Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p63
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 63/161)
Character Range: 14165098–14170952

guidance.
                                                                                   State each of (a) the patient's bone age in numerical figures at the time when it was most recently determined, (b) the date (dd/mm/yy) of this determination that is within 12 months of this authority application;
                                                                                   (5) The patient's weight (kg);
                                                                                   (6) The prescribed dose (mg/kg) (between 0.04 to 0.12);
                                                                                   (7) The number of vials rounded to the nearest whole number, to provide sufficient drug quantity for 30 days of treatment per dispensing - see the relevant 'NOTE' attached to this listing for guidance.
                                                                                   Height, growth velocity and weight measurements must not be more than three months old at the time of application.
                                                                                   If the application is submitted through HPOS form upload or mail, it must include
                                                                                   (i) A completed authority prescription form; and
                                                                                   (ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
C13321              P13321         CN13321          Trientine                      Chelation of elevated copper levels                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       Compliance with Authority Required procedures
                                                                                   Patient must have a diagnosis of Wilson disease; AND
                                                                                   Patient must be intolerant to penicillamine; AND
                                                                                   Must be treated by a specialist medical practitioner, where this authority application is to initiate treatment with this drug, of the following type:
                                                                                    (i) gastroenterologist, (ii) hepatologist, (iii) neurologist; the authority prescription must be completed by the specialist prescriber.  or
                                                                                   Must be treated by a medical practitioner (of any type), where this authority application is continuing established trientine treatment (of any specified salt) initiated by one of the above mentioned specialist types.  or
                                                                                   Must be treated by a nurse practitioner where this authority application is continuing established trientine treatment (of any specified salt) initiated by one of the above mentioned specialist types.
                                                                                   Prior to seeking the initial authority approval, establish evidence of excess copper levels based on at least one of (i) clinical symptoms, (ii) measured serum copper levels, (iii) measured urinary copper levels.
                                                                                   Document what these findings were in the patient's medical records. Do not supply them in this authority application.
                                                                                   Refer to the following definitions if in doubt over what constitutes an acceptable intolerance to penicillamine
                                                                                   Side effects of penicillamine occurring soon after initiation (within first few weeks/months)
                                                                                   (i) fever, (ii) rash, (iii) enlarged lymph nodes, (iv) neutropenia, (v) thrombocytopenia, (vi) proteinuria, (vii) severe, persistent nausea.
                                                                                   (i) nephrotic syndrome, (ii) glomerulonephritis, (iii) total bone marrow aplasia, (iv) skin changes (cutis laxa, elastosis perforans serpiginosa, pemphigus), (v) myasthenia gravis, (vi) polymyositis, (vii) Goodpasture syndrome, (viii) optic neuritis, (ix) proteinuria (1-2 grams/day or equivalent in children, depending on specialist Wilson disease and renal review), (x) haematuria (if cause unknown), (xi) thrombocytopenia/leukopenia, (xii) bleeding related to thromobocytopenia/leukopenia, (xiii) lupus-like syndrome (haematuria, proteinuria, positive antinuclear antibody), (xiv) arthralgia.
                                                                                   Side effects of