Document ID: chunk:federal_register_of_legislation:F2024L01543:reg:14a:p1
Version: federal_register_of_legislation:F2024L01543
Segment Type: reg
Provision Reference: reg 14A (pt 1/3)
Character Range: 4305–7812

14A  Prescribing amounts of active ingredients in dose of chemotherapy drug
  In a chemotherapy prescription for a dose of any of the following chemotherapy drugs, the amounts of each active ingredient directed to be supplied must be in the same proportion as the proportion of the active ingredients in the form of a chemotherapy pharmaceutical benefit that has that chemotherapy drug:
 (a) daunorubicin with cytarabine;
 (b) nivolumab with relatlimab.

     1.            After Part 2, Division 2, Subsection 21(1)
Insert:
 (1A) If the direction is for a new dose of a chemotherapy drug mentioned in section 14A, the amounts of each active ingredient in the new dose must be in the same proportion as the proportion of the active ingredients in the form of a chemotherapy pharmaceutical benefit that has that chemotherapy drug.

     1.            Part 2, Division 2, Subsections 21(2) and (3)
Omit "subsection (1)", substitute "subsections (1) and (1A)".

     1.            Schedule 1, Part 1, entry for Bortezomib in the form Powder for injection 3.5 mg
    omit:
         BORTEZOMIB TEVA  C11099 C13745

     1.            Schedule 1, Part 1, after entry for Daratumumab in the form Solution concentrate for I.V. infusion 400 mg in 20 mL
    insert:
Daunorubicin with cytarabine  Powder for I.V. infusion containing daunorubicin 44 mg (as hydrochloride) and cytarabine 100 mg  Injection  Vyxeos  C16187 C16197

     1.        Schedule 1, Part 1, entry for Elotuzumab in each of the forms: Powder for injection 300 mg; and Powder for injection 400 mg
    omit from the column headed "Circumstances": C12891

     1.        Schedule 1, Part 1, after entry for Nivolumab in the form Injection concentrate for I.V. infusion 100 mg in 10 mL
    insert:
Nivolumab with relatlimab  Solution concentrate for I.V. infusion containing 240 mg nivolumab and 80 mg relatlimab in 20 mL  Injection  Opdualag  C16151 C16188

     1.        Schedule 1, Part 1, entry for Trastuzumab in the form Powder for I.V. infusion 420 mg
    omit from the column headed "Circumstances": C155831 substitute: C15831

     1.        Schedule 1, Part 2, after entry for Daratumumab [Maximum Amount: 1920 mg; Number of Repeats: 8]
    insert:
Daunorubicin with cytarabine  P16197  64 mg  3
                              P16187  97 mg  4

     1.        Schedule 1, Part 2, entry for Elotuzumab
    omit:
   P12891  1200 mg  9

     1.        Schedule 1, Part 2, after entry for Nivolumab [Maximum Amount: 480 mg; Number of Repeats: 13]
    insert:
Nivolumab with relatlimab  P16188  480 mg   8
                           P16151  480 mg   11

     1.        Schedule 3, Part 1, omit entry for Circumstances Code "C12891"

     2.        Schedule 3, Part 1, after entry for Circumstances Code "C16085"
    insert:
C16151  P16151  Nivolumab with relatlimab     Unresectable Stage III or Stage IV malignant melanoma                                                                                                                                                                                                                                                                                Compliance with Authority Required procedures - Streamlined Authority Code 16151
                                              Continuing treatment
                                              Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                              The