October 2021

New Products

• Lemborexant (Dayvigo) is a competitive antagonist of both orexin receptors, OX1R and OX2R, with a higher affinity for OX2R. The orexin neuropeptide signalling system is a central promoter of wakefulness. Blocking the binding of wake-promoting neuropeptides orexin A and orexin B to receptors OX1R and OX2R is thought to suppress wake drive. Dayvigo is indicated for the treatment of insomnia, characterised by difficulties with sleep onset and/or sleep maintenance in accordance with latest Diagnostic and Statistical Manual of Mental Disorders (DSM) criteria. It is contraindicated in patients with narcolepsy. Dayvigo tablets contain lemborexant 5 mg or 10 mg and are available in a pack size of 28.
   
• Sotrovimab (Xevudy) is an engineered human IgG1 monoclonal antibody (mAb) that binds to a highly conserved epitope on the spike protein receptor binding domain of SARS-CoV-2 with high affinity (dissociation constant K_d = 31 ng/mL). The Fc domain of sotrovimab includes M428L and N434S amino acid substitutions (LS modification) that extends antibody elimination half-life, but does not impact wild-type Fc-mediated effector functions when compared with the original mAb with LS modification (S309+LS) in cell culture. Xevudy has provisional approval for the treatment of adults and adolescents ≥ 12 years weighing ≥ 40 kg with coronavirus disease 2019 (COVID‑19) who do not require initiation of oxygen due to COVID-19 and who are at increased risk of progression to hospitalisation or death. Xevudy concentrate for infusion contains sotrovimab 500 mg/8 mL and is available in pack size of 1 vial.

New Presentation

• Pertussis vaccine-acellular combined with diphtheria and tetanus toxoids (adsorbed) (Adacel) is now available as a suspension for injection containing pertussis toxoid 2.5 mcg, pertussis filamentous haemagglutinin 5 mcg, pertussis fimbriae (types 2 and 3) 5 mcg, pertussis pertactin 3 mcg, diphtheria toxoid ≥ 2 IU (2 LfU), tetanus toxoid ≥ 20 IU (5 LfU) in a pack size of 1 or 10 prefilled syringes.

New Indications

• Dupilumab (rch) (Dupixent) is now indicated for the treatment of severe atopic dermatitis in children 6-11 years of old who are candidates for chronic systemic therapy. It is not intended for episodic use. Dupixent is also now indicated as an add-on maintenance treatment in adults with inadequately controlled chronic rhinosinusitis with nasal polyposis.
   
• Elasomeran (Spikevax COVID-19 Vaccine) now has provisional approval for the active immunisation of individuals ≥ 12 years to prevent COVID-19 caused by SARS-CoV-2.
   
• Triptorelin (embonate) (Diphereline) is now indicated for the treatment of children ≥ 2 years with central precocious puberty (22.5 mg 6 month formulation only).

New Contraindications

• Fluticasone propionate/salmeterol (xinafoate) (Pavtide, Seretide Accuhaler) and salmeterol (xinafoate) (Serevent Accuhaler) are now contraindicated in patients with severe milk protein allergy.
   
• Naproxen (Phebra Naproxen Suspension) is now contraindicated during the third trimester of pregnancy. 
   
• Obeticholic acid (Ocaliva) is now contraindicated in patients with decompensated cirrhosis (e.g. Child-Pugh Class B or C) or a prior decompensation event.
   
• Triptorelin (embonate) (Diphereline) is now contraindicated in pregnancy and during 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.