dalteparin (Rx)

Brand and Other Names:Fragmin
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Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

injectable solution, single-dose prefilled syringe

  • 2,500 IU/0.2 mL
  • 5,000 IU/0.2 mL
  • 7,500 IU/0.3 mL
  • 12,500 IU/0.5 mL
  • 15,000 IU/0.6 mL
  • 18,000 IU/0.72 mL

injection, single-dose graduated syringe

  • 10,000 IU/mL

injection, multiple-dose vials

  • 95,000 IU/3.8 mL (25,000 IU/mL)

Unstable Angina and Non-Q-Wave Myocardial Infarction

Indicated for prophylaxis of ischemic complications in unstable angina and non-Q-wave myocardial infarction, when concurrently administered with aspirin therapy

120 IU/kg total body weight (TBW) SC q12hr with concurrent oral aspirin (75-165 mg qDay) therapy; not to exceed 10,000 IU q12hr  

Continued until patient is clinically stabilized

Usual duration of administration: 5-8 days

Concurrent aspirin therapy is recommended except when contraindicated

Weight-based dosing

  • <50 kg: 5500 IU SC q12hr
  • 50-59 kg: 6500 IU SC q12hr
  • 60-69 kg: 7500 IU SC q12hr
  • 70-79 kg: 9000 IU SC q12hr
  • ≥80 kg: 10,000 IU SC q12hr

Deep Vein Thrombosis

Indicated for prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE) in patients undergoing hip replacement, in patients undergoing abdominal surgery who are at risk for thromboembolic complications, and in medical patients who are at risk for thromboembolic complications due to severely restricted mobility during acute illness

Hip replacement surgery

  • 10-14 hr before surgery: 5000 IU SC preoperative; start the evening before surgery; allow ~24 hr between doses OR
  • Within 2 hr before surgery: 2500 IU SC preoperative; start day of surgery
  • 4-8 hr after surgery
    • Postoperative start: 2,500 IU SC
    • Preoperative start, day of surgery: 2,500 IU SC
    • Preoperative start, evening before surgery: 5,000 IU SC
    • Allow at least 6 hr between this dose and dose to be given on postoperative Day 1
    • Adjust timing of dose on postoperative Day 1 accordingly

Postoperative period

  • Postoperative start: 5,000 IU SC qDay
  • Preoperative start, day of surgery: 5,000 IU SC qDay
  • Preoperative start, evening before surgery: 5,000 IU SC qDay
  • Usual duration of treatment was 5-10 days postoperatively; up to 14 days of treatment was well tolerated in clinical trials

Abdominal surgery

  • Patients with a risk of thromboembolic complications
    • 2,500 IU SC qDay, starting 1-2 hr prior to surgery and repeated qDay postoperatively
    • Usual duration of administration is 5-10 days
  • Patients with a high risk of thromboembolic complications (eg, malignant disorder)
    • 5,000 IU SC the evening before surgery, THEN qDay postoperatively
    • Usual duration of administration is 5-10 days
    • Alternatively, in patients with malignancy, 2,500 IU SC 1-2 hr before surgery followed by 2,500 IU SC 12 hr later, and then 5,000 IU qDay postoperatively
    • Usual duration of administration is 5-10 days

Patients with severely restricted mobility during acute illness

  • 5,000 IU SC qDay
  • In clinical trials, usual duration of administration was 12-14 days

Venous Thromboembolism in Patients with Cancer

Indicated for extended treatment of symptomatic venous thromboembolism (VTE) (proximal DVT and/or PE), to reduce recurrence of VTE in adult patients with cancer

In these patients, begin therapy with initial VTE treatment and continues for 6 months

Month 1

  • Administer 200 IU/kg TBW SC qDay; total daily dose should not exceed 18,000 IU  
  • ≤56 kg: 10,000 SC qDay
  • 57-68 kg: 12,500 SC qDay
  • 69-82 kg: 15,000 SC qDay
  • ≥83 kg: 18,000 SC qDay

Months 2-6

  • Administer at a dose of ~150 IU/kg SC qDay during Months 2-6; total daily dose should not exceed 18,000 IU  
  • ≤56 kg: 7,500 SC qDay
  • 57-68 kg: 10,000 SC qDay
  • 69-82 kg: 12,500 SC qDay
  • 83-98 kg: 15,000 SC qDay
  • ≥99 kg: 18,000 SC qDay

Anticoagulation Therapy (Off-label)

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

Dosage Modifications

Dose reductions for thrombocytopenia in patients with cancer

  • Platelets ≥50,000/mm³: Discontinue dalteparin until platelet count recovers to >50,000/mm³
  • Platelets 50,000-100,000/mm³: Reduce daily dose by 2500 units until 100,000/mm³

Renal impairment (VTE in adult patients with cancer)

  • Severe (CrCl<30 mL/min): Monitor anti-Xa levels to determine appropriate dose; target anti-Xa range is 0.5-1.5 IU/mL; perform sampling 4-6 hr after dosing and only after patient has received 3-4 doses

Dosing Considerations

Limitation of use: Not indicated for acute treatment of VTE

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

Dosage Forms & Strengths

injectable solution, single-dose prefilled syringe

  • 2,500 IU/0.2 mL
  • 5,000 IU/0.2 mL
  • 7,500 IU/0.3 mL
  • 12,500 IU/0.5 mL
  • 15,000 IU/0.6 mL
  • 18,000 IU/0.72 mL

injection, single-dose graduated syringe

  • 10,000 IU/mL

injection, multiple-dose vials

  • 95,000 IU/3.8 mL (25,000 IU/mL)

Venous Thromboembolism

Indicated for treatment of symptomatic venous thromboembolism (VTE) to reduce the recurrence of VTE in pediatric patients ≥1 month

<4 weeks: Safety and efficacy not established

4 weeks to <2 years: 150 IU/kg SC BID  

2 to <8 years: 125 IU/kg SC BID

8 to <17 years: 100 IU/kg SC BID

Dosage Modifications

Dose reductions for thrombocytopenia

  • Platelets ≥50,000/mm³: Discontinue dalteparin until platelet count recovers to >50,000/mm³
  • Platelets 50,000-100,000/mm³: Reduce daily dose by 50% until 100,000/mm³

Dosing Considerations

Limitation of use: Not indicated for acute treatment of VTE

After initiation

  • Measure anti-Xa level prior to 4th dose
  • Draw samples for anti-Xa level 4 hr after administration
  • Adjust doses in increments of 25 IU/kg to achieve target anti-Xa level at 0.5-1 IU/mL
  • Individualize maintenance dose based on the dose that achieves target anti-Xa level collected 4 hr
  • Monitor anti-Xa level periodically in pediatric patients to maintain anti-Xa level at 0.5-1 IU/mL

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 and 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 for 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

Deep vein thrombosis prophylaxis for 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

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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)

            Postmarketing Reports

            Osteoporosis

            Skin necrosis

            Alopecia

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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

            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 routine complete blood cell counts, including platelet count, blood chemistry, and stool occult blood tests are recommended during treatment

            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 CrCl <30 mL/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 qDay) and at least 48 hr for higher dose (200 IU/kg once daily, 120 IU/kg BID)

            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 have not reported a clear association with dalteparin and adverse developmental outcomes

            There are risks to the mother associated with untreated VTE in pregnancy, and a potential for adverse effects on the preterm infant when used in pregnancy

            Animal data

            • In animal reproduction studies, there was no evidence of embryofetal toxicity or teratogenicity when dalteparin sodium was administered to pregnant rats and rabbits during organogenesis at doses 2-4 times (rats) and 4 times (rabbits) the human dose of 100 IU/kg dalteparin based on the BSA
            • Since animal studies are not always indicative of human response, use during pregnancy only if clearly needed

            Clinical considerations

            • 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
            • Cases of “gasping syndrome” have occurred in premature infants when large amounts of benzyl alcohol have been administered (99-404 mg/kg/day)
            • Multiple-dose 3.8 mL vials of dalteparin contain 14 mg/mL of benzyl alcohol

            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

            Absorption

            Adults

            • Peak plasma anti-Xa activity: 0.19 IU/mL (2500 IU-dose), 0.41 IU/mL (5000 IU-dose), and 0.82 IU/mL (10,000 IU-dose)
            • Absolute bioavailability: 87%

            Distribution

            • Adults
              • Vd: 40-60 mL/kg

            Elimination

            Half-life (pediatrics)

            • 3 to <8 weeks: 2.25 hr
            • ≥8 weeks to <2 years: 3.02 hr
            • ≥2 to <8 years: 4.27 hr
            • ≥8 to <12 years: 5.11 hr
            • ≥12 to <20 years: 6.28 hr

            Half-life (adults)

            • 2.1 hr (40 IU/kg); 2.3 hr (60 IU/kg); 5.7 hr (single IV 5000 IU-dose)
            • Longer apparent terminal half-lives (3-5 hr) are observed following SC dosing, possibly due to delayed absorption

            Clearance (pediatrics)

            • 3 to <8 weeks: 55.8 mL/hr/kg
            • ≥8 weeks to <2 years: 40.4 mL/hr/kg
            • ≥2 to <8 years: 26.7 mL/hr/kg
            • ≥8 to <12 years: 22.4 mL/hr/kg
            • ≥12 to <20 years:18.8 mL/hr/kg

            Clearance (adults)

            • Clearance: 24.6 mL/hr/kg (30 IU/kg); 15.6 mL/hr/kg (120 IU/kg)
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            Administration

            SC Administration

            SC use only; do not be administer IM

            Do not be mixed with other injections or infusions unless specific compatibility data supports such mixing

            Patients should be sitting or lying down and administered by deep SC injection

            Inject in a U-shape area around navel, upper outer side of thigh or upper outer quadrangle of the buttock; injection site should be varied daily

            When area around the navel or thigh is used, using the thumb and forefinger, you must lift up a fold of skin while giving the injection

            Entire length of the needle should be inserted at a 45-90° angle

            Inspect prefilled syringes and vials visually for particulate matter and discoloration prior to administration

            Fixed dose syringes: Ensure delivery of the full dose; do not expel the air bubble from prefilled syringe before injection; discard syringe assembly after use

            Graduated syringes: Hold syringe assembly by the open sides of the device; with the needle pointing up, expel air bubble(s) and then continue to push plunger to desired dose or volume, discarding extra solution in an appropriate manner; discard the syringe assembly after use

            Storage

            Opened vials

            • After first penetration of the rubber stopper, store multiple-dose vials at room temperature for up to 2 weeks
            • Discard any unused solution after 2 weeks

            Unopened syringes and vials

            • Store at 20-25°C (68-77°F); excursion permitted to 15-30°C (59-86°F)
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            Formulary

            FormularyPatient Discounts

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            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.