RYDAPT should be taken orally twice daily at approximately 12-hour intervals | |
RYDAPT capsules should be swallowed whole with a glass of water | |
RYDAPT should be taken with food |
Not actual size.
The recommended starting dose for RYDAPT is 100 mg (four 25-mg capsules) twice daily
Treatment should be continued as long as clinical benefit is observed or until unacceptable toxicity occurs
If a dose is missed, the patient should take the next dose at the scheduled time
If vomiting occurs, the patient should not take an additional dose of RYDAPT, but should take the next scheduled dose
RYDAPT capsules should not be opened, crushed, or chewed to ensure proper dosing and avoid the unpleasant taste of the capsule content
Criteria | RYDAPT Dosing |
ANC <1 x 109/L attributed to RYDAPT in patients without MCL, or ANC <0.5 x 109/L attributed to RYDAPT in patients with baseline ANC value of 0.5-1.5 x 109/L | Interrupt RYDAPT until ANC ≥1 x 109/L, then resume RYDAPT at 50 mg twice daily and, if tolerated, increase to 100 mg twice daily.Discontinue RYDAPT if low ANC persists for >21 days and is suspected to be related to RYDAPT. |
Platelet count <50 x 109/L attributed to RYDAPT in patients without MCL, or platelet count <25 x 109/L attributed to RYDAPT in patients with baseline platelet count of 25-75 x 109/L | Interrupt RYDAPT until platelet count ≥50 x 109/L, then resume RYDAPT at 50 mg twice daily and, if tolerated, increase to 100 mg twice daily.Discontinue if low platelet count persists for >21 days and is suspected to be related to RYDAPT. |
Haemoglobin <8 g/L attributed to RYDAPT in patients without MCL, or life-threatening anaemia attributed to RYDAPT in patients with baseline haemoglobin value of 8-10 g/L | Interrupt RYDAPT until haemoglobin ≥8 g/L, then resume RYDAPT at 50 mg twice daily and, if tolerated, increase to 100 mg twice daily.Discontinue if low haemoglobin persists for >21 days and is suspected to be related to RYDAPT. |
Grade 3/4 nausea and/or vomiting despite optimal antiemetic therapy | Interrupt RYDAPT for 3 days (6 doses), then resume RYDAPT at 50 mg twice daily and, if tolerated, gradually increase to 100 mg twice daily. |
Other grade 3/4 nonhaematologic toxicities | Interrupt RYDAPT until event has resolved to grade ≤2, then resume RYDAPT at 50 mg twice daily and, if tolerated, increase to 100 mg twice daily.Discontinue RYDAPT if toxicity is not resolved to grade ≤2 within 21 days or severe toxicity recurs at a reduced dose of RYDAPT. |
Common Terminology Criteria for Adverse Events severity: grade 1 = mild symptoms; 2 = moderate symptoms;
3 = severe symptoms; 4 = life-threatening symptoms.
ANC, absolute neutrophil count; MCL, mast cell leukaemia.
Reference: 1. RYDAPT [Summary of Product Characteristics]. Novartis Pharma AG; 2017.