Description
Indication & Scope
Treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH).
- Mechanism: Oral complement factor B inhibitor; blocks alternative complement pathway activation to prevent red blood cell hemolysis in PNH patients.
- Drug class: Oral small-molecule alternative complement pathway inhibitor, hematologic disease therapeutic.
- Clinical use: Oral monotherapy to reduce hemolysis, raise hemoglobin and eliminate transfusion requirements in adult PNH patients.
| Generic Name | Iptacopan Hydrochloride Capsules |
| Brand Name | FABHALTA |
| Ingredient | Iptacopan Hydrochloride Capsules |
| Dosage Form | Capsules |
| Package | 200mg*56 capsules/box |
| Conditions Treated | Adult paroxysmal nocturnal hemoglobinuria (PNH) |
| Taboos | 1. Hypersensitivity to iptacopan hydrochloride or capsule excipients
2. Active untreated invasive encapsulated bacterial infection 3. Patients without meningococcal/pneumococcal vaccination |
| Place of origin | Oeflinger Str. 44, 79664 Wehr, Germany |
| Prescription type | Prescription-only |
| Storage Conditions | Store tightly sealed below 30°C, avoid moisture and high temperature |
| Manufacturer | Novartis Pharma Schweiz AG, Ltd |
| Registration Authority | National Medical Products Administration (NMPA), China |
| Approval number | HJ20240016 |
| Date of Revision | 2024 |
| Shelf Life | 24 months |
How to use ?
Recommended Dose: 200 mg oral twice daily (morning and evening).
Time: Dose separated by 12 hours, can be taken with or without food.
Instructions for use:
1. Complete meningococcal and pneumococcal vaccination ≥14 days before starting treatment.
2. Capsules swallowed whole with water, no splitting or crushing.
3. Monitor for fever/infection symptoms continuously.
4. Do not abruptly discontinue to avoid hemolytic crisis.
Interaction:
1. CYP2C9 inhibitors increase iptacopan blood concentration.
2. CYP2C9 inducers lower drug efficacy.
3. Concurrent immunosuppressants increase invasive bacterial infection risk.
Side effects:
1. Common: Nasopharyngitis, diarrhea, abdominal pain, nausea, fatigue, rash
2. Severe: Life-threatening encapsulated bacterial sepsis, severe allergic reaction, severe hemolytic crisis upon sudden withdrawal
Important Notice
This product should be administered only by qualified healthcare professionals in accordance with the approved prescribing information and local clinical guidelines. Dosage and administration may vary depending on patient condition, indicatiaon, and regional regulatory requirements.
Packaging & Shipping
Packaging
Original manufacturer’s packaging with secure export carton. Customized export packaging is available upon request.
Shipping Methods
Express Courier (EMS, DHL, FedEx, UPS), Air Freight, and Sea Freight. Cold-chain transportation is available for products requiring temperature-controlled logistics.
Export Support
Certificate of Analysis
GMP Certificate
Commercial Invoice
Packing List & CPP
Cold Chain Logistics
Customs Documentation
Scientific and regulatory sources
FAQ
What complement protein does Iptacopan Hydrochloride target, and how does this differ from traditional anti-C5 therapies?
It is an oral factor B inhibitor that acts upstream of C5 in the alternative complement pathway, providing an alternative mechanism for treating PNH.
What is Iptacopan Hydrochloride's oral bioavailability, and how does this support once-daily dosing?
It has good oral bioavailability, with a half-life supporting once-daily administration, offering a convenient alternative to injectable anti-C5 therapies
What is the primary efficacy endpoint in PNH trials, and how does Iptacopan Hydrochloride improve patient outcomes?
Key endpoints include reduction in hemolysis (LDH levels) and transfusion independence, leading to improved hemoglobin levels and quality of life.
What safety precautions are required due to Iptacopan Hydrochloride's complement inhibition mechanism?
Similar to anti-C5 therapies, patients require meningococcal vaccination to reduce the risk of serious encapsulated bacterial infections.
FABHALTA® | Iptacopan Hydrochloride Capsules | Paroxysmal Nocturnal Hemoglobinuria (PNH) | DengYueRX
INN: Iptacopan Hydrochloride Capsules
Indications: Treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH)
Dosage Form: Capsules
Strength: 200mg/capsule
