Piasky Crovalimab Application Scope

Piasky (crovalimab-akkz), classified under Hematology, is indicated for the treatment of adult and pediatric patients aged 13 years and older with paroxysmal nocturnal hemoglobinuria (PNH) who weigh at least 40 kg.

piasky crovalimab akkz

Piasky Crovalimab Characteristics

Ingredients: Crovalimab-akkz (active ingredient) and excipients.
Properties: Crovalimab is a monoclonal antibody that inhibits complement component 5 (C5), preventing the formation of the membrane attack complex and subsequent hemolysis in PNH patients.
Specification: Available as an injection with a concentration of 100 mg/mL.
Packaging Specification: Supplied in single-dose vials; each vial contains 100 mg of crovalimab in 1 mL solution.
Storage: Store refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze.
Expiry Date: Refer to the packaging for the expiration date.
Executive Standard: Manufactured in compliance with current Good Manufacturing Practices (cGMP).
Approval Number: Refer to the FDA approval number: BLA 761388.
Date of Revision: June 2024.
Manufacturer: Genentech, Inc., a member of the Roche Group.

Guidelines For The Use Of Piasky Crovalimab

Dosage and Administration:
- Initial Loading Dose: Administer Piasky intravenously based on body weight.
- Maintenance Dose: After the loading dose, administer Piasky subcutaneously once every four weeks.
- Detailed dosing schedules are provided in the prescribing information.
Adverse Reactions:
- Common adverse reactions include headache, diarrhea, and injection site reactions.
- Serious infections, including meningococcal infections, have been reported.
- Patients should be monitored for signs and symptoms of infection.

Medication Limitations

Contraindications:
- Patients with unresolved Neisseria meningitidis infection.
- Patients who are not currently vaccinated against Neisseria meningitidis, unless the risks of delaying therapy outweigh the risks of developing a serious infection.
Precautions:
- Vaccinate patients against meningococcal infections at least two weeks prior to initiating therapy.
- Consider prophylactic antibiotics to reduce the risk of infection.
- Monitor for signs of infusion-related reactions during and after administration.

Piasky Crovalimab Interactions

No formal drug-drug interaction studies have been conducted with Piasky.
Use caution when co-administering with other immunosuppressive agents.

Note: If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYueMed. 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.