Fabhalta Iptacopan Application Scope

Fabhalta (Iptacopan) is indicated for the treatment of paroxysmal nocturnal hemoglobinuria (PNH), a rare, life-threatening condition caused by the excessive activation of the complement system leading to the destruction of red blood cells, resulting in hemolysis and increased risk of thrombosis.

Iptacopan is a complement factor B inhibitor that specifically targets the alternative complement pathway, providing a novel treatment approach to reduce the activity of the complement system in PNH patients. It can also be used to treat other complement-mediated disorders.

Fabhalta Iptacopan Characteristics

Ingredients:
- Active ingredient: Iptacopan
- Excipients: Includes stabilizers and other inactive ingredients.
Properties:Iptacopan is a complement inhibitor that selectively targets factor B in the alternative complement pathway, preventing the formation of the C3 convertase and subsequent activation of the complement system. This inhibition reduces red blood cell destruction and decreases the risks of thrombosis.
Specification:Available as oral capsules (typically 100 mg).
Storage:Store at room temperature (15°C to 30°C) in a dry place, away from direct light.
Expiry Date:Typically 24 months from the manufacturing date (check packaging for exact expiry dates).
Executive Standard:Meets regulatory standards, such as FDA or EMA approval for complement inhibitors.
Approval Number:Specific approval number would be assigned by relevant health authorities like FDA or EMA.

Guidelines For The Use Of Fabhalta Iptacopan

Dosage and Administration:

The typical starting dose of Fabhalta is 100 mg taken orally twice daily, with or without food.
Dosing may be adjusted based on treatment response and tolerability.

Adverse Reactions:

Common side effects include headache, nausea, fatigue, and diarrhea.
Serious side effects include infection, liver function abnormalities, and anemia.

Medication Limitations

Contraindications:

Fabhalta should not be used in patients with known hypersensitivity to Iptacopan or any of its components.
Contraindicated in patients with active infections or severe liver disease.

Precautions:

Patients should be monitored for liver function, as Iptacopan can cause hepatic enzyme elevations.
Caution should be taken in patients with immune system disorders.

Fabhalta Iptacopan Interactions

Drug Interactions:

Iptacopan may interact with immunosuppressive drugs, anticoagulants, and other complement inhibitors.
Use with caution alongside CYP450-modulating drugs (e.g., strong CYP3A inhibitors or inducers).

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from HongKong DengYue Medicine, HongKong Drug Wholesale Distributor.
It is only for internal discussion among medical staff and does not serve as a basis for medication. For specific medication guidelines, please consult the attending physician.