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109102003

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Safety in Lactation: Metabolic disorders

18 September 2020These drugs are used for a variety of metabolic conditions, most of which are rare, and therefore give very limited opportunity to assess their impact…
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Refrigerated Storage

CufenceUnivar

Univar
Cufence
Hard capsules, 200mg

This medicinal product does not require any special storage conditions when unopened.

After opening the bottle, store in a refrigerator (2°C-8°C).

Contact Univar directly for information regarding any temperature excursion of Cufence after the bottle has been opened. 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

3 months (after first opening the bottle)
11 December 2020
London MI Service

Medicine Compliance Aid Stability

genericUnivar

Univar
generic
Capsules 300mg
R1 · Red 1Stability data indicates that the drug is not suitable for CAs.
Unsuitable
Protect from light and store in airtight containers. Requires storage between 2-8 deg C.
29 March 2015

Lactation Safety Information

For Wilson's disease

For Wilson's disease
Very limited published evidence of safety
May reduce copper levels in milk although the impact on the breastfed infant is unknown
16 September 2020

New Medicines

CufenceWilson’s disease in adults, adolescents and children aged 5 years or older, intolerant to D-penicillamine therapy

Information

Cufence
New formulation
Univar Solutions B.V.
Univar Solutions Inc.

Development and Regulatory status

Launched
Launched
None
November 2020
Dec 20Univar reports that Cufence has replaced their previous trientine dihydrochloride 300mg product fully. The transition went smoothly and from 1 November, Cufence is available for dispensing and trientine dihydrochloride is not available anymore. The formal withdrawal of trientine dihydrochloride 300mg is underway. Price for Cufence 200mg (equivalent to tientene dihydrochloride 300mg), 100 capsules =£3,090 [4,5].
Sep 20Is already available in other European countries. Cufence will replace Univar ´s unbranded trientine dihydrochloride 300mg capsules [3].
Sep 20UK launch is planned for October 2020 [3].
Sep 20Each hard capsule contains 300mg trientine dihydrochloride equivalent to 200 mg trientine base [1].
Jul 19Trientine dihydrochloride capsules (Cufence) received EU-wide approval from the EMA. Trientine is a well-established active substance and trientine dihydrochloride 300mg capsules were first licensed in the United Kingdom (UK) in 1985 [2].

Category

A copper-selective chelator that enhances systemic elimination of divalent copper by forming a stable complex readily excreted by the kidneys. Branded original (replaces trientine dihydrochloride 300mg). Capsules 300mg (equiv. to 300mg salt/200mg base).
Wilson disease is found worldwide, with an estimated prevalence of approximately 1:30,000. This estimation may vary by population with Japan/Asia having a higher prevalence compared with an estimated prevalence in Europe of approximately 5.84 per 100,000 population [2].
Wilson’s disease in adults, adolescents and children aged 5 years or older, intolerant to D-penicillamine therapy
Oral

Trial or other data

Jul 19Cufence capsules do not require any special storage conditions unopened. After opening the bottle containing the capsules should be stored in a refrigerator (2ºC-8ºC) [1].

Evidence based evaluations

Tillomed Treatment of Wilson's disease in patients intolerant to D-penicillamine therapy, in adults, adolescents and children aged 5 years or older

Information

Tillomed
New formulation
Tillomed
Not Known

Development and Regulatory status

Launched
None
None
June 2020
Mar 21Has been available in the UK for some time (exact launch date unknown but presume Jun 20) [6].
May 20Launch in the UK is now planned for June 2020 [5].
Jan 20Launch in the UK is planned for April 2020 [4].
Jan 20Trientine dihydrochloride 250mg capsules (Tillomed) were approved by the MHRA [1]. Trientine is a well-established active substance and trientine dihydrochloride 300mg capsules were first licensed in the United Kingdom (UK) in 1985 [2]. However, this product offers the advantage of room temperature storage, in comparison to the 300mg capsules which require fridge storage [1,3].

Category

A copper-selective chelator that enhances systemic elimination of divalent copper by forming a stable complex that is readily excreted by the kidneys [1]. Available as a 250mg capsule.
Wilson disease is found worldwide, with an estimated prevalence of approximately 1:30,000. This estimation may vary by population with Japan/Asia having a higher prevalence compared with an estimated prevalence in Europe of approximately 5.84 per 100,000 population [2].
Treatment of Wilson's disease in patients intolerant to D-penicillamine therapy, in adults, adolescents and children aged 5 years or older
Oral

Evidence based evaluations

SPC