Other safety alerts
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| European Union : Ustekinumab (Stelara): warning on use of live vaccines in infants whose mothers received ustekinumab during pregnancy |
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The European Medicines Agency (EMA) announces that its Pharmacovigilance Risk Assessment Committee (PRAC) has recommended adding a warning to the product information for ustekinumab (Stelara) on the use of live vaccines in infants whose mothers received ustekinumab during their pregnancy.
Ustekinumab is authorised in the European Union (EU) to treat severe plaque psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis.
The product information already advises that it is preferable to avoid use of ustekinumab during pregnancy. People of childbearing potential are advised to avoid becoming pregnant and must use adequate contraception while using Stelara and for at least 15 weeks after the last Stelara treatment.
The Committee has reviewed the available evidence regarding use of ustekinumab during pregnancy, including observational studies from the EU, United States and Canada, as well as a cumulative review requested from the marketing authorisation holder.
Ustekinumab can cross the placenta. It has been detected in the serum (the fluid component of the blood) of infants who were exposed to ustekinumab in utero (infants whose mothers were treated with the medicine during pregnancy).
Although the data on ustekinumab are limited, the risk of infection may be increased after birth in infants who were exposed to ustekinumab in utero.
Therefore, the PRAC recommended that, in infants who were exposed to ustekinumab in utero, the administration of live vaccines (vaccines made from a virus or bacterium that has been weakened) is not recommended for six months following birth or until the infant’s serum levels of ustekinumab are undetectable. In case of a clear clinical benefit for the individual infant, administration of a live vaccine might be considered earlier, if the infant’s serum levels of ustekinumab are undetectable.
The PRAC’s recommendation will be forwarded to EMA’s Committee for Medicinal Products for Human Use (CHMP) for adoption.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-24-27-october-2022
In Hong Kong, there are 6 registered pharmaceutical products containing ustekinumab, namely Stelara solution for injection in pre-filled syringe 90mg/1ml (HK-60837), Stelara solution for injection in pre-filled syringe 45mg/0.5ml (HK-60838), Stelara solution for injection in pre-filled syringe 45mg/0.5ml (Switzerland) (HK-62386), Stelara solution for injection in pre-filled syringe 90mg/1ml (Switzerland) (HK-62387), Stelara concentrate for solution for injection 130mg/26ml (HK-65510) and Stelara solution for injection 45mg/0.5ml (HK-67380) registered by Johnson & Johnson (Hong Kong) Ltd. All products are prescription-only medicines. So far the Department of Health (DH) has received 4 cases of adverse drug reaction related to ustekinumab, of which one case was related to mycobacterial infection, one case was related to cardiac arrest, one case was related to severe urticaria and one case was related to Crohn’s disease. In light of the above EMA’s announcement, letters to inform local healthcare professionals will be issued, and the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board.
Ends/ Saturday, October 29, 2022
Issued at HKT 13:30
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