Fragmin 2500 [iU]/mL
Dalteparin Sodium · INJECTION · Pfizer Laboratories Div Pfizer Inc
Fragmin is a injection containing dalteparin sodium at 2500 [iU]/mL, taken subcutaneous. Manufactured by Pfizer Laboratories Div Pfizer Inc.
Key Facts
- Brand Name
- Fragmin
- Generic Name
- Dalteparin Sodium
- NDC Code (Product)
0069-0253- Manufacturer
- Pfizer Laboratories Div Pfizer Inc
- Strength
- 2500 [iU]/mL
- Dosage Form
- INJECTION
- Route
- SUBCUTANEOUS
- Marketing Status
- Application #
- NDA020287
- Marketing Start
- 10/17/2022
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE FRAGMIN is a low molecular weight heparin (LMWH) indicated for • Prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction ( 1.1 ) • Prophylaxis of deep vein thrombosis (DVT) in abdominal surgery, hip replacement surgery or medical patients with severely restricted mobility during acute illness ( 1.2 ) • 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 ) • Treatment of symptomatic venous thromboembolism (VTE) to reduce the recurrence in pediatric patients from birth (gestational age at least 35 weeks) ( 1.4 ) • Limitations of Use FRAGMIN is not indicated for the acute treatment of VTE ( 1.5 ) 1.1 Prophylaxis of Ischemic Complications in Unstable Angina and Non-Q-Wave Myocardial Infarction FRAGMIN Injection is indicated for the prophylaxis of ischemic complications in unstable angina and non-Q-wave myocardial infarction, when concurrently administered with aspirin therapy [see Clinical Studies (14.1) ] . 1.2 Prophylaxis of Deep Vein Thrombosis F…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Indication 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 pat…
Contraindications
4 CONTRAINDICATIONS FRAGMIN is contraindicated in: • Patients with active major bleeding. • Patients with a history of heparin induced thrombocytopenia or heparin induced thrombocytopenia with thrombosis. • Patients with prior hypersensitivity to dalteparin sodium (e.g., pruritis, rash, anaphylactic reactions) [see Adverse Reactions (6.1) ] . • Patients undergoing Epidural/Neuraxial anesthesia, do not administer FRAGMIN [see Boxed Warning and Warnings and Precautions (5.1) ] ; o As a treatment for unstable angina and non-Q-wave MI. o For prolonged VTE prophylaxis. • Patients with prior hypersensitivity to heparin or pork products. • Active major bleeding ( 4 ) • History of heparin induced thrombocytopenia or heparin induced thrombocytopenia with thrombosis ( 4 ) • Hypersensitivity to dalteparin sodium ( 4 , 6.1 ) • In patients undergoing Epidural/Neuraxial anesthesia, do not administer FRAGMIN ( 5.1 ) o As a treatment for unstable angina and non-Q-wave MI o For prolonged VTE prophylaxis ( 4 ) • Hypersensitivity to heparin or pork products ( 4 )
Drug Interactions
7 DRUG INTERACTIONS The use of FRAGMIN in patients receiving oral anticoagulants, platelet inhibitors, and thrombolytic agents may increase the risk of bleeding [see Warnings and Precautions (5) ] . The use of FRAGMIN in patients receiving oral anticoagulants, platelet inhibitors, and thrombolytic agents may increase the risk of bleeding ( 7 )
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described in more detail in other sections of the prescribing information . • Risk of Hemorrhage including Spinal/Epidural Hematomas [see Warnings and Precautions (5.1) ] • Thrombocytopenia [see Warnings and Precautions (5.2) ] • Benzyl Alcohol Preservative Risk to Premature Infants [see Warnings and Precautions (5.3) ] Most 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 . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not accurately reflect the rates observed in practice. Hemorrhage The most commonly reported adverse reactions are hematoma at the injection site and hemorrhagic complications. The risk for bleeding varies with the i…
Frequently Asked Questions
What is Fragmin used for?
Fragmin contains Dalteparin Sodium. It is a injection taken subcutaneous. Consult your doctor for specific uses.
Is Fragmin a controlled substance?
Fragmin is not classified as a controlled substance by the DEA.
What is the generic name for Fragmin?
The generic name for Fragmin is Dalteparin Sodium. There are no other listed brand versions of Dalteparin Sodium.
What is the NDC code for Fragmin 2500 [iU]/mL?
The NDC (National Drug Code) for Fragmin 2500 [iU]/mL is 0069-0253, listed by Pfizer Laboratories Div Pfizer Inc.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)