HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use FRAGMIN safely and effectively. See full prescribing information for FRAGMIN.
FRAGMIN® (dalteparin sodium) injection, USP, for subcutaneous use
Initial U.S. Approval: 1994 WARNING: SPINAL/EPIDURAL HEMATOMASSee full prescribing information for complete boxed warning.
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:
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- Use of indwelling epidural catheters
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- Concomitant use of other drugs that affect hemostasis, such as non-steroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, other anticoagulants.
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- A history of traumatic or repeated epidural or spinal punctures
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- A history of spinal deformity or spinal surgery
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- Optimal timing between the administration of FRAGMIN and neuraxial procedures is not known
Monitor patients frequently for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary. Consider the benefits and risks before neuraxial intervention in patients anticoagulated or to be anticoagulated for thromboprophylaxis (5.1, 7). RECENT MAJOR CHANGES Indications and Usage, Treatment of Symptomatic Venous Thromboembolism (VTE) in Pediatric Patients (1.4) | 10/2024 | Dosage and Administration, Treatment of Symptomatic Venous Thromboembolism (VTE) in Pediatric Patients (2.4) | 10/2024 | Dosage and Administration, Dose Reductions for Thrombocytopenia in Adult Patients with Cancer and in Pediatric Patients with Symptomatic VTE (2.5) | 10/2024 |
INDICATIONS AND USAGEFRAGMIN is a low molecular weight heparin (LMWH) indicated for - •
- Prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction (1.1)
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- Prophylaxis of deep vein thrombosis (DVT) in abdominal surgery, hip replacement surgery or medical patients with severely restricted mobility during acute illness (1.2)
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- Extended treatment of symptomatic venous thromboembolism (VTE) to reduce the recurrence in adult patients with cancer. In these patients, the FRAGMIN therapy begins with the initial VTE treatment and continues for six months (1.3)
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- Treatment of symptomatic venous thromboembolism (VTE) to reduce the recurrence in pediatric patients from birth (gestational age at least 35 weeks) (1.4)
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- Limitations of Use
FRAGMIN is not indicated for the acute treatment of VTE (1.5)
DOSAGE AND ADMINISTRATIONIndication | Dosing Regimen | Unstable angina and non-Q-wave MI | 120 units/kg subcutaneous every 12 hours (with aspirin) (2.1) | 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 (2.2) | DVT prophylaxis 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 (2.2)
Preoperative start – Evening Before Surgery 5,000 units subcutaneous followed by 5,000 units subcutaneous 4 hours to 8 hours after surgery (2.2) | DVT prophylaxis in medical patients | 5,000 units subcutaneous once daily (2.2) | Extended treatment of VTE in adult patients with cancer | Month 1: 200 units/kg subcutaneous once daily (2.3)
Months 2 to 6: 150 units/kg subcutaneous once daily (2.3) | Treatment of VTE in pediatric patients (see Table 5) (2.4) | Age Group | Starting Dose | Birth (gestational age at least 35 weeks) to less than 2 Years | 150 units/kg twice daily | 2 Years to less than 8 Years | 125 units/kg twice daily | 8 Years to less than 17 Years | 100 units/kg twice daily |
Do not use as intramuscular injection. FRAGMIN should not be mixed with other injections or infusions (2.7) DOSAGE FORMS AND STRENGTHS- •
- Injection: 2,500 units/ 0.2 mL, 5,000 units/ 0.2 mL, 7,500 units/ 0.3 mL, 12,500 units/ 0.5 mL, 15,000 units/ 0.6 mL, and 18,000 units/ 0.72 mL single-dose prefilled syringes (3)
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- Injection: 10,000 units/mL single-dose graduated syringes (3)
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- Injection: 95,000 units/ 3.8 mL (25,000 units/mL) multiple-dose vials (3)
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- Injection: 10,000 units/ 4 mL (2,500 units/mL) single-dose vials (3)
CONTRAINDICATIONS- •
- Active major bleeding (4)
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- History of heparin induced thrombocytopenia or heparin induced thrombocytopenia with thrombosis (4)
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- Hypersensitivity to dalteparin sodium (4, 6.1)
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- In patients undergoing Epidural/Neuraxial anesthesia, do not administer FRAGMIN (5.1)
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- As a treatment for unstable angina and non-Q-wave MI
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- For prolonged VTE prophylaxis (4)
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- Hypersensitivity to heparin or pork products (4)
WARNINGS AND PRECAUTIONS- •
- Hemorrhage: Use caution in conditions with increased risk of hemorrhage (5.1)
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- Thrombocytopenia: Monitor thrombocytopenia of any degree closely (5.2)
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- Benzyl Alcohol Preservative: Do not use multiple-dose formulations in neonates and infants as they contain benzyl alcohol (5.3)
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- Laboratory Tests: Periodic blood counts recommended (5.4)
ADVERSE REACTIONSMost common adverse reactions (>1%) are: bleeding (including hemorrhage), thrombocytopenia (Type I), hematoma at the injection site, pain at the injection site, transient elevation of transaminases (6)
To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. DRUG INTERACTIONSThe use of FRAGMIN in patients receiving oral anticoagulants, platelet inhibitors, and thrombolytic agents may increase the risk of bleeding (7)
See 17 for PATIENT COUNSELING INFORMATION. Revised: 10/2024 |