What are the precautions for Wayrilz (Rilzabrutinib)?

During clinical studies of Wayrilz (Rilzabrutinib) for the treatment of persistent or chronic immune thrombocytopenia (ITP), warnings and precautions such as serious infection, hepatotoxicity, including drug-induced liver injury, and embryo-fetal toxicity emerged. Discontinue and resume at reduced dose upon recovery, or permanently discontinue based on severity.

1. Severe infection:

Patients receivingBruton tyrosine kinase (BTK) inhibitors (includingWayrilz) are at increased risk of developing serious infections (including bacterial, viral, or fungal). Monitor patients for signs and symptoms of infection and treat appropriately.

2. Hepatotoxicity, including drug-induced liver injury

Patients treated with BTK inhibitors may develop hepatotoxicity, including severe, life-threatening and potentially fatal cases of DILI. In Wayrilzclinical trials in patients with ITP, elevations in hepatic transaminases occurred and were usually mild to moderately severe. Assess bilirubin and transaminases at baseline and for clinical indications during treatment with Wayrilz. Patients who develop liver function abnormalities after treatment with Wayrilz should be monitored more frequently for liver function abnormalities and clinical signs and symptoms of hepatotoxicity. If you suspectDILI, stop using Wayrilz.

3. Embryo-Fetotoxicity

Wayrilz may cause fetal harm when given to pregnant women, according to results from preliminary animal reproduction studies. Adverse visceral and skeletal findings were seen in rat fetuses at the maximum recommended human dose (MRHD), a maternally toxic dose that was 22 times the human exposure (based on the area under the curve (AUC)), and a rabbit fetus developed renal visceral abnormalities at the MRHD, a maternal exposure 5.6 times the human exposure (based on the AUC). Before initiating treatment with Wayrilz, verify pregnancy status in females of reproductive potential. Females of reproductive potential should use an effective method of contraception during treatment with Wayrilz and for 1 week after the final dose.

Reference materials:https://go.drugbank.com/drugs/DB17709