Crovalimab, marketed under the trade name PiaSky, is a monoclonal antibody used to treat paroxysmal nocturnal hemoglobinuria (PNH). It is a complement component 5 (C5) inhibitor. Crovalimab was approved in China in February 2024, in Japan in April 2024, and in the United States in June 2024. The drug was developed and marketed by Roche/Genentech.
[PiaSky Composition]
- Active ingredient: crovalimab-akkz
- Inactive ingredients: arginine hydrochloride, histidine, poloxamer 188, and water for injection. Aspartic acid may be added to adjust pH.
PiaSky is supplied as crovalimab-akkz 340 mg/2 mL (170 mg/mL) in a single-dose vial.
[Manufacturer]
Genentech, Inc.
[Storage]
Your healthcare provider will store PiaSky in a refrigerator at 2–8°C (36°F to 46°F), protected from light. Do not freeze or shake.
Unopened PiaSky vials may be kept at room temperature (up to 30°C or 86°F) for up to 7 days, after which they must be discarded if not used.
Once diluted for intravenous infusion, PiaSky should be used immediately, as it contains no antimicrobial preservatives. If not used immediately, refer to the product information for detailed storage conditions depending on the type of infusion bag used.
[Use of PiaSky (Crovalimab) in Special Populations]
- Pregnancy
Available data on PiaSky use in pregnant women are insufficient to evaluate the risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Human IgG antibodies are known to cross the placenta, with transfer increasing as pregnancy progresses and peaking in the third trimester; therefore, PiaSky may be transferred from mother to the developing fetus. Untreated pregnancy-associated hypertensive disorders pose risks to both mother and fetus. In an enhanced prenatal and postnatal developmental study, monkeys exposed to crovalimab-akkz from organogenesis through delivery showed no adverse developmental outcomes, even at maternal exposures 14 times the maximum recommended human dose (MRHD). - Lactation
There are no data on the presence of crovalimab-akkz in human or animal milk, nor on its effects on breastfed infants or milk production. Endogenous IgG and monoclonal antibodies are known to transfer into human milk. The potential impact of local gastrointestinal exposure and limited systemic absorption in breastfed infants remains unclear. Because serious adverse reactions may occur in breastfed children, breastfeeding is not recommended during PiaSky treatment and for 9 months following the last dose. - Pediatric Use
The safety and efficacy of PiaSky for treating PNH have been established in pediatric patients aged 13 years and older weighing ≥40 kg. Use in children is supported by adequate and well-controlled studies in adults, with additional pharmacokinetic, pharmacodynamic, efficacy, and safety data from patients aged 13 to 17 years. Safety and efficacy in patients younger than 13 years or weighing <40 kg have not been established. - Geriatric Use
Clinical studies of PiaSky did not include enough subjects aged 65 and over to determine whether they respond differently from younger patients. In general, dose selection for elderly patients should be cautious, reflecting the higher likelihood of decreased hepatic, renal, or cardiac function, and of concomitant diseases or therapies. Among 393 patients treated with PiaSky in COMMODORE 1, 2, and 3 trials, 43 (10.9%) were aged 65 years or older. Among treatment-naïve patients (not previously treated with complement inhibitors), serious adverse reactions occurred in 1 patient (8%) aged 65 or older, compared with 6 patients (4%) aged 18–64. Among patients switched from a prior C5 inhibitor to PiaSky, 3 patients (7%) aged 65 or older experienced serious adverse reactions, compared with 12 patients (4%) aged 18–64.
[Adverse Reactions of PiaSky]
The most common adverse reactions include: infusion-related reactions, respiratory infections (including lung infections), cold-like symptoms, nasal or throat pain/swelling, viral infections, and type III hypersensitivity reactions.
Note: The above information was compiled and edited by DengYue Medicine (please help point out any errors or omissions). It is intended solely to provide the latest information on newly approved global drugs and to help Chinese patients understand international drug developments. For internal discussion among healthcare professionals only. Not intended as medical advice. For specific guidance on drug use, please consult the treating physician.
