Names and pronunciation
(dahl′ta-pear-in) Fragmin
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Drug reference
(dahl′ta-pear-in) Fragmin
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Func. class.: Anticoagulant
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Chem. class.: Low-molecular-weight heparin
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ACTION: Inhibits factor Xa/IIa (thrombin), resulting in anticoagulation
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USES: Unstable angina/non–Q-wave MI; prevention/treatment of deep venous throm- bosis in abdominal surgery, hip replace- ment, or in those with restricted mobility during acute illness, pulmonary embolism, reduced recurrence of VTE in pediatrics
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Unlabeled uses: VTE prophylaxis in gynecologic surgery
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CONTRAINDICATIONS: Hyper- sensitivity to this product, heparin, or pork products; active major bleeding, hemophilia, leukemia with bleeding, thrombocytopenic purpura, cerebrovas- cular hemorrhage, cerebral aneurysm; those undergoing regional anesthesia for unstable angina, non–Q-wave MI, dalte- parin-induced thrombocytopenia Precautions: Hypersensitivity to benzyl alcohol, pregnancy, breastfeeding, children, recent childbirth, geriatric patients; hepatic disease; severe renal disease; blood dyscra- sias; bacterial endocarditis; acute nephritis; uncontrolled hypertension; recent brain, spine, eye surgery; congenital or acquired disorders; severe cardiac disease; peptic ulcer disease; hemorrhagic stroke; history of HIT; pericarditis; pericardial effusion; recent lumbar puncture; vasculitis; other diseases in which bleeding is possible
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Black Box Warning: Epidural/spinal an- esthesia, lumbar puncture Black Box Warning: Epidural/spinal an- esthesia: neurologic impairment may oc- cur frequently when neuraxial anesthesia has been used; spinal/epidural hematomas may occur with paralysis; numbness in lower extremities; bowel, bladder changes; back pain; notify prescriber immediately; those at greatest risk are taking products that cause increased bleeding risk • Hypersensitivity: fever, skin rash, ur- ticaria; notify prescriber immediately • Needed dosage change q1-2wk; dose may need to be decreased if bleeding occurs • Pregnancy/breastfeeding: no well-con- trolled studies; use only if clearly needed; LMWH does not cross placenta; benefits and risk must be weighed with provider; if used, discontinue 24 hr prior to induction or cesarean delivery; use of multidose vials containing benzyl alcohol is contraindi- cated; use caution in breastfeeding
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SIDE EFFECTS CNS: Intracranial bleeding, fever HEMA: Thrombocytopenia, DIC GU: Hematuria INTEG: Skin necrosis, injection site reaction SYST: Hypersensitivity, hemorrhage, anaphylaxis
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INTERACTIONS Increase: bleeding risk—aspirin, oral anti- coagulants, platelet inhibitors, NSAIDs, salicylates, thrombolytics, some cephalo- sporins, SSRIs; cautious use Drug/Herb Increase: bleeding risk— angelica, capsi- cum, chamomile, dandelion, dan shen, feverfew, garlic, ginger, ginkgo, horse chestnut, avoid using together Drug/Lab Test Increase: AST, ALT Decrease: platelets
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TREATMENT OF OVERDOSE: Protamine sulfate 1% given IV; 1 mg protamine/100 anti-Xa international units of dalteparin given HIGH ALERT
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DOSAGE AND ROUTES DVT/pulmonary embolism (cancer- associated venous thrombosis) • Adult: SUBCUT 200 IU/kg daily during first mo (max single dose 18,000 IU), then 150 IU/kg daily for mo 2-6 (max single dose 18,000 IU), use prefilled sy- ringe that is closest to calculated dose; if platelets are 50,000-100,000/mm3, reduce dose by 2500 units until platelets ≥100,000 mm3; if platelets <50,000/mm3, discon- tinue until >50,000/mm3 Hip replacement surgery/DVT D prophylaxis • Adult: SUBCUT 2500 IU 2 hr prior to surgery and second dose in the evening on the day of surgery (4-8 hr postop), then 5000 IU SUBCUT first postop day and daily × 5-10 days Unstable angina/non–Q-wave MI • Adult: SUBCUT 120 IU/kg q12hr × 5-8 days, max 10,000 IU q12hr × 5-8 days with concurrent aspirin; continue until stable DVT, prophylaxis for abdominal surgery • Adult: SUBCUT 2500 IU 1-2 hr prior to surgery; repeat daily × 5-10 days; for high- risk patients, >3400 IU should be used DVT prophylaxis in patients with severely restricted mobility due to acute illness Adult: SUBCUT 5000 IU daily × 12-14 days VTE in pediatrics. See manufacturer’s information Renal dose • Adult: SUBCUT cancer patient with CCr <30 mL/min, monitor and adjust based on anti–factor Xa during extended treatment VTE prophylaxis in gynecologic sur- gery (unlabeled) • Adults: SUBCUT 2500 IU daily starting 1-2 hr prior to surgery then daily
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Available forms: Prefilled syringes, 2500, 5000 IU/0.2 mL; 7500 IU/0.3 mL; 10,000 IU/mL, 12,500 IU/0.5 mL, 15,000 IU/0.6 mL, 18,000 IU/0.72 mL, 95,000 IU/3.8 mL
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Administer: • Cannot be used interchangeably (unit for unit) with unfractionated heparin or other LMWHs • Do not give IM or IV product route; approved is SUBCUT only; do not mix with other injections or solutions • Have patient sit or lie down; SUBCUT injection may be 2 inches from umbilicus in a U-shape, upper outer side of thigh, or upper outer quadrangle of the buttocks; rotate injection sites • Change injection site daily; use at same time of day
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Assess: • Blood studies (Hct/HB, CBC, platelets, anti-Xa,) during treatment because bleed- ing can occur • Bleeding: bleeding gums, petechiae, ecchymosis, black tarry stools, hematu- ria, epistaxis; decrease in Hct, B/P may indicate bleeding, possible hemorrhage; notify prescriber immediately; product should be discontinued
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Evaluate: • Therapeutic response: absence of DVT/PE, prevention of complication (unstable angina, non-Q-wave MI)
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CLINICAL CONSIDERATIONS
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Patient and caregiver information: • To avoid OTC preparations that con- tain aspirin, other anticoagulants unless approved by prescriber; serious product interactions may occur • To use soft-bristle toothbrush to avoid bleeding gums; to avoid contact sports; to use electric razor; to avoid IM injections • Bleeding: to report any signs of bleed- ing (gums, under skin, urine, stools), un- usual bruising
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PHARMACOKINETICS 87% absorbed, excreted by kidneys, elimination half-life 2-2.3 hr, peak 2-4 hr, onset 1-2 hr, duration up to 24 hr
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• Adult: SUBCUT 200 IU/kg daily during first mo (max single dose 18,000 IU), then 150 IU/kg daily for mo 2-6 (max single dose 18,000 IU), use prefilled sy- ringe that is closest to calculated dose; if platelets are 50,000-100,000/mm3, reduce dose by 2500 units until platelets ≥100,000 mm3; if platelets <50,000/mm3, discon- tinue until >50,000/mm3 Hip replacement surgery/DVT D prophylaxis
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• Adult: SUBCUT 2500 IU 2 hr prior to surgery and second dose in the evening on the day of surgery (4-8 hr postop), then 5000 IU SUBCUT first postop day and daily × 5-10 days Unstable angina/non–Q-wave MI
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• Adult: SUBCUT 120 IU/kg q12hr × 5-8 days, max 10,000 IU q12hr × 5-8 days with concurrent aspirin; continue until stable DVT, prophylaxis for abdominal surgery
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• Adult: SUBCUT 2500 IU 1-2 hr prior to surgery; repeat daily × 5-10 days; for high- risk patients, >3400 IU should be used DVT prophylaxis in patients with severely restricted mobility due to acute illness Adult: SUBCUT 5000 IU daily × 12-14 days VTE in pediatrics. See manufacturer’s information Renal dose
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• Adult: SUBCUT cancer patient with CCr <30 mL/min, monitor and adjust based on anti–factor Xa during extended treatment VTE prophylaxis in gynecologic sur- gery (unlabeled)
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• Adults: SUBCUT 2500 IU daily starting 1-2 hr prior to surgery then daily
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