Special Warning : אזהרת שימוש

4.4   Special warnings and precautions for use
Women of childbearing potential

Women of childbearing potential should be advised to avoid becoming pregnant while taking belumosudil and of the potential risk to a foetus, and to have a pregnancy test prior to starting treatment with belumosudil.

Women of childbearing potential must use a highly effective method of contraception during treatment with belumosudil and for at least one week after the last dose of belumosudil (see sections 4.6 and 5.3).

Male patients

Male patients with female partners of childbearing potential should be advised that their female partners should avoid becoming pregnant while taking belumosudil and of the potential risk to a foetus.

Males with female partners of childbearing potential must use a highly effective method of contraception during treatment with belumosudil and for at least a week after the last dose of belumosudil (see sections 4.6 and 5.3).
Breast-feeding

Breast-feeding is not recommended during treatment with belumosudil and for at least one week after the last dose (see section 4.6).

Hepatotoxicity

Increases in liver function tests were observed in clinical studies with belumosudil and generally occurred early during treatment with the incidence decreasing thereafter (see section 4.8). Liver function tests should be performed prior to the initiation of treatment with belumosudil and monitored at least monthly during treatment with belumosudil and the dose should be adjusted for ≥ Grade 2 toxicities (see section 4.2)

Effects on Driving

4.7    Effects on ability to drive and use machines

Belumosudil may cause fatigue and dizziness (see section 4.8). Patients should be advised not to drive or operate machines if they experience these symptoms.