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Safety in lactation: Drugs for chronic bowel disorders

21 September 2020Additional information relating to breastfeeding To be used in conjunction with individual drug entries for specific information and guidance. Aminosalicylates for chronic bowel disorders Mesalazine…

Safety in Lactation: Systemic preparations for eczema and psoriasis

7 January 2019Drugs used orally or parenterally for severe eczema and psoriasis have a varied pharmacology, mainly either modifying the immune response to the disease or modifying…
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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
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

For psoriasis

For psoriasis
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
22 January 2020

For inflammatory bowel disease

For inflammatory bowel disease
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

New Medicines

StelaraActive systemic lupus erythematosus (SLE) - second-line

Information

Stelara
Licence extension / variation
Janssen
Johnson & Johnson

Development and Regulatory status

Discontinued
Discontinued
Discontinued
Jun 20Janssen decides to terminate this clinical program based the outcome from a pre-planned interim analysis for efficacy which has shown a lack of differentiation between ustekinumab and placebo. There were no new safety signals identified in the interim analysis, and the observed safety profile was consistent with the known safety profile of ustekinumab. As the decision to terminate the study was made solely due to lack of efficacy in SLE, the outcome of this study does not impact the approved indications or other ongoing studies [7].
Jun 20PIII trial suspended due to lack of efficacy. The company intends to thoroughly analyze the totality of the study data and publish findings [6].

Category

A fully human interleukin (IL)-12 and IL-23 antagonist
Lupus is estimated to affect at least 1.5 million Americans and 5 million people worldwide. The disease most often affects women and disproportionately affects women of African American, Hispanic, Asian and Native American descent compared to Caucasian women [1]
Active systemic lupus erythematosus (SLE) - second-line
Intravenous &
Subcutaneous

Ustekinumab biosimilar (FYB202)Psoriasis

Information

Ustekinumab biosimilar (FYB202)
Biosimilar
Formycon
Formycon

Development and Regulatory status

None
Phase III Clinical Trials
None

Category

Human monoclonal antibody that targets cytokines interleukin-12 and interleukin-23.
The prevalence of psoriasis is estimated to be about 1.3-2.2% in the UK [2].
Psoriasis
Subcutaneous injection

Ustekinumab biosimilar (ABP654)Psoriasis

Information

Ustekinumab biosimilar (ABP654)
Biosimilar
Amgen
Amgen

Development and Regulatory status

None
None
Phase III Clinical Trials

Category

A biosimilar of monoclonal antibody ustekinumab, that binds to the p40 subunit of interleukin-12 and IL-23, and inhibits their activities, thereby preventing these cytokines from binding to their receptors expressed on natural killer T-cells.
The prevalence of psoriasis is estimated to be about 1.3-2.2% in the UK, with the highest prevalence being in white people. Men and women are equally affected. It can occur at any age but the majority of cases first present before the age of 35 years. It is uncommon in children [1].
Psoriasis
Subcutaneous injection

Ustekinumab biosimilar (CT-P43)Psoriasis, Crohn's disease, ulcerative colitis

Information

Ustekinumab biosimilar (CT-P43)
Biosimilar
Celltrion
Celltrion

Development and Regulatory status

None
Phase III Clinical Trials
None

Category

Human monoclonal antibody that targets the p40 subunit of interleukin-12 (IL-12) AND interleukin-23 (IL-23), preventing binding to T-cells and natural–killer cells. Given initially as 2 doses 4 weeks apart, then 12-weekly.
The prevalence of psoriasis is estimated to be about 1.3-2.2% in the UK, with the highest prevalence being in white people [2].
Psoriasis, Crohn's disease, ulcerative colitis
Subcutaneous injection

Ustekinumab biosimilar (AVT04)Moderate to severe chronic plaque psoriasis

Information

Ustekinumab biosimilar (AVT04)
Biosimilar
Alvotech/Cipla Gulf
Teva

Development and Regulatory status

None
Phase III Clinical Trials
None

Category

A monoclonal antibody that binds to the p40 subunit of interleukin-12 (IL-12) and interleukin-23 (IL-23), and inhibits the activity of human IL-12 and IL-23, by preventing these cytokines from binding to their receptors expressed on natural killer T-cells
The prevalence of psoriasis is estimated to be about 1.3-2.2% in the UK, with the highest prevalence being in white people [3].
Moderate to severe chronic plaque psoriasis
Subcutaneous injection