Active Ingredient: Crovalimab
Crovalimab as monotherapy is indicated for the treatment of adult and paediatric patients 12 years of age or older with a weight of 40 kg and above with paroxysmal nocturnal haemoglobinuria (PNH):
For this indication, competent medicine agencies globally authorize below treatments:
For:
Regimen A: In case that patient weight is ≥ 40 kg and patient weight is ≤ 100 kg, intravenous, 1,000 milligrams crovalimab, one dose, over the duration of 1 day. Afterwards, in case that patient weight is ≥ 40 kg and patient weight is ≤ 100 kg, subcutaneous, 340 milligrams crovalimab, once every 7 days, 4 doses in total. Afterwards, in case that patient weight is ≥ 40 kg and patient weight is ≤ 100 kg, subcutaneous, 680 milligrams crovalimab, once every 4 weeks.
Regimen B: In case that patient weight is ≥ 100 kg, intravenous, 1,500 milligrams crovalimab, one dose, over the duration of 1 day. Afterwards, in case that patient weight is ≥ 100 kg, subcutaneous, 340 milligrams crovalimab, once every 7 days, 4 doses in total. Afterwards, in case that patient weight is ≥ 100 kg, subcutaneous, 1,020 milligrams crovalimab, once every 4 weeks.
The recommended dosing regimen consists of one loading dose administered by intravenous infusion (on Day 1), followed by four additional weekly loading doses administered by subcutaneous injection (on Days 2, 8, 15, and 22). The maintenance dose starts on Day 29 and is then administered every 4 weeks by subcutaneous injection. The doses to be administered are based on the patient’s body weight, as shown in Table 1.
For patients switching from treatment with another complement inhibitor, the first intravenous loading dose of Piasky should be administered at the time of the next scheduled complement inhibitor administration. The administration of the additional subcutaneous loading doses and maintenance doses of Piasky will follow as per the schedule shown in Table 1.
Table 1. Piasky dosing regimen based on body weight:
| Body weight | ≥40 kg to <100 kg | ≥100 kg |
|---|---|---|
| Loading Dose | ||
| Day 1 Day 2, 8, 15, 22 | 1 000 mg (intravenous) 340 mg (subcutaneous) | 1 500 mg (intravenous) 340 mg (subcutaneous) |
| Maintenance dose | ||
| Day 29 and Q4Wa thereafter | 680 mg (subcutaneous) | 1 020 mg (subcutaneous) |
a Q4W=every 4 weeks
The dosing schedule is allowed to occasionally vary within 2 days of the scheduled administration day (except at Day 1 and Day 2). If this occurs, the subsequent dose should be administered according to the regular schedule.
Piasky is intended for long-term treatment unless the discontinuation of this medicinal product is clinically indicated.
If an entire planned dose or part of a planned dose of Piasky is missed, the missing dose or remainder of the planned dose should be administered as soon as possible before the day of the next scheduled dose. The next dose should then be administered on the regular scheduled dosing day. Do not take two doses or administer more than the prescribed dose on the same day to make up for a missed dose.
Modification of the maintenance dose is required if the patient’s body weight changes by 10% or more to become consistently greater than or lower than 100 kg during the course of treatment (see Table 1 for recommended dose). Accordingly, the patient’s body weight should be monitored periodically and on an ongoing basis, as appropriate.
Crovalimab is administered as an intravenous infusion (first dose) and as a subcutaneous injection (subsequent doses).
Crovalimab should not be administered as an intravenous push or bolus.
The infusion of crovalimab may be slowed or interrupted if the patient develops an infusion related reaction. The infusion should be discontinued immediately if the patient experiences a serious hypersensitivity reaction.
It is recommended to inject crovalimab into the abdomen. Within the abdomen, injection sites should be rotated with every injection. Injections should never be given into moles, scars, or areas where the skin is tender, bruised, red, hard, or not intact.
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