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  • Ocrevus

    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

  • #2
    Kflesch:

    First, this drug is really dangerous when used during pregnancy, so if this arises again, I would strongly recommend against it use during pregnancy. Lots of this drug would be transferred in the last trimester to the infant leading to heightened risk of serious infections after delivery.

    As for lactation, some has been detected in the milk of monkeys. That said, there is probably not a lot in human milk because this is a large molecular weight product and is basically excluded from the milk compartment.

    IN YOUR SITUATION with a 3 year old, I doubt this product will have any effect on your infant. I'd observe for any kind of gut infection, diarrhea, etc. But I doubt the clinical dose transferred now is enough to induce these changes.

    Lastly, I doubt the benefit of breastfeeding at this time is worth the risk(albeit limited) of infection.

    Tom Hale Ph.D.

    Comment


    • #3
      Good morning Dr. Hale,
      I am working with a breastfeeding mom in a similar situation. However, her child is 7 months old. Do you have any advice for a mom taking ocrevus with a younger child? I hate to recommend weaning unless appropriately necessary.
      Thank you!

      Comment


      • #4
        bfarrell,

        We do not have any data regarding this medication. It is an monoclonal antibody that has a large molecular weight of 147,000 daltons. The size alone would largely preclude it's entry into breast milk. "Although the molecular weight of this medication is very large and the amount in breastmilk is very low, there are no long term data concerning the safety of using immune modulating medications in breastfeeding mothers. Further there are current data that suggest that other IgG drugs also transfer into milk, and perhaps the breastfed infant. Therefore, some caution is recommended and each woman should understand the benefits and risk of using this type of medication in lactation." (Medication and Mothers' Milk database, Dr Thomas Hale PhD). This mother could continue to breastfeed as long as the infant is monitored closely and is not symptomatic. Monitor for frequent infections including upper and lower respiratory infections, diarrhea, and other gut infections, fever, poor feedings and poor weight gain. We recommend the mother discuss this with the Dr, as the ultimate decision is up to her and the pediatrician.

        Sandra Lovato R.N.
        InfantRisk Center
        806-352-2519

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        • #5
          Dr Hale,
          Do you have any information for Ocrevus prior to TTC? I have had my 1st full dose but wondered about to safety of pregnancy after an infusion and not continuing Ocrevus during a pregnancy.

          Comment


          • #6
            krisg923,

            According to the European Medicines Agency they recommend waiting 12 months to try and conceive, and Genentech and Medscape recommend waiting 6 months, but there just doesn't seem to be much data regarding the use of Ocrevus prior to conception. The terminal elimination half-life is 26 days. Please read sections 4.6, 5.1 and 5.2 of the first article below. The data from Genentech is in second article and Medscape is in the third article.


            [url]http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/004043/WC500241124.pdf[/url]

            [url]https://www.gene.com/medical-professionals/medicines/ocrevus[/url]

            [url]http://www.medsafe.govt.nz/profs/Datasheet/o/Ocrevusinf.pdf[/url]

            Sandra Lovato R.N.
            InfantRisk Center
            806-352-2519
            Last edited by Sandra; 07-19-2018, 11:12 AM.

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            • #7
              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!!

              Comment


              • #8
                Would it be safe to pump and dump and let a 5 month old go to the breast after pumping for comfort if needed?
                Last edited by Lmh318; 08-31-2018, 12:19 PM.

                Comment


                • #9
                  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!

                  Comment


                  • #10
                    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.

                    Comment


                    • #11
                      Thank you Dr. Hale. I am excited to start the medication!

                      Comment


                      • #12
                        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 ❤️

                        Comment


                        • #13
                          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.



                          Comment


                          • #14
                            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 🙏🏻

                            Comment


                            • #15
                              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.





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