March 2020

New Products

• Brigatinib (Alunbrig) is a tyrosine kinase inhibitor of multiple kinases including anaplastic lymphoma kinase (ALK), ROS1 and insulin-like growth factor 1 receptor (IGF-1R), with most activity against ALK. Brigatinib inhibited autophosphorylation of ALK and ALK-mediated phosphorylation of the downstream signaling protein STAT3 in in vitro and in vivo assays. Alunbrig is indicated for the treatment of adults with ALK-positive advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib. Alunbrig tablets contain 30 mg, 90 mg or 180 mg brigatinib and are available in a pack size of 28, and as an initiation pack containing 7 x 90 mg tablets and 21 x 180 mg tablets.
   
• Brolucizumab (rbe) (Beovu) binds with picomolar affinity to vascular endothelial growth factor (VEGF)-A isoforms (e.g. VEGF110, VEGF121, and VEGF165), thereby preventing binding of VEGF-A to its receptors VEGFR-1 and VEGFR-2. This suppresses endothelial cell proliferation, thereby reducing pathological neovascularisation and decreasing vascular permeability. Beovu is indicated for the treatment of neovascular (wet) age-related macular degeneration. Beovu is contraindicated in patients with active or suspected ocular or periocular infections, or with active intraocular inflammation. Beovu solution for injection contains 19.8 mg/0.165 mL (≡ 120 mg/mL) brolucizumab and is available in a pack size of 1 pre-filled syringe.
   
• Inactivated quadrivalent influenza vaccine (surface antigen), adjuvanted (Fluad Quad) contains 15 mcg haemagglutinin (HA) per dose of each of four influenza virus surface antigens representative of the influenza virus types expected to circulate in the Southern Hemisphere winter according to WHO recommendations for the 2020 season: A/Brisbane/02/2018 (H1N1)pdm09-like virus (A/Brisbane/02/2018 IVR-190), A/South Australia/34/2019 (H3N2)-like virus (A/South Australia/34/2019 IVR-197), B/Washington/02/2019-like virus (B/Victoria/705/2018 BVR-11), B/Phuket/3073/2013-like virus (B/Phuket/3073/2013 BVR-1B). Fluad Quad is indicated for the active immunisation against influenza in persons 65 years of age and older. It is contraindicated in individuals with known severe allergic reactions to any component of the vaccine, except egg proteins, or to a previous dose of any influenza vaccine. Fluad Quad suspension for injection contains 60 mcg HA/0.5 mL and is available in a pack size of 10 needle-free prefilled syringes.
   
• Upadacitinib (Rinvoq) is a selective and reversible inhibitor of Janus kinase (JAK)-1. Janus kinases are intracellular enzymes that transmit cytokine or growth factor signals involved in a broad range of cellular processes including inflammatory responses, haematopoiesis and immune surveillance. JAK1 is important in inflammatory cytokine signals. Rinvoq is indicated for the treatment of moderate to severe active rheumatoid arthritis in adults who have responded inadequately to, or who are intolerant to, one or more disease-modifying anti-rheumatic drugs (DMARDs). Rinvoq may be used as monotherapy or in combination with methotrexate or other conventional synthetic DMARDs. Rinvoq must not be used in combination with biologic DMARDs. Rinvoq modified release tablets contain 15 mg upadacitinib and is available in a pack size of 28.
   

New Indications

• Fentanyl (Durogesic) is now indicated for the management of pain associated with cancer, palliative care, and other conditions in patients where: other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain, and the pain is opioid-responsive and severe enough to require daily, continuous, long term opioid treatment. Durogesic is not for use in opioid-naïve patients.
   
• Rocuronium bromide (Esmeron) is now indicated as an adjunct to general anaesthesia to facilitate endotracheal intubation during routine induction, to provide muscle relaxation and to facilitate mechanical ventilation in paediatric patients from term newborn infants to adolescents.

New Contraindications

• Fentanyl (Durogesic) is now contraindicated in patients with acute respiratory disease and respiratory depression.
   
• Morphine sulfate pentahydrate (Kapanol) is now contraindicated in patients with hypersensitivity to opioid analgesics; obstructive airway diseases; cor pulmonale; acute alcoholism or delirium tremens; convulsive disorders, severe CNS depression; increased cerebrospinal or intracranial pressure; head injury; brain tumor; suspected surgical abdomen; severe liver disease; incipient hepatic encephalopathy; severe renal dysfunction; and history of alcohol or substance abuse.
   
• Somatropin (rbe) (Omnitrope) is now contraindicated in patients with extensive burns; and with Prader-Willi syndrome who are severely obese or have severe respiratory impairment.

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.