dalteparin (Rx)

Brand and Other Names:Fragmin
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Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

injectable solution

  • 10,000 International Units/mL
  • 25,000 International Units/mL

prefilled syringe

  • 2500 International Units/0.2mL
  • 5000 International Units/0.2mL
  • 7500 International Units/0.3mL
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Extended VTE Treatment in Patients with Cancer

200 units IU/kg SC qDay for 30 days, THEN 

Months 2-6: 150 units/kg SC qDay

Not to exceed 18,000 units daily

Treatment Duration: 5-10 days usual

Severe Mobility Restriction: 5000 units SC qDay

Thrombocytopenia: Dose Reduction

  • Plts 50,000-100,000/mm³: Reduce daily dose by 2500 units until 100,000/mm³
  • Plts <50,000/mm³, discontinue until >50,000/mm³

Renal Impairment, Severe: Dose Reduction

  • CrCl < 30 mL/min: Monitor anti-Xa level to determine appropriate dose

Deep Vein Thrombosis Prophylaxis

Hip Replacement

  • PostOp Start
  • 2500 units SC 4-8 hr postsurgery, THEREAFTER 5000 units qDay
  • PreOp Start
  • On day of surgery: 2500 IU SC within 2 hours presurgery, THEN 2500 units SC 4-8 hr postsurgery, THEREAFTER 5000 units SC qDay (administration: At least 6 hr between first post-op dose & Post-op Day 1 dose)
  • Evening before Surgery: 5000 units SC 10-14 hr presurgery, THEN 5000 units SC 4-8 hr postsurgery, THEREAFTER 5000 units SC qDay

Abdominal Surgery

  • 2500 IU SC 1-2 hr preop, THEREAFTER 2500 units SC qDay
  • High risk of thromboembolic complications (eg, malignancy): 5000 units SC evening before surgery, THEN 5000 units qDay (first dose may be evenly split in a preop & postop dose)

Unstable Angina & Non-Q-Wave MI

120 IU/kg SC q12hr for 5-8 days (concurrent with aspirin 75-165 mg qDay) 

Not to exceed 10,000 units/dose or 18,000 units/day

Treatment Duration: Continue until patient stabilized; 5-10 days usual

Anticoagulation Therapy (Off-label)

200 IU/kg SC qDay or 100 units/kg SC q12hr 

Other Indications & Uses

Symptomatic venous thromboembolism (DVT/PE) treatment to reduce recurrence in patients with cancer

Off-label: Treatment of thromboembolism during pregnancy, DVT prophylaxis during knee replacement surgery, neurosurgery, trauma, burns, pediatric

Safety & efficacy not established

Extended VTE Treatment in Patients with Cancer

200 units/kg SC qDay for 30 days, THEN 

Months 2-6: 150 units/kg SC qDay

Not to exceed 18,000 units daily

Treatment Duration: 5-10 days usual

Severe Mobility Restriction: 5000 units SC qDay

Unstable Angina & Non-Q-Wave MI

120 IU/kg SC q12hr for 5-8 days (concurrent with aspirin 75-165 mg qDay)

Not to exceed 10,000 units/dose or 18,000 units/day

Treatment Duration: Continue until patient stabilized; 5-10 days usual

Deep Vein Thrombosis Prophylaxis

Hip Replacement

PostOp Start: 2500 units SC 4-8 hr postsurgery, THEREAFTER 5000 units qDay

PreOp Start: On day of surgery: 2500 IU SC within 2 hours presurgery, THEN

2500 units SC 4-8 hr postsurgery, THEREAFTER 5000 units SC qDay (administration: At least 6 hr between first post-op dose & Post-op Day 1 dose)

Evening before surgery: 5000 units SC 10-14 hr presurgery, THEN 5000 units SC 4-8 hr postsurgery, THEREAFTER 5000 units SC qDay

Abdominal Surgery

2500 IU SC 1-2 hr preop, THEREAFTER 2500 units SC qDay

High risk of thromboembolic complications (eg, malignancy): 5000 units SC evening before surgery, THEN 5000 units qDay (first dose may be evenly split in a preop & postop dose)

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Interactions

Interaction Checker

and dalteparin

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    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            1-10%

            Injection site hematoma (7-35%)

            Thrombocytopenia (10.9-13.6%, patients with cancer )

            Injection site pain (4.5-12%)

            Major hemorrhage (up to 4.6%)

            Increased liver function test (up to 4.3%)

            Wound hematoma

            Hematuria

            Frequency Not Defined

            Epidural hematoma

            Spinal hematoma

            Hemorrhagic cerebral infarction

            Intracranial hemorrhage

            Intrauterine subdural hemorrhage

            Thrombocytopenia (<1%, non-cancer indications)

            Anaphylactoid reaction (rare)

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            Warnings

            Black Box Warnings

            Epidural or spinal hematomas may occur in patients anticoagulated with LMWH or heparinoids who receive neuraxial (epidural/spinal) anesthesia or spinal puncture

            These hematomas may result in long-term or permanent paralysis

            Patients should be frequently monitored for signs and symptoms of neurologic impairment; if neurological compromise noted, urgent treatment necessary

            Optimal timing between the administration of dalteparin and neuraxial procedures is not known

            Physicians should consider the benefits versus risk before neuraxial intervention in patients anticoagulated or to be anticoagulated for thromboprophylaxis

            Factors increasing risk of epidural or spinal hematomas

            • Indwelling epidural catheters
            • Concomitant use of other drugs that affect hemostasis (eg, NSAIDs, platelet inhibitors, other anticoagulants)
            • History of traumatic or repeated epidural or spinal punctures
            • History of spinal deformity or spinal surgery

            Contraindications

            Hypersensitivity to dalteparin, heparin or pork products

            Active major bleeding, thrombocytopenia associated with antiplatelet antibodies

            History of heparin induced thrombocytopenia or heparin induced thrombocytopenia with thrombosis

            As a treatment for unstable angina and non-Q-wave MI, in patients undergoing epidural/neuraxial anesthesia

            For prolonged VTE prophylaxis, in patients undergoing epidural/neuraxial anesthesia

            Patients that have undergone epidural neuraxial anesthesia

            Cautions

            Risk of epidural/spinal hematoma if used in patients getting epidural/spinal anesthesia which may result in paralysis

            Use caution in conditions with increased risk of hemorrhage, hemorrhagic diathesis, severe uncontrolled HTN, severe hepatic/renal impairment, retinopathy, thrombocytopenia, bacterial endocarditis, GI ulcer, hemorrhagic stroke, recent brain, spinal or ophthalmologic surgery

            Periodic blood counts recommended

            History of heparin-induced thrombocytopenia

            Do not give IM

            Can't be used interchangeably with other LMW heparins

            Multidose vials contain benzyl alcohol as preservative (associated with potentially fatal "Gasping Syndrome" in preemies); when prescribing dalteparin multiple-dose vials in infants, consider combined daily metabolic load of benzyl alcohol from all sources including multiple-dose vials (dalteparin contains 14 mg of benzyl alcohol per mL) and other drugs containing benzyl alcohol; minimum amount of benzyl alcohol at which serious adverse reactions may occur not known

            Therapy may enhance risk of bleeding in patients with thrombocytopenia or platelet defects; severe liver or kidney insufficiency, hypertensive or diabetic retinopathy, and recent gastrointestinal bleeding; bleeding can occur at any site during therapy; monitor thrombocytopenia of any degree closely

            If signs or symptoms of spinal hematoma are suspected, initiate urgent diagnosis and treatment including consideration for spinal cord decompression even though such treatment may not prevent or reverse neurological sequelae

            For patients with creatinine clearance <30mL/min, elimination of dalteparin may be prolonged; consider doubling the timing of removal of a catheter, at least 24 hr for lower prescribed dose of dalteparin (2500 IU or 5000 IU once daily) and at least 48 hr for higher dose (200 IU/kg once daily, 120 IU/kg twice daily)

            Although specific recommendation for timing of a subsequent dose after catheter removal is unknown, consider delaying this next dose for at least four hours, based on a benefit-risk assessment considering both the risk for thrombosis and the risk for bleeding in the context of the procedure and patient risk factors

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            Pregnancy & Lactation

            Pregnancy

            Available data from published literature and postmarketing reports have not reported a clear association with dalteparin and adverse developmental outcomes; there are risks to mother associated with untreated venous thromboembolism (VTE) in pregnancy, and a potential for adverse effects on preterm infant when dalteparin is used in pregnancy; in animal reproduction studies, there was no evidence of embryo-fetal toxicity or teratogenicity when dalteparin sodium was administered to pregnant rats and rabbits during organogenesis at doses 2 to 4 times (rats) and 4 times (rabbits) the human dose of 100 IU/kg dalteparin based on the body surface area

            Published data describe that women with a previous history of VTE in pregnancy are at higher risk for recurrence during subsequent pregnancies compared to those with no risk factor for VTE (4.5% versus 2.7% respectively, relative risk 1.7, 95% CI: 1.0-2.8)

            Lactation

            Limited published data indicate that the drug is present in human milk in small amounts; no adverse effects on breastfed infant reported; there are no data on effects of drug on milk production; oral absorption of dalteparin is expected to be low, but clinical implications, if any, of this small amount of anticoagulant activity on a breastfed infant are unknown; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed child from the drug or from underlying maternal condition

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            LMW heparin with antithrombotic properties; enhances inhibition of Factor Xa & thrombin by antithrombin, minimal effect on APTT

            Pharmacokinetics

            Half-Life: 3-5 hr

            Onset of action: 1-2 hr (anti Xa activity)

            Peak plasma time: 4 hr

            Duration: >12hr

            Peak plasma concentration: 0.19 IU/mL (2500 IU dose)

            Protein binding: Low

            Bioavailability: 81-93%

            Vd: 40-60 mL/kg

            Excretion: Urine

            Clearance: 15-25 mL/hr/kg (dose-dependent)

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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