OCREVUS SC Administration Video

The OCREVUS (ocrelizumab) licence has been updated to include reduced contraception requirements and revised breastfeeding advice.^1-3

The current licence now states the following^1,2:

4.6 Fertility, pregnancy and lactation

Woman of Childbearing potential

Woman of Childbearing potential should use contraception

• While receiving ocrelizumab; and
• For 4 months after the last administered dose of ocrelizumab

Breastfeeding

• Ocrelizumab can be used during breastfeeding starting a few days after birth

Ocrelizumab should be avoided during pregnancy unless the potential benefit to the mother outweighs the potential risk to the foetus.

Give your patients the confidence of disease control with a 6-monthly administration, even when dosing is paused during pregnancy⁴

Peripartum disease activity was evaluated retrospectively in women who fell pregnant whilst receiving OCREVUS during 13 interventional clinical trials.
Data was available for 103 pregnant women, and 81 postpartum women.
Median time between first OCREVUS dose and LMP was 29 months in both groups, median time between last OCREVUS administration and LMP before pregnancy was 4.2 months in the pregnant group and 4.1 months in the postpartum group. Time between delivery and first OCREVUS administration postpartum was 3.8 months.

The annualised relapse rate* remained low (per PY [95% CI]): 0.06 (0.02–0.14) pre-pregnancy, 0.03 (0.00–0.09) during pregnancy and 0.04 (0.01–0.14) postpartum.

*Only those with live births were included in this analysis. Per clinical study protocols, women were required to discontinue OCR treatment.

SOPRANINO - breastfeeding study³

The results of the SOPRANINO study, amongst other data, have formed the foundation for updating the OCREVUS SPC to permit its administration in women who are breastfeeding^1-3

Peter Brex's talk on SOPRANINO and the label update at the MS academy symposium in September 2025

Study Design

The SOPRANINO study was a phase IV, multicentre, open-label study designed to assess the impact of maternal OCREVUS dosing on breastfeeding mothers and their infants³:

Key Inclusion Criteria

Age 18–40 years
Diagnosis of MS/CIS
Delivered full-term (≥37 weeks) singleton infant

Infant was 2–24 weeks old at the mother’s first postpartum OCR infusion
Mother received last dose of OCR >3 months before the LMP to exclude potential in utero exposure

The clinical decision to start OCR during breastfeeding preceded enrollment into the study.

*Measured as ADID, calculated as the arithmetic mean of the mother’s OCREVUS milk concentration (μg/ml) over 60 days post-OCREVUS infusion 1, multiplied by an estimated infant milk intake of 150 ml/kg/day and based on the weight (kg) recorded at the Day 30 visit.³

The results of SOPRANINO demonstrated that:

OCREVUS levels in breastmilk were negligible†

All infants had B-cell levels within age-specific normal ranges^§

All infants showed consistent growth and development during the first year of life^¶

OCREVUS was undetectable in infant serum‡

Infant safety: Infections were typical childhood infections⁹ or co-occuring in the mother; most were mild to moderate and all resolved

Maternal safety: AEs were expected as per established OCREVUS® safety profile and/or occuring in postpartum/breastfeeding women as well as in the context of the COVID-19 pandemic³

ACT NOW: use OCREVUS to support your patients plan for their families on their own terms

An article by Dr Murray

Navigating Multiple Sclerosis Treatment in Women of Childbearing Age: Balancing Family Planning and Effective Disease Management

Proactive discussions about family planning and individualised treatment strategies can empower women living with multiple sclerosis to make informed choices. OCREVUS is a high efficacy disease modifying therapy that can be used during breastfeeding thanks to recent data from a phase IV study; with negligible levels of the drug found in breastmilk and undetectable levels in infant serum 30 days after the mother’s first postpartum infusion.

This promotional supplement was commissioned, supported and funded by Roche Products Ltd., is co-authored with Dr Katy Murray, Consultant Neurologist, Anne Rowling Clinic, Edinburgh, and is intended for UK healthcare professionals.

Access the Article

It is important for HCPs to ensure patients are informed about potential adverse events that may occur with OCREVUS. HCPs should refer to the Summary of Product Characteristics (SmPC) for a comprehensive list of these events.

† Measured as ADID, calculated as the arithmetic mean of the mother’s OCREVUS^® milk concentration (µg/ml) over 60 days post-OCREVUS^® infusion 1, multiplied by an estimated infant milk intake of 150 ml/kg/day and based on the weight (kg) recorded at the Day 30 visit.
‡ 9 out of 9 infants with serum OCREVUS^® concentration below LLQ=156 ng/ml, based on serum OCREVUS^® concentration measured 30 days after the mother’s first postpartum infusion; OCREVUS^® could not be measured in 4/13 infants due to: Healthcare professional unable to draw blood (n=2), early discontinuation (n=1) and an accidentally discarded sample (n=1).
^§ Infant B-cell levels at 30 days after the first postpartum OCREVUS^® infusion (absolute count of CD19+ B cells). 10/13 infants had B-cell data for the primary analysis; Normal B-cell ranges in infants are defined by Borriello et al. 2022⁹, Dynamic changes occur in the ULN and LLN of B-cell levels throughout the first year. A reduction in B-cell levels is observed from cord blood to the first week of life, followed by a rapid increase over the next 2 months. At ~6 months of age maximum levels are attained, after which levels decrease progressively and stabilise at ~1 year of age; Infants were on average 2 months (2 to 24 weeks) old at the time of the mother’s first postpartum OCREVUS^® infusion (corresponding to the WHO and UNICEF’s recommended 6 months of exclusive breastfeeding).¹⁰
^¶Infant growth was captured at Months 2, 4, 6, 9 and 12 using age-adjusted weight, height/length and head circumference (according to the World Health Organization’s Child Growth Standards); The total pooled number of infants at each observation is as follows: At birth (N=13), Month 2 (n=12), Month 4 (n=12), Month 6 (n=8), Month 9 (n=7) and Month 12 (n=8).Assessment of infant developmental milestones was assessed through the Ages and Stages Questionnaire Version 3 completed by the parents; Number of infants at Month 2 (n=10), Month 4 (n=11), Month 6 (n=8), Month 9 (n=8) and Month 12 (n=8); Abnormal scores as per cut-offs from the Ages and Stages Questionnaire 3rd Edition user guide.¹¹

Abbreviations

LMP: L M P; ARR: Annualised Relapse Rate ; ICT: ; PY: ;

References:

OCREVUS® SC Summary of Product Characteristics.
OCREVUS® IV Summary of Product Characteristics.
Bove R, et al. Presented at ECTRIMS 2024 (Oral O039)
Vukusic A et al. ECTRIMS 2024; Poster P591
Størdal K, et al. J Pediatr Gastroenterol Nutr 2017;65:225–231.
Hauser S et al. Presented at ECTRIMS 2024 (Poster P1664)
Hauser SL et al. presented at ECTRIMS 2024; (Poster P300).
Newsome SD et al. ACTRIMS 2025; Presentation P089.
Borriello F, et al. J Allergy Clin Immunol 2022;150:1216–24;
World Health Organization (WHO). Infant and young child feeding. December 2023. Available from: https://www.who.int/news-room/fact-sheets/detail/infant-and-young-child-feeding. Accessed October 2025.
Squires J, and Bricker DD. Ages & Stages Questionnaires®: A Parent-Completed Child Monitoring System. 3rd edn. Baltimore: Paul H Brookes Publishing Co., 2009.

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. You can also report via the free Yellow Card app available from the Apple App Store or Google Play Store. Adverse events should also be reported to Roche Products Ltd. Please contact Roche Drug Safety Centre by emailing welwyn.uk_dsc@roche.com or calling +44 (0)1707 367554.
Adverse reactions should be reported by brand name and batch number.