Molecule
Crovalimab 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. MedsAcross supplies Crovalimab for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
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. 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
Source: US FDA prescribing information
Crovalimab-akkz is a monoclonal antibody that specifically binds with high affinity to the complement protein C5, inhibiting its cleavage into C5a and C5b, preventing the formation of the membrane attack complex (MAC). Crovalimab-akkz inhibits terminal complement-mediated intravascular hemolysis in patients with PNH.
Source: US FDA prescribing information
See Full Prescribing Information for instructions on preparation, dosage, and administration. Start with one loading dose administered by intravenous infusion, followed by 4 additional loading doses administered by subcutaneous injection. Then administer a maintenance dose every 4 weeks by subcutaneous injection. For patients switching from another complement inhibitor, the first loading dose of PIASKY should be administered no sooner than the time of the next scheduled complement inhibitor administration. See Full Prescribing Information for considerations when switching from another C5 inhibitor. Administer doses based on the patient's actual body weight
Source: US FDA prescribing information
PIASKY is contraindicated: For initiation in patients with an unresolved serious Neisseria meningitidis infection. In patients with a known serious hypersensitivity reaction to crovalimab or any of the excipients. Initiation during unresolved serious Neisseria meningitidis infection. Serious hypersensitivity to crovalimab or any of the excipients
Source: US FDA prescribing information
Boxed warning (serious meningococcal infections piasky): a complement inhibitor, increases the risk of serious infections caused by Neisseria meningitidis. 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. Type III hypersensitivity reactions: Monitor patients switching from another C5 inhibitor to PIASKY or from PIASKY to another C5 inhibitor as they are at risk of Type III hypersensitivity reactions related to the formation of drug-target-drug complexes. Other Infections: PIASKY can increase susceptibility to serious infections especially those caused by encapsulated bacteria. Infusion- and Injection-Related Reactions: Monitor for these reactions and initiate medical management as needed
Source: US FDA prescribing information
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 The most common adverse drug reactions (incidence ≥10%) were infusion-related reaction, respiratory tract infection, viral infection, and Type III hypersensitivity reactions.
Source: US FDA prescribing information
7. 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. 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.
Source: US FDA prescribing information
Store refrigerated at 2°C to 8°C (36°F to 46°F) in the outer carton to protect from light. Do not freeze. Once removed from the refrigerator, the unopened vial can be kept at room temperature up to 30°C (86°F) in its outer carton for no longer than 7 days. Prior to administration, unopened vials of PIASKY may be stored out of the refrigerator at room temperature if needed and then returned to refrigeration. The total combined time out of refrigeration should not exceed 7 days and the temperature should not exceed 30°C (86°F). Discard if stored out of the refrigerator at room temperature for longer than 7 days. Do not shake.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
1 presentations of Crovalimab, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Piasky 340 mg/2 mL injectionSubcutaneous Cold chain | Genentech | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Yes, on request. MedsAcross lists 1 presentations of Crovalimab and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Crovalimab, including Piasky.
Yes. The US FDA first approved Crovalimab on 20 June 2024, according to Drugs@FDA.
Yes. Crovalimab has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
At least one listed presentation of Crovalimab must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.
Crovalimab is classified under ATC code L04AJ07 (Crovalimab).
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.