Drug Information Summary: Lucius Bosentan Tablets

Disclaimer: This is a synthesized summary based on the known pharmacological profile of Bosentan. This is not the official manufacturer's leaflet and does not replace professional medical advice.Bosentan is a potent prescription drug with serious risks and must only be prescribed and monitored by physicians experienced in the treatment of pulmonary arterial hypertension.

1. Brand and Generic Name

• Generic Name: Bosentan

• Brand/Manufacturer: Lucius Pharmaceuticals (Laos) - Note: This is a generic/manufactured version. The original brand name is Tracleer®.

2. What is Bosentan and what is it used for?

• Bosentan is an endothelin receptor antagonist (ERA). It works by blocking the action of endothelin, a substance that causes blood vessels to narrow.

• It is used to treat Pulmonary Arterial Hypertension (PAH), specifically WHO Functional Class II-IVsymptoms. It improves exercise ability and slows the clinical worsening of the disease.

3. Before you take Lucius Bosentan
Do NOT take if you:

• Are allergic to bosentan or any of its ingredients.

• Are pregnant, planning to become pregnant, or not using reliable contraception. (See Boxed Warning)

• Have moderate to severe liver problems.

• Are taking cyclophosphamide or glyburide (glibenclamide).

Warnings and Precautions (Black Box Warning):
Bosentan carries a BOXED WARNING for the following risks:

• Hepatotoxicity (Liver Injury): Can cause serious and potentially fatal liver injury. Monthly blood tests to monitor liver enzymes (ALT/AST) are MANDATORY.

• Embryo-Fetal Toxicity: Based on animal data, bosentan is very likely to cause major birth defects. It is contraindicated in pregnancy.

Other Important Precautions:
Talk to your doctor about:

• Pregnancy Test Requirements: Females of childbearing potential must have a negative pre-treatment pregnancy test and must use two reliable forms of contraception during treatment and for one month after stopping treatment.

• Hemoglobin Monitoring: Can cause a significant drop in red blood cell count (hemoglobin). Blood counts should be checked regularly.

• Sperm Count Reduction: May affect male fertility.

• Fluid Retention (Edema): Can cause swelling in the legs and ankles, and may lead to heart failure in some patients.

• Pulmonary Veno-Occlusive Disease (PVOD): If patients experience pulmonary edema upon initiation of therapy, consider the possibility of associated PVOD and consider discontinuing treatment.

4. How to take Lucius Bosentan

• Dosage: The dose must be initiated and adjusted by your doctor.

  • Starting Dose: 62.5 mg orally, twice daily (morning and evening).

  • Maintenance Dose: After 4 weeks, the dose is typically increased to the target maintenance dose of 125 mg twice daily.

• Administration: Take with or without food.

• Missed Dose: Take the next dose at the scheduled time. Do not take a double dose.

5. Possible Side Effects
Common side effects may include:

• Headache

• Flushing

• Edema (swelling of legs and ankles)

• Nasopharyngitis (common cold)

• Irregular heart palpitations

• Low blood pressure

• Stuffy nose

• Diarrhea

• Itching

• Serious Side Effects (Contact your doctor immediately):

  • Signs of liver problems: nausea, vomiting, fever, tiredness, abdominal pain, jaundice (yellowing of skin/eyes), dark urine.

  • Signs of anemia: unusual tiredness, shortness of breath, pale skin.

  • Significant fluid retention and sudden weight gain.

6. Drug Interactions
Bosentan has significant interactions with many drugs. Inform your doctor about ALL medications you take, especially:

• Strong CYP2C9 and CYP3A4 Inhibitors (e.g., ketoconazole, fluconazole): May increase bosentan levels.

• Strong CYP2C9 and CYP3A4 Inducers (e.g., rifampin, carbamazepine, St. John's Wort): May drastically decrease bosentan levels, making it ineffective.

• Hormonal Contraceptives: Bosentan may make birth control pills less effective, which is why two forms of contraception are required.

• Statins (e.g., simvastatin): Bosentan may decrease their levels.

• Warfarin: Bosentan may affect its anticoagulant effect; monitoring is required.

• Cyclophosphamide and Glyburide: Contraindicated for concurrent use.

7. Storage

• Store below 30°C (86°F).

• Keep in the original container, tightly closed.

• Protect from light and moisture.

• Keep out of reach of children and pets.

8. Packaging

• Typically supplied in foil blister packs to protect from moisture.

Final Crucial Advice:
Treatment with Bosentan requires an absolute commitment to monthly liver function monitoring and (for females) strict pregnancy prevention protocols. The risks of liver injury and birth defects are severe and require diligent management by a specialist. Always follow your physician's specific instructions and report any side effects immediately.

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