August 2020

New Products

• Entrectinib (Rozlytrek) is an inhibitor of the tropomyosin receptor tyrosine kinases (TRK) TRKA, TRKB and TRKC, proto-oncogene tyrosine-protein kinase ROS1, and anaplastic lymphoma kinase (ALK). Fusion proteins that include TRK, ROS1 or ALK kinase domains can drive tumourigenic potential through hyperactivation of downstream signalling pathways leading to unconstrained cell proliferation. Entrectinib inhibits the TRK kinases, ROS1 and ALK, leading to inhibition of downstream signalling pathways, cell proliferation and induction of tumour cell apoptosis. Entrectinib demonstrated in vitro and in vivo inhibition of cancer cell lines derived from multiple tumour types harbouring neurotrophic tyrosine receptor kinase (NTRK), ROS1 and ALK fusion genes. Rozlytrek is indicated for the treatment of adults with advanced non-small cell lung cancer (NSCLC) whose tumours are ROS1-positive; adults and children ≥ 12 years with solid tumours that have a NTRK gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have either progressed following treatment or have no satisfactory alternative therapy. This indication was approved via the provisional approval pathway, based on objective response rate and duration of response in single-arm trials. Full registration for this indication depends on verification and description of clinical benefit in confirmatory trials. Rozlytrek capsules contain entrectinib 100 mg (available in packs of 30) or 200 mg (available in packs of 90).
   
• Olopatadine hydrochloride and mometasone furoate monohydrate (Ryaltris) contains olopatadine, a selective H₁ antagonist, and mometasone furoate, a topical glucocorticosteroid with local anti-inflammatory properties. Ryaltris is indicated for the treatment of symptoms associated with allergic rhinitis and rhinoconjunctivitis in children ≥ 12 years. It is contraindicated with severe nasal infection, especially candidiasis; haemorrhagic diathesis; and in patients with a history of recurrent nasal bleeding. Ryaltris nasal spray contains olopatadine 600 microgram and mometasone furoate 25 microgram per spray in a pack size of 1 (240 metered doses).
   
• Remdesivir (Veklury) is an adenosine nucleotide prodrug that distributes into cells where it is metabolised to form the pharmacologically active nucleoside triphosphate metabolite. Metabolism of remdesivir to remdesivir triphosphate has been demonstrated in multiple cell types. Remdesivir triphosphate acts as an analogue of adenosine triphosphate (ATP) and competes with the natural ATP substrate for incorporation into nascent RNA chains by the SARS-CoV-2 RNA-dependent RNA polymerase, which results in delayed chain termination during replication of the viral RNA. It is a weak inhibitor of mammalian DNA and RNA polymerases with low potential for mitochondrial toxicity. Veklury has provisional approval for the treatment of coronavirus disease 2019 (COVID‑19) in adults and adolescents (aged 12 years and older weighing at least 40 kg) with pneumonia, requiring supplemental oxygen. The decision to approve this medicine has been made based on limited data. More comprehensive evidence is required to be submitted. Veklury is available as a concentrate for infusion containing remdesivir 100 mg/20 mL, or as a powder for infusion containing remdesivir 100 mg/vial, in a pack size of 1 vial.
   
• Siponimod (hemifumarate) (Mayzent) is a sphingosine-1-phosphate (S1P) receptor modulator. It binds selectively on two out of five G-protein-coupled receptors for S1P: S1P₁ and S1P₅. By acting as a functional antagonist on S1P₁ receptors on lymphocytes, siponimod prevents egress from lymph nodes. This reduces the recirculation of T-cells into the central nervous system to limit central inflammation. Siponimod spares effector memory T-cells in peripheral tissues and blood and does not impair lymphocyte activation. It readily crosses the blood brain barrier. Mayzent is indicated for the treatment of adults with secondary progressive multiple sclerosis. Mayzent should not be administered to patients with a CYP2C9*3/*3 genotype. Mayzent tablets contain siponimod 0.25 mg (available in packs of 12 (titration pack) or 120) or 2 mg (available in packs of 28).

New Indications

• Dasatinib (Sprycel) is now indicated for the treatment of paediatric patients with Philadelphia chromosome positive (Ph+) chronic myeloid leukaemia (CML) in chronic phase; and newly diagnosed Ph+ acute lymphoblastic leukaemia (ALL) in combination with chemotherapy.
   
• Eculizumab (rmc) (Soliris) is now indicated in adults with neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 (AQP4) antibody-positive. It is not intended for acute treatment of a NMOSD relapse.
   
• Pembrolizumab (rch) (Keytruda), in combination with axitinib, is now indicated for the first-line treatment of advanced renal cell carcinoma.

New Contraindications

• Zopiclone (Imovane) is now contraindicated in patients who have previously experienced complex sleep behaviours after taking zopiclone.

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.