Fragmin

dalteparin sodium

Fragmin

FDA Box Warning

Epidural or spinal hematomas may occur in patients who are anticoagulated with low-molecular-weight heparins or heparinoids and are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures. Risk increases with use of indwelling epidural catheters, concomitant use of drugs affecting hemostasis (such as nonsteroidal anti-inflammatory drugs, platelet inhibitors, or other anticoagulants), traumatic or repeated epidural or spinal puncture, or history of spinal deformity or spinal surgery.

Monitor patient frequently for signs and symptoms of neurologic impairment. If these occur, provide urgent treatment.

Consider benefits and risks before neuraxial intervention in patients anti-coagulated or to be anticoagulated for thromboprophylaxis.

Action

Inhibits thrombus and clot formation by blocking factor Xa and thrombin

Availability

Solution for injection (prefilled syringes): 12,500 units/0.5 ml, 15,000 units/0.6 ml, 18,000 units/0.72 ml, 5,000 units/0.2 ml, 7,500 units/0.3 ml, 10,000 units/0.4 ml

Solution for injection (multidose vials): 95,000 units/3.8 ml, 95,000 units/9.5 ml

Solution for injection (single-dose graduated syringe): 10,000 units/1 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. Or, 2,500 international units subcutaneously within 2 hours before surgery, followed by 2,500 international units subcutaneously 4 to 8 hours after surgery (allowing at least 6 hours between doses), followed by 5,000 international units subcutaneously daily for 5 to 10 days. Or, 2,500 international units subcutaneously 4 to 8 hours after surgery, followed by 5,000 international units subcutaneously daily for 5 to 10 days.

Patients with severely restricted mobility during acute illness

Adults: 5,000 international units subcutaneously daily for 12 to 14 days

Extended treatment of symptomatic venous thromboembolism in patients with cancer

Adults: For first 30 days of treatment, 200 international units/kg subcutaneously daily. Total daily dosage shouldn't exceed 18,000 international units. Give approximately 150 international units/kg subcutaneously daily during months 2 through 6. Total daily dosage shouldn't exceed 18,000 international units.

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

• Renal insufficiency

• Thrombocytopenia

Off-label uses

• Systemic anticoagulation

Contraindications

• Hypersensitivity to drug, heparin, pork products, sulfites, or benzyl alcohol

• Active major bleeding

• Thrombocytopenia

• Patients with unstable angina or non-Q-wave myocardial infarction who are undergoing regional anesthesia; cancer patients with symptomatic VTE who are undergoing regional anesthesia

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.

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

• Teach patient proper injection technique if self-administering at home.

• 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.

McGraw-Hill Nurse's Drug Handbook, 7th Ed. Copyright © 2013 by The McGraw-Hill Companies, Inc. All rights reserved

dalteparin

(dal-te-pa-rin) ,

Fragmin

(trade name)

Classification

Therapeutic: anticoagulants
Pharmacologic: antithrombotics
Pregnancy Category: B

Indications

Prevention of venous thromboembolism (deep vein thrombosis (DVT) and/or pulmonary embolism (PE)) in surgical or medical patients.Extended treatment of symptomatic DVT and/or PE in patients with cancer.Prevention of ischemic complications (with aspirin) in patients with:
  • unstable angina,
  • non–Q-wave MI.

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 administration.
Distribution: Unknown.
Metabolism and Excretion: Unknown.
Half-life: 2.1–2.3 hr.

Time/action profile (antithrombotic effect)

ROUTEONSETPEAKDURATION
Subcutrapid4 hrup to 24 hr

Contraindications/Precautions

Contraindicated in: Hypersensitivity to dalteparin, heparin, or pork products; Active major bleeding; Thrombocytopenia related to previous dalteparin therapy.
Use Cautiously in: Patients with severe renal or hepatic impairment; Retinopathy (hypertensive or diabetic); Spinal or epidural anesthesia; Geriatric: Risk of bleeding may be ↑, consider age-related ↓ in renal function and body weight; Obstetric / Lactation / Pediatric: Safety not established; products containing benzyl alcohol should not be used in neonates.
Exercise Extreme Caution in: 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; Active GI bleeding/ulceration; History of thrombocytopenia related to heparin.

Adverse Reactions/Side Effects

Central nervous system

  • dizziness

Gastrointestinal

  • reversible ↑ in liver enzymes

Hematologic

  • bleeding
  • thrombocytopenia

Interactions

Drug-Drug interaction

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

Route/Dosage

DVT Prophylaxis

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

Extended Treatment of Symptomatic VTE in Patients with Cancer

Subcutaneous (Adults) 200 IU/kg once daily (not to exceed 18,000 IU/day) for first 30 days, then 150 IU/kg once daily (not to exceed 18,000 IU/day) for months 2–6.

Angina/Non–Q-wave MI

Subcutaneous (Adults) 120 IU/kg (not to exceed 10,000 IU) q 12 hr with concurrent aspirin.

Renal Impairment

Subcutaneous (Adults) Cancer patients receiving extended treatment of symptomatic VTE with CCr <30 mL/min—Monitor anti-Xa levels (target 0.5–1.5 IU/mL).

Availability

Solution for injection (prefilled syringes): 2500 IU/0.2 mL, 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
Solution for injection (multidose vials): 25,000 IU/mL in 3.8–mL vials

Nursing implications

Nursing 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.
  • Subcutaneous: 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.
    • Special monitoring of clotting times (aPTT) is not necessary.
    • May cause asymptomatic ↑ in transaminase levels (AST, ALT).

Potential Nursing Diagnoses

Ineffective tissue perfusion (Indications)
Risk for injury (Side Effects)

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.
  • Subcutaneous: Administer deep subcut while patient is sitting or lying down. Dalteparin may be injected into the abdominal wall inferior and 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 IM.
  • Syringe Incompatibility: Do not mix with other injections or infusions.

Patient/Family Teaching

  • 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.

Evaluation/Desired Outcomes

  • Prevention of deep vein thrombosis and pulmonary embolism.
  • Prevention of ischemic complications (with aspirin) in patients with unstable angina or non-Q-wave MI.
  • Reduction of recurrence of VTE in patients with cancer.
Drug Guide, © 2015 Farlex and Partners

Fragmin

A brand name for DALTEPARIN SODIUM.
Collins Dictionary of Medicine © Robert M. Youngson 2004, 2005
References in periodicals archive ?
-- The Food and Drug Administration last month approved Pfizer Inc.'s Fragmin (dalteparin sodium) injection, for subcutaneous use, to reduce the recurrence of symptomatic venous thromboembolism (VTE) in pediatric patients one month of age and older.
M2 PHARMA-May 20, 2019-US Food and Drug Administration grants approval to Pfizer's Fragmin injection
M2 EQUITYBITES-May 20, 2019-US Food and Drug Administration grants approval to Pfizer's Fragmin injection
Low molecular weight heparin, therapy with dalteparin, and survival in advanced cancer: the fragmin advanced malignancy outcome study (FAMOUS).
Serial analyses of N-terminal pro-B-type natriuretic peptide in patients with non-ST-segment elevation acute coronary syndromes: a Fragmin and fast Revascularisation during InStability in Coronary artery disease (FRISC)-II substudy.
All patients were administered dalteparin sodium (Fragmin) by subcutaneous injection and diazepam (Normabel) orally at 10 pm the night before surgery.
Upper extremity deep venous thrombosis in cancer patients with venous access devices--prophylaxis with a low molecular weight heparin (Fragmin).
Fragmin. Fragmin, purified from Physarum plasmodium, bound to actin filaments at the barbed end to shorten them in the presence of [Ca.sup.2+].
So I give myself an injection of a drug called Fragmin four hours before a long-haul flight and 24 hours afterwards too, just to prevent any blood clots forming.
Timing of angiography with a routine invasive strategy and long-term outcomes in non-ST-segment elevation acute coronary syndrome: A collaborative analysis of individual patient data from the FRISC II (Fragmin and Fast Revascularization During Instability in Coronary Artery Disease), ICTUS (Invasive Versus Conservative Treatment in Unstable Coronary Syndromes), and RITA-3 (Intervention Versus Conservative Treatment Strategy in Patients With Unstable Angina or Non-ST Elevation Myocardial Infarction) Trials.
After 3 days, his orders were changed to include Fragmin (dalteparin) of 12,500 units subcutaneous daily, Percocet (oxycodone/acetaminophen) of 5- to 325-mg tablet q4h pm; Unasyn (ampicillin-sulbactam) IVPB of 3 g q6h, and Lovenox (enoxaparin) injection of 70 mg subcutaneous daily.