INHIXA 80/MG/0.8/ML 2/PREF.SYR

Indications

Approved Uses

VTE prophylaxis in surgical patients (including abdominal and orthopedic surgery) and in acutely ill medical patients with restricted mobility; treatment of acute DVT with or without PE (inpatient and, where appropriate, outpatient); prevention of ischemic complications in unstable angina and NSTEMI; treatment of acute STEMI.

Dosage & Administration

Dosing by Condition

Treatment of DVT/PE: 1 mg/kg SC every 12 hours OR 1.5 mg/kg SC once daily; VTE prophylaxis-general surgery/medical patients: 40 mg SC once daily (typical) with renal adjustment as needed; VTE prophylaxis-hip replacement: 40 mg SC once daily (or 30 mg SC q12h in some regions) and knee replacement: 30 mg SC q12h (common regimen); Unstable angina/NSTEMI: 1 mg/kg SC q12h with antiplatelet therapy; STEMI: 30 mg IV bolus then 1 mg/kg SC, followed by 1 mg/kg SC q12h (with age/renal-related modifications and first two SC doses capped in some labeling).

Initial Dose

1mg/kg SC every 12 hours (for DVT/PE treatment); 40mg SC once daily (for VTE prophylaxis)

Maintenance Dose

1mg/kg SC every 12 hours or 1.5mg/kg SC once daily depending on indication

Maximum Dose

No single absolute maximum dose is defined; dosing is indication- and weight-based, and very high weights may warrant anti-Xa monitoring rather than a fixed cap.

Dose Adjustment Notes

Severe renal impairment (CrCl <30 mL/min): reduce treatment dosing to 1 mg/kg SC once daily (instead of q12h) and use reduced prophylaxis dosing per indication/product labeling (commonly 30 mg SC once daily for surgical/medical prophylaxis); consider anti-Xa monitoring in special populations (pregnancy, extremes of body weight, significant renal dysfunction) and monitor renal function.

Side Effects

Common Side Effects

Bleeding; injection-site reactions (pain, bruising, hematoma, erythema); anemia; thrombocytopenia (including risk of HIT); transient elevations in liver enzymes (AST/ALT); less commonly nausea/diarrhea and peripheral edema.

Safety & Warnings

Contraindications

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

Warnings & Precautions

Key warnings/precautions: bleeding risk; spinal/epidural hematoma risk with neuraxial anesthesia/spinal puncture (monitor neurologic signs); not interchangeable unit-for-unit with UFH/other LMWHs; caution/adjust in renal impairment; monitor platelets for HIT; caution in elderly and low body weight; avoid IM injection. Benzyl alcohol warning applies to multi-dose vials, not this SFDA-listed prefilled syringe.

Age Restriction

No fixed minimum age in labeling; pediatric/neonatal use is off-label and should be under specialist supervision. Avoid benzyl-alcohol-containing multi-dose vials in neonates (not applicable to this prefilled syringe product).

Drug Interactions

Interaction Severity

MAJOR: concomitant anticoagulants (e.g., warfarin, DOACs, other heparins) and thrombolytics (e.g., alteplase/tenecteplase) due to markedly increased bleeding; MODERATE: antiplatelets (aspirin, P2Y12 inhibitors), NSAIDs, SSRIs/SNRIs, and other agents affecting hemostasis (including some herbal products like ginkgo/garlic) due to additive bleeding risk.

Special Populations

Kidney Impairment

CrCl <30 mL/min: reduce dose (common labeling approach: treatment 1 mg/kg SC once daily; prophylaxis 30 mg SC once daily-some local protocols use 20 mg daily for certain prophylaxis indications). CrCl ≥30 mL/min: no adjustment.

Storage & Patient Advice

Missed Dose

Take/administer the missed dose as soon as remembered; if it is close to 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 removes anticoagulant protection and may increase thrombosis risk-plan transitions/holds (e.g., peri-procedure) with a clinician.

Patient Counseling

Inject SC into abdominal fatty tissue as instructed, rotate sites, do not expel the air bubble, and do not rub the site; avoid activities/medicines that increase bleeding unless prescribed (e.g., NSAIDs) and report unusual bleeding/bruising, black stools, or blood in urine; inform all healthcare providers/dentists before procedures; seek urgent care for symptoms of spinal/epidural hematoma after neuraxial procedures (back pain, numbness/weakness, bowel/bladder changes); store below 30°C and do not freeze (per SFDA storage).

Monitoring Requirements

Monitor for bleeding (clinical signs/symptoms) and hemoglobin/hematocrit as clinically indicated; platelet count at baseline and periodically to detect HIT; renal function (SCr/CrCl) at baseline and during therapy; anti-Xa levels only in selected patients (pregnancy, severe renal impairment, extremes of body weight, pediatrics if applicable); if neuraxial anesthesia/spinal puncture is used, monitor for neurologic impairment (spinal/epidural hematoma).

Pharmacology

Mechanism of Action

Binds to and potentiates antithrombin (ATIII), accelerating inhibition of factor Xa and, to a lesser extent, factor IIa (thrombin), thereby reducing fibrin clot formation.

Onset of Action

After SC administration, peak anti-Xa activity occurs about 3-5 hours (often cited ~4 hours).

Duration of Effect

Anti-factor Xa activity persists for approximately 12 hours after a SC dose (supporting q12h regimens), with clinically relevant activity extending closer to 24 hours in once-daily regimens.

Bioavailability

Approximately 100% after subcutaneous injection

Metabolism

Primarily metabolized in the liver via desulfation and depolymerization to smaller fragments with reduced anticoagulant activity.

Protein Binding

Binds to antithrombin (AT/ATIII) and has lower, less nonspecific plasma protein binding than unfractionated heparin (not ‘minimal’ overall binding).

Product Information

Composition per Dose

Each 0.8ml pre-filled syringe: Enoxaparin sodium 80mg (equivalent to approximately 8,000 IU anti-Xa activity)

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Cv Drug Class

Anticoagulant

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