Brand Name

Fragmin

Generic Name
Dalteparin
View Brand Information
FDA approval date: April 01, 2015
Classification: Low Molecular Weight Heparin
Form: Injection

What is Fragmin (Dalteparin)?

FRAGMIN is a low molecular weight heparin indicated for Prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction.

Approved To Treat

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Brand Information

Fragmin (Dalteparin Sodium)
WARNING: SPINAL/EPIDURAL HEMATOMAS
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 non-steroidal 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 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
1DOSAGE FORMS AND STRENGTHS
FRAGMIN (dalteparin sodium) injection is a sterile, aqueous, clear, colorless or straw-colored solution for injection, available in the following 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 sterile, single-dose, prefilled syringes preassembled with a needle guard device.
  • Injection: 10,000 units/mL sterile, single-dose, graduated syringes preassembled with a needle guard device.
  • Injection: 95,000 units/ 3.8 mL (25,000 units/mL) sterile, multiple-dose vials.
  • Injection: 10,000 units/ 4 mL (2,500 units/mL) sterile, single-dose vials.
2CONTRAINDICATIONS
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)
  • Patients undergoing Epidural/Neuraxial anesthesia, do not administer FRAGMIN
  • Patients with prior hypersensitivity to heparin or pork products.
3ADVERSE 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
  • Thrombocytopenia
  • Benzyl Alcohol Preservative Risk to Premature Infants
3.1Clinical 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.
3.1.1Neonatal Patients
No controlled clinical trials have been conducted with FRAGMIN in neonatal patients with VTE; however, data are available from a non‑interventional retrospective medical chart review study of 16 neonates with VTE in the UK who were admitted to hospital between January 2010 and December 2021 and were treated with FRAGMIN. The mean (±SD) duration of dalteparin treatment was 62±30 days. For these 16 neonatal patients, the mean (±SD) daily dose of dalteparin at initiation was 365±196 units/kg (median:309 units/kg). The mean (±SD) daily dose of dalteparin including dose at initiation and dose changes was 575±320 units/kg (median: 450 units/kg). After the initial dose, all patients required one or more dose changes; 15 of 16 patients required dose increases due to anti-Xa level being initially below the target range of 0.5 units/mL to 1 units/mL.
The safety profile in neonates was similar to other pediatric patients.
3.2Postmarketing Experience
The following adverse reactions have been identified during post-approval use of FRAGMIN. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Since first international market introduction in 1985, there have been more than 15 reports of epidural or spinal hematoma formation with concurrent use of FRAGMIN and spinal/epidural anesthesia or spinal puncture. The majority of patients had postoperative indwelling epidural catheters placed for analgesia or received additional drugs affecting hemostasis. In some cases, the hematoma resulted in long-term or permanent paralysis (partial or complete)
Musculoskeletal system: Osteoporosis
Skin or subcutaneous tissues disorders: Skin necrosis, cases of alopecia reported that improved on drug discontinuation
Metabolism and nutrition disorders: Hyperkalemia
4DRUG INTERACTIONS
The use of FRAGMIN in patients receiving oral anticoagulants, platelet inhibitors, and thrombolytic agents may increase the risk of bleeding
5OVERDOSAGE
An excessive dosage of FRAGMIN Injection may lead to hemorrhagic complications. These may generally be stopped by slow intravenous injection of protamine sulfate (1% solution), at a dose of 1 mg protamine for every 100 anti-Xa units of FRAGMIN given. If the APTT measured 2 hours to 4 hours after the first infusion remains prolonged, a second infusion of 0.5 mg protamine sulfate per 100 anti-Xa units of FRAGMIN may be administered. Even with these additional doses of protamine, the APTT may remain more prolonged than would usually be found following administration of unfractionated heparin. In all cases, the anti-Xa activity is never completely neutralized (maximum about 60% to 75%).
Take particular care to avoid overdosage with protamine sulfate. Administration of protamine sulfate can cause severe hypotensive and anaphylactoid reactions. Because fatal reactions, often resembling anaphylaxis, have been reported with protamine sulfate, give protamine sulfate only when resuscitation techniques and treatment for anaphylactic shock are readily available. For additional information, consult the labeling of Protamine Sulfate Injection, USP, products.
6DESCRIPTION
FRAGMIN Injection (dalteparin sodium injection) is a sterile, low molecular weight heparin. It is available in single-dose, prefilled syringes preassembled with a needle guard device, and multiple-dose vials. With reference to the W.H.O. First International Low Molecular Weight Heparin Reference Standard, each syringe contains either 2,500 units, 5,000 units, 7,500 units, 10,000 units, 12,500 units, 15,000 units or 18,000 anti-Xa international units (units), equivalent to 16 mg, 32 mg, 48 mg, 64 mg, 80 mg, 96 mg or 115.2 mg dalteparin sodium, respectively. Each multiple-dose vial contains 25,000 anti-Xa units per 1 mL (equivalent to 160 mg dalteparin sodium), for a total of 95,000 anti-Xa units per vial. Each single-dose vial contains 2,500 anti-Xa units per 1 mL (equivalent to 16 mg dalteparin sodium) for a total of 10,000 anti-Xa units per vial.
Each prefilled syringe also contains Water for Injection and sodium chloride, when required, to maintain physiologic ionic strength. The prefilled syringes are preservative-free. Each multiple-dose vial also contains Water for Injection and 14 mg of benzyl alcohol per mL as a preservative. The pH of both formulations is 5.0 to 7.5. When necessary, the pH of FRAGMIN is adjusted with hydrochloric acid and/or sodium hydroxide
Dalteparin sodium is produced through controlled nitrous acid depolymerization of sodium heparin from porcine intestinal mucosa followed by a chromatographic purification process. It is composed of strongly acidic sulfated polysaccharide chains (oligosaccharide, containing 2,5-anhydro-D-mannitol residues as end groups) with an average molecular weight of 5,000 and about 90% of the material within the range 2,000–9,000. The molecular weight distribution is:
Structural Formula
Chemical Structure
7HOW SUPPLIED/STORAGE AND HANDLING
FRAGMIN (dalteparin sodium) injection, USP, is a sterile, aqueous, clear, colorless or straw-colored solution available as follows:
8PRINCIPAL DISPLAY PANEL - 0.2 mL Syringe Label - 0195
0.2 mL
Fragmin®
(dalteparin sodium) Injection, USP
2,500 units/0.2 mL
For Subcutaneous Use
Single-dose prefilled syringe
Pfizer Labs
Rx only
PAA233623
PRINCIPAL DISPLAY PANEL - 0.2 mL Syringe Label - 0195
9PRINCIPAL DISPLAY PANEL - 0.2 mL Syringe Blister Pack Label - 0195
0.2 mL Single-dose prefilled syringe
Fragmin (dalteparin sodium) Injection, USP
2,500 units/0.2 mL
For Subcutaneous Use
Rx only
PAA233721
PRINCIPAL DISPLAY PANEL - 0.2 mL Syringe Blister Pack Label - 0195
10PRINCIPAL DISPLAY PANEL - 0.2 mL Syringe Carton - 0195
NDC 0069-0195-02
10 x 0.2 mL Single-dose prefilled syringes. Discard unused portion.
Fragmin
(dalteparin sodium) Injection, USP
2,500 units/0.2 mL
For Subcutaneous UsePreservative Free
Pfizer
Hospital
Rx only
PRINCIPAL DISPLAY PANEL - 0.2 mL Syringe Carton - 0195
11PRINCIPAL DISPLAY PANEL - 0.2 mL Syringe Label - 0196
0.2 mL
Fragmin®
(dalteparin sodium) Injection, USP
5,000 units/0.2 mL
For Subcutaneous UsePfizer Labs
Division of Pfizer Inc.
NY, NY 10001
Rx only
PAA233624
PRINCIPAL DISPLAY PANEL - 0.2 mL Syringe Label - 0196
12PRINCIPAL DISPLAY PANEL - 0.2 mL Syringe Blister Pack Label - 0196
0.2 mL Single-dose prefilled syringe
Fragmin
5,000 units/0.2 mL
For Subcutaneous Use
Rx only
PAA233722
PRINCIPAL DISPLAY PANEL - 0.2 mL Syringe Blister Pack Label - 0196
13PRINCIPAL DISPLAY PANEL - 0.2 mL Syringe Carton - 0196
NDC 0069-0196-02
10 x 0.2 mL Single-dose prefilled syringes. Discard unused portion.
Fragmin
(dalteparin sodium) Injection, USP
5,000 units/0.2 mL
For Subcutaneous Use
SterilePreservative Free
Pfizer
Hospital
Rx only
PRINCIPAL DISPLAY PANEL - 0.2 mL Syringe Carton - 0196
14PRINCIPAL DISPLAY PANEL - 0.3 mL Syringe Label - 0206
0.3 mL
Fragmin
(dalteparin sodium) Injection, USP
7,500 units/0.3 mL
For Subcutaneous UsePfizer Labs
Division of Pfizer Inc.
NY, NY 10001
Rx only
PAA233625
PRINCIPAL DISPLAY PANEL - 0.3 mL Syringe Label - 0206
15PRINCIPAL DISPLAY PANEL - 0.3 mL Syringe Blister Pack Label - 0206
0.3 mL Single-dose prefilled syringe
Fragmin
7,500 units/0.3 mL
For Subcutaneous Use
Rx only
PAA233723
PRINCIPAL DISPLAY PANEL - 0.3 mL Syringe Blister Pack Label - 0206
16PRINCIPAL DISPLAY PANEL - 0.3 mL Syringe Carton - 0206
NDC 0069-0206-02
10 x 0.3 mL Single-dose prefilled syringes. Discard unused portion.
Fragmin
(dalteparin sodium) Injection, USP
7,500 units/0.3 mL
For Subcutaneous UsePreservative Free
PfizerHospital
Rx only
PRINCIPAL DISPLAY PANEL - 0.3 mL Syringe Carton - 0206
17PRINCIPAL DISPLAY PANEL - 1 mL Syringe Label - 0217
PAA233626
Fragmin 1 mL
(dalteparin sodium) Injection, USP
10,000
For Subcutaneous Use
Pfizer Labs
Division of Pfizer Inc.
NY, NY 10001
NDC 0069-0217-01
Rx only
PRINCIPAL DISPLAY PANEL - 1 mL Syringe Label - 0217
18PRINCIPAL DISPLAY PANEL - 1 mL Syringe Blister Pack Label - 0217
1 mL Single-dose graduated syringe
Fragmin (dalteparin sodium) Injection, USP
10,000 units/mL
For Subcutaneous Use
Rx only
PAA233724
PRINCIPAL DISPLAY PANEL - 1 mL Syringe Blister Pack Label - 0217
19PRINCIPAL DISPLAY PANEL - 1 mL Syringe Carton - 0217
NDC 0069-0217-02
10 x 1 mL Single-dose graduated syringes. Discard unused portion.
Fragmin
(dalteparin sodium) Injection, USP
10,000 units/mL
For Subcutaneous UsePreservative Free
Pfizer
Hospital
Rx only
PRINCIPAL DISPLAY PANEL - 1 mL Syringe Carton - 0217
20PRINCIPAL DISPLAY PANEL - 0.5 mL Syringe Label - 0220
0.5 mL NDC 0069-0220-01
Fragmin®
(dalteparin sodium) Injection, USP
12,500 units/0.5 mL
For Subcutaneous UsePfizer Labs
Division of Pfizer Inc.
NY, NY 10001
Rx only
PAA233627
PRINCIPAL DISPLAY PANEL - 0.5 mL Syringe Label - 0220
21PRINCIPAL DISPLAY PANEL - 0.5 mL Syringe Blister Pack Label - 0220
0.5 mL Single-dose prefilled syringe
Fragmin (dalteparin sodium) Injection, USP
12,500 units/0.5 mL
For Subcutaneous Use
Rx only
PAA233725
PRINCIPAL DISPLAY PANEL - 0.5 mL Syringe Blister Pack Label - 0220
22PRINCIPAL DISPLAY PANEL - 0.5 mL Syringe Carton - 0220
NDC 0069-0220-02
10 x 0.5 mL Single-dose prefilled syringes. Discard unused portion.
Fragmin
(dalteparin sodium) Injection, USP
12,500 units/0.5 mL
For Subcutaneous Use
SterilePreservative Free
Pfizer
Hospital
Rx only
PRINCIPAL DISPLAY PANEL - 0.5 mL Syringe Carton - 0220
23PRINCIPAL DISPLAY PANEL - 0.6 mL Syringe Label-0223
0.6 mL NDC 0069-0223-01
Fragmin®
(dalteparin sodium) Injection, USP
15,000 units/0.6 mL
For Subcutaneous UsePfizer Labs
Division of Pfizer Inc.
NY, NY 10001
Rx only
PAA233629
PRINCIPAL DISPLAY PANEL - 0.6 mL Syringe Label-0223
24PRINCIPAL DISPLAY PANEL - 0.6 mL Syringe Blister Pack Label - 0223
0.6 mL Single-dose prefilled syringe
Fragmin (dalteparin sodium) Injection, USP
15,000 units/0.6 mL
For Subcutaneous Use
Rx only
PAA233727
PRINCIPAL DISPLAY PANEL - 0.6 mL Syringe Blister Pack Label - 0223
25PRINCIPAL DISPLAY PANEL - 0.6 mL Syringe Carton - 0223
NDC 0069-0223-02
10 x 0.6 mL Single-dose prefilled syringes. Discard unused portion.
Fragmin
(dalteparin sodium) Injection, USP
15,000 units/0.6 mL
For Subcutaneous UsePreservative Free
Pfizer
Hospital
Rx only
PRINCIPAL DISPLAY PANEL - 0.6 mL Syringe Carton - 0223
26PRINCIPAL DISPLAY PANEL - 0.72 mL Syringe Label - 0228
0.72 mL
Fragmin®
(dalteparin sodium) Injection, USP
18,000 units/0.72 mL
For Subcutaneous Use
Single-dose prefilled syringe
Pfizer Labs
Rx only
PAA233628
PRINCIPAL DISPLAY PANEL - 0.72 mL Syringe Label - 0228
27PRINCIPAL DISPLAY PANEL - 0.72 mL Syringe Blister Pack Label - 0228
0.72 mL Single-dose prefilled syringe
Fragmin
18,000 units/0.72 mL
For Subcutaneous Use
Rx only
PAA233726
PRINCIPAL DISPLAY PANEL - 0.72 mL Syringe Blister Pack Label - 0228
28PRINCIPAL DISPLAY PANEL - 0.72 mL Syringe Carton - 0228
NDC 0069-0228-02
10 x 0.72 mL Single-dose prefilled syringes, Discard unused portion.
Fragmin
(dalteparin sodium) Injection, USP
18,000 units/0.72 mL
For Subcutaneous UsePreservative Free
Pfizer
Hospital
Rx only
PRINCIPAL DISPLAY PANEL - 0.72 mL Syringe Carton - 0228
29PRINCIPAL DISPLAY PANEL - 95,000 IU Vial Label - 0232
NDC 0069-0232-01
3.8 mL Multiple-dose vial
Fragmin
(dalteparin sodium) Injection, USP
95,000 units/3.8 mL
(25,000 units/mL)
For Subcutaneous Use
Rx only
PRINCIPAL DISPLAY PANEL - 95,000 IU Vial Label - 0232
30PRINCIPAL DISPLAY PANEL - 95,000 IU Vial Carton - 0232
NDC 0069-0232-01
3.8 mL Multiple-dose vial
Fragmin
(dalteparin sodium) Injection, USP
95,000 units/3.8 mL
(25,000 units/mL)
For Subcutaneous Use
Sterile
Pfizer
Hospital
Rx only
PRINCIPAL DISPLAY PANEL - 95,000 IU Vial Carton - 0232
31PRINCIPAL DISPLAY PANEL - 10,000 IU Vial Label - 0253
NDC 0069-0253-01
4 mL single-dose vial
Fragmin
10,000 IU/4 mL
For subcutaneous injection
Rx only
PRINCIPAL DISPLAY PANEL - 10,000 IU Vial Label - 0253
32PRINCIPAL DISPLAY PANEL - 10,000 IU Vial Carton - 0253
NDC 0069-0253-10
Ten 4 mL single-dose vials
Fragmin
10,000 IU/4 mL
For subcutaneous injection
Rx only
Pfizer
PRINCIPAL DISPLAY PANEL - 10,000 IU Vial Carton - 0253