Dalteparin Sodium

Approved Indications:

• Prevention of Deep Vein Thrombosis (DVT):
• In patients undergoing abdominal surgery with high thromboembolic risk.
• In patients undergoing orthopedic surgery (e.g., hip or knee replacement).
• Treatment of Deep Vein Thrombosis and Pulmonary Embolism (PE):
• For initial treatment and secondary prevention of venous thromboembolism (VTE).
• Prevention of Ischemic Complications:
• In patients with unstable angina or non-Q-wave myocardial infarction.
• Dialysis:
• Prevention of clotting in extracorporeal circuits during hemodialysis.

Clinically Accepted Off-label Uses:

• Thromboprophylaxis in medical patients at risk (e.g., hospitalized immobilized patients).
• Prevention of clotting in extracorporeal membrane oxygenation (ECMO) or continuous renal replacement therapy (CRRT).
• Adjunctive use in acute coronary syndromes.

Adults:

• DVT Prophylaxis in Surgery:
• 2,500 to 5,000 IU subcutaneously once daily, starting 1 to 2 hours preoperatively or 4 to 8 hours postoperatively.
• Treatment of DVT/PE:
• Initial: 200 IU/kg subcutaneously once daily or 100 IU/kg twice daily.
• Adjust dose based on anti-Xa activity if needed.
• Continue for 5–10 days, overlapping with oral anticoagulants if applicable.
• Prevention in Unstable Angina/Non-Q-Wave MI:
• 120 IU/kg subcutaneously every 12 hours, max 10,000 IU per dose, plus aspirin.
• Hemodialysis:
• Initial dose of 2,500 IU IV bolus or 5,000 IU subcutaneously before dialysis session; adjust as needed.

Pediatrics:

• Dose individualized based on weight and indication; anti-Xa monitoring recommended.

Elderly:

• Use standard dosing; monitor renal function and bleeding risk.

Renal Impairment:

• Use caution in severe renal impairment (creatinine clearance <30 mL/min); dose adjustment and monitoring advised.

Hepatic Impairment:

• Limited data; use with caution.

Route: Subcutaneous injection or intravenous (for dialysis).

Dalteparin sodium is a low molecular weight heparin (LMWH) that exerts its anticoagulant effect primarily by potentiating the activity of antithrombin III (ATIII). This potentiation leads to selective inhibition of activated factor Xa, with lesser effect on thrombin (factor IIa). Inhibition of factor Xa prevents conversion of prothrombin to thrombin, thereby reducing fibrin formation and preventing thrombus development. Dalteparin’s predictable pharmacokinetics allow for subcutaneous administration without routine coagulation monitoring.

Absorption:

• Rapid and nearly complete after subcutaneous administration; bioavailability approximately 87%.

Distribution:

• Volume of distribution approximately 4.3 L; does not bind significantly to plasma proteins except ATIII.

Metabolism:

• Partially metabolized in the liver.

Elimination:

• Primarily renal excretion; half-life approximately 3–5 hours after subcutaneous dose.

Onset of Action:

• Anticoagulant effect begins within 2–4 hours post subcutaneous injection.

• Pregnancy:
• Category B (FDA): No evidence of risk in animal studies; widely used clinically.
• Preferred anticoagulant in pregnancy due to inability to cross placenta.
• Lactation:
• Excretion into breast milk is negligible; considered safe during breastfeeding.

• Primary Class: Anticoagulant
• Subclass: Low molecular weight heparin (LMWH)

• Known hypersensitivity to dalteparin, heparin, or pork products.
• Active major bleeding or high risk of bleeding.
• Severe thrombocytopenia or heparin-induced thrombocytopenia (HIT).
• Severe uncontrolled hypertension.
• Recent or impending neuraxial anesthesia or spinal puncture without appropriate precautions.

• Bleeding Risk: Monitor for signs of hemorrhage; adjust dose in renal impairment.
• Heparin-Induced Thrombocytopenia (HIT): Discontinue if HIT suspected; monitor platelet counts regularly.
• Spinal/Epidural Anesthesia: Risk of epidural hematoma; follow guidelines for timing of anticoagulation and catheter placement/removal.
• Renal Impairment: Dose adjustment and careful monitoring required.
• Thrombocytopenia: Monitor platelet counts regularly.
• Use with caution in patients with bleeding disorders or on concomitant anticoagulants/antiplatelets.

Common:

• Injection site reactions (pain, bruising, erythema)
• Mild bleeding (e.g., gum bleeding, epistaxis)
• Thrombocytopenia (mild)

Serious:

• Major bleeding (gastrointestinal, intracranial)
• Heparin-induced thrombocytopenia (HIT)
• Osteoporosis with prolonged use
• Allergic reactions (rare)

• Other Anticoagulants/Antiplatelets: Increased bleeding risk.
• Nonsteroidal Anti-inflammatory Drugs (NSAIDs): Increased bleeding risk.
• Thrombolytics: Additive anticoagulant effect; caution.
• Vitamin K Antagonists (Warfarin): Requires monitoring during overlap.
• CYP450 interactions: Minimal impact expected.

• Guidelines endorse LMWH including dalteparin as first-line anticoagulants for VTE treatment and prophylaxis in cancer patients and perioperative settings.
• Recommendations emphasize anti-Xa monitoring in renal impairment and obesity.
• Updated protocols for neuraxial anesthesia to minimize bleeding risk.
• WHO includes dalteparin in its Essential Medicines list.

• Store at 20°C to 25°C (68°F to 77°F).
• Protect from light and moisture.
• Do not freeze.
• Keep in original packaging until use.
• Prefilled syringes should be handled with care.