dalteparin injection (Fragmin)

Dalteparin is a low molecular weight heparin (LMWH) similar to enoxaparin (Lovenox) and tinzaparin. Dalteparin is used to treat or prevent blood clots and their complications (deep vein thrombosis or DVT and pulmonary embolism or PE). Deep vein thrombosis is the formation of blood clots in veins deep in a muscle, most often in the legs. Deep vein thrombosis may lead to pulmonary embolism, a condition in which a piece of the clot (the embolus) breaks loose and travels through the veins to the lung. In the lung the clot blocks an artery and prevents the part of the lung that is supplied by the artery from working normally. If the artery that is blocked is a large artery, the embolus can cause sudden death. Patients undergoing hip replacement and other major surgery are at increased risk of deep vein thrombosis and pulmonary embolism. Dalteparin, like other LMWHs is derived from breaking heparin into smaller units. Dalteparin prevents clot formation by accelerating the breakdown of clotting factors Xa and IIa (thrombin) by antithrombin III. Unfractionated heparin, unlike LMWHs, also breaks down clotting factors IX, XI, XII, and plasmin. Unlike heparin, the effect of dalteparin does not need to be monitored with blood tests. The FDA approved dalteparin in December 1994.

What brand names are available for dalteparin injection?

Fragmin

Is dalteparin injection available as a generic drug?

No

Do I need a prescription for dalteparin injection?

Yes

The most frequent adverse reactions are:

• bleeding,
• drop in platelet count,
• bruising,
• pain at injection site, and
• increase in certan factors inliver function tests.

An immune reaction resulting in a drop in platelets and clotting (heparin-induced thrombocytopenia) is very rare, and significantly lower than with heparin use. LMWHs should be avoided in patients with epidural or spinal punctures as there is significant risk of spinal or epidural hematomas resulting in paralysis.

To prevent blood clots in immobile patients at risk for clots or high risk patients undergoing abdominal surgery or hip replacement, the dose is 5000 units subcutaneously (SQ) once daily. In low risk abdominal surgery patients, the dose is 2500 units SQ once daily. To treat clots in cancer patients, the dose is 200 units per kg weight SQ once daily (max 18,000 units) for month 1, followed by 150 units per kg weight SQ once daily (max 18,000 units) during months 2 to 6. To treat clots in unstable angina or heart attack, the dose is 120 units per kg weight (max 10,000 units) every 12 hours.

Combining dalteparin with other blood thinning agents may increase the risk of severe bleeding. Dalteparin should not be combined with urokinase or other anticoagulants such as apixaban (Eliquis), dabigatran (Pradaxa) and rivaroxaban (Xarelto). Therapy should be monitored when used with platelet inhibitors (such as aspirin and clopidogrel [Plavix]), serotonin reuptake inhibitors (such as sertraline [Zoloft] and fluoxetine [prozac, Sarafem, Prozac Weekly]), and nonsteroidal anti-inflammatory drugs (such as ibuprofen). Dalteparin may increase potassium levels, so caution with and monitoring of potassium levels is advised with drugs such as ACE inhibitors (for example, lisinopril [Zestril, Prinivil]), angiotensin II receptor blockers (for example, losartan [Cozaar]), and other drugs like aliskiren, spironolactone (Aldactone), eplerenone, and potassium salts.

Adverse effects were not observed in animal studies, as LMWHs do not cross the placenta. LMWHs are preferred over unfractionated heparin and warfarin (Coumadin) in women who are pregnant. Agents should be discontinued at least 24 hours before planned delivery.

Dalteparin enters breast milk, though oral absorption by the infant is extremely low. The effect of this low level of exposure on the infant is unknown.

What preparations of dalteparin injection are available?

• Single-dosed prefilled syringe: 2500 units (u)/0.2 mL, 5000 u/0.2 mL, 7500 u/0.3 mL, 12,500 u/0.5 mL, 15,000 u/0.6 mL, 18,000 u/0.72 mL
• Single-dose graduated syringe: 10,000 u/mL
• Multiple dose vial: 95,000 u/9.5 mL, 95,000u/3.8 mL

How should I keep dalteparin injection stored?

Store at room temperature, between 20 C to 25 C (68 F to 77 F).