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
Color
s
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
1. Abdominal surgery - Postoperative deep vein thrombosis; Prophylaxis
2. Acute coronary syndrome, Associated with unstable angina or non-Q-wave
myocardial infarction - Myocardial ischemia; Prophylaxis
3. Venous thromboembolism treatment in patients with active cancer: Provides
extended (6 months) treatment for acute symptomatic
4. Deep venous thrombosis, In medical patients with severely restricted mobility due to
acute illness; Prophylaxis
5. Postoperative deep vein thrombosis; Prophylaxis - Total replacement of hip
6. 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.
Common
• Dermatologic: Contusion (12%), Hematoma,
Injection site (7% to 35%), Injection site
bruising (30%), Injection site pain (4.5% to
12%)
•Respiratory: Bleeding from nose (10%)
•Other: Irritation symptom, Local
Serious
•Hematologic: Extradural intracranial
hematoma, Hematoma, Spinal, Hemorrhage,
Major (Up to 13.6%), Hemorrhagic cerebral
infarction (8%), Intracranial hemorrhage,
Subdural hemorrhage, Intrauterine.
•Thrombocytopenia (Adult, non-cancer
indications, less than 1%; patients with
cancer, 10.9% to 13.6%; pediatric, 21%)
•Hepatic: Increased liver function test

6. DRUG-DRUG, DRUG-HERB, AND DRUG-FOOD
INTERACTIONS
Anticoagulants /
Streptokinase
 Mechanism: Streptokinase enhances
the anticoagulant effect of
Anticoagulants, leading to increased
risk of bleeding events due to
additive effects on the coagulation
system.
 Dose Modifications: Avoid the
combination. For patients on
heparin, administer protamine and
ensure prothrombin time (PT) is ≤2
times the normal control value
before initiating streptokinase. For
patients on vitamin K antagonists,
ensure INR is <1.3 before initiating
streptokinase.
 .
Anticoagulants / Ginger
•Mechanism enhance the
adverse/toxic effect of
Anticoagulants, leading to an
increased risk of bleeding.
•Patient Management: Monitor for
signs and symptoms of bleeding if
these agents are combined.
•Herbal Products with
Anticoagulant/Antiplatelet
Effects: Bilberry; Bromelain;
Emblica; Garlic; Ginger; Ginkgo
Biloba; Ginseng (American);
Ginseng (Panax); Ginseng
(Siberian); Octacosanol; Policosanol;
Saw Palmetto; Sweet Vernal Grass
Anticoagulants / (Fish Oil
Based) Foods
•Mechanism: enhance the
anticoagulant effect of
Anticoagulants by impairing
platelet function, prolonging
bleeding time, and potentially
affecting various coagulation
mechanisms
•Patient Management: Monitor
patients for signs and symptoms of
bleeding.

7. 3. 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:
o Target anti-Xa range: 0.5 to 1.5 international units/mL.
o 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:
o 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.
o CrCl < 20 mL/min or obese patients (BMI > 40 kg/m (2)) with renal
impairment: Use unfractionated heparin.
 Renal Impairment in Thromboprophylaxis:
o 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:
o Use unfractionated heparin may be
preferred.
o Consider trough anti-Xa measurements
if LMWH is used beyond 5 to 7 days.
o Avoid LMWH with CrCl < 20 mL/min
and in those receiving renal replacement
therapy.
 Hemodialysis:
o 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. 3. 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:
o 5000 units subQ once daily throughout pregnancy.
o Consider dose modification at body weight extremes.
 Pregnancy, Intermediate-Dose:
o 5000 units subQ every 12 hours throughout pregnancy.
 Pregnancy, Therapeutic:
o 100 units/kg subQ every 12 hours or 200 units/kg subQ once daily throughout pregnancy.
o 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.
o 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

1. Roaa Taha Yousry 11910784
2. Samaa Soliman 11910767
3. Madona Marsel 11910758
4. Esraa Emad 11910692
5. Fady Sameh 11910735
6. Mohamed Hassan 11910706
