Fragmin

(Dalteparin Sodium)

The active ingredient in Fragmin is dalteparin sodium. It is a low molecular weight heparin that helps reduce the blood’s ability to form clots. It works by enhancing the activity of antithrombin, a natural substance in the body that blocks clotting factors such as factor Xa. By reducing clot formation, Fragmin helps prevent conditions like deep vein thrombosis, pulmonary embolism, and other clot-related complications, including those that may occur after a heart attack (myocardial infarction).

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Fragmin. However, the following is a synopsis of the general guidelines for the use of Fragmin:

• Your healthcare professional will decide the correct dose based on your condition, body weight, kidney function, and whether the medication is being used for prevention or treatment.
• Fragmin is usually given as a subcutaneous injection, meaning it is injected under the skin. The injection is often given in the abdomen, rotating injection sites to reduce irritation.
• In some hospital situations, it may be given by intravenous injection through a catheter.
• If you miss a dose, contact your healthcare professional for advice about the next dose. Do not double up doses unless instructed.
• Fragmin may be used in adults and, in specific situations, pediatric patients under specialist care.

Some mild or common side effects of Fragmin seen in clinical trials include:

• Bruising, redness, swelling, or pain at the injection site.
• Minor bleeding, such as nosebleeds or bleeding gums.
• Mild back pain.
• Changes in blood test results, including platelet levels.

Some individuals may experience serious side effects while using Fragmin. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Severe or uncontrolled bleeding.
• Signs of internal bleeding, such as black stools, blood in urine, or vomit that looks like coffee grounds.
• Sudden back pain, numbness, or weakness, especially after spinal puncture or epidural procedures, may signal spinal cord compression.
• Allergic reaction, including hives, rash, swelling, or trouble breathing.
• Signs of heparin-induced thrombocytopenia, such as new or worsening blood clots with low platelets.

These are not all of the possible side effects of Fragmin. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Fragmin, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including if you have:

• Bleeding disorders or an increased risk of bleeding.
• A history of heparin-induced thrombocytopenia.
• Kidney problems, including renal insufficiency.
• Recent or planned surgery, especially involving the spine or brain.
• A history of spinal puncture or use of epidural catheters.
• Endocarditis or other serious infections affecting the heart.
• Known allergies to heparin, dalteparin sodium, or benzyl alcohol used as a preservative in some dosage forms.

Boxed Warning

Fragmin has a boxed warning for the risk of spinal or epidural hematomas in patients receiving neuraxial anesthesia or undergoing spinal puncture. These bleeding events can cause long-term or permanent paralysis. The risk is higher in patients with indwelling epidural catheters, those taking other drugs that affect bleeding, or those with a history of spinal surgery. Careful monitoring by healthcare professionals is required.

Fragmin should not be used in patients who:

• Have active major bleeding.
• Have a known hypersensitivity or allergic reaction to dalteparin, heparin, or pork products.
• Have a history of immune-mediated heparin-induced thrombocytopenia.
• Neonates should not use formulations that contain benzyl alcohol as a preservative.

Fragmin begins to work soon after injection. Its anticoagulant effect develops within hours, based on its pharmacokinetics and half-life. While it works quickly to reduce clot formation, ongoing use as prescribed is important for full protection against blood clots such as DVT or pulmonary embolism.

When Fragmin is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking, including:

• Warfarin, due to the increased risk of bleeding.
• NSAIDs such as ibuprofen may increase bleeding risk.
• Platelet inhibitors such as clopidogrel or dipyridamole may further affect clotting.

Fragmin is available in several dosage forms and strengths, measured in anti-factor Xa units, including:

• Single-dose and multi-dose vials.
• Prefilled syringe options for subcutaneous injection.
• Multiple strengths are used for prophylaxis, treatment of VTE, or extended treatment as determined by a healthcare professional.

It should be stored at room temperature, away from the reach of children or pets.

Fragmin is manufactured by Pfizer.

Fragmin is the brand name for dalteparin sodium. Dalteparin may be available under other names depending on the country and regulatory approval.

Do not stop taking Fragmin without talking to your healthcare professional. Stopping a blood thinner suddenly can increase the risk of blood clots. Your provider will guide you on when and how to stop treatment safely.

Fragmin may be used in pregnant women when the benefits outweigh the risks, and careful medical supervision is required. Talk to your doctor if you are already pregnant or if you have plans to become pregnant.

Talk to your doctor if you are already breastfeeding or if you have plans to breastfeed. Your healthcare provider will help determine if Fragmin is appropriate during breastfeeding.