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Articles

Using Tocilizumab or Sarilumab for hospitalised patients with COVID-19 who are pregnant

12 October 2021A careful risk assessment should be done on the benefits of this off-label use to the mother, and the risks it poses to the fetus or neonate.

Using Tocilizumab or Sarilumab for hospitalised patients with COVID-19 who are breastfeeding

12 October 2021Tocilizumab and sarilumab can be used off-label to treat hospitalised patients with COVID-19. Breastfeeding can continue if these treatments are required.

Providing patient information leaflets following COVID-19 treatment

31 March 2021Following treatment for COVID-19 with tocilizumab, sarilumab, or steroids, clinicians should provide suitable patient information leaflets at discharge

Evidence for use of siltuximab or anakinra as second line therapies (after failure of tocilizumab) for Cytokine Release Syndrome following use of Chimeric Antigen Receptor T-cell (CAR-T) therapy

10 May 2019CAR-T therapy often causes cytokine release syndrome (CRS) which is treated with tocilizumab as first-line therapy. Tocilizumab is licensed for this indication but in some…
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Refrigerated Storage

RoActemraRoche Products Ltd

Roche Products Ltd
RoActemra
162mg pre-filled syringes/pen and 20mg/mL concentrate for solution for infusion

Contact Roche in all cases where a deviation from the recommended storage conditions has occurred. Refer to the current BNF for company contact details.

28 September 2020
London MI Service

Lactation Safety Information

See summary
Very limited published evidence of safety indicates negligible amounts in breast milk, which are likely to be degraded in the infant’s GI tract
Theoretically, absorption may be increased slightly in the neonatal period due to increased gastrointestinal permeability
Negligible infant serum levels and no adverse effects reported to date in infants exposed
Can be used during breastfeeding for patients with COVID-19
Live vaccination does not need to be withheld, unless exposure also occurred during pregnancy
As a precaution, monitor the infant for adequate feeding, fever, frequent infections, diarrhoea, or unusual behaviour
30 November 2021

New Medicines

Tocilizumab biosimilar (BAT1806)Rheumatoid arthritis (RA)

Information

Tocilizumab biosimilar (BAT1806)
Biosimilar
Biogen
Biogen

Development and Regulatory status

None
Phase III Clinical Trials
Phase III Clinical Trials

Category

Humanised anti-interleukin 6 (IL-6) receptor monoclonal antibody
One UK study found the population minimum prevalence of RA to be 1.16% in women and 0.44% in men [3].
Rheumatoid arthritis (RA)
Subcutaneous injection

Tocilizumab biosimilar (MSB11456) Rheumatoid arthritis (RA)

Information

Tocilizumab biosimilar (MSB11456)
Biosimilar
Fresenius Kabi
Fresenius Kabi

Development and Regulatory status

None
Phase III Clinical Trials
None

Category

A humanised anti-interleukin-6 receptor monoclonal antibody
The prevalence of confirmed RA is about 1% of the UK population. One study in the UK found the population minimum prevalence of RA to be 1.16% in women and 0.44% in men. The incidence of the condition is low, with around 1.5 men and 3.6 women developing RA per 10,000 people per year in the UK [1].
Rheumatoid arthritis (RA)
Subcutaneous injection

RoActemra (EU), Actemra (US) Interstitial lung disease associated with systemic sclerosis

Information

RoActemra (EU), Actemra (US)
Licence extension / variation
Roche
Roche

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Launched
Dec 21Roche appears to have no plans to file in the EU or UK for this indication [3-5].
Mar 21The FDA has approved tocilizumab for slowing the rate of decline in pulmonary function in adult patients with systemic sclerosis-associated interstitial lung disease [1]. 08/03/2021 10:09:53

Category

Anti-interleukin-6 (IL-6) receptor monoclonal antibody
SSc affects about 2.5 million people worldwide.4 Interstitial lung disease (ILD), which may occur in approximately 80% of SSc patients, causes inflammation and scarring of the lungs and can be life-threatening [1].
Interstitial lung disease associated with systemic sclerosis
Subcutaneous injection

Trial or other data

May 21Review of the focuSSced RCT (210 patients with early systemic sclerosis) found that, amongst the 136 patients with ILD, tocilizumab demonstrated an improved FVC% preservation than placebo after 48 weeks treatment (-0.1% vs -6.3%) [2].
Mar 21PIII randomised placebo-controlled clinical trial (focuSSced) of 212 adults with systemic sclerosis found patients on tocilizumab had less decline from baseline to week 48 in percent predicted FVC in a post hoc analysis (0.07% vs. -6.4%, mean difference 6.47%), and a smaller decline in FVC compared to placebo (mean change -14 mL vs. -255 mL, mean difference 241 mL) [1].