Trientine-Reddy's, Trientine-RZ, Trientine Dr.Reddy's and Trientine-DRLA
Registration timeline
The following table summarises the key steps and dates for this application.
| Description | Date |
|---|---|
| Designation (Orphan) | 9 October 2019 |
| Submission dossier accepted and first round evaluation commenced | 31 March 2020 |
| First round evaluation completed | |
| Sponsor provides responses on questions raised in first round evaluation | 2 September 2020 |
| Second round evaluation completed | 15 December 2020 |
| Delegate's overall benefit-risk assessment | 14 January 2021 |
| Sponsor's pre-Advisory Committee response | Not applicable |
| Advisory Committee meeting | Not applicable |
| Registration decision (Outcome) | 15 February 2021 |
| Completion of administrative activities and registration on ARTG | 29 March 2021 |
| Number of working days from submission dossier acceptance to registration decision* | 160 |
*Statutory timeframe for standard applications is 255 working days
The doses are expressed in terms of trientine dihydrochloride and the equivalent dose of trientine free base. It should be noted that a dose of 250 mg trientine dihydrochloride corresponds to a dose of 167 mg trientine free base. This should be considered if a patient is transferred from one trientine formulation to another.
Children > 5 years
500 to 750 mg trientine dihydrochloride /day (2 to 3 capsules) given in divided doses two or three times daily. This may be increased to a maximum of 1500 mg/day for children aged > 5 years. The paediatric dosage in terms of trientine free base is 333 to 500 mg/day to a maximum of 1000 mg/day.
The initial dose for children > 5 years can be expressed on a weight basis as 20 mg/kg body weight trientine dihydrochloride in 2 to 3 divided doses, rounded up to the nearest number of whole capsules
Adults
750 to 1250 mg trientine dihydrochloride /day (3 to 5 capsules) given in divided doses two, three or four times daily. This may be increased to a maximum of 2000 mg/day for adults. The adult dosage in terms of trientine free base is 500 to 833 mg/day to a maximum of 1333 mg/day.
The daily dose of trientine dihydrochloride capsules should be increased only when the clinical response is not adequate or the concentration of free serum copper is persistently above 20 µg/dL (3.1 µmol/L). Optimal long-term maintenance dosage should be determined at 6 to 12 month intervals (see 4.4 special warnings and precautions for use; effects on laboratory tests).
It is important that trientine dihydrochloride capsules be given on an empty stomach, at least one hour before meals or two hours after meals and at least one hour apart from any other drug, food, or milk. The capsules should be swallowed whole with water and should not be opened or chewed.
For further information refer to the Product Information.
Trientine-Reddy's, Trientine-RZ, Trientine Dr.Reddy's and Trientine-DRLA (trientine dihydrochloride) was approved for the following therapeutic use:
Trientine dihydrochloride capsules are indicated for the treatment of patients with Wilson's disease who are intolerant of penicillamine.
- Trientine-DRLA, Trientine-RZ, Trientine-Reddy's, Trientine Dr. Reddy's (trientine dihydrochloride) is to be included in the Black Triangle Scheme. The Product Information (PI) and Consumer Medicines Information (CMI) for Trientine-DRLA, Trientine-RZ, Trientine-Reddy's, Trientine Dr. Reddy's must include the black triangle symbol and mandatory accompanying text for five years, which starts from the date that the sponsor notifies the TGA of supply of the product.
- The trientine dihydrochloride Australian Risk Management Plan (RMP) (version 0.4, dated 22 December 2020, data lock point 31 March 2020), included with submission PM-2020-00155-1-3, and any subsequent revisions, as agreed with the TGA will be implemented in Australia.
An obligatory component of risk management plans is routine pharmacovigilance. Routine pharmacovigilance includes the submission of periodic safety update reports (PSURs).
Unless agreed separately between the supplier who is the recipient of the approval and the TGA, the first report must be submitted to TGA no later than 15 calendar months after the date of this approval letter. The subsequent reports must be submitted no less frequently than annually from the date of the first submitted report until the period covered by such reports is not less than three years from the date of this approval letter. The annual submission may be made up of two PSURs each covering six months. If the sponsor wishes, the six monthly reports may be submitted separately as they become available.
If the product is approved in the European Union (EU) during the three years period, reports can be provided in line with the published list of EU reference dates no less frequently than annually from the date of the first submitted report until the period covered by such reports is not less than three years from the date of this approval letter.
The reports are to at least meet the requirements for PSURs as described in the European Medicines Agency's Guideline on Good Pharmacovigilance Practices (GVP) Module VII-periodic safety update report (Rev 1), Part VII.B Structures and processes. Note that submission of a PSUR does not constitute an application to vary the registration. Each report must have been prepared within ninety calendar days of the data lock point for that report.