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This safety information highlights the potential risks and necessary precautions when using this medication. Please carefully review the following points and discuss any concerns with your healthcare provider.

• Spinal Bleeding Risk: There is a risk of bleeding around the spinal cord during spinal procedures if you are using this medication. This bleeding could lead to temporary or permanent paralysis. Consult your doctor about the benefits and risks prior to any spinal procedures. You may be advised to discontinue the medication for a period before and after the procedure. Follow your doctor’s instructions closely. The risk is elevated if you have a spinal deformity, a history of spinal surgeries (such as epidurals), or are taking other medications that increase bleeding risk, like antiplatelet drugs, blood thinners, or NSAIDs. Immediately report symptoms like back pain, numbness or weakness in the legs, or loss of bladder/bowel control to your doctor.

• General Bleeding Risk: This medication can increase bleeding risk, especially if you are also taking other blood-thinning medications. In case of a serious bleed, your provider may use a medication called protamine to counteract the effects. Notify your healthcare provider if you sustain any injuries, as they might need to check for internal bleeding. Seek immediate medical attention if you experience unusual bleeding, such as dark or tarry stools or bleeding that is difficult to stop.

• Low Platelet Counts and Clotting Issues: This medication can lower platelet counts, potentially leading to a severe condition known as heparin-induced thrombocytopenia (HIT). This condition can result in blood clots forming in various parts of the body, causing blockages in veins or arteries. If you have a history of HIT or HITT, discuss this with your provider.

• Pregnant Women with Prosthetic Heart Valves: Pregnant women with artificial heart valves are at increased risk of blood clots when using this medication, which can lead to serious complications. Regular monitoring and lab tests may be necessary to ensure safe use.

• Risk of Gasping Syndrome in Infants: Some formulations of this medication contain benzyl alcohol, which can cause a rare but severe condition called gasping syndrome in newborns and infants, especially those with low birth weight. If you are pregnant or breastfeeding, consult your provider to ensure you receive a formulation without this preservative.

• Contraindications: This medication should not be used in individuals with uncontrolled bleeding, a history of HIT or HITT, or allergies to heparin, pork, or benzyl alcohol. Discuss these conditions with your healthcare provider before starting treatment.

In case of overdose or emergency, contact medical services immediately. Always communicate openly with your healthcare provider about any other medications you are taking or any changes in your condition.

Common side effects:

• Mild irritation
• Pain at the injection site
• Bruising at the injection site
• Redness at the injection site
• Swelling at the injection site
• Tiredness
• Fever

Less common but important to monitor:

• Abnormal liver test results
• Low red blood cell count (anemia)

Serious side effects:

• Severe bleeding
• Dark urine
• Black stools
• Severe headaches
• Confusion
• Vision changes
• Numbness
• Heparin-induced thrombocytopenia (HIT) and thrombosis (HITT)
• Very serious allergic reaction
• Swelling of the face, tongue, or throat
• Severe dizziness
• Trouble breathing
• Blood clots
• Chest discomfort
• Difficulty breathing

Interactions with high risk of serious adverse effects and should be avoided:

• Defibrotide

Interactions with moderate risk that may require dose adjustment, closer monitoring, or timing changes:

• Mifepristone
• Aspirin
• Clopidogrel
• Warfarin
• Abciximab
• Apixaban

Interactions with low risk that usually do not require a change in therapy:

• NSAIDs (e.g., Ibuprofen, Naproxen)