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Rituximab

Published
Topics: Allergy and immunologyCancersMusculo-skeletal disorders · Patent expiriesRituximabSafety in BreastfeedingSkin disordersStability outside the fridge ·
Contents
  1. dm+d
  2. Articles
  3. Refrigerated Storage
    1. MabThera · Roche Products Ltd
    2. Truxima · Napp Pharmaceuticals
    3. Rixathon · Sandoz Limited
  4. Lactation Safety Information
    1. for lymphoma/CLL
    2. for rheumatoid arthritis

dm+d

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Articles

Rituximab: informing intrathecal risk assessment

11 August 2022Rituximab products vary in their licensed status and other characteristics which affects their suitability for intrathecal administration
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Refrigerated Storage

MabTheraRoche Products Ltd

Roche Products Ltd
MabThera
Injection, 100mg and 500mg concentrate for solution for infusion and 1400mg solution for subcutaneous injection

Contact Roche in all cases where a deviation from the recommended storage conditions has occurred. Refer to the electronic medicines compendium (eMC) at https://www.medicines.org.uk for company contact details.

12 October 2022
London MI Service

TruximaNapp Pharmaceuticals

Napp Pharmaceuticals
Truxima
Concentrate for solution for infusion (100mg and 500mg)

In the event of an inadvertent temperature excursion the following data may be used:

In-house stability data from the manufacturers have shown that the unopened vials (100mg and 500mg) may be kept up to 25°C for 1 month.

Additionally, 500mg vials were stable when exposed to -20 ± 5 °C for 1 month.

Please also refer to the manufacturer’s product literature for recommended storage information at https://www.medicines.org.uk

26 January 2022
London MI Service

RixathonSandoz Limited

Sandoz Limited
Rixathon
Injection, 100mg and 500mg concentrate for solution for infusion

Rixathon may be stored at temperatures up to a maximum of 30°C for a single period of up to 7 days, but not exceeding the original expiry date. The new expiry date must be written on the carton. Upon removal from the refrigerated storage, Rixathon must not be returned to refrigerated storage.

yes - see above
No
14 October 2022
London MI Service

Lactation Safety Information

for lymphoma/CLL

for lymphoma/CLL
Caution
-
Limited published evidence of safety indicates small amounts in breast milk which are likely to be degraded in infants GI tract
Long half-life increases risk of accumulation in breastfed infants
Infants should be monitored for signs of infection and immunosuppression
Although large protein molecules may appear in colostrum, risk to preterm infants and neonates is considered to be small and unproven
16 August 2020
Bibliography

for rheumatoid arthritis

for rheumatoid arthritis
Caution
See summary
Limited published evidence of safety indicates small amounts in breast milk which are likely to be degraded in infants GI tract
Long half-life increases risk of accumulation in breastfed infant
Although large protein molecules may appear in colostrum, risk to preterm infants and neonates is considered to be small and unproven
16 August 2020
Bibliography