. Store prefilled syringes below 30°C and do not freeze (per SFDA storage conditions).

Monitoring Requirements

Monitor for bleeding clinically; CBC including hemoglobin/hematocrit and platelet count (baseline and periodically to detect thrombocytopenia/HIT); renal function (SCr/CrCl) for dosing; consider anti‑Xa levels in selected patients (severe renal impairment, pregnancy, extremes of body weight, pediatrics, or unexpected bleeding/thrombosis); consider serum potassium in at‑risk patients (heparin‑induced hyperkalemia); if neuraxial anesthesia/spinal puncture is used, monitor for neurologic impairment.

Pharmacology

Mechanism of Action

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

Onset of Action

After SC injection, peak anti‑Xa activity occurs about 3-5 hours (with anticoagulant effect beginning earlier).

Half-Life

Apparent half‑life of anti‑Xa activity is ~4.5 hours after a single subcutaneous dose and increases to ~7 hours at steady state with repeated dosing.

Excretion

Primarily renal elimination; anti‑Xa activity/metabolites are excreted mainly in urine (with minor fecal/biliary contribution).

Product Information

Available Dosage Forms

Solution for injection in a pre-filled syringe.

Composition per Dose

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

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Cv Drug Class

Anticoagulant

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