Pixorel 2.5

Indications:

Pixorel is a Factor Xa inhibitor used to prevent and treat blood clots. It is indicated for:

• Reducing the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation.
• Prophylaxis of deep vein thrombosis (DVT), which can lead to pulmonary embolism (PE), in patients who have undergone hip or knee replacement surgery.
• Treatment of DVT and PE, and to reduce the risk of recurrent DVT and PE after initial therapy.

Always follow the advice of a registered healthcare professional when using Pixorel.

Pharmacology:

Pixorel (Apixaban) works by inhibiting Factor Xa, a key enzyme in the coagulation cascade, preventing the formation of blood clots. By inhibiting Factor Xa, it prolongs clotting times, including prothrombin time (PT), INR, and activated partial thromboplastin time (aPTT). However, these changes are small and highly variable, so routine monitoring of clotting parameters is not recommended during therapy.

Dosage & Administration:

• Recommended Dose: For most patients, the typical dose is 5 mg taken orally twice daily.
• Dosage Adjustments: In patients with two or more of the following conditions: age ≥80 years, body weight ≤60 kg, or serum creatinine ≥1.5 mg/dL, the recommended dose is 2.5 mg twice daily.
• CYP3A4 and P-gp inhibitors: When coadministered with strong inhibitors of CYP3A4 and P-gp (e.g., ketoconazole, itraconazole, ritonavir), the recommended dose is 2.5 mg twice daily.

Missed Dose: If a dose is missed, take it as soon as possible on the same day and resume the regular schedule. Do not double the dose.

Discontinuation for Surgery: Stop Pixorel 48 hours before surgeries with moderate/high bleeding risk or 24 hours before surgeries with low bleeding risk.

Switching Medications:

• From Warfarin to Pixorel: Stop Warfarin when the INR falls below 2.0 and initiate Pixorel.
• From Pixorel to Warfarin: Discontinue Pixorel and begin a parenteral anticoagulant and Warfarin at the time the next dose of Pixorel would have been due.

Consult your healthcare provider for personalized guidance on switching therapies.

Interactions:

• CYP3A4 and P-gp inhibitors (e.g., ketoconazole, ritonavir) may increase the blood levels of Pixorel, increasing the risk of bleeding.
• CYP3A4 and P-gp inducers (e.g., rifampin) may lower Pixorel levels, reducing its effectiveness and increasing the risk of stroke.

Contraindications:

Pixorel is contraindicated in patients with:

• Active pathological bleeding.
• Severe hypersensitivity to Pixorel (e.g., anaphylactic reactions).

Side Effects:

• Skin rashes and severe allergic reactions are possible side effects. If these occur, contact your healthcare provider immediately.

Pregnancy & Lactation:

• Pregnancy: There is insufficient data on the safety of Pixorel during pregnancy. It should only be used if the potential benefit outweighs the risks to the mother and fetus.
• Labor and Delivery: Pixorel has not been studied for safety during labor and delivery. Use caution due to the risk of bleeding.
• Breastfeeding: The safety of Pixorel during breastfeeding is unknown. Discontinue breastfeeding or stop the medication, depending on its importance to the mother.

Precautions & Warnings:

• Increased Risk of Stroke: Discontinuing Pixorel without adequate anticoagulation increases the risk of thrombotic events. If discontinuation is necessary, switch to an alternative anticoagulant to prevent stroke.

Use in Special Populations:

• Hepatic Impairment: No dose adjustment is required for mild hepatic impairment. Pixorel is not recommended for use in severe hepatic impairment.
• Renal Impairment: Adjustments may be necessary for moderate renal impairment. No data is available for patients with creatinine clearance <15 mL/min or those on dialysis.
• Pediatric Use: The safety and effectiveness of Pixorel in pediatric patients have not been established.
• Geriatric Use: Clinical studies have shown Pixorel to be effective and safe in elderly patients (≥65 years), maintaining stroke risk and bleeding control similar to warfarin.

Overdose Effects:

There is no specific antidote for Pixorel. In the event of an overdose, the risk of bleeding increases. Activated charcoal may be useful in managing an overdose.

Therapeutic Class:

• Anticoagulants
• Anti-platelet drugs
• Oral anticoagulants

Storage Conditions:

• Store Pixorel in a dry place below 30°C.
• Keep away from light and out of reach of children.