Dalteparin.pptx all about this drug and its effects

Dalteparin

1. Dalteparin

2. It is given as a shot into the fatty part of the skin on the right or left side of the stomach, thigh, or buttocks. Do not use as intramuscular injection. FRAGMIN should not be mixed with other injections or infusions. US Trade Names : Fragmin Class Anticoagulant Low Molecular Weight Heparin

3. Image Generic Name Brand Name Labeler Dosage Form Strength Colors Dalteparin Fragmin EISAI Solution 5000 units/0.2 mL clear Dalteparin Fragmin PFIZER U.S. Solution Prefilled Syringe 2500 units/0.2 mL clear Dalteparin Fragmin PFIZER U.S. Solution Prefilled Syringe 5000 units/0.2 mL clear Dalteparin Fragmin PFIZER U.S. Solution Prefilled Syringe 7500 units/0.3 mL clear

4. Drug uses FRAGMIN is a low molecular weight heparin (LMWH) indicated for: FDA-Labeled Indications Abdominal surgery - Postoperative deep vein thrombosis; Prophylaxis Acute coronary syndrome, Associated with unstable angina or non-Q-wave myocardial infarction - Myocardial ischemia; Prophylaxis Venous thromboembolism treatment in patients with active cancer: Provides extended (6 months) treatment for acute symptomatic Deep venous thrombosis, In medical patients with severely restricted mobility due to acute illness; Prophylaxis Postoperative deep vein thrombosis; Prophylaxis - Total replacement of hip Venous thromboembolism, Symptomatic MOA Dalteparin inhibits both factor Xa and factor IIa (thrombin), with a higher ratio of anti-Factor Xa to anti-Factor IIa activity (2.7:1), contributing to its antithrombotic effect.

5. Drug’s adverse reactions The incidence of hemorrhagic complications during treatment with FRAGMIN Injection has been low. The most commonly reported side effect is hematoma at the injection site. The risk for bleeding varies with the indication and may increase with higher doses. Six of the patients treated with FRAGMIN experienced seven major bleeding reactions. Two of the reactions were wound hematoma (one requiring reoperation), three were bleeding from the operative site, one was intraoperative bleeding due to vessel damage, and one was gastrointestinal bleeding. None of the patients experienced retroperitoneal or intracranial hemorrhage or died of bleeding complications. Hyperkalemia and GI ulceration.

6. Drug-Drug, drug-herb, and drug-food interactions

7. Effect of chronic renal failure on drug dosing, mechanism involved and treatment/dose modifications. ( LMWHs) have been cautiously used in patients with chronic kidney disease (CKD) due to fear of accumulation. Renal Impairment in Extended Treatment of Acute VTE in Adults with Cancer: Target anti-Xa range: 0.5 to 1.5 international units/ mL. Perform sampling 4 to 6 hours post dose after the patient has received 3 to 4 doses. Renal Impairment in Hospitalized Patients with COVID-19: CrCl 20 to 30 mL/min: Use usual prophylactic dose (5000 units subQ daily) or therapeutic dose (100 units/kg subQ twice daily) cautiously OR unfractionated heparin. CrCl < 20 mL/min or obese patients (BMI > 40 kg/m (2)) with renal impairment: Use unfractionated heparin. Renal Impairment in Thromboprophylaxis: 5000 units fixed dose (range 2500 units to 7500 units) subQ daily did not result in drug accumulation in patients with mild to severe renal impairment. Renal Impairment in VTE Treatment: Use unfractionated heparin may be preferred. Consider trough anti-Xa measurements if LMWH is used beyond 5 to 7 days. Avoid LMWH with CrCl < 20 mL/min and in those receiving renal replacement therapy. Hemodialysis: Consider 50 to 70 international units/kg IV bolus or 2500 units IV bolus prior to dialysis.

8. Effect of liver disease on drug dosing, mechanism involved and treatment/dose modifications There are no dosage adjustments provided in the manufacturer's labeling. Use with caution in patients with hepatic impairment as these patients may have potentially higher risk of bleeding

9. Effect of aging (drug dosing in elderly patients) on drug dosing, mechanism involved and treatment/dose modifications. Elderly: Increased risk of bleeding; close attention to dosing and concomitant medication use is advised, especially in patients with low body weight (less than 45 kg) and those predisposed to decreased renal function.

10. Effect of age (neonates and pediatric patients) on drug dosing, mechanism involved and treatment/dose modifications.

11. Pediatric Dosage General Information : Initiate vitamin K antagonists early if needed for long-term treatment. Continue low molecular weight heparin for at least 5 days, discontinue on day 6 or when INR exceeds 2. Round doses for patients ≥44 kg to nearest 100 units; adjust doses for obese patients based on lean body weight. Avoid benzyl alcohol-containing forms for infants. Gasping syndrome: Some dosage forms may contain benzyl alcohol Contain benzyl alcohol, which may cause "gasping syndrome" in premature infants; use caution in pregnant women and administer preservative-free formulations when possible; In neonates, large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity (“gasping syndrome”); the “gasping syndrome” consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension, and cardiovascular collapse 

12. Effect of pregnancy on drug dosing, mechanism involved and treatment/dose modifications. LMWH does not cross the placenta. No reported increased risk of fetal bleeding or teratogenic effects. Pharmacokinetic properties may be altered due to pregnancy-induced changes, requiring dosing adjustments. Some dosage forms may contain benzyl alcohol and should not be used in pregnant women

13. Pregnancy, Prophylactic: 5000 units subQ once daily throughout pregnancy. Consider dose modification at body weight extremes. Pregnancy, Intermediate-Dose: 5000 units subQ every 12 hours throughout pregnancy. Pregnancy, Therapeutic: 100 units/kg subQ every 12 hours or 200 units/kg subQ once daily throughout pregnancy. Target anti-Xa level: 0.6 to 1 units/mL (4 hours after last injection) for twice-daily dosing; adjust slightly higher doses may be needed with once-daily regimen. For VTE treatment, continue therapeutic dosage for 3 to 6 months then administer prophylactic doses for the remainder of pregnancy.

14. References Food and Drug Administration Micromedex applications Lexicomp website Uptodate Group Members   Roaa Taha Yousry 11910784 Samaa Soliman 11910767 Madona Marsel 11910758 Esraa Emad 11910692 Fady Sameh 11910735 Mohamed Hassan 11910706