Fragmin

Fragmin,

trademark for a low-molecular-weight heparin (dalteparin sodium).

---

dalteparin sodium Warning - High-alert drug!

Fragmin

Pharmacologic class: Low-molecular-weight heparin

Therapeutic class: Anticoagulant

Pregnancy risk category B

FDA Boxed Warning

• When epidural or spinal anesthesia or spinal puncture is used, patients receiving or scheduled to receive thromboprophylactic drugs may develop epidural or spinal hematoma, which can result in long-term or permanent paralysis. Risk increases with use of indwelling epidural catheter for analgesia administration or concomitant use of drugs affecting hemostasis (such as nonsteroidal anti-inflammatory drugs, platelet inhibitors, or other anticoagulants). Traumatic or repeated epidural or spinal puncture also may increase risk. Before neuraxial intervention, physician should weigh drug's potential benefit against risk.
• Monitor patient frequently for signs and symptoms of neurologic impairment. If these occur, provide urgent treatment.

Action

Inhibits thrombus and clot formation by blocking factor Xa and thrombin

Availability

Solution for injection (prefilled syringes): 2,500 antifactor Xa international units/0.2 ml; 5,000 antifactor Xa international units/0.2 ml; 7,500 antifactor Xa international units/0.3 ml; 10,000 antifactor Xa international units/1 ml; 25,000 antifactor Xa international units/0.2 ml

⊘Indications and dosages

➣ Extended treatment of symptomatic venous thromboembolism (VTE), including proximal deep vein thrombosis (DVT) and pulmonary embolism (PE) to reduce recurrence of VTE in patients with cancer

Adults: Recommended dosing: For first 30 days of treatment, give 200 international units/kg total body weight subcutaneously once daily. Give at dose of approximately 150 International Units/kg subcutaneously once daily during months 2 through 6. Safety and efficacy beyond 6 months not established. Total daily dose shouldn't exceed 18,000 international units.

➣ To prevent DVT, which can lead to PE in patients undergoing hip and abdominal surgery who are at risk for thromboembolic complications

Adults: Abdominal surgery - 2,500 international units subcutaneously 1 to 2 hours before surgery; then once daily for 5 to 10 days. For high-risk patients, 5,000 international units subcutaneously on evening before surgery; then once daily for 5 to 10 days. For cancer patients, 2,500 international units subcutaneously 1 to 2 hours before surgery; repeat dose 12 hours later, then give 5,000 international units subcutaneously every day for 5 to 10 days. Hip replacement surgery - 5,000 international units subcutaneously 10 to 14 hours before surgery; repeat dose 4 to 8 hours after surgery, then give 5,000 international units daily for 5 to 10 days.

➣ To prevent ischemic complications in patients with unstable angina and non-Q-wave myocardial infarction

Adults: 120 international units/kg (not to exceed 10,000 international units) subcutaneously q 12 hours (concurrently with aspirin P.O.) for 5 to 8 days

Dosage adjustment

• Severe renal impairment
• Thrombocytopenia

Off-label uses

• Systemic anticoagulation

Contraindications

• Hypersensitivity to drug, heparin, pork products, sulfites, or benzyl alcohol
• Active major bleeding
• Thrombocytopenia

Precautions

Use cautiously in:
• bacterial endocarditis, bleeding disorders, hemorrhagic stroke, severe uncontrolled hypertension, GI ulcer, severe renal or hepatic insufficiency, hypertensive or diabetic retinopathy
• history of thrombocytopenia from heparin use
• history of congenital or acquired bleeding disorder
• recent CNS or ophthalmologic surgery
• recent GI disease
• spinal or epidural anesthesia
• pregnant or breastfeeding patients
• children (safety not established).

Administration

☞ Know that dalteparin sodium is a high-alert drug.
☞ Administer by subcutaneous route only. Don't give by I.M. or I.V. route.
• To minimize bruising at injection site, massage site with ice before giving injection.
• To give subcutaneous injection, have patient either sit up or lie down. Inject in U-shaped area around navel, upper outer side of thigh, or upper outer quadrangle of buttock. Rotate injection sites daily.
• Don't use interchangeably with heparin or other low-molecular-weight heparins.

Route	Onset	Peak	Duration
Subcut.	20-60 min	3-5 hr	12 hr

Adverse reactions

Hematologic: anemia, ecchymosis, bleeding, thrombocytopenia, hemorrhage

Skin: rash, urticaria

Other: pain, irritation, and hematoma at injection site; fever; edema

Interactions

Drug-drug. Antiplatelet drugs (aspirin, clopidogrel, dipyridamole, ticlopidine), thrombolytics, warfarin: increased risk of bleeding

Drug-diagnostic tests. Alanine aminotransferase, aspartate aminotransferase: increased levels

Platelets: decreased count

Drug-herbs. Anise, arnica, chamomile, clove, feverfew, garlic, ginger, ginkgo, ginseng: increased risk of bleeding

Patient monitoring

☞ Monitor patient for increased risk of bleeding if he's receiving concomitant drugs that affect platelet function.
• Monitor CBC and platelet count.
• Monitor stools for occult blood.

Patient teaching

• Tell patient that drug may cause him to bleed easily. To avoid injury, advise him to brush teeth with soft toothbrush, use electric razor, and avoid scissors and sharp knives.
☞ Advise patient to immediately report bleeding, bruising, dizziness, light-headedness, itching, rash, fever, swelling, or difficulty breathing.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, and herbs mentioned above.