Dalteparin Sodium

Dalteparin Sodium is used for: Unstable angina, Pulmonary embolism, Deep-vein thrombosis, Prophylaxis of clotting in extracorporeal circulation in haemodialysis or haemofiltration, Prophylaxis of venous thromboembolism during surgery

Subcutaneous Unstable angina and non-Q-wave MI 120 units/kg subcutaneous every 12 hours (with aspirin) DVT prophylaxis in abdominal surgery 2,500 units subcutaneous once daily or 5,000 units subcutaneous once daily or 2,500 units subcutaneous followed by 2,500 units subcutaneous 12 hours later and then 5,000 units subcutaneous once daily DVT in hip replacement surgery Postoperative start – 2,500 units subcutaneous 4 hours to 8 hours after surgery, then 5,000 units subcutaneous once daily, or Preoperative start – day of surgery 2,500 units subcutaneous 2 hours before surgery, followed by 2,500 units subcutaneous 4 hours to 8 hours after surgery, then 5,000 units subcutaneous once daily Preoperative start – Evening Before Surgery 5,000 units subcutaneous, followed by 5,000 units subcutaneous 4 hours to 8 hours after surgery Prophylaxis of venous thromboembolism during surgical procedures Adult: Moderate risk patients: 2,500 U given 1-2 hr before the procedure, followed by 2,500 U once daily for 5-7 days or until the patient is fully ambulant. High risk patients: 2,500 U given 1-2 hr before and 8-12 hr after the procedure, followed by 5,000 U daily. Alternatively, 5,000 U given in the evening before surgery,y followed by 5,000 U each subsequent evening for 5-10 days DVT prophylaxis in medical patients 5,000 units subcutaneous once daily Extended treatment of VTE in adult patients with cancer Month 1: 200 units/kg subcutaneous once daily Months 2 to 6: 150 units/kg subcutaneous once daily Venous thromboembolism Adult: 200 U/kg daily as a single or in 2 divided doses in pregnant and high-risk patients. Max: 18,000 U/day. Intravenous Prophylaxis of clotting in extracorporeal circulation in haemodialysis or haemofiltration Adult: 30-40 U/kg IV inj, followed by an IV infusion of 10-15 U/kg/hr. A single dose of 5,000 U may be given for haemodialysis or haemofiltration session lasting <4 hr. For patients at high risk of bleeding or in acute renal failure: 5-10 U/kg IV inj followed by an infusion of 4-5 U/kg/hr.

Venous Thromboembolism Indicated for the treatment of symptomatic venous thromboembolism (VTE) to reduce the recurrence of VTE in pediatric patients from birth (gestational age [GA] >35 weeks) Birth (GA >35 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

Renal impairment: CrCl <30 mL/min: Dosage adjustment needed based on anti-Factor Xa activity.

SC Administration SC use only; do not be administer IM

Active major bleeding History of heparin-induced thrombocytopenia or heparin-induced thrombocytopenia with thrombosis Hypersensitivity to dalteparin sodium In patients undergoing Epidural/Neuraxial anesthesia, do not administer As a treatment for unstable angina and non-Q-wave MI For prolonged VTE prophylaxis Hypersensitivity to heparin or pork products

Epidural or spinal hematomas may occur in patients who are anticoagulated with low molecular weight heparins (LMWH) 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. Factors that can increase the risk of developing epidural or spinal hematomas in these patients include: Use of indwelling epidural catheters Concomitant use of other drugs that affect hemostasis, such as nonsteroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, other anticoagulants. • A history of traumatic or repeated epidural or spinal punctures • A history of spinal deformity or spinal surgery • Optimal timing between the administration of Dalteparin Sodium and neuraxial procedures is not known Consider the benefits and risks before neuraxial intervention in patients anticoagulated or to be anticoagulated for thromboprophylaxis Hemorrhage: Use caution in conditions with increased risk of hemorrhage Thrombocytopenia: Monitor thrombocytopenia of any degree closely Benzyl Alcohol Preservative: Do not use multiple-dose formulations in neonates and infants as they contain benzyl alcohol MONITORING PARAMETERS For monitoring during treatment of deep-vein thrombosis and of pulmonary embolism, blood should be taken 3–4 hours after a dose (recommended plasma concentration of anti-Factor Xa 0.5–1 unit/mL); monitoring not required for once-daily treatment regimen and not generally necessary for twice-daily regimen. Routine monitoring of anti-Factor Xa activity is not usually required during treatment with dalteparin, but may be necessary in patients at increased risk of bleeding (e.g. in renal impairment and those who are underweight or overweight). Monitor patients frequently for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary. Periodic blood counts are recommended

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 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

Increased risk of haemorrhage w/ other anticoagulant/antiplatelet agents (e.g. aspirin/dipyridamole, glycoprotein IIb/IIIa receptor antagonists, vit K antagonists, NSAIDs, cytostatics, dextran, thrombolytics, sulfinpyrazone, probenecid, etacrynic acid). Reduced anticoagulant effect w/ antihistamines, cardiac glycosides, tetracycline and ascorbic acid. Contraindicated (3) defibrotide mifepristone prothrombin complex concentrate, human

Side effects of Dalteparin Sodium : 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) Potentially Fatal: Severe haemorrhage.

Dalteparin sodium is a low molecular weight heparin analogue which inhibits factor Xa more than factor IIa (thrombin).