Aspaveli Pegcetacoplan Application Scope

Aspaveli (pegcetacoplan) is a medication indicated for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH) who remain anemic after treatment with a C5 inhibitor for at least three months.

Below is detailed information regarding its characteristics, usage guidelines, interactions, and other pertinent details.

Aspaveli Pegcetacoplan Characteristics

Ingredients:
- Active Substance: Pegcetacoplan, with each 20 mL vial containing 1,080 mg (54 mg/mL).
- Excipients: Sorbitol (E 420), glacial acetic acid, sodium acetate trihydrate, sodium hydroxide, and water for injection.
Properties:
- Aspaveli is a targeted C3 complement inhibitor designed to regulate excessive activation of the complement cascade, thereby reducing hemolysis in PNH patients.
Specification:
- The solution is clear, colorless to slightly yellowish, with a pH of 5.0.
Packaging Specification:
- Available in packs containing either one vial or a multipack of 1 × 8 vials. Note that alcohol swabs, needles, and other supplies or equipment are not included in the pack.
  
  Storage:
- Store in a refrigerator at 2°C – 8°C. Keep the vial in the original carton to protect it from light.
Expiry Date:
- Do not use this medicine after the expiry date stated on the carton after “EXP,” which refers to the last day of that month.
Executive Standard:
- Aspaveli has been approved by the European Medicines Agency (EMA) for the specified indication.
Approval Number:
- EMA product number: EMEA/H/C/005553.
Date of Revision:
- The patient information leaflet was last revised in August 2024.
Manufacturer:
- Swedish Orphan Biovitrum AB (publ), SE-112 76 Stockholm, Sweden.

Guidelines For The Use Of Aspaveli Pegcetacoplan

Dosage and Administration:

Administered twice weekly as a 1,080 mg subcutaneous infusion. The typical infusion time is approximately 30 minutes when using two sites or 60 minutes with one site.

Adverse Reactions:

Common side effects include injection-site reactions, infections, and gastrointestinal symptoms. Patients should report any side effects to their healthcare provider or via the Yellow Card Scheme.

Contraindications:

Hypersensitivity to pegcetacoplan or any of its excipients.

Precautions:

Patients should be monitored for signs of serious infection, particularly those caused by encapsulated bacteria. Regular laboratory testing of renal function is recommended due to potential PEG accumulation.

Aspaveli Pegcetacoplan Interactions

Drug Interactions:

No formal interaction studies have been performed. In vitro data suggest a low potential for clinical drug-drug interactions.

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
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.