Brand Name
Piasky
Generic Name
Crovalimab
View Brand Information FDA approval date: June 20, 2024
Form: Injection
What is Piasky (Crovalimab)?
PIASKY is indicated for the treatment of adult and pediatric patients 13 years and older with paroxysmal nocturnal hemoglobinuria and body weight of at least 40 kg. PIASKY is a complement C5 inhibitor indicated for the treatment of adult and pediatric patients 13 years and older with paroxysmal nocturnal hemoglobinuria and body weight of at least 40 kg
Approved To Treat
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Brand Information
Piasky (Crovalimab)
WARNING: SERIOUS MENINGOCOCCAL INFECTIONS
PIASKY, a complement inhibitor, increases the risk of serious infections caused by
- Complete or update vaccination for meningococcal bacteria (for serogroups A, C, W, Y, and B) at least 2 weeks prior to the first dose of PIASKY, unless the risks of delaying therapy with PIASKY outweigh the risk of developing a serious infection. Comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for meningococcal vaccination in patients receiving a complement inhibitor. See
- Patients receiving PIASKY are at increased risk for invasive disease caused by
Because of the risk of serious meningococcal infections, PIASKY is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called PIASKY REMS
1INDICATIONS AND USAGE
PIASKY is indicated for the treatment of adult and pediatric patients 13 years and older with paroxysmal nocturnal hemoglobinuria (PNH) and body weight of at least 40 kg.
2DOSAGE FORMS AND STRENGTHS
Injection: 340 mg/2 mL (170 mg/mL) as a clear to opalescent and almost colorless to brownish-yellow solution in a single-dose vial.
3CONTRAINDICATIONS
PIASKY is contraindicated:
- For initiation in patients with an unresolved serious
- In patients with a known serious hypersensitivity reaction to crovalimab or any of the excipients
4ADVERSE REACTIONS
The following clinically significant adverse reactions are discussed in greater detail in other sections of the label:
- Serious Meningococcal Infection
- Type III Hypersensitivity Reactions Related to Drug-Target-Drug Complexes
- Other Infections
- Infusion- and Injection-Related Reactions
4.1Clinical Trial Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
5DRUG INTERACTIONS
PIASKY binds different epitopes on C5 compared to eculizumab and ravulizumab, which can lead to the formation of DTDCs when patients switch between PIASKY and either eculizumab or ravulizumab. These DTDCs comprise one or more units of C5 bound to both PIASKY and to eculizumab or ravulizumab. These DTDCs are expected to be cleared within approximately 8 weeks (in the case of eculizumab) or longer (in the case of ravulizumab) and can result in Type III hypersensitivity reactions
6DESCRIPTION
Crovalimab-akkz, a complement C5 inhibitor, is a humanized monoclonal antibody based on a human IgG1 framework. The recombinant antibody is produced in Chinese hamster ovary CHO cells and consists of two heavy chains (451 amino acid residues each) and two light chains (217 amino acid residues each). The approximate molecular weight is 145 kDa.
PIASKY (crovalimab-akkz) injection is a preservative-free, sterile, clear to opalescent, almost colorless to brownish-yellow, solution supplied in a single-dose vial for intravenous use or subcutaneous use. Intravenous use requires dilution prior to administration.
Each single-dose vial contains a 2 mL solution of crovalimab-akkz (340 mg), arginine hydrochloride (42.2 mg), histidine (9.4 mg), poloxamer 188 (1 mg), and Water for Injection USP. The pH is 5.8. Aspartic acid may be added to adjust the pH.
7PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
8PRINCIPAL DISPLAY PANEL - 340 mg/2 mL Vial Carton
NDC 50242-115-01
Piasky
340 mg/2 mL
For Intravenous Infusion After Dilution
Single-Dose Vial.
Administered by Healthcare Professionals Only.
Discard unused portion.
ATTENTION: Dispense the enclosed
1 vial
Rx only
Genentech
11005534
