Description
Indication & Scope
Treatment of paroxysmal nocturnal hemoglobinuria (PNH) in patients aged ≥12 years with body weight ≥40 kg
- Mechanism: Monoclonal antibody binding complement protein C5, blocking C5 cleavage and preventing MAC complex formation to stop complement-mediated red blood cell hemolysis.
- Drug class: Complement C5 inhibitory monoclonal antibody, biologic hematologic therapeutic.
- Clinical use: Reduce intravascular hemolysis, stabilize hemoglobin and eliminate transfusion dependence in PNH patients.
| Generic Name | Crovalimab Injection |
| Brand Name | Piasky |
| Ingredient | Crovalimab Injection |
| Dosage Form | Injection |
| Package | 2ml: 340ml*1 vial/box |
| Conditions Treated | Paroxysmal nocturnal hemoglobinuria (PNH) in adolescents ≥12 years and adults |
| Taboos | 1. Severe hypersensitivity to crovalimab or formulation excipients
2. Unresolved invasive encapsulated bacterial infection (meningococcus, pneumococcus) 3. Patients without complete meningococcal/pneumococcal vaccination |
| Place of origin | 1 DNA Way, South San Francisco, California (CA) 94080, United States (USA); Sandhoferstrasse 116, 68305 Mannheim, Germany |
| Prescription type | Prescription-only |
| Storage Conditions | Refrigerate at 2°C–8°C; do not shake or freeze pre-filled syringes/vials |
| Manufacturer | Roche Pharma (Schweiz) AG , Ltd |
| Registration Authority | National Medical Products Administration (NMPA), China |
| Approval number | SJ20240007 |
| Date of Revision | 2024 |
| Shelf Life | 36 months |
How to use ?
Recommended Dose: Loading IV dose on Day 1, followed by weekly subcutaneous maintenance injections.
Time: Initial IV infusion over 1 hour; weekly fixed subcutaneous injection interval.
Instructions for use:
1. Complete encapsulated bacteria vaccination minimum 2 weeks before initiation.
2. Administer under supervision of hematology specialists.
3. Monitor for infection signs throughout treatment.
4. Subcutaneous injection may be self-administered after training.
Interaction: No direct CYP450 metabolic interactions; concurrent immunosuppressants raise infection risk.
Side effects:
1. Common: Injection site reaction, headache, nasopharyngitis, fatigue, arthralgia.
2. Severe: Meningococcal/pneumococcal sepsis, severe anaphylaxis, hemolytic crisis after treatment interruption.
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 pathway does it target, and how does Crovalimab treat paroxysmal nocturnal hemoglobinuria (PNH)?
It is an anti-C5 monoclonal antibody that inhibits terminal complement activation, preventing red blood cell lysis and hemolysis in PNH patients.
What key lab parameter is used to monitor treatment response in PNH patients?
Lactate dehydrogenase (LDH) levels, which correlate with hemolysis and are expected to normalize with effective treatment.
What is Crovalimab dosing interval, and how long does its terminal half-life support therapeutic effect?
Administered subcutaneously every 4 weeks after loading doses. Its long half-life (~21 days) allows sustained complement inhibition throughout the dosing cycle.
What is a critical safety consideration before initiating therapy with Crovalimab?
Patients must be vaccinated against encapsulated bacteria (e.g., Neisseria meningitidis) due to the risk of serious infections from complement inhibition.
Piasky® | Crovalimab Injection | Paroxysmal Nocturnal Hemoglobinuria in Adults and Adolescents (≥ 12 years old) | DengYueRX
INN: Crovalimab Injection
Indications: Treatment of paroxysmal nocturnal hemoglobinuria.
Dosage Form: Injection
Strength: 2ml: 340ml/vial
