Concerning Columvi (Glofitamab), Enspryng (satralizumab), Evrysdi (risdiplam), Gavreto (pralsetinib), Lunsumio (mosunetuzumab), Phesgo (pertuzumab & trastuzumab), Polivy (polatuzumab), Ronapreve (casirivimab & imdevimab), Rozlytrek (entrectinib), Vabysmo (faricimab), Xofluza (baloxavir marboxil):
▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.
If a pregnancy occurs while using Herceptin/PERJETA/Kadcyla/Phesgo or within 7 months following the last dose of Herceptin/Kadcyla/Phesgo or within 6 months following the last dose of PERJETA, please immediately report pregnancy to the local Roche Adverse Event line at +32 (0)2 525 82 99.
Additional information will be requested during a Herceptin/PERJETA//Phesgo/Kadcyla-exposed pregnancy and the first year of the infant's life. This will enable Roche to better understand the safety of Herceptin/PERJETA/Kadcyla/Phesgo and to provide appropriate information to health authorities, healthcare providers and patients.