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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…
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Refrigerated Storage

SimponiMerck Sharp & Dohme Limited

Merck Sharp & Dohme Limited
Simponi
Solution for injection in pre-filled syringe and pre-filled pen

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

Simponi may be stored at temperatures up to a maximum of 25°C for a single period of up to 30 days, but not exceeding the original expiry date printed on the carton. The new expiry date must be written on the carton (up to 30 days from the date removed from the refrigerator).

Once Simponi has been stored at room temperature, it should not be returned to refrigerated storage. Simponi must be discarded if not used within the 30 days of room temperature storage.

Contact MSD in all cases where a deviation from the recommended storage conditions has occurred, with details of the specific temperature excursion and the batch numbers of the products affected each time.

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 - as stated above
No
15 May 2020
London Medicines Information Service

Lactation Safety Information

For rheumatoid arthritis

For rheumatoid arthritis
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
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
15 September 2019

For inflammatory bowel disease

For inflammatory bowel disease
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
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
15 September 2019

New Medicines

SimponiModerate to severe ulcerative colitis (UC) in children aged 2 to 17 years

Information

Simponi
Licence extension / variation
Merck Sharp & Dohme (MSD)
Johnson & Johnson

Development and Regulatory status

None
Phase III Clinical Trials
Phase III Clinical Trials
Nov 20PIII PURSUIT 2 (NCT03596645) trial is still recruiting with an estimated primary completion date of Dec 21 [3].
Oct 19PIII PURSUIT 2 trial to evaluate efficacy of golimumab vs. i.v. infliximab in inducing clinical remission as assessed by the Mayo score, in paediatric participants aged 2 to 17 years with moderately to severely active ulcerative colitis starts (NCT03596645). Participants will receive subcutaneous (SC) golimumab through Week 50. Doses will be based on body surface area. After the Week 54 evaluations, at the discretion of investigator, participants benefiting from continued SC golimumab will continue to receive SC golimumab in the extension until end of study. In the comparator group, participants will receive infliximab intravenous (IV) through Week 46. Doses will be based on body weight. After the Week 54 evaluations, participants receiving infliximab will be withdrawn from study participation and transition to local standard of care which may include continued commercially available infliximab at the discretion of their physician. The open-label, randomised trial is enrolling approximately 125 patients in the US, EU and other countries (not UK). Collection of primary outcome data (clinical remission at week 6 according to Mayo score) is due to complete Dec 21 [2].

Category

A high affinity, humanised anti-tumour necrosis factor-α (anti-TNF-α) monoclonal antibody
Ulcerative colitis is the most common type of inflammatory disease of the bowel. It has an incidence in the UK of approximately 10 per 100,000 people annually and a prevalence of approximately 240 per 100,000. Ulcerative colitis can develop at any age but peak incidence is between the ages of 15 and 25 years, with a second, smaller peak between 55 and 65 years [1].
Moderate to severe ulcerative colitis (UC) in children aged 2 to 17 years
Subcutaneous injection