Hi @cactusk I have the below additional information from our policy & advocacy team. Please reach out if you need further clarification about the information provided:
Thank you for your post about changes relating to
ribociclib for early breast cancer. This issue recently came to our attention
and we have gathered some information for yourself and others reading this post
as we appreciate the issue may be quite confusing.
Kind regards,
BCNA Policy & Advocacy team.
What
are nitrosamines? Nitrosamines
are common in water and foods, including cured and grilled meats, dairy
products and vegetables. They can also be produced during the manufacturing of
certain medications, particularly those containing specific ingredients or
undergoing certain chemical reactions. Everyone is exposed to some level of
nitrosamines.
There are
internationally recognized acceptable daily intake limits for nitrosamines.
Regulatory authorities like the Food and Drug Administration (FDA), European
Medicines Agency (EMA) and Therapeutic Goods Administration (TGA) continuously
monitor and evaluate the safety of medicines, including their potential for
nitrosamine levels. If new evidence emerges, or if safety concerns arise, these
regulators may adjust their limits. In August 2023, the FDA lowered acceptable
intake limits for nitrosamines in medications in the early breast cancer
setting.
What is the issue with ribociclib? Ribociclib contains a nitrosamine
impurity that exceeds these new limits. To comply with the new guidelines, Novartis (the
manufacturer) is required to make some manufacturing adjustments to ribociclib.
What is being done: Novartis
is implementing manufacturing adjustments for ribociclib to ensure alignment
with the latest regulatory standards, but it will take some months before it is
available. Between now and the new product being available, no one will be able
to commence taking ribociclib.
What do you
need to do if you are currently taking ribociclib for early breast cancer? All clinicians in Australia with
patients taking ribociclib have been advised about these changes. People
already taking ribociclib for early breast cancer should consult with their
healthcare provider as they are the best resource for personalized guidance and
advice regarding medication safety and management.
What about
other drugs used for early breast cancer? BCNA is not aware of any other breast cancer drugs being
impacted by these changes at this time.
