Adult Dosing

Unstable angina/Non-Q Wave MI

• 120 IU/kg SC q12 hrs x5-8 days with aspirin (75-165 mg PO daily)
• Max: 10,000 IUnits/dose
• For ischemic complications prophylaxis continue therapy until patients are stabilized

DVT prophylaxis in abdominal surgery

• High risk patients
• Start: 5000 IU SC daily x5-10 days the evening before surgery
• Alt: In patients with malignancy Start 2500 IU SC x1 dose; administer 1-2 hr before surgery then, 2500 IU SC x1 12 hrs later, then 5000 IU SC daily x5-10 days

• Other patients
• 2500 IU SC daily x5-10 days; Start: 1-2 hr before surgery

DVT prophylaxis in hip replacement

• Postoperative start
• Start: 2500 IU SC x1 4-8 hrs post surgery, then 5000 IU SC daily x5-10 days

• Notes
• Up to 14 days treatment is well tolerated
• Allow 6 hrs between first dose and the dose to be given on postoperative Day 1

• Preoperative start day of surgery
• Start: 2500 IU SC x1 2 hrs before surgery, then 2500 IU SC x1 dose 4-8hr before surgery, then 5000 IU SC qd x5-10 days

• Notes
• Up to 14 days treatment is well tolerated
• Allow >6 hr between first postoperative dose and first daily dose

• Preoperative start, evening before surgery
• Start: 5000 IU SC x1 dose, administer 10-14 hrs before surgery, then 5000 IU SC x1 dose, administer dose 4-8 hrs after surgery, then 5000 IU SC daily x5-10 days

• Notes
• Up to 14 days treatment is well tolerated
• Allow 24 hr between preoperative and first postoperative doses

DVT prophylaxis restricted mobility

• 5000 IU SC daily x12-14 days

VTE in cancer patients

Month 1

• 200 IU/kg SC daily x1 month
• Max: 18,000 IU
• Dose to be administered according to patient weight during the first month:
• 124 lbs, 56 kg: 10,000 IU SC daily
• 125-150 lbs, 57-68 kg: 12,500 IU SC daily
• 151-181 lbs, 69-82 kg: 15,000 IU SC daily
• 182-216 lbs, 83-98 kg: 18,000 IU SC daily
• 217 lbs, 99 kg: 18,000 IU SC daily

Months 2-6

• 150 IU/kg SC daily during months 2 through 6
• Max: 18,000 IU
• Dose to be administered according to patient weight during during months 2-6:
• 124 lbs, 56 kg: 7,500 IU SC daily
• 125-150 lbs, 57-68 kg: 10,000 IU SC daily
• 151-181 lbs, 69-82 kg: 12,500 IU SC daily
• 182-216 lbs, 83-98 kg: 15,000 IU SC daily
• 217 lbs, 99 kg: 18,000 IU SC daily

• Max: 18,000 IU
• Notes
• Decrease dose by 2500 IU/day until the platelet count recovers to 100,000/mm³ from 50,000-100,000/mm³. Discontinue therapy if the patients experience platelet counts <50,000/mm³ until the platelet counts are recovered >50,000/mm³
• May extend duration of therapy if benefit outweighs risk

DVT/PE therapy [Not FDA approved]

• 200 units/kg/day SC div qd-bid
• Max: 18,000 units/dose
• Continue therapy for >5 days and overlap with warfarin until INR is 2-3

Pediatric Dosing

• Safety and effectiveness in pediatric patients has not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• Acute coronary syndrome, Associated with unstable angina or non-Q-wave myocardial infarction - Myocardial ischemia; Prophylaxis
• Prophylaxis of deep vein thrombosis (DVT) in abdominal surgery, total hip replacement surgery or medical patients with severely restricted mobility during acute illness
• Venous thromboembolism (VTE) associated with cancer

• Hypersensitivity to any of the ingredients of the product
• Hypersensitivity to heparin or pork products
• Active major bleeding
• History of heparin induced thrombocytopenia (HIT) with or without thrombosis
• Patients undergoing epidural/neuraxial anesthesia (Non-Q-wave MI, unstable angina, or long term VTE prophylaxis)
• Hypersensitivity to dalteparin sodium, heparin, or pork products
• Mifepristone

• Patients anticoagulated with low molecular weight heparins (LMWH) or heparinoids and also receiving neuraxial anesthesia or undergoing spinal puncture are prone for development of epidural or spinal hematomas; such manifestations are associated with long-term or permanent paralysis. Consider such risks while scheduling patients for spinal procedures. Use of indwelling epidural catheters, concomitant use of other drugs affecting hemostasis, history of traumatic or repeated epidural or spinal punctures, history of spinal deformity or spinal surgery are the factors associated with increasing the risk for developing epidural or spinal hematomas in these patients
• Frequently monitor patients for signs and symptoms of neurological impairment. Initiate urgent treatment on observation of neurological compromise
• Consider the potential benefits and risks before neuraxial intervention in anticoagulated patients or to be anticoagulated for thromboprophylaxis

Obesity

• Dose based on total body weight for patients weighing up to 190 kg

Renal Dose Adjustment (Based on CrCl)

• VTE in cancer patients
• <30 mL/min: Monitor anti-Xa levels 4-6 hrs post dose to determine appropriate dose range of 0.5-1.5 units/mL

• Other indications
• Severe renal impairment: Use with caution; dose adjustments not defined

Hepatic Dose Adjustment

• Severe hepatic impairment: Use with caution; dose adjustments not defined

Platelet Adjustments

• Thrombocytopenia in cancer patients: (platelet 50,000 and 100,000/mm(3)) reduce daily dose by 2500 international units until platelet count increases to 100,000/mm(3) or above
• Thrombocytopenia in cancer patients: (platelet less than 50,000/mm(3)) discontinue therapy until platelet counts recovers above 50,000/mm(3)

See Supplemental Patient Information

• Spinal or epidural hematomas have developed with the associated use of low molecular weight heparins or heparinoids and neuraxial (spinal/epidural) anesthesia or spinal puncture. Risk factors associated with increasing such events are use of post-operative indwelling epidural catheters with the concomitant use of other drugs affecting hemostasis, with traumatic or repeated epidural or spinal puncture, or in patients with a history of spinal surgery or spinal deformity [US Black Box Warning]
• Heparin-induced thrombocytopenia have occurred in association with this drug. Occasions of thrombocytopenia with thrombosis, amputation and death have occurred. Closely monitor thrombocytopenia of any degree
• Benzyl alcohol is associated with a fatal Gasping Syndrome in premature infants. Exercise caution while administering dalteparin preserved with benzyl alcohol to pregnant women. If anticoagulation with dalteparin is essential during pregnancy use preservative-free formulations
• Periodically determine CBC including platelet count, blood chemistry, and stool occult blood tests during the course of therapy with this drug. While administration at recommended prophylaxis doses, routine coagulation tests such as prothrombin time and activated partial thromboplastin time are relatively insensitive measures of dalteparin activity and are unsuitable for monitoring the anticoagulant effect of this drug. Use anti-factor Xa for monitoring the anticoagulant effect of dalteparin in patients with severe renal impairment or on development of abnormal coagulation parameters or bleeding during therapy

Cautions: Use cautiously in

• Renal impairment
• Hepatic impairment
• Spinal puncture
• Risk of bleeding
• Epidural or spinal anesthesia
• Pregnant patients (benzyl alcohol-containing forms)
• Breastfeeding patients
• Geriatrics

Supplemental Patient Information

• Advise patients to immediately contact his or her physician on development of signs and symptoms of spinal or epidural hematoma, such as tingling, numbness (especially in the lower limbs) and muscular weakness

Pregnancy Category:B

Breastfeeding: Low levels of dalteparin are excreted in breastmilk and as it exhibits large molecular weight of 2000-9000 daltons, amounts expected to be ingested by the infant are small and would not be expected to be absorbed from breastmilk by the infant. No special precautions are required. This information is (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 4 March 2011). Manufacturer advises caution.

• LOCAL: Epidural/spinal hematoma hematoma, wound hematoma, injection site hematoma, injection site reaction, hemorrhage
• HEMA: Thrombocytopenia
• GU: Hematuria
• DERM: Skin necrosis, pruritus, rash
• GI: Elevated liver transaminases
• MISC: Hypersensitivity reactions, anaphylactoid reactions, fever

• Low molecular weight heparin; inhibits coagulation Factor Xa and thrombin by antithrombin
• Absolute bioavailability: 87+/-6%
• Metabolized by liver; CYP450: Unknown
• Excreted in urine
• Half-life: 3-5 hr; 6-7 hr (renal impairment)

US Trade Name(s)

• Fragmin

US Availability

Fragmin

• INJ (prefilled syringes): 2,500 IU/0.2 mL
• INJ (prefilled syringes): 5,000 IU/0.2 mL
• INJ (prefilled syringes): 7,500 IU/0.3 mL
• INJ (prefilled syringes): 10,000 IU/0.4 mL
• INJ (prefilled syringes): 10,000 IU/1 mL
• INJ (prefilled syringes): 12,500 IU/0.5 mL
• INJ (prefilled syringes): 15,000 IU/0.6 mL
• INJ (prefilled syringes): 18,000 IU/0.72 mL

Canadian Trade Name(s)

• Fragmin

Canadian Availability

Fragmin

• INJ (prefilled syringes): 2,500 IU/0.2 mL
• INJ (prefilled syringes): 5,000 IU/0.2 mL
• INJ (prefilled syringes): 7,500 IU/0.3 mL
• INJ (prefilled syringes): 10,000 IU/0.4 mL
• INJ (prefilled syringes): 12,500 IU/0.5 mL
• INJ (prefilled syringes): 15,000 IU/0.6 mL
• INJ (prefilled syringes): 18,000 IU/0.72 mL
• INJ: 10,000 IU/mL (1 mL amp)
• INJ: 25,000 IU/3.8 mL (3.8 mL vial)

UK Trade Name(s)

• Fragmin

UK Availability

Fragmin

• INJ (prefilled syringes): 2,500 IU/0.2 mL
• INJ (prefilled syringes): 5,000 IU/0.2 mL
• INJ (prefilled syringes): 7,500 IU/0.3 mL
• INJ (prefilled syringes): 10,000 IU/0.4 mL
• INJ (prefilled syringes): 12,500 IU/0.5 mL
• INJ (prefilled syringes): 15,000 IU/0.6 mL
• INJ (prefilled syringes): 18,000 IU/0.72 mL
• INJ: 10,000 IU/mL (1 mL amp)
• INJ: 10,000 IU/4 mL (4 mL vial)
• INJ: 100,000 IU/4 mL (4 mL vial)

Australian Trade Name(s)

• Fragmin

Australian Availability

Fragmin

• INJ (prefilled syringes): 2,500 IU/0.2 mL
• INJ (prefilled syringes): 5,000 IU/0.2 mL
• INJ (prefilled syringes): 7,500 IU/0.75 mL
• INJ (prefilled syringes): 10,000 IU/mL
• INJ (prefilled syringes): 12,500 IU/0.5 mL
• INJ (prefilled syringes): 15,000 IU/0.6 mL
• INJ (prefilled syringes): 18,000 IU/0.72 mL

[Outline]

Hematology/Oncology

Anticoagulants

Heparins

Cardiovascular

Anticoagulants

Heparins

Pricing data from www.DrugStore.com in U.S.A.

• Fragmin 10000 UNIT/ML SOLN [Syringe] (EISAI)
  1 ml = $76.99
  3 ml = $225.96
• Fragmin 2500 UNIT/0.2ML SOLN [Syringe] (EISAI)
  0.2 0.2ml = $30.99
  0.6 0.2ml = $75.59
• Fragmin 25000 UNIT/ML SOLN [Vial] (EISAI)
  3.8 ml = $623.96
  11.4 ml = $1828.97
• Fragmin 5000 UNIT/0.2ML SOLN [Syringe] (EISAI)
  0.2 0.2ml = $42.19
  1 0.2ml = $189.87

Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.