Document ID: chunk:federal_register_of_legislation:F2025C00119:clause:3_1:p5
Version: federal_register_of_legislation:F2025C00119
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 5/69)
Character Range: 201344–209740

patient's body weight must be documented in the patient's medical records at the time treatment is initiated.
C6585               P6585          Ipilimumab                                                                   Unresectable Stage III or Stage IV malignant melanoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Compliance with Authority Required procedures ‑ Streamlined Authority Code 6585
                                                                                                                Re‑induction treatment
                                                                                                                The treatment must be the sole PBS‑subsidised therapy for this condition; AND
                                                                                                                Patient must have progressive disease after achieving an initial objective response to the most recent course of ipilimumab treatment (induction or re‑induction); AND
                                                                                                                The treatment must not exceed a total of 4 doses at a maximum dose of 3 mg per kg every 3 weeks.
                                                                                                                An initial objective response to treatment is defined as either:
                                                                                                                (i) sustained stable disease of greater than or equal to 3 months duration measured from at least 2 weeks after the date of completion of the most recent course of ipilimumab; or
                                                                                                                (ii) a partial or complete response.
                                                                                                                The patient's body weight must be documented in the patient's medical records at the time treatment with ipilimumab is initiated.
C6852                              Fosaprepitant                                                                Nausea and vomiting                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  Compliance with Authority Required procedures ‑ Streamlined Authority Code 6852
                                                                                                                The condition must be associated with cytotoxic chemotherapy being used to treat malignancy; AND
                                                                                                                The treatment must be in combination with a 5‑hydroxytryptamine receptor (5HT3) antagonist and dexamethasone on day 1 of a chemotherapy cycle; AND
                                                                                                                Patient must be scheduled to be administered a chemotherapy regimen that includes either carboplatin or oxaliplatin.
                                                                                                                No more than 1 vial of fosaprepitant 150 mg injection will be authorised per cycle of cytotoxic chemotherapy.
                                                                                                                Concomitant use of a 5HT3 antagonist should not occur with fosaprepitant on days 2 and 3 of any chemotherapy cycle.
C6886                              Fosaprepitant                                                                Nausea and vomiting                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  Compliance with Authority Required procedures ‑ Streamlined Authority Code 6886
                                                                                                                The condition must be associated with cytotoxic chemotherapy being used to treat malignancy; AND
                                                                                                                The treatment must be in combination with a 5‑hydroxytryptamine receptor (5HT3) antagonist and dexamethasone; AND
                                                                                                                Patient must be scheduled to be administered a chemotherapy regimen that includes any 1 of the following agents: altretamine; carmustine; cisplatin when a single dose constitutes a cycle of chemotherapy; cyclophosphamide at a dose of 1500 mg per square metre per day or greater; dacarbazine; procarbazine when a single dose constitutes a cycle of chemotherapy; streptozocin.
                                                                                                                No more than 1 vial of fosaprepitant 150 mg injection will be authorised per cycle of cytotoxic chemotherapy.
C6887                              Fosaprepitant                                                                Nausea and vomiting                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  Compliance with Authority Required procedures ‑ Streamlined Authority Code 6887
                                                                                                                The condition must be associated with moderately emetogenic cytotoxic chemotherapy being used to treat malignancy; AND
                                                                                                                The treatment must be in combination with a 5‑hydroxytryptamine receptor (5HT3) antagonist and dexamethasone on day 1 of a chemotherapy cycle; AND
                                                                                                                Patient must have had a prior episode of chemotherapy