June 2020

New Products

• Axicabtagene ciloleucel (Yescarta) is a CD19-directed genetically modified autologous T‑cell immunotherapy. It is prepared from the patient’s peripheral blood mononuclear cells, which are enriched for T-cells and activated with anti-CD3 antibody in the presence of IL-2, then transduced with the replication incompetent retroviral vector containing the anti-CD19 chimeric antigen receptor (CAR) transgene. The transduced T-cells are expanded in cell culture, washed, formulated into a suspension, and cryopreserved. Yescarta is indicated for the treatment of relapsed or refractory large B-cell lymphoma (LBCL) after two or more lines of systemic therapy, including diffuse LBCL (DLBCL) not otherwise specified, primary mediastinal LBCL, high grade B‑cell lymphoma, and DLBCL arising from follicular lymphoma. Yescarta is not indicated for the treatment of primary central nervous system lymphoma. Contraindications of the lymphodepleting chemotherapy must be considered. Each patient-specific bag of Yescarta suspension for intravenous infusion contains 1-2.4 x 10⁶ anti-CD19 CAR-positive viable T-cells/kg in approximately 68 mL for a target dose of 2 x 10⁶ cells/kg.
   
• Darolutamide (Nubeqa) is a non-steroidal androgen receptor antagonist with a flexible polar-substituted pyrazole structure that binds with nanomolar affinity directly to the receptor ligand binding domain to retain antagonistic activity against the androgen receptor (AR). It competitively inhibits androgen binding, AR nuclear translocation and AR mediated transcription. Nubeqa is indicated for the treatment of non-metastatic castration resistant prostate cancer. It is contraindicated in women who are or may become pregnant. Nubeqa tablets contain 300 mg darolutamide and are available in packs of 112 and 120.

New Indications

• Avelumab (rch) (Bavencio), in combination with axitinib, is now indicated for first-line treatment of advanced renal cell carcinoma.
   
• Brentuximab vedotin (rch) (Adcetris), in combination with cyclophosphamide, doxorubicin, and prednisone, is now indicated for the treatment of adults with previously untreated CD30+ peripheral T-cell lymphoma.
   
• Codeine phosphate hemihydrate (Aspen Codeine) is now indicated for the short-term management of severe pain for which other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain.
   
• Dapagliflozin (propanediol monohydrate) (Forxiga) and dapagliflozin (propanediol monohydrate)/metformin HCl (Xigduo XR) are now indicated in adults with type 2 diabetes mellitus and established cardiovascular disease or risk factors for cardiovascular disease to reduce the risk of hospitalisation for heart failure.
   
• Daratumumab (Darzalex) is now indicated for the treatment of newly diagnosed multiple myeloma in patients who are eligible for autologous stem cell transplant (ASCT) in combination with bortezomib, thalidomide, and dexamethasone; and patients who are ineligible for ASCT in combination with lenalidomide and dexamethasone.
   
• Venetoclax (Venclexta), in combination with obinutuzumab, is now indicated for the treatment of chronic lymphocytic leukaemia or small lymphocytic lymphoma (SLL) in patients who are considered unfit or unsuitable for chemo-immunotherapy.

New Contraindications

• Ertugliflozin/metformin HCl (Segluromet) is now contraindicated in patients with chronic kidney disease receiving dialysis; eGFR < 30 mL/min/1.73 m² or eGFR persistently < 45 mL/min/1.73 m² (CKD stages 3B, 4 and 5).
   
• Fluvoxamine maleate (Luvox) is now contraindicated in combination with pimozide and ramelteon.

This list is a summary of only some of the changes that have occurred over the last month.
Before prescribing, always refer to the full product information.

Revised opioids PBS listings from 1 June 2020