Dalteparin Sodium

What it is and how it works

Mechanism of Action Dalteparin is a low molecular weight heparin with antithrombotic properties. It acts by enhancing the inhibition of Factor Xa and thrombin by antithrombin. In humans, dalteparin potentiates preferentially the inhibition of coagulation Factor Xa, while only slightly affecting the activated partial thromboplastin time (APTT).

Indications

is a low molecular weight heparin (LMWH) indicated for • Prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction • Prophylaxis of deep vein thrombosis (DVT) in abdominal surgery, hip replacement surgery or medical patients with severely restricted mobility during acute illness • Extended treatment of symptomatic venous thromboembolism (VTE) to reduce the recurrence in adult patients with cancer. In these patients, the FRAGMIN therapy begins with the initial VTE treatment and continues for six months • Treatment of symptomatic venous thromboembolism (VTE) to reduce the recurrence in pediatric patients from birth (gestational age at least 35 weeks) • Limitations of Use FRAGMIN is not indicated for the acute treatment of VTE Prophylaxis of Ischemic Complications in Unstable Angina and Non-Q-Wave Myocardial Infarction FRAGMIN Injection is indicated for the prophylaxis of ischemic complications in unstable angina and non-Q-wave myocardial infarction, when concurrently administered with aspirin therapy .

Dosage and administration (summary)

Indication Dosing Regimen Unstable angina and non-Q-wave MI 120 units/kg subcutaneous every 12 hours (with aspirin) DVT prophylaxis in abdominal surgery 2,500 units subcutaneous once daily or 5,000 units subcutaneous once daily or 2,500 units subcutaneous followed by 2,500 units subcutaneous 12 hours later and then 5,000 units subcutaneous once daily DVT prophylaxis in hip replacement surgery Postoperative start – 2,500 units subcutaneous 4 hours to 8 hours after surgery, then 5,000 units subcutaneous once daily, or Preoperative start – day of surgery 2,500 units subcutaneous 2 hours before surgery followed by 2,500 units subcutaneous 4 hours to 8 hours after surgery, then 5,000 units subcut…

Contraindications

is contraindicated in: • Patients with active major bleeding. • Patients with a history of heparin induced thrombocytopenia or heparin induced thrombocytopenia with thrombosis. • Patients with prior hypersensitivity to dalteparin sodium (e.g., pruritis, rash, anaphylactic reactions) . • Patients undergoing Epidural/Neuraxial anesthesia, do not administer FRAGMIN ; o As a treatment for unstable angina and non-Q-wave MI. o For prolonged VTE prophylaxis.

Warnings and precautions

• Hemorrhage: Use caution in conditions with increased risk of hemorrhage • Thrombocytopenia: Monitor thrombocytopenia of any degree closely • Benzyl Alcohol Preservative: Do not use multiple-dose formulations in neonates and infants as they contain benzyl alcohol • Laboratory Tests: Periodic blood counts recommended Risk of Hemorrhage including Spinal/Epidural Hematomas Spinal or epidural hemorrhage and subsequent hematomas can occur with the associated use of low molecular weight heparins or heparinoids and neuraxial (spinal/epidural) anesthesia or spinal puncture.

Pregnancy

Pregnancy Risk Summary Available data from published literature and postmarketing reports have not reported a clear association with FRAGMIN and adverse developmental outcomes. There are risks to the mother associated with untreated VTE in pregnancy, and a potential for adverse effects on the preterm infant when FRAGMIN is used in pregnancy (see Cl…

Storage and supply

Store at 20°C to 25°C (68°F to 77°F); excursion permitted between 15°C to 30°C (59°F to 86°F) . Latex Allergy: The needle shield of the prefilled syringe may contain natural rubber latex .

Source: Dalteparin Sodium (Fragmin) — US FDA prescribing information, 2025-09-30, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.