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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

HumiraAbbVie

AbbVie
Humira
40 mg solution for injection pre-filled syringe, pre-filled pen

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

A single Humira pre-filled syringe or pre-filled pen may be stored at temperatures up to a maximum of 25°C for a period of up to 14 days. The syringe or pen must be protected from light, and discarded if not used within the 14 -day period

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

For information outside of this excursion, contact AbbVie Ltd directly. Refer to the current BNF for company contact details.

25 March 2021
London MI Service

Amgevita Amgen Ltd

Amgen Ltd
Amgevita
Solution for injection in pre-filled syringe/pen

In the event of an inadvertent temperature excursion the following data may be used:
The pre-filled syringe or pre-filled pen may be stored at temperatures up to a maximum of 25°C for a period of up to 14 days. The pre-filled syringe or pre-filled pen must be protected from light, and discarded if not used within the 14-day period.
Please also refer to the manufacturer’s product literature for recommended storage information at https://www.medicines.org.uk

15 March 2021
London MI Service

ImraldiBiogen

Biogen
Imraldi
Solution for injection in a pre-filled pen or syringe

Once exposed to temperatures up to 25°C, the syringe or pen must be used within 28 days or discarded, even if it is returned to the refrigerator.

You should record the date when the syringe or pen is first removed from refrigerator, and the date after which it should be discarded.

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

19 March 2021
London MI Service

HyrimozSandoz

Sandoz
Hyrimoz
20mg and 40mg Solution for injection in pre-filled syringe and pen

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

A single Hyrimoz pre-filled syringe / pre-filled pen may be stored at temperatures up to a maximum of 25°C for a period of up to 21 days. The pre-filled syringe / pre-filled pen must be protected from light, and discarded if not used within the 21-day period.
The manufacturers have stated that they will deal with temperature excursions on a case by case basis to ensure the most up to date information is provided each time.
Refer to the electronic medicines compendium (eMC) at www.medicines.org.uk/emc/ for company contact details.

14 October 2022
London MI Service

Lactation Safety Information

For rheumatoid arthritis

For rheumatoid arthritis
See summary
Moderate amount of published evidence of safety indicates small amounts in breast milk which are likely to be degraded in the infant’s GI tract
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

HumiraModerate-to-severe ulcerative colitis (UC) in children unable to have conventional therapies

Information

Humira
Licence extension / variation
AbbVie
AbbVie

Development and Regulatory status

Launched
Launched
Phase III Clinical Trials
November 2020
Nov 20Licence extension approved in the EU [6].
Oct 20Recommended for EU approval by CHMP - the additional indication is "for the treatment of moderately to severely active ulcerative colitis in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including corticosteroids and/or 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies" [5].

Category

TNF-alfa antagonist
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 unable to have conventional therapies
Subcutaneous injection

Trial or other data

Jun 21Analysis of PIII ENVISION I trial (n=77;age 4-17 years), showed a significantly higher proportion of patients were in partial Mayo score (PMS) remission at 8 weeks with high-dose induction adalimumab vs placebo (60 vs 19.8%;p=0.0001) and similarly with full MS remission at week 52 in 8 week PMS responders (45 vs 18.4%;p=0.0001) [7].
Jan 20The PIII study NCT02065557, and the open-label long-term PIII trial are ongoing, with estimated primary completion dates of Jun 2020 and May 2023, respectively [4].
Nov 18The PIII study NCT02065557 is still recruiting with estimated primary completion date of May 2021. The open-label long-term PIII trial is still enrolling by invitation with estimated primary completion date of May 2023 [3].
Jan 18PIII study (NCT02065557) is still recruiting [2].
Nov 15Open-label long-term safety and efficacy PIII trial of repeated SC injections of adalimumab in paediatric subjects with ulcerative colitis, who completed M11-290 study starts (M10-870; NCT02632175). The single-group trial is recruiting 93 patients, by invitation only, in the US, Slovakia and Japan [2].
Aug 14PIII trial to investigate the efficacy, tolerability, and pharmacokinetics of induction and maintenance therapy with adalimumab in paediatric patients with moderate to severe ulcerative colitis starts (M11-290; NCT02065557). The trial is intended to enrol 225 patients aged 4 to 17 years old from sites around the world including the US and EU (incl. UK). Collection of primary outcome data (clinical remission at 8 and 52 weeks) is due to complete May 21 [2].

Evidence based evaluations