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New Products
- Cannabidiol (Epidyolex) reduces neuronal hyper-excitability through modulation of intracellular calcium via G protein-coupled receptor 55 (GPR55) and transient receptor potential vanilloid 1 (TRPV-1) channels, and modulates adenosine-mediated signalling through inhibition of adenosine cellular uptake via the equilibrative nucleoside transporter 1 (ENT-1). Epidyolex is indicated for use as adjunctive therapy of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients 2 years of age and older. Epidyolex should be initiated and supervised by a neurologist. It is contraindicated in patients with transaminase elevations greater than 3 x ULN and bilirubin greater than 2 x ULN. Epidyolex oral solution contains cannabidiol 100 mg/mL and is available in pack size of one 100 mL bottle with two 5 mL and two 1 mL calibrated oral dosing syringes and two bottle adapters.
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New Indications
- Atezolizumab (rch) (Tecentriq), in combination with bevacizumab, is now indicated for the treatment of patients with unresectable or metastatic hepatocellular carcinoma who have not received prior systemic therapy.
- Bictegravir (sodium)/emtricitabine/tenofovir alafenamide (fumarate) (Biktarvy) is now indicated for the treatment of HIV-1 infection in paediatric patients weighing at least 25 kg who are antiretroviral therapy (ART)-naïve or to replace the current antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA < 50 copies/mL) on a stable antiretroviral regimen at the start of therapy with no history of treatment failure, and no known substitutions associated with resistance to the individual components of Biktarvy.
- Secukinumab (rch) (Cosentyx) is now indicated for the treatment of adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or MRI change, who have had an inadequate response to, or are intolerant to, NSAIDs.
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New Contraindications
- Nomegestrol acetate/estradiol (hemihydrate) (Zoely) is now contraindicated in patients with meningioma or a history of meningioma.
- Yellow fever vaccine, live (Stamaril) should not be administered to individuals receiving any other medicinal products, including biologicals, with known immunosuppressive or immunomodulating properties.
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New Presentation
- Hydralazine HCl (Hydralazine Link) is now available as a solution for injection containing hydralazine HCl 20 mg/mL in a pack size of 10 x 1 mL vials.
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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.
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