Classes
DEA Class; Rx
Common Brand Names; Fragmin
- Anticoagulants, Cardiovascular;
- Anticoagulants, Hematologic
Description
Low molecular weight heparin
Used for DVT prophylaxis, treatment of VTE, and prophylaxis of ischemic complications in unstable angina and non-Q-wave MI
Consists of heparin molecules ranging in size from 2,000 to 9,000 daltons (14% to 26% are more than 8,000 daltons)
Indications
Indicated for prophylaxis of ischemic complications in unstable angina and non-Q-wave myocardial infarction, when concurrently administered with aspirin therapy
Indicated for prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE) in patients undergoing hip replacement, in patients undergoing abdominal surgery who are at risk for thromboembolic complications, and in medical patients who are at risk for thromboembolic complications due to severely restricted mobility during acute illness
Indicated for extended treatment of symptomatic venous thromboembolism (VTE) (proximal DVT and/or PE), to reduce recurrence of VTE in adult patients with cancer
Symptomatic venous thromboembolism (DVT/PE) treatment to reduce recurrence in patients with cancer
Off-label: Treatment of thromboembolism during pregnancy, DVT prophylaxis during knee replacement surgery, neurosurgery, trauma, burns, pediatric
Contraindications
Hypersensitivity to dalteparin, heparin or pork products
Active major bleeding, thrombocytopenia associated with antiplatelet antibodies
History of heparin-induced thrombocytopenia or heparin-induced thrombocytopenia with thrombosis
Patients undergoing epidural/neuraxial anesthesia, as a treatment for unstable angina and non-Q-wave MI or for prolonged VTE prophylaxis
Adverse Effects
Injection site hematoma (7-35%)
Thrombocytopenia (10.9-13.6%, patients with cancer )
Injection site pain (4.5-12%)
Major hemorrhage (up to 4.6%)
Increased liver function test (up to 4.3%)
Wound hematoma
Hematuria
Epidural hematoma
Spinal hematoma
Hemorrhagic cerebral infarction
Intracranial hemorrhage
Intrauterine subdural hemorrhage
Thrombocytopenia (<1%, non-cancer indications)
Anaphylactoid reaction (rare)
Osteoporosis
Skin necrosis
Alopecia
Warnings
Risk of epidural/spinal hematoma if used in patients getting epidural/spinal anesthesia which may result in paralysis
Periodic routine complete blood cell counts, including platelet count, blood chemistry, and stool occult blood tests are recommended during treatment
Use caution in patients with history of heparin-induced thrombocytopenia; heparin-induced thrombocytopenia can occur with administration of this drug; the incidence of this complication is unknown at present; in clinical practice, cases of thrombocytopenia with thrombosis, amputation and death have been observed; closely monitor thrombocytopenia of any degree
Do not give IM
Can’t be used interchangeably with other LMW heparins
Multidose vials contain benzyl alcohol as preservative (associated with potentially fatal “Gasping Syndrome” in preemies); when prescribing dalteparin multiple-dose vials in neonates and low-birth-weight infants, consider combined daily metabolic load of benzyl alcohol from all sources including multiple-dose vials (dalteparin contains 14 mg of benzyl alcohol per mL) and other drugs containing benzyl alcohol; minimum amount of benzyl alcohol at which serious adverse reactions may occur not known
If signs or symptoms of spinal hematoma are suspected, initiate urgent diagnosis and treatment including consideration for spinal cord decompression even though such treatment may not prevent or reverse neurological sequelae
Although specific recommendation for timing of a subsequent dose after catheter removal is unknown, consider delaying this next dose for at least four hours, based on a benefit-risk assessment considering both the risk for thrombosis and the risk for bleeding in the context of the procedure and patient risk factors
Pregnancy and Lactation
Available data have not reported a clear association with dalteparin 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 used in pregnancy
Limited published data indicate that the drug is present in human milk in small amounts; no adverse effects on breastfed infant reported; there are no data on effects of drug on milk production; oral absorption of dalteparin is expected to be low, but clinical implications, if any, of this small amount of anticoagulant activity on a breastfed infant are unknown; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed child from the drug or from underlying maternal condition
Maximum Dosage
How supplied
Dalteparin sodium
injectable solution, single-dose prefilled syringe
- 2,500 IU/0.2 mL
- 5,000 IU/0.2 mL
- 7,500 IU/0.3 mL
- 12,500 IU/0.5 mL
- 15,000 IU/0.6 mL
- 18,000 IU/0.72 mL
injection, single-dose graduated syringe
- 10,000 IU/mL
injection, multiple-dose vials
- 95,000 IU/3.8 mL (25,000 IU/mL)