Dalteparin Sodium (1 brand name, 1 dosage form, 2 routes)
Available dosage forms: INJECTABLE.
Routes of administration: SUBCUTANEOUS, INJECTION.
Brand Names
- FRAGMIN
Related Health Topics
Boxed Warning
Epidural or spinal hematomas may occur in patients who are anticoagulated with low molecular weight heparins (LMWH) or heparinoids and are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures. Factors that can increase the risk of developing epidural or spinal hematomas in these patients include: • Use of indwelling epidural catheters • Concomitant use of other drugs that affect hemostasis, such as non-steroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, other anticoagulants. • A history of traumatic or repeated epidural or spinal punctures • A history of spinal deformity or spinal surgery • Optimal timing between the administration of FRAGMIN and neuraxial procedures is not known Monitor patients frequently for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary. Consider the benefits and risks before neuraxial intervention in patients anticoagulated or to be anticoagulated for thromboprophylaxis [see Warnings and Precautions (5.1) and Drug Interactions (7)].
Contraindications
FRAGMIN 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) [see Adverse Reactions (6.1)]. •Patients undergoing Epidural/Neuraxial anesthesia, do not administer FRAGMIN [see Boxed Warning and Warnings and Precautions (5.1)]; oAs a treatment for unstable angina and non-Q-wave MI. oFor prolonged VTE prophylaxis. •Patients with prior hypersensitivity to heparin or pork products.
Adverse Reactions
The following clinically significant adverse reactions are described in more detail in other sections of the prescribing information. •Risk of Hemorrhage including Spinal/Epidural Hematomas [see Warnings and Precautions (5.1)] •Thrombocytopenia [see Warnings and Precautions (5.2)] •Benzyl Alcohol Preservative Risk to Premature Infants [see Warnings and Precautions (5.3)]
Drug Interactions
The use of FRAGMIN in patients receiving oral anticoagulants, platelet inhibitors, and thrombolytic agents may increase the risk of bleeding [see Warnings and Precautions (5)].
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).
Overdosage
An excessive dosage of FRAGMIN Injection may lead to hemorrhagic complications. These may generally be stopped by slow intravenous injection of protamine sulfate (1% solution), at a dose of 1 mg protamine for every 100 anti-Xa units of FRAGMIN given. If the APTT measured 2 hours to 4 hours after the first infusion remains prolonged, a second infusion of 0.5 mg protamine sulfate per 100 anti-Xa units of FRAGMIN may be administered. Even with these additional doses of protamine, the APTT may remain more prolonged than would usually be found following administration of unfractionated heparin. In all cases, the anti-Xa activity is never completely neutralized (maximum about 60% to 75%). Take particular care to avoid overdosage with protamine sulfate. Administration of protamine sulfate can cause severe hypotensive and anaphylactoid reactions. Because fatal reactions, often resembling anaphylaxis, have been reported with protamine sulfate, give protamine sulfate only when resuscitation techniques and treatment for anaphylactic shock are readily available. For additional information, consult the labeling of Protamine Sulfate Injection, USP, products.