dalteparin

High Alert

Prevention of deep vein thrombosis (DVT) in patients undergoing hip replacement surgery or abdominal surgery, or medical patients with restricted mobility.
Extended treatment of symptomatic venous thromboembolism (VTE) (DVT and/or pulmonary embolism [PE]) in patients with cancer.
Prevention of ischemic complications (with aspirin) in patients with unstable angina or non-ST-segment elevation MI
Treatment of symptomatic VTE in pediatric patients.

Action ⬆ ⬇

Potentiates the inhibitory effect of antithrombin on Factor Xa and thrombin.

Therapeutic effects:

Prevention of thrombus formation.
Decreased incidence of death or recurrent MI.

Pharmacokinetics ⬆ ⬇

Absorption: Well absorbed (87%) after SUBQ administration.

Distribution: Unknown.

Metabolism/Excretion: Unknown.

Half-Life: 2.1–2.3 hr.

Time/Action Profile ⬆ ⬇

(antithrombotic effect)

ROUTE	ONSET	PEAK	DURATION
SUBQ	rapid	4 hr	up to 24 hr

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Hypersensitivity to dalteparin, heparin, or pork products;
Active major bleeding;
Thrombocytopenia related to previous dalteparin therapy.

Use Cautiously in:

Severe renal or hepatic impairment;
Retinopathy (hypertensive or diabetic);
Spinal or epidural anesthesia;
OB: Use during pregnancy only if potential maternal benefit justifies potential fetal risk;
Lactation: Use while breastfeeding only if potential maternal benefit justifies potential risk to infant;
Pedi: Children 1 mo (safety and effectiveness not established); products containing benzyl alcohol should be used in neonates or infants;
Geri: Risk of bleeding may be in older adults; consider age-related in renal function and body weight.

Spinal/epidural anesthesia or spinal puncture (↑ risk of spinal/epidural hematoma that may lead to long-term or permanent paralysis);
Severe uncontrolled hypertension;
Bacterial endocarditis;
Bleeding disorders;
GI bleeding/ulceration/pathology;
Hemorrhagic stroke;
Recent CNS or ophthalmologic surgery;
History of heparin-induced thrombocytopenia.

Adv. Reactions/Side Effects ⬆ ⬇

GI: reversible ↑ in liver enzymes

Hemat: bleeding, thrombocytopenia

Neuro: dizziness

Interactions ⬆ ⬇

Drug-drug:

Risk of bleeding ↑ by concurrent use of thrombolytics, anticoagulants, or agents that affect platelet function including NSAIDs, clopidogrel, tirofiban, or eptifibatide.

Route/Dosage ⬆ ⬇

DVT Prophylaxis

SC (Adults ): Abdominal surgery: 2500 units 1–2 hr before surgery, then once daily for 5–10 days; High-risk patients undergoing abdominal surgery: 5000 units evening before surgery, then once daily for 5–10 days or 2500 units 1–2 hr before surgery, another 2500 units 12 hour later, then 5000 units daily for 5–10 days; Hip replacement surgery: 2500 units within 2 hr before surgery, another 2500 units evening of the day of surgery ≥6 hr after first dose, then 5000 units daily for 5–10 days (if surgery is in the evening omit second dose day of surgery) or 5000 units evening before surgery, then 5000 units daily for 5–10 days.Medical patients with severely restricted mobility: 5000 units for 12 to 14 days.

Extended Treatment of Symptomatic VTE in Patients with Cancer

SC (Adults ): 200 units/kg once daily (not to exceed 18,000 units/day) for first 30 days, then 150 units/kg once daily (not to exceed 18,000 units/day) for mo 2–6.

Renal Impairment

SC (Adults ): CCr <30 mL/min: Monitor anti-Xa levels (target 0.5–1.5 IU/mL).

Angina/Non ST-Segment-Elevation MI

SC (Adults ): 120 units/kg (not to exceed 10,000 units) every 12 hr with concurrent aspirin.

Treatment of Symptomatic VTE

SC (Children 8–<17 yr): 100 units/kg twice daily
SC (Children 2–<8 yr): 125 units/kg twice daily
SC (Children 1 mo–<2 yr): 150 units/kg twice daily

Availability ⬆ ⬇

Solution for injection (prefilled syringes): 2500 units/0.2 mL; 3500 units/0.28 mL; 5000 units/0.2 mL; 7500 units/0.3 mL; 10,000 units/0.4 mL; 10,000 units/mL; 12,500 units/0.5 mL; 15,000 units/0.6 mL; 16,500 units/0.66 mL; 18,000 units/0.72 mL
Solution for injection (multidose vials): 25,000 units/mL

Assessment ⬆ ⬇

Assess for signs of bleeding and hemorrhage (bleeding gums; nosebleed; unusual bruising; black, tarry stool; hematuria; fall in hematocrit or BP; guaiac-positive stools). Notify health care professional if these occur.
SC: Observe injection sites for hematoma, ecchymosis, or inflammation.

Lab Test Considerations:

Monitor CBC, platelet count, and stools for occult blood periodically during therapy. If thrombocytopenia occurs, monitor closely. If hematocrit ↓ unexpectedly, assess patient for potential bleeding sites. Adults patients with cancer and Pediatric patients with symptomatic VTE : If platelet count ≥50,000 and <100,000/mm³:In adults — decrease dose by 2,500 units/day until platelet count ≥ 100,000/mm³. In children 4 wks to <17 yrs — decrease by 50% per day until platelet count ≥100,000/mm³. If platelet court ≤50,000/mm³: In adults or children— Discontinue dalteparin until platelet count recovers to >50,000/mm³.
- Special monitoring of clotting times (aPTT) is not necessary.
- May cause asymptomatic ↑ in transaminases (AST, ALT).

Implementation ⬆ ⬇

First dose is administered 1–2 hr before surgery.
- Dalteparin cannot be used interchangeably (unit for unit) with unfractionated heparin or other low-molecular-weight heparins.
- Persons with latex allergy should not handle the prefilled syringes; needle shield may contain latex.
SC: Administer deep SUBQ while patient is sitting or lying down. Dalteparin may be injected into the abdominal wall inferior, lateral to the umbilicus, the upper outer side of the thigh, or the upper outer quadrant of the buttock. Rotate injection sites daily. Inject entire length of needle at a 45° or 90° angle while lifting and holding skin between thumb and forefinger. Do not administer solutions that are discolored or contain particulate matter. May be stored at room temperature.
- Do not administer IM.
Do not mix with other injections or infusions.

Patient/Family Teaching ⬆ ⬇

Instruct patient in correct technique for injections, and care and disposal of equipment.
Advise patient to report any symptoms of unusual bleeding or bruising, dizziness, itching, rash, fever, swelling, or difficulty breathing to health care professional immediately.
Instruct patient not to take aspirin or NSAIDs without consulting health care professional while on dalteparin therapy.
Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care professional before taking any other Rx, OTC, or herbal products.
Advise patient to notify health care professional of medication regimen prior to treatment or surgery.
Advise patient to notify health care professional if pregnancy is planned or suspected or if breast feeding.

Evaluation/Desired Outcomes ⬆ ⬇

Prevention of deep vein thrombosis and pulmonary embolism.
Prevention of ischemic complications (with aspirin) in patients with unstable angina or non-ST-segment elevation MI.
Reduction of recurrence of VTE in patients with cancer.

US Brand Names ⬆ ⬇

Code ⬆

NDC Code

0069- Pfizer Laboratories Div Pfizer Inc
- 0069-0195- Fragmin
  - 0069-0195-02- 10 SYRINGE in 1 CARTON (0069-0195-02) > .2 mL in 1 SYRINGE (0069-0195-01)

0069- Pfizer Laboratories Div Pfizer Inc
- 0069-0196- Fragmin
  - 0069-0196-02- 10 SYRINGE in 1 CARTON (0069-0196-02) > .2 mL in 1 SYRINGE (0069-0196-01)

0069- Pfizer Laboratories Div Pfizer Inc
- 0069-0206- Fragmin
  - 0069-0206-02- 10 SYRINGE in 1 CARTON (0069-0206-02) > .3 mL in 1 SYRINGE (0069-0206-01)

0069- Pfizer Laboratories Div Pfizer Inc
- 0069-0217- Fragmin
  - 0069-0217-02- 10 SYRINGE in 1 CARTON (0069-0217-02) > 1 mL in 1 SYRINGE (0069-0217-01)

0069- Pfizer Laboratories Div Pfizer Inc
- 0069-0220- Fragmin
  - 0069-0220-02- 10 SYRINGE in 1 CARTON (0069-0220-02) > .5 mL in 1 SYRINGE (0069-0220-01)

0069- Pfizer Laboratories Div Pfizer Inc
- 0069-0223- Fragmin
  - 0069-0223-02- 10 SYRINGE in 1 CARTON (0069-0223-02) > .6 mL in 1 SYRINGE (0069-0223-01)

0069- Pfizer Laboratories Div Pfizer Inc
- 0069-0228- Fragmin
  - 0069-0228-02- 10 SYRINGE in 1 CARTON (0069-0228-02) > .72 mL in 1 SYRINGE (0069-0228-01)

0069- Pfizer Laboratories Div Pfizer Inc
- 0069-0232- Fragmin
  - 0069-0232-01- 1 VIAL, MULTI-DOSE in 1 CARTON (0069-0232-01) > 3.8 mL in 1 VIAL, MULTI-DOSE

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Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇