Paroxysmal nocturnal hemoglobinuria: What to confirm before assessing eligibility for crovalimab in China
If you have been diagnosed with paroxysmal nocturnal hemoglobinuria (PNH), first give your hematology team your history of complement inhibitor use and vaccination records. China was the first country to approve crovalimab (派圣凯), in February 2024. The Chinese prescribing information covers adults and adolescents aged ≥12 years who have not previously received complement inhibitors, and the dosing table starts at a body weight of 40 kg.
Key points
- If you have used a drug in the same class before, your eligibility needs to be checked again against the Chinese prescribing information.
- Meningococcal infection is a serious risk that requires preventive measures in advance and immediate medical attention if symptoms appear.
How the hematology team will assess your condition
Bring the report confirming PNH by flow cytometry, recent hemoglobin and lactate dehydrogenase (LDH) results, and your transfusion history. Record any changes in urine color, blood clots, or hospital stays. If you have previously used any complement inhibitor, provide its generic name and the date of your last dose, even if you have already stopped treatment. Prescribing information differs between countries in its requirements regarding previous treatment.
Check vaccinations before scheduling the first infusion
Medicines that inhibit complement C5 increase the risk of serious meningococcal infection. The Chinese prescribing information requires vaccination with a quadrivalent meningococcal vaccine at least two weeks before the first dose. If your condition requires treatment to start immediately, the team must arrange vaccination as soon as possible and preventive antibiotic protection. Bring the vaccine type, vaccination dates, and proof of vaccination, and ask your doctor to provide a medication record that local emergency department staff can understand.
Why the first month needs a day-by-day schedule
If your doctor follows the regimen in the Chinese prescribing information, check the dosing calendar against your prescription: an intravenous infusion on day 1, subcutaneous injections on days 2, 8, 15, and 22, followed by a subcutaneous injection every 4 weeks starting on day 29. Doses are based on weight bands. Ask the teams in both locations to mark each date, location, and responsible team together, and specify who can administer the medicine, what training is needed before home injections, and whom to contact if a dose is delayed. Stopping treatment on your own may cause hemolysis to recur.
What to include when calculating a month's medication costs
First ask the pharmacy to list the number of vials needed for the first month and the maintenance phase based on your weight. For vials containing 340 mg each, the maintenance dose listed in the prescribing information for patients weighing 40 to less than 100 kg is 680 mg every four weeks, or two vials. List vaccination, the first intravenous infusion, blood tests, and follow-up visits separately.
Frequently asked questions
I have already used eculizumab. What should I check before coming to China?
The population listed in the Chinese prescribing information consists of patients who have not previously used complement inhibitors. The EU prescribing information also covers patients aged 12 years or older who weigh at least 40 kg and have been receiving a C5 inhibitor for at least 6 months with stable disease. Give the hematology teams in both locations your previous medication history and the date of your last dose, and first confirm arrangements for continuing treatment.
If my child weighs less than 40 kg, can they receive the adolescent dosing regimen?
The dosing table starts at 40 kg. Patients below this weight should be assessed individually by a pediatric hematology team. Parents should not calculate an adjusted dose themselves.
If I have been vaccinated, does a fever still require emergency care?
There is still a risk of serious infection. If a fever is accompanied by a severe headache, a stiff neck, a rash, or rapid deterioration, go immediately to the nearest emergency department and explain that you are using a C5 inhibitor.
Does every maintenance dose require an infusion like the first dose?
The first dose is given by intravenous infusion, followed by subcutaneous administration according to the prescribing information. Whether you can inject it at home depends on your doctor's assessment and training.
Can I collect all my future medication during one trip back to China?
First ask the pharmacy to check how much can be dispensed under your prescription and the cold-chain requirements. Also ask the team where you live to confirm import rules, a legal medication supply, and your next prescription. Do not base long-term treatment on an unconfirmed plan to carry medication with you.