Prescription medicine
Crovalimab Brand names: Piasky
Crovalimab (Piasky) is a prescription medicine. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the crovalimab FDA label on DailyMed (effective November 11, 2025); every crovalimab label on DailyMed.
Highlights of the record
FDA label of November 11, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
SERIOUS MENINGOCOCCAL INFECTIONS PIASKY,.
a complement inhibitor, increases the risk of serious infections caused by Neisseria meningitidis [see Warnings and Precautions (5.1) ]. Life-threatening and fatal meningococcal infections have occurred in patients treated with complement inhibitors. These infections may become rapidly life-threatening or fatal if not recognized and treated early. 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 Warnings and Precautions (5.1) for additional guidance on the management of the risk of serious infections caused by meningococcal bacteria. Patients receiving PIASKY are at increased risk for invasive disease caused by N. meningitidis, even if they develop antibodies following vaccination. Monitor patients for early signs of serious meningococcal infections and evaluate immediately if infection is suspected. […]
Used for
From the label: indications and usagePIASKY 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.
Forms and strengths
- 340 mg/2ml
Injection (solution).
On the market
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 93 through July 30, 2026
What is crovalimab used for?
From the label: indications and usagePIASKY 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. PIASKY is a complement C5 inhibitor 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
FDA pharmacologic class: Complement C5 Inhibitor.
Source: FDA drug label (Piasky), Genentech, Inc., effective November 11, 2025 (SPL set 2597efc2-a97b-487c-b500-a67fd282a73b), via openFDA; the full label on DailyMed
What does the patient leaflet for crovalimab say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about PIASKY?PIASKY is a medicine that affects your immune system. PIASKY may lower the ability of your immune system to fight infections. PIASKY increases your chance of getting serious infections caused by Neisseria meningitidis. Meningococcal infections may quickly become life-threatening or cause death if not recognized and treated early. You must complete or update your meningococcal vaccines at least 2 weeks before your first dose of PIASKY. If you have not completed your meningococcal vaccines and PIASKY must be started right away, you should receive the required vaccines as soon as possible. If you have not been vaccinated and PIASKY must be started right away, you should also receive antibiotics to take for as long as your healthcare provider tells you to. If you had a meningococcal vaccine in the past, you might need additional vaccines before starting PIASKY. Your healthcare provider will decide if you need additional meningococcal vaccines. Meningococcal vaccines do not prevent all meningococcal infections. Call your healthcare provider or get emergency medical care right away if you get any of these signs and symptoms of a serious meningococcal infection: fever fever and a rash fever with a high heart rate fever with a headache headache with nausea or vomiting headache with a stiff neck or stiff back confusion muscle aches, with flu-like symptoms eyes sensitive to light Your healthcare provider will give you a Patient Safety Card about the risk of serious meningococcal infection. Carry it with you at all times during treatment and for 11 months after your last dose of PIASKY. Your risk of meningococcal infection may continue for several months after your last dose of PIASKY. It is important to show this card to any healthcare provider who treats you. […]
Source: FDA drug label (Piasky), Genentech, Inc., effective November 11, 2025 (SPL set 2597efc2-a97b-487c-b500-a67fd282a73b), via openFDA; the full label on DailyMed
Is there a generic for crovalimab (Piasky)?
No generic crovalimab is approved (Drugs@FDA, October 8, 2026).
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the crovalimab label say about other medicines?
The crovalimab label names 2 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Eculizumab | drug interactions | DRUG 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. |
| Ravulizumab | drug interactions | DRUG 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. |
Source: FDA drug label (Piasky), Genentech, Inc., effective November 11, 2025 (SPL set 2597efc2-a97b-487c-b500-a67fd282a73b), via openFDA; the full label on DailyMed
What do FAERS reports show for crovalimab?
The FDA Adverse Event Reporting System holds 93 reports that list crovalimab among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 9 are coded as a death and 53 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Crovalimab side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other