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Rituximab use while Breastfeeding

Drugs containing Rituximab: Rituxan

Rituximab Levels and Effects while Breastfeeding

Summary of Use during Lactation

Because rituximab is a large protein molecule with a molecular weight of 143,860. Limited data indicate that the amount in milk is very low and absorption is unlikely because it is probably destroyed in the infant's gastrointestinal tract.[1][2] Although 2 breastfed infants apparently experienced no adverse effects during maternal use of rituximab, no long-term data are available. If rituximab is required by the mother, it is not a reason to discontinue breastfeeding.[3] Until more data become available, rituximab should be used with caution during breastfeeding, especially while nursing a newborn or preterm infant.[4][5][6]

Drug Levels

Maternal Levels. A patient who had granulomatosis with polyangiitis received rituximab 1000 mg intravenously while exclusively breastfeeding her infant. Milk samples were collected daily for 4 days starting 7 days after the infusion. Milk rituximab concentrations averaged 0.5 mcg/L (range 0.4 to 0.6 mcg/L).[2]

Infant Levels. A woman received rituximab 375 mg/square meter once weekly for 4 weeks beginning at week 30 of gestation. Her infant was born at 40 weeks of gestation and was exclusively breastfed with no major health issues. At 4 months of age, trace amounts of rituximab heavy and light chains were detected, but not quantified, in the infant's serum. Whether the drug was acquired transplacentally or during breastfeeding was not determined.[7]

Effects in Breastfed Infants

A woman received rituximab 375 mg/square meter once weekly for 4 weeks beginning at week 30 of gestation. Her infant was born at 40 weeks of gestation and was exclusively breastfed with no major health issues. At 4 months of age, the infant's B-cell population and immunoglobulin levels did not appear to be affected.[7]

A woman received an IV infusion of 1000 mg of rituximab at about 3 months postpartum. Her infant who was fully breastfed had no serious infections during the lactation period and developed normally during a 1.5 year follow-up period.[2]

Effects on Lactation and Breastmilk

Relevant published information was not found as of the revision date.

Alternate Drugs to Consider

(Multiple Sclerosis) Glatiramer, Immune Globulin, Interferon Beta, Methylprednisolone (Rheumatoid Arthritis) Auranofin, Gold Sodium Thiomalate, Hydroxychloroquine, Infliximab, Methotrexate, Penicillamine, Sulfasalazine

References

1. Pistilli B, Bellettini G, Giovannetti E et al. Chemotherapy, targeted agents, antiemetics and growth-factors in human milk: How should we counsel cancer patients about breastfeeding? Cancer Treat Rev. 2013;39:207-11. PMID: 23199900

2. Bragnes Y, Boshuizen R, de Vries A et al. Low level of rituximab in human breast milk in a patient treated during lactation. Rheumatology (Oxford). 2017;56:1047-8. PMID: 28339781

3. Gotestam Skorpen C, Hoeltzenbein M, Tincani A et al. The EULAR points to consider for use of antirheumatic drugs before pregnancy, and during pregnancy and lactation. Ann Rheum Dis. 2016;75:795-810. PMID: 26888948

4. Ostensen M. Management of early aggressive rheumatoid arthritis during pregnancy and lactation. Expert Opin Pharmacother. 2009;10:1469-79. PMID: 19505214

5. Keeling SO, Oswald AE. Pregnancy and rheumatic disease: "by the book" or "by the doc". Clin Rheumatol. 2009;28:1-9. PMID: 18987777

6. Almas S, Vance J, Baker T et al. Management of multiple sclerosis in the breastfeeding mother. Mult Scler Int. 2016;2016:6527458. PMID: 26966579

7. Jin J, Mills J, Conboy E et al. In utero rituximab: Detection of rituximab in an infant at 4 months of age. Ann Allergy Asthma Immunol. 2014;113:A14. Abstract 36. http://www.sciencedirect.com/science/journal/10811206/113/5/supp/S

Rituximab Identification

Substance Name

Rituximab

CAS Registry Number

174722-31-7

Drug Class

Antibodies, Monoclonal

Antirheumatic Agents

Antineoplastic Agents

Administrative Information

LactMed Record Number

888

Last Revision Date

20170601

Disclaimer

Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.

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