November 2022

New Products

• Daunorubicin (hydrochloride) and cytarabine (Vyxeos) is a liposomal formulation of a fixed combination of daunorubicin and cytarabine in a 1:5 molar ratio. Daunorubicin has antimitotic and cytotoxic activity, which is achieved by forming complexes with DNA, inhibiting topoisomerase II activity, inhibiting DNA polymerase activity, affecting regulation of gene expression, and producing DNA-damaging free radicals. Cytarabine is a cell cycle phase-specific antineoplastic agent, affecting cells only during the S-phase of cell division. The 1:5 molar ratio has been shown in vitro and in vivo to maximise synergistic antitumour activity in acute myeloid leukaemia (AML). Vyxeos is indicated for the treatment of adults with newly diagnosed, therapy-related AML or AML with myelodysplasia-related changes. Vyxeos powder for injection contains daunorubicin 44 mg and cytarabine 100 mg and is available in a pack of 1 vial.
   
• Fluocinolone acetonide (Iluvien) is an intravitreal corticosteroid implant. Iluvien is indicated for the treatment of diabetic macular oedema in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure. Iluvien is contraindicated in the presence of pre-existing glaucoma or active or suspected ocular or periocular infection including most viral diseases of the cornea and conjunctiva, including active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections, and fungal diseases. Iluvien intravitreal implant contains fluocinolone acetonide 190 mcg and is available in a single use applicator in a pack of 1.
   
• Pemigatinib (Pemazyre) is a small molecule kinase inhibitor of FGFR1, 2 and 3. It inhibits FGFR 1-3 phosphorylation and signalling and decreases cell viability in cancer cell lines with activating FGFR genetic alterations, including point mutations, amplifications, and fusions or rearrangements that result in constitutive activation of FGFR signalling. Constitutive FGFR signalling can support the proliferation and survival of malignant cells. Pemazyre has provisional approval for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that has progressed after at least one prior line of systemic therapy. Pemazyre is contraindicated with concomitant St. John’s wort. Pemazyre tablets are available in 4.5 mg, 9 mg and 13.5 mg packs of 14.
   
• Treosulfan (Trecondi) is a prodrug of a bifunctional alkylating agent with cytotoxic activity to haematopoietic precursor cells. The activity of treosulfan is due to the spontaneous conversion into a mono-epoxide intermediate and L-diepoxybutane. The epoxides form alkylate nucleophilic centres of deoxyribonucleic acid (DNA) and are able to induce DNA cross-links which are considered responsible for the stem cell depleting and antineoplastic effects. Trecondi is indicated in combination with fludarabine as part of conditioning treatment prior to allogeneic hematopoietic stem cell transplantation (alloHSCT) in adult patients with acute myeloid leukaemia (AML) or myelodysplastic syndrome (MDS) at increased risk for standard conditioning therapies; and, in combination with fludarabine, with or without thiotepa, as part of conditioning treatment prior to alloHSCT in paediatric patients older than one month with malignant and non-malignant diseases. Trecondi is contraindicated in active non-controlled infectious disease; severe concomitant cardiac, lung, liver, and renal impairment; Fanconi anaemia and other DNA breakage repair disorders; pregnancy and lactation; and with concomitant administration of a live vaccine. Trecondi powder for infusion contains treosulfan 5 g and is available in a pack of 1 vial.
   

New Presentation

• Brexucabtagene autoleucel (Tecartus) is now available in an intravenous infusion bag containing a target dose of 1 × 106 anti‑CD19 CAR T cells per kg body weight in approximately 68 mL of suspension.
   
• Tozinameran (Comirnaty (Tris/Sucrose Presentation)) is now available as a concentrate for suspension for injection (dilute to use) containing tozinameran 3 mcg/0.2 mL after dilution in packs of 10 or 195  ten dose vials with a maroon cap.

New Indications

• Belimumab (Benlysta) is now indicated for the treatment of active lupus nephritis in adult patients who are receiving standard therapy.
   
• Brexucabtagene autoleucel (Tecartus) is now indicated in adult patients ≥ 18 years of age with relapsed or refractory B‑cell precursor acute lymphoblastic leukaemia.
   
• Pembrolizumab (Keytruda) is now indicated for the treatment of patients with high‑risk early‑stage triple‑negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery; and in combination with chemotherapy, for the treatment of patients with locally recurrent unresectable or metastatic TNBC whose tumours express PD‑L1 (CPS ≥10) as determined by a validated test and who have not received prior chemotherapy for metastatic disease.
   
• Secukinumab (Cosentyx) is now indicated for the treatment of active enthesitis-related arthritis in patients 4 years and older who have had an inadequate response or were intolerant to at least one NSAID and at least one DMARD; and for the treatment of active juvenile psoriatic arthritis in patients 2 years and older who have had an inadequate response or were intolerant to at least one NSAID and at least one DMARD.
   
• Tozinameran (Comirnaty (Tris/Sucrose Presentation)) now has provisional approval for the active immunisation to prevent coronavirus disease 2019 (COVID‑19) caused by SARS‑CoV‑2, in individuals 6 months of age and older.

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.