Ocrevus

[kflesch]

After nursing on Copaxone for just over 2 years I have new disease activity. My neurologist is recommending Ocrevus infusions. I know it's a new medication but the information on Lactmed sounds like it should be OK. My son just turned 3 and generally only nurses at night. Do you have any information on the safety?

Thank you

[admin]

Lisa:

We actually have NO data on the transfer of this monoclonal IgG1 antibody into human milk. Of three cases reported in postmarketing surveillance, only one infant of the the three reported slight changes in B cells at 1 month of age. They returned to normal subsequently.

Assuming the mother did not use this during pregnancy, the risk is much less as the infant would NOT have have full plasma levels of this drug following exposure in the third trimester.

I think it would probably be OK for the mom to breastfeed as long as the pediatrician followed the infants B cell count.

Tom Hale Ph.d.



Oreja-Guevara C, Wray S, Buffels R, et al. Pregnancy outcomes in patients treated with ocrelizumab. ECTRIMS Online Library 2019. https: //onlinelibrary .ectrims-congress.eu /pdfviewer/web/viewer .html?file=https%3A//onlinelibrary .ectrims-congress .eu/ectrims /download/poster%3Fcm_id%3D282372 ([url]https://onlinelibrary.ectrims-congress.eu/pdfviewer/web/viewer.html?file=https%3A//onlinelibrary.ectrims-congress.eu/ectrims/download/poster%3Fcm_id%3D282372[/url]).

[lisabrannon]

I am working with a new mom and baby. The mom is expecting to resume Ocrevus at 2 months postpartum. She is planning to wean based on the recommendation of her doctor. Is breastfeeding while on Ocrevus an option for a mom with a 2-month-old baby, or is that too young?

Thank you,
Lisa, RN, CLC

[admin]

Kaylarivera:

Probably very little risk after this long. Most, but not all, will be gone from your blood compartment by 4-5 months. Below is the data from the package insert.

Tom Hale Ph.D.


Risk Summary

OCREVUS is a humanized monoclonal antibody of an immunoglobulin G1 subtype and immunoglobulins are known to cross the placental barrier. There are no adequate data on the developmental risk associated with use of OCREVUS in pregnant women. However, transient peripheral B-cell depletion and lymphocytopenia have been reported in infants born to mothers exposed to other anti-CD20 antibodies during pregnancy. B-cell levels in infants following maternal exposure to OCREVUS have not been studied in clinical trials. The potential duration of B-cell depletion in such infants, and the impact of B-cell depletion on vaccine safety and effectiveness, is unknown [see WARNINGS AND PRECAUTIONS (5.2) ([url]https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9da42362-3bb5-4b83-b4bb-b59fd4e55f0d#S5.2)][/url].

Following administration of ocrelizumab to pregnant monkeys at doses similar to or greater than those used clinically, increased perinatal mortality, depletion of B-cell populations, renal, bone marrow, and testicular toxicity were observed in the offspring in the absence of maternal toxicity.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknown.

Please note, they always use large to massive doses in animals as compared to humans.

[Kaylarivera]

I had my first Ocrevus infusion in July now it is November and I may be pregnant. How dangerous is it for the fetus if I am?

[HMaMa]

Oh, that’s sounds nice!
Can my neurolog contact you, if she has any questions? 🙏🏻

[admin]

hMaMa:

Side effects? Gastric disturbances, such as pain, diarrhea, infections. As for studies, we have studies on Etanercept, Infliximab, and Cimzia. All show low to no levels in milk, and no untoward effects in infants.

Tom Hale Ph.D.

[HMaMa]

Thank you Dr. Hale

Should my son be screened for anything, while I’m on Ocrevus?

And what kind of sideeffects could it have for my son?

And is there any articles I can show my neurolog, when she ask us to wean 🙏🏻

[admin]

HMaMa:

We do not yet have breastfeeding data on Ocrevus. Ocrelizumab is a recombinant humanized monoclonal antibody directed against CD20-expressing B-cells and is indicated for the treatment of Multiple Sclerosis. It is a glycosylated immunoglobulin G1 (IgG1).


While no levels in milk have been published, it is likely they are low, and that present, is probably not orally bioavailable. IgG molecules in the gut are metabolized quite rapidly by pancreatic proteases and I'm pretty sure none or very little of this one will be absorbed. Thus far, none of these monoclonal antibodies have been extensively absorbed.

Further, at 15 months, you baby can metabolize this product quite easily.

So i think the risk for your infant in your situation is quite low.

Tom Hale Ph.D.

[HMaMa]

Dear Dr. Hale 🙏🏻

After almost 1,5 year on Ivig post partum - my MR show new activity as I really want to nurse my son (almost 15 months old) my neurolog started me on copaxone. And new mr every third month.. If the next mr shows more activity, they recommend me to wean my son 😭 and start up on Ocrevus... I Will ofc do what is best my ms, but we really like to nurse, so is there any new research on nursing while being treated with Ocrevus?
If we keep nursing, should my son be checked by our gp more often than normal? Bloodsamples or?

Thank you for setting this forum up for questions ❤️

[Yags]

Thank you Dr. Hale. I am excited to start the medication!

[admin]

Yags

There is virtually no risk to your 13 month old infant from the large molecular weight monoclonal. I wouldn't worry about this one at all.

We don't have any data on this one, but we have dozens of similar monoclonal antibody studies all of which show very limited levels in breastmilk.

Tom Hale Ph.d.

[Yags]

I also am a bfing mother of a 13 month old. He eats solids and formula but I am having a hard time nightweaning him as he suckles for comfort. I scheduled my first Ocrevus infusion for Nov 5 but I think I have to reschedule as I can’t wean him.
Is there any new information on Ocrevus’ effects on breastmilk. Is there any possibilty that I’m overthinking it and it shouldn’t be a problem.

Thank you for any help!

[Lmh318]

Would it be safe to pump and dump and let a 5 month old go to the breast after pumping for comfort if needed?

[Ashalyne88]

Dr Hale,

I am in a similar situation to kflesch but I have a 16 month old daughter. I would prefer to continue to breastfeed her for the foreseeable future but obviously do not want to hurt her. She currently only feeds to sleep. Has there been any new information on the safety of this drug?

Thank you for your time and consideration!!