breastfeeding and tocilizumab

[happymum]

Hi. I am due to start tocilizumab(actemra) for active RA and I am still nursing. I am currently on prednisolone 10 mg, plaquenil 400mg and paracetomol. I'm told I have to stop bf by my hospital( I'm in Ireland). They refer to the manufacturer. Is anyone bf on this drug? Is it likely to pass to my baby (10 months) and how might it affect her?

[admin-james]

Hi, thanks for your post.

Tocilizumab is not very well studied with respect to breastfeeding safety. There are no studies on the passage of tocilizumab into human milk. Tocilizumab has a large molecular weight and is unlikely to pass into breastmilk, at least not in significant quantities. The studies on a similar medication, infliximab, have demonstrated no passage into milk. Although some studies suggest that other drugs of this class get into breastmilk, there is evidence that oral absorption (in the baby) is generally poor. There are no long term data concerning the safety of using immune modulating medications in breastfeeding mothers. Therefore, some caution is recommended and each woman should understand the benefits and risk of using this type of medication in lactation. Fever, diarrhea, abnormal weight gain, and frequent infections are possible reactions in a child, although none have been reported so far.

In general, the risk of breastfeeding on any drug declines as the child gets older. A child's liver and kidneys get progressively better at clearing drugs and he or she drinks less and less breastmilk relative to body weight. After nine months, the risk drops dramatically for all but the most dangerous of drugs. Keep that in mind when making your decision.

Please call us at the InfantRisk Center if this has not completely answered your question.*(806)352-2519

-James Abbey, MD
and
-Thomas W. Hale, Ph.D.

[happymum]

Thanks James. More Questions sorry stressful time. How long does it take for drug to enter Milk? How long if absorbed does drug stay in babies system? Would effects be immediate and obvious? Could the drug cause serious irreversible damage? I've tried Methotrexate, Humira and Enbrel. Its thought I don't respond to anti tnf's. Is there any other biologic agent that I could try and still breastfeed?

[admin-james]

The elimination time for this drug is so long (on the order of a month) that there is no way to work around your dosing schedule. If it is absorbed by the baby, it would take the same amount of time to be eliminated. I want to emphasize that we believe this drug is very poorly absorbed by babies. Fever, diarrhea, abnormal weight gain, and frequent infections are possible reactions in a child, although none have been reported so far. There is nothing in particular that would be immediate and obvious.

For the most part, the biologics are new enough that they haven't been studied in breastfeeding mothers very thoroughly. I don't think we can responsibly state that there is a choice out there that has been shown to be substantially safer than any other. Consider the entire drug class fair game when you and your physician are trying to find something that works for you. We would be glad to discuss any specifics that come up in conversation with your doctor.

-James Abbey, MD