Fragmin

Quick links to important sections

Fragmin

Selected form

Medically reviewed

Marina Burgos

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Fragmin

Quick Facts: Fragmin (Dalteparin Sodium)

Property Description
Active ingredient Dalteparin Sodium
Form Sterile Solution for Injection (pre-filled syringes)
Pharmacological class Antithrombotic agent (Anticoagulant)
Type/Subclass Low Molecular Weight Heparin (LMWH)
Manufacturer / Status Pfizer / Prescription-only (Rx)

What Type of Medicine is Fragmin (Dalteparin Sodium)?

Fragmin is the trade name for the injectable antithrombotic agent whose active ingredient is Dalteparin Sodium. It is classified as a Low Molecular Weight Heparin (LMWH), placing it within the larger Heparin group of anticoagulants. Dalteparin Sodium is a semi-synthetic compound, produced through the controlled chemical degradation of standard Heparin derived from porcine intestinal mucosa. Fragmin is manufactured by Pfizer and is supplied as a prescription-only (Rx) medication, specifically as a sterile aqueous solution for injection in pre-filled syringes.

Composition and General Purpose as an Anticoagulant

The primary purpose of Fragmin is to function as a powerful anticoagulant, helping to maintain the fluidity of the blood. Its core mechanism relies on binding to the plasma protein Antithrombin, which enhances Antithrombin's ability to selectively deactivate Factor Xa, a key component of the clotting process. This focused action on Factor Xa supports the drug's general function in helping to manage the risk of unwanted thrombosis in the circulation, a use clinically recognized across major medical institutions.

How Dalteparin Sodium Differs from Standard Heparin

As a fractionated product with a smaller, more consistent molecular size, Dalteparin preferentially targets Factor Xa over thrombin compared to Unfractionated Heparin (UFH). This structural differentiation results in a more stable and predictable pharmacological profile. Fragmin's presentation in distinct, calibrated pre-filled syringes is a differentiating feature intended to facilitate precise, standardized administration, which supports their widespread use in patient management.

Regulatory References

  1. Dalteparin - StatPearls - NCBI Bookshelf

What side effects are possible with Fragmin?

Possible Side Effects and Safety Information

The following details the officially documented safety profile of Dalteparin Sodium (Fragmin), derived strictly from government-approved regulatory documents. As an anticoagulant, the core safety considerations revolve around its effect on the blood and vascular system.

Adverse Reaction Classification

Adverse reactions are classified by the physiological system affected and their estimated frequency during clinical use, adhering to regulatory standards.

Frequency Classification System Organ Class (SOC) Examples Adverse Reaction Examples
Very Common (≥ 1/10) General, Blood and Lymphatic Haematoma at injection site, transient Thrombocytopenia
Common (≥ 1/100 to < 1/10) Vascular, Nervous, Skin Haemorrhage, Headache, Ecchymoses
Uncommon (≥ 1/1,000 to < 1/100) Blood and Lymphatic, Skin Drug-induced Thrombocytopenia (Type II), Skin Necrosis
Rare (≥ 1/10,000 to < 1/1,000) Immune, Musculoskeletal Anaphylactic reactions, Osteoporosis (associated with long-term use)

Serious Safety Considerations

The prescribing information highlights the potential for Major Haemorrhage as the primary serious risk associated with all anticoagulants. A specific, serious adverse reaction is the potential for Spinal or Epidural Haematoma when Dalteparin is used in patients undergoing neuraxial (spinal) anesthesia or lumbar puncture.

Population-Specific Safety Notes

The official labeling notes that patients 65 years and older have a documented increased risk for bleeding compared to younger patients. Additionally, caution is advised for use in individuals with severe renal impairment due to the drug's substantial renal elimination, which may lead to accumulation. Concomitant use with agents like NSAIDs is also documented to increase the overall risk of haemorrhage.

Overdose and Emergency Response

Overdose and When to Seek Help

The official regulatory documentation for Fragmin (Dalteparin Sodium) establishes that the primary documented manifestation of an overdose is hemorrhage or bleeding, which is a consequence of the drug’s intended anticoagulant activity. Overdose presentations can range from minor signs of bleeding to severe, clinically significant, or potentially fatal hemorrhage.


Official Regulatory Actions and Management

Overdose Action Regulatory Mandate
Immediate Help-Seeking Seek immediate medical attention for any suspected overdose. Contact emergency services immediately if severe or uncontrolled bleeding occurs.
Initial Response Discontinuation of Fragmin is required as the first management step.
Partial Neutralization Protamine Sulfate is documented as the available neutralizing agent; however, regulatory documents specify that it only partially reverses the anti-Factor Xa activity of Dalteparin Sodium.
Supportive Care Management requires symptomatic and supportive treatment, which may include administering blood products for major bleeding.

Population Considerations

Regulatory information notes a specific consideration for patients with severe renal impairment, as drug accumulation in this population increases the potential for overdose-related hemorrhage. Monitoring of Anti-Factor Xa activity may be required to assess the degree of exposure and treatment effectiveness during overdose management.

Therapeutic Uses of Fragmin

Fragmin (dalteparin sodium) is used in situations involving certain distressing symptoms linked to clotting. Its core therapeutic domain is applied in addressing venous thromboembolism (VTE), a group of conditions that includes deep vein thrombosis (DVT) and pulmonary embolism (PE). The drug is applied for the management of DVT symptoms related to physical discomfort in patients facing major surgery or symptoms that interfere with daily functioning during acute illness.


What Fragmin Treats: Main Uses and Benefits

This medicine is commonly used across conditions presenting with acute episodes and provides support that helps ease the overall symptom burden associated with clotting.

It is relevant for easing symptoms related to inflammatory or irritative states associated with established blood clots. The therapeutic domain is applied across areas where short-term symptom management is appropriate, relevant to conditions characterized by periods of heightened symptoms such as VTE in adult patients with cancer, VTE in pediatric patients, and symptoms linked to organ-specific functional stress. It contributes to easing the overall symptom load.

Quick Fact: Supports patients during episodes of heightened discomfort.

Eligibility and Restrictions for Use

Fragmin (dalteparin sodium) is a prescription anticoagulant. Eligibility for its use is strictly determined by governmental regulatory documentation concerning specific medical conditions, age, and physiological status.

Contraindicated (Must NOT use) Use Requires Caution/Special Consideration
Active major bleeding Severe renal or hepatic impairment
History of Heparin-Induced Thrombocytopenia (HIT) or HITT Advanced age (especially 80 years and older)
Known hypersensitivity to dalteparin, heparin, or pork products Conditions with increased risk of hemorrhage
Patients undergoing epidural/neuraxial anesthesia for certain indications (due to risk of spinal hematoma) Pregnancy/Lactation (multidose vials with benzyl alcohol are not recommended)

Age-Related Eligibility:

  • Adults: Generally eligible for approved uses.
  • Pediatric Use: Approved for the treatment of venous thromboembolism (VTE) in patients 1 month of age and older. Safety and effectiveness have not been established in children younger than 1 month.
  • Neonates/Infants: Multiple-dose formulations containing benzyl alcohol preservative are not for use in this population, nor are they recommended for pregnant women.

Use is not recommended in patients with a prosthetic heart valve who are pregnant and receiving Fragmin for VTE prophylaxis.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The regulatory interaction profile for Dalteparin Sodium (Fragmin) is dominated by the risk of pharmacodynamic reinforcement and specific administrative prohibitions, all strictly documented in official government labels.

Interaction Type Interacting Medicines & Outcome Restriction Status
Pharmacodynamic Oral Anticoagulants, Platelet Inhibitors (e.g., ASA), NSAIDs, Thrombolytic Agents, and Dextran may increase the risk of hemorrhage due to additive effects on hemostasis. Use with Caution
Procedural Neuraxial Anesthesia (spinal/epidural) is officially restricted and contraindicated during treatment with high-dose Fragmin (e.g., therapeutic VTE regimens) due to the increased risk of spinal/epidural hematoma. Contraindicated
Potassium Effect Potassium-sparing medicines require caution due to the documented risk of hyperkalemia, as Dalteparin may suppress adrenal aldosterone secretion. Caution

Administration and Timing Constraints

The product must not be mixed with other medicinal products except for specific isotonic sodium chloride or glucose infusion solutions. The official labeling notes that the interaction risk associated with NSAIDs or high-dose ASA requires particular care in patients with renal failure. Furthermore, interactions with food, alcohol, or herbal products are formally stated in regulatory documents as not established.

Mechanism of Action

How Fragmin Works: Mechanism of Action

The mechanism of Dalteparin Sodium (Fragmin) is defined by its highly specific action on the blood coagulation cascade, resulting in reduced potential for clot formation through enzyme activity modulation.

Potentiation of Antithrombin Activity and Factor Xa Inhibition

Dalteparin acts primarily by binding to the endogenous cofactor Antithrombin ( ATIII) via a unique molecular sequence, which immediately enhances ATIII's ability to inactivate clotting factors. This potentiation is overwhelmingly directed at Activated Coagulation Factor X ( Factor Xa), thus preventing the core enzymatic step required to generate the powerful clotting factor Thrombin. The physiological effect is a rapid systemic change to a hypocoagulable state, established by suppressing a critical step in the upstream coagulation pathway.

Structural Constraints and Endothelial Modulation

The relatively short polymer chain length of Dalteparin structurally limits its ability to efficiently inhibit Thrombin ( Factor IIa), leading to a high anti- Factor Xa:anti- Factor IIa ratio that defines its mechanistic specificity. This focused suppression is supplemented by the drug's influence on the vascular wall, promoting the release of natural inhibitors like Tissue-Factor Pathway Inhibitor ( TFPI). This overall modulation establishes an antithrombotic physiological state and contributes to the characteristics of the molecule's specific anti-Factor Xa activity.

Dosage and Administration Information

Administration Overview

Fragmin is administered via subcutaneous injection, which means it is delivered into the fatty tissue layer just beneath the skin. It is not intended for intramuscular injection. The administration process typically involves the use of pre-filled syringes or graduated syringes, depending on the specific volume required for the individual.

Preparation for Injection

Before administration, the injection site should be selected and cleaned. Common sites for subcutaneous injection include the fatty tissue of the lower abdomen, at least five centimeters away from the navel, or the outer aspect of the thighs. It is recommended to rotate the injection site with each dose to minimize local irritation.

Handling the Syringe

When using a pre-filled syringe, a small air bubble may be present. This bubble is intended to remain in the syringe and should not be expelled before the injection, as it helps ensure the full delivery of the dose. The needle shield should be removed only when the individual is ready to perform the injection.

Injection Technique

To perform the injection, a fold of skin is gently gathered between the thumb and forefinger. The needle is inserted vertically into the skin fold at a 90-degree angle. The plunger is then depressed steadily to deliver the solution. Once the injection is complete, the needle is withdrawn, and the skin fold is released.

Disposal and Storage

Used syringes and needles must be disposed of immediately in a puncture-resistant container. This ensures that sharp objects are handled safely and kept out of reach of others. The medication should be stored according to the temperature requirements specified on the product packaging, away from direct heat and light.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Fragmin (Dalteparin Sodium)


Evidence for Extended Management of VTE in Cancer Patients

For patients dealing with cancer and an associated blood clot (VTE), research has studied dalteparin over several months. These studies tracked outcomes related to systemic or functional imbalance, specifically monitoring the recurrence of a new clot. The evaluations involved large randomized controlled trials (RCTs) where VTE event frequency was observed and tracked in the dalteparin group versus a comparator group (typically warfarin) over the six-month study period.

What remains uncertain is the long-term effect of dalteparin beyond the standard six-month treatment period; long-term effects are not fully established. Also, while evidence was studied for comparisons against warfarin, comparative evidence is limited for dalteparin against newer direct oral anticoagulants (DOACs) for this specific indication, although several trials have tracked these comparisons.


Evidence for VTE Prevention in Acutely Ill Hospitalized Patients

Research has studied dalteparin in preventing VTE in severely ill adult patients who are hospitalized and experience severely restricted mobility. These studies are typically large-scale, randomized, double-blind, placebo-controlled trials.

Studies observed patterns in which VTE frequency was tracked in the dalteparin group compared to the placebo group during the 14-day treatment period and the 90-day observation period. The results are specific to the short-term use during a hospital stay; therefore, data for long-term outcomes or prevention after the patient leaves the hospital are limited.


Evidence in Special Populations, Including Pediatric Patients

Clinical studies explored the use of dalteparin in pediatric patients (infants and children) with symptomatic VTE. This research was structured as open-label, single-arm studies and primarily monitored a pharmacodynamic endpoint: whether the treatment could consistently achieve a target anti-clotting level in the blood (anti-Factor Xa level).

These studies reported that dosing adjustments based on age and weight resulted in achievement of the targeted anti-Xa levels in the observed populations. A limitation here is the study design: because there was no placebo or active comparator group, comparative evidence is limited for direct clinical outcomes, and the evidence is considered less definitive than evidence from randomized, placebo-controlled trials.

Frequently Asked Questions (FAQ)

Common questions about Fragmin (FAQ)


Q: Is Fragmin used to treat existing clots or only to prevent new ones?

Official regulatory labeling indicates that Fragmin (dalteparin sodium) is approved for both the treatment of existing blood clots (venous thromboembolism) and the prophylaxis (prevention) of new clot formation. Its use in these two capacities depends on the specific medical condition and patient population.


Q: What are the general signs of a serious allergic reaction associated with Fragmin?

Signs of a serious allergic reaction may include itching, developing a skin rash or hives, nausea or vomiting, and feeling dizzy or fainting. Serious reactions can also involve stomach cramps and joint pain. If a serious allergic reaction is suspected, official safety guidelines emphasize the need for immediate medical evaluation.


Q: How quickly can a person typically expect Fragmin to begin its blood-thinning activity?

As a low molecular weight heparin, Fragmin is designed to work rapidly. Studies have shown that the concentration of the drug reaches its highest level in the blood—where it exerts its anti-clotting effect—within a few hours of the injection.


Q: Does Fragmin typically require regular blood monitoring or lab tests?

Official labeling states that periodic blood counts and other laboratory tests may be recommended by a healthcare professional during the use of Fragmin. The need for these tests is assessed based on the individual patient's condition and the medical reason for using the medication.


Q: What is the factual difference between the high dose and low dose uses of Fragmin?

The difference between high and low doses relates directly to the medical purpose. Higher doses are generally utilized for the extended treatment of existing blood clots. Lower doses are typically used for the prophylaxis (prevention) of blood clots in patients who are at risk.


Q: What types of planned surgeries or procedures might require stopping Fragmin briefly?

Official prescribing information highlights a safety concern when Fragmin is used in the time period surrounding certain procedures. Specifically, official information describes that the drug must be temporarily withheld in specific periods close to neuraxial (spinal or epidural) anesthesia or lumbar puncture due to the risk of spinal bleeding.


Q: Is Fragmin used to manage medical conditions other than deep vein thrombosis (DVT)?

Yes, in addition to managing venous thromboembolism (which includes DVT), official product information lists other approved uses. These indications also include the prophylaxis of ischemic complications in unstable angina and non-Q-wave myocardial infarction, when the drug is used with aspirin therapy.


Q: What are the general considerations for using Fragmin before a dental extraction or major procedure?

Regulatory patient safety information advises individuals to inform all of their healthcare providers, including their dentist, about their use of Fragmin before any procedure. This ensures that the medical team can consider the anticoagulant effect of the medicine during planning.


Q: Is hair loss a known or studied side effect of Fragmin therapy?

Hair loss, or thinning of the hair, is included in the list of possible side effects that regulatory data indicates may occur in some patients using Fragmin. As with any potential side effect, if this occurs, it is necessary to consult with a healthcare professional.


Q: How long does the active ingredient in Fragmin typically stay in the body's system?

Studies examining how the body processes Fragmin show that the drug has a half-life of approximately 5 hours following a single intravenous dose. The half-life measures the time it takes for the body to eliminate half of the dose, which provides an indication of the drug’s duration of activity.


Q: What are the general guidelines for managing a missed dose of Fragmin?

Regulatory patient information states a missed dose may be taken when remembered. However, if the time is near for the next scheduled dose, the missed dose should be skipped, and two doses it is described that two doses should not be administered together.


Q: What are the general safety guidelines for stopping Fragmin treatment?

Official safety information strongly describes that treatment must not be initiated, discontinued, or altered, including Fragmin, without professional clinical guidance. Treatment changes are based on clinical evaluation and monitoring.


Q: Does taking Fragmin have any known effect on caffeine or coffee consumption?

According to official regulatory documents, a formal interaction between Fragmin and common food or dietary products is not established. This information is based on the available regulatory safety profiles and studies.


Q: Is it generally safe to take standard multivitamins while on Fragmin therapy?

Regulatory safety information does not contain specific warnings or contraindications regarding the use of standard multivitamins. Official guidance emphasizes informing a healthcare professional about all products being taken.


Q: What happens in the body if a larger-than-prescribed amount of Fragmin is taken?

Official prescribing information indicates that accidental overdosage with Fragmin may lead to the potential risk of hemorrhagic complications. This means the risk of significant bleeding problems is increased and is a situation that necessitates immediate clinical evaluation.

How should Fragmin be stored and disposed of?

Storage and Disposal Requirements

Fragmin (dalteparin sodium) must be stored according to official regulations to maintain its stability. The product must be kept at controlled room temperature, typically below 25°C (77°F) or below 30°C (86°F), and must not be frozen.

Stability and Handling

Syringes should be kept in their original pack. To ensure child safety, the medicine must be kept out of the sight and reach of children.

For multidose vials, any unused solution must be discarded 14 days after the first use. The product should never be used past its expiry date.

Disposal of Used Product

Official disposal instructions require that used syringes and needles be placed in a designated, puncture-proof sharps container. Unused or expired Fragmin must be disposed of in accordance with local regulatory requirements and should not be thrown into household waste or wastewater.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

Available in countries:

Equivalent of Fragmin found in:

A-Z Index: