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Ustekinumab

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Topics: Gastrointestinal disordersPatent expiriesSafety in Breastfeeding · Skin disordersStability outside the fridgeUstekinumab ·
Contents
  1. dm+d
  2. Articles
  3. Refrigerated Storage
    1. Stelara · Janssen Cilag Ltd
    2. Stelara · Janssen-Cilag Ltd
  4. Lactation Safety Information
    1. For rheumatoid arthritis
    2. For psoriasis
    3. For inflammatory bowel disease

dm+d

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Articles

Preparing to use ustekinumab biosimilar

16 July 2024
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Refrigerated Storage

StelaraJanssen Cilag Ltd

Janssen Cilag Ltd
Stelara
45mg solution for injection (vials), 130mg concentrate for solution for infusion

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

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

29 October 2021
London MI Service

StelaraJanssen-Cilag Ltd

Janssen-Cilag Ltd
Stelara
45mg and 90mg solution for injection in pre-filled syringe

In the event of an inadvertent temperature excursion the following data may be used:
Individual pre-filled syringes may be stored at room temperature up to 30°C for a maximum single period of up to 30 days.

Once a syringe has been stored at room temperature (up to 30°C), it should not be returned to the refrigerator. Discard the syringe if not used within 30 days at room temperature storage or by the original expiry date, whichever is earlier.

Contact Janssen-Cilag Ltd in cases where additional stability data is required. Refer to the current BNF for company contact details.
Please also refer to the manufacturer’s product literature for recommended storage information at https://www.medicines.org.uk

Yes - reduce to 30 days from date of excursion as above.
No- keep outside of the fridge
29 October 2021
London MI Service

Lactation Safety Information

For rheumatoid arthritis

For rheumatoid arthritis
Caution
See summary
Limited published evidence of safety indicates negligible to small amounts in breast milk which are likely to be degraded in the infant’s GI tract
Very long half-life increases risk of accumulation in breastfed infants
Although large protein molecules may appear in colostrum, risk to preterm infants and neonates is considered to be small and unproven
22 January 2020
Bibliography

For psoriasis

For psoriasis
Caution
Topical psoriasis preparation / corticosteroid if appropriate
Limited published evidence of safety indicates negligible to small amounts in breast milk which are likely to be degraded in the infant’s GI tract
Very long half-life increases risk of accumulation in breastfed infants
Although large protein molecules may appear in colostrum, risk to preterm infants and neonates is considered to be small and unproven
Safety in Lactation: Systemic preparations for eczema and psoriasis
22 January 2020
Bibliography

For inflammatory bowel disease

For inflammatory bowel disease
Caution
See summary
Limited published evidence of safety indicates negligible to small amounts in breast milk which are likely to be degraded in the infant’s GI tract
Very long half-life increases risk of accumulation in breastfed infants
Although large protein molecules may appear in colostrum, risk to preterm infants and neonates is considered to be small and unproven
Safety in lactation: Drugs for chronic bowel disorders
22 January 2020
Bibliography