Ocrevus

[kaytlin]

It's a LR4 - No Data, Possibly Hazardous. Waiting will surely reduce exposure (not eliminate it).

[Henley25]

Okay, thank you so much for all of this information and insight. I appreciate it! Is there a lactation risk category assigned to Ocrevus? Also, would pumping and dumping for a full half life (26 days) and then resuming breastfeeding significantly reduce infant drug exposure?

[kaytlin]

Unfortunately, your questions are better than our knowledge. We believe that antibodies are somewhat resistant to degradation in infants (I'll include a reference below in case you are interested). Although not ideal in your scenario, it is how we believe babies get benefits from natural antibodies in milk.

I wouldn't think gut-B cell destruction would directly relate to blood counts. The goal would be to monitor two things: GI symptoms AND B cells in the serum. I would think the GI symptoms would be much more likely, but the severity of any risk of B cell depletion in the baby shouldn't be ignored. Simple monitoring is a good compromise to keep everyone healthy.

Kaytlin

Kim BJ, Lueangsakulthai J, Sah BNP, Scottoline B, Dallas DC. Quantitative Analysis of Antibody Survival across the Infant Digestive Tract Using Mass Spectrometry with Parallel Reaction Monitoring. Foods. 2020;9(6)
Jasion VS, Burnett BP. Survival and digestibility of orally-administered immunoglobulin preparations containing IgG through the gastrointestinal tract in humans. Nutr J. 2015;14:22. Published 2015 Mar 7. doi:10.1186/s12937-015-0010-7

[Henley25]

Also, if b cells in the gut are destroyed, would that be reflected in bloodwork? Thank you!

[Henley25]

Thank you. If the drug is destroyed in gut before becoming systemically absorbed, would the gastric acids destroy the drug before it had a chance to affect b cells in gut?

[kaytlin]

Hello Henley,

While we don't have any data on Ocrevus, we expect transfer through breastmilk to be low. Poor oral bioavailability protects the infant to some degree as well.

There is a risk that the drug would decrease B cells in the infant's gut. If you want to continue breastfeeding, I'd watch for GI trouble in the baby and ask if your pediatrician would monitor B cell counts.

Kaytlin Krutsch, PharmD

[Henley25]

Dr. Hale,

I have to go back on Ocrevus treatment for MS soon. Is it safe to breastfeed my 7 month old while on Ocrevus? Baby was full term and not exposed to Ocrevus during pregnancy. 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.