June 2021

New Products

• Beclometasone dipropionate/formoterol (eformoterol) fumarate dihydrate/glycopyrronium bromide (Trimbow) combines beclometasone dipropionate, a glucocorticoid, formoterol, a selective β₂-adrenergic agonist, and glycopyrronium, a high-affinity, long-acting muscarinic receptor antagonist (LAMA). Trimbow is indicated for maintenance treatment in adults with moderate to severe chronic obstructive pulmonary disease who are not adequately treated by the combination of an inhaled corticosteroid and a long-acting β₂-agonist (LABA), or the combination of LABA and LAMA. Trimbow pressurised solution for inhalation contains beclomethasone dipropionate 100 mcg, formoterol fumarate dihydrate 6 mcg and glycopyrronium 10 mcg per metered dose (equivalent to a delivered dose of beclomethasone dipropionate 87 mcg, formoterol fumarate dihydrate 5 mcg and glycopyrronium 9 mcg), and is available in a pack size of 120 actuations.
   
• Recombinant varicella zoster virus glycoprotein E antigen (AS01_B adjuvanted vaccine) (Shingrix) induces antigen-specific cellular and humoral immune responses in individuals with pre-existing immunity against varicella zoster virus (VZV) by combining the VZV specific antigen (gE) with an adjuvant system (AS01_B). Non-clinical data show that AS01_B induces a local and transient activation of the innate immune system, which facilitates the recruitment and activation of antigen presenting cells carrying gE-derived antigens in the draining lymph node, which in turn leads to the generation of gE-specific CD4+ T cells and antibodies. The adjuvant effect of AS01_B is the result of interactions between 3-O-desacyl-4’-monophosphoryl lipid A (MPL) and Quillaja saponaria saponin (QS-21) formulated in liposomes. Shingrix is indicated for the prevention of herpes zoster and post-herpetic neuralgia in adults ≥ 50 years. Shingrix powder and suspension for injection contains 50 mcg/0.5 mL of VZV gE antigen adjuvanted with AS01_B and is available in a pack size of 1.
   
• Satralizumab (Enspryng) is a humanised IgG₂ monoclonal antibody that binds to soluble and membrane-bound human IL-6 receptor and thereby prevents IL-6 downstream signalling through these receptors. IL-6 is a pleiotropic cytokine produced by a variety of cell types and is involved in diverse processes such as B-cell activation, differentiation of B-cells to plasma blasts and production of autoantibodies, Th17-cell activation and differentiation, T-regulatory cell inhibition, and changes in blood-brain barrier permeability. IL-6 levels are increased in the cerebrospinal fluid and serum of patients with neuromyelitis optica (NMO) and neuromyelitis optica spectrum disorders (NMOSD) during periods of disease activity. Some IL-6 functions have been implicated in the pathogenesis of NMO and NMOSD, including production of pathological autoantibodies against aquaporin-4, a water channel protein mainly expressed by astrocytes in the central nervous system. Enspryng is indicated as monotherapy, or in combination with immunosuppressive therapy, for the treatment of adults with NMOSD who have an anti-aquaporin 4 antibody IgG positive status. Enspryng is contraindicated in patients with known hypersensitivity to Chinese hamster ovary cell proteins. Enspryng solution for injection contains satralizumab 120 mg/mL and is available in a pack size of 1 prefilled syringe.
   
• Trabectedin (Yondelis) binds to the minor groove of deoxyribonucleic acid (DNA), bending the helix to the major groove. This binding to DNA triggers a cascade of events affecting several transcription factors, DNA binding proteins, and DNA repair pathways, resulting in perturbation of the cell cycle. Yondelis is indicated for the treatment of patients with unresectable or metastatic liposarcoma or leiomyosarcoma who received a prior anthracycline-containing regimen. It is contraindicated with concurrent serious or uncontrolled infection, during breastfeeding, or in combination with yellow fever vaccine. Yondelis powder for solution for infusion contains trabectedin 0.25 mg or 1 mg per vial and is available in a pack size of 1.

New Indications

• Buprenorphine (Buvidal Monthly) is now indicated for maintenance treatment of opioid dependence with prior stabilisation on Buvidal Weekly, sublingual buprenorphine or buprenorphine/naloxone, within a framework of medical, social and psychological support.
   
• Buprenorphine (Buvidal Weekly) is now indicated for initiation and maintenance treatment of opioid dependence, with or without prior stabilisation on sublingual buprenorphine or buprenorphine/naloxone, within a framework of medical, social and psychological support.
   
• Combined diphtheria, tetanus, acellular pertussis (dTpa) vaccine (Boostrix) and Combined dTpa and inactivated poliovirus vaccine (Boostrix IPV) are now also indicated for passive protection against pertussis in early infancy following maternal immunisation during pregnancy.
   
• Osimertinib (mesilate) (Tagrisso) is now indicated as an adjuvant therapy after tumour resection in patients with non-small cell lung cancer whose tumours have activating epidermal growth factor receptor mutations, as detected by a validated test.
   
• Sofosbuvir/velpatasvir (Epclusa) is now indicated for the treatment of chronic hepatitis C virus infection (genotype 1, 2, 3, 4, 5 or 6) in children ≥ 12 years weighing ≥ 30 kg.
   
• Upadacitinib (Rinvoq) is now indicated for the treatment of moderate to severe active psoriatic arthritis in adults who have responded inadequately to, or are intolerant to, one or more disease-modifying anti-rheumatic drugs (DMARDs). It may be used as monotherapy or in combination with a non-biological DMARD. Rinvoq is also indicated for the treatment of adults with active ankylosing spondylitis.

New Contraindications

• COVID-19 (ChAdOx1-S) vaccine (COVID-19 Vaccine AstraZeneca) is now contraindicated in patients who have experienced major venous and/or arterial thrombosis in combination with thrombocytopenia following vaccination with any COVID-19 vaccine.
   
• Cyclopentolate hydrochloride (Minims Cyclopentolate Eye Drops) is now contraindicated in patients with narrow-angle glaucoma or in those with a shallow anterior chamber; in the elderly (> 65 years) and other patients who may be predisposed to increased intraocular pressure; in at risk patients, especially premature babies, infants, and patients with Down syndrome, as well as in children with brain damage; in children with organic brain syndromes, including congenital or neurodevelopmental abnormalities, particularly those predisposing to epileptic seizures; and in patients with cardiovascular disorders.
   
• Trastuzumab (rch) (Ogivri) is now contraindicated in patients with known hypersensitivity to murine proteins.
   
• Zoster virus vaccine, live (Zostavax) is now contraindicated in patients with current or recent severe immunocompromising conditions from either a primary or acquired medical condition or medical treatment.

Safety Related Changes

• Buprenorphine (Buvidal Weekly, Monthly) is no longer contraindicated during pregnancy and lactation.

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.