Treatment should be initiated under the supervision of a physician experienced in the treatment of haematological disorders. Posology 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. 4 for additional information related to switching between complement 3 component 5 [C5] inhibitor treatments).
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. 4). Delayed or missed doses 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. Dose modifications 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. 2). 2). 4 Hepatic impairment No dose adjustment is recommended for patients with mild hepatic impairment. 2). Paediatric population No dose adjustment of crovalimab is required in paediatric patients 12 years of age or older with body weight ≥ 40 kg.
The safety and efficacy of crovalimab in children less than 12 years of age and children with body weight < 40 kg have not yet been established. No data are available. Method of administration Piasky is administered as an intravenous infusion (first dose) and as a subcutaneous injection (subsequent doses).
Intravenous administration Piasky should be prepared for intravenous administration using appropriate aseptic technique. Piasky must be diluted and administered by a healthcare professional as an intravenous infusion over 60 minutes ± 10 minutes (1 000 mg) or 90 minutes ± 10 minutes (1 500 mg).
Piasky should not be administered as an intravenous push or bolus. 6. The infusion of crovalimab may be slowed or interrupted if the patient develops an infusion related reaction. 4). Subcutaneous administration Piasky must be used undiluted and should be prepared using appropriate aseptic technique.
It is recommended to inject Piasky 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.
Administration by the patient and/or caregiver After proper training in subcutaneous injection technique, the patient may self-administer Piasky or the caregiver may administer Piasky without healthcare professional (HCP) supervision if the treating physician determines that it is appropriate.
Comprehensive instructions for the administration of Piasky are given at the end of the Package Leaflet.