dalteparin

General

High Alert Medication: This medication bears a heightened risk of causing significant patient harm when it is used in error.

Pronunciation:
dal-te-pa-rin


Trade Name(s)

  • Fragmin

Ther. Class.

anticoagulants

Pharm. Class.

antithrombotics

low molecular weight heparins

Indications

  • Prevention of deep vein thrombosis (DVT) in patients undergoing hip replacement surgery or abdominal surgery or in 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 Effect(s):

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

Pharmacokinetics

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

Distribution: Unknown.

Metabolism and Excretion: Unknown.

Half-life: 2.1–2.3 hr.

TIME/ACTION PROFILE (antithrombotic effect)

ROUTEONSETPEAKDURATION
SUBQrapid4 hrup to 24 hr

Contraindication/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);
  • 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:   Products containing benzyl alcohol should not be used in neonates or infants;
  • Geri:   Risk of bleeding may be ↑ in older adults; consider age-related ↓ in renal function and body weight.

Exercise Extreme Caution in:

  • Black Box:  Neuroaxial spinal anesthesia or spinal puncture, especially if concurrent with an indwelling epidural catheter, drugs affecting hemostasis, history of traumatic/repeated spinal puncture, or spinal deformity (↑ risk of spinal hematoma);
  • Severe uncontrolled hypertension;
  • Bacterial endocarditis;
  • Bleeding disorders;
  • GI bleeding/ulceration/pathology;
  • Hemorrhagic stroke;
  • Recent CNS or ophthalmologic surgery;
  • History of heparin-induced thrombocytopenia.

Adverse Reactions/Side Effects

GI: reversible ↑ in liver enzymes

Hemat: BLEEDING, thrombocytopenia

Neuro: dizziness

* CAPITALS indicate life-threatening.
Underline indicate most frequent.

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

SUBQ (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 hr 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

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

Angina/Non ST-Segment-Elevation MI

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

Treatment of Symptomatic VTE

SUBQ (Children  8–<17 yr): 100 units/kg twice daily.

SUBQ (Children  2–<8 yr): 125 units/kg twice daily.

SUBQ (Children  Gestational age ≥35 wk–<2 yr): 150 units/kg twice daily.

Availability

Solution for injection (prefilled syringes): 2500 units/0.2 mL, 3500 units/0.28 mL Canadian Trade name, 5000 units/0.2 mL, 7500 units/0.3 mL, 10,000 units/0.4 mL Canadian Trade name, 10,000 units/mL, 12,500 units/0.5 mL, 15,000 units/0.6 mL, 16,500 units/0.66 mL Canadian Trade name, 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; guaiac-positive stools, ↓ in hematocrit or BP). Notify health care provider if these occur.
  • SUBQ Observe injection sites for hematoma, ecchymosis, or inflammation.

Lab Test Considerations:

Monitor CBC and stools for occult blood periodically during therapy. If thrombocytopenia occurs, monitor closely. If hematocrit ↓ unexpectedly, assess patient for potential bleeding sites.  Adult patients with cancer and pediatric patients with symptomatic VTE:  If platelet count 50,000–100,000/mm3 :  In adults, ↓ dose by 2500 units/day until platelet count ≥ 100,000/mm3 . For gestational age ≥35 wk–<17 yr, ↓ dose by 50% /day until platelet count ≥100,000/mm3 .  If platelet court ≤50,000/mm3 : Discontinue therapy until platelet count recovers to >50,000/mm3 .

  • Monitoring of aPTT is not necessary.
  • Monitor anti-Xa periodically in pediatric patients.
  • May cause asymptomatic ↑ in AST and ALT.

Implementation

  • First dose is administered 1–2 hr before surgery.

    • Cannot be used interchangeably (unit for unit) with unfractionated heparin or enoxaparin.
    • Persons with latex allergy should not handle the prefilled syringes; needle shield may contain latex.
  • SUBQ Administer deep SUBQ while patient is sitting or lying down. Inject 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.

  • Syringe IncompatibilityDo not mix with other injections or infusions.

Patient/Family Teaching

  • Explain purpose and side effects of medication to patient. Advise patient to read  Patient Information  before starting therapy. Instruct patient in correct technique for injections and care and disposal of equipment.
  • Instruct patient to notify health care provider of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care provider before taking any other Rx, OTC, or herbal products. Instruct not take aspirin or NSAIDs without consulting health care provider.
  • Black Box:  Inform patient having had neuraxial anesthesia or spinal puncture to watch for signs and symptoms of spinal or epidural hematoma (numbness or weakness of legs, bowel or bladder dysfunction). Notify health care provider immediately if symptoms occur.
  • Advise patient to report any symptoms of unusual bleeding or bruising, dizziness, itching, rash, fever, swelling, or difficulty breathing to health care provider immediately.
  • Advise patient to notify health care provider of medication regimen prior to treatment or surgery.
  • Rep:  Advise patient to notify health care provider if pregnancy is planned or suspected or if breastfeeding.

Evaluation/Desired Outcomes

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

dalteparinis the Emergency Central Word of the day!