June 2025

New Products

• Lazertinib (as mesilate monohydrate) (Lazcluze) is a third generation, epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor that selectively inhibits both primary activating EGFR mutations (exon 19 deletions and exon 21 L858R substitution mutations) and the EGFR T790M resistance mutation, while having less activity against wild-type EGFR. Lazertinib demonstrated anti-tumour activity in human non-small cell lung cancer (NSCLC) cells and mouse xenograft models of EGFR exon 19 deletions or L858R substitution mutations. Treatment with lazertinib in combination with amivantamab increased in vivo anti-tumour activity compared to either agent alone in mouse xenograft models of human NSCLC with an EGFR L858R mutation. Lazcluze in combination with amivantamab is indicated for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations. Lazcluze tablets contain lazertinib 80 mg or 240 mg and are available in packs of 60 (80 mg) or 30 (240 mg).
   
• Vutrisiran (as sodium) (Amvuttra) is a chemically stabilised double-stranded small interfering ribonucleic acid (siRNA) that specifically targets variant and wild-type transthyretin (TTR) messenger RNA (mRNA) and is covalently linked to a ligand containing three N‑acetylgalactosamine residues to enable delivery of the siRNA to hepatocytes. Through a natural process called RNA interference, vutrisiran causes the catalytic degradation of TTR mRNA in the liver, resulting in the reduction of variant and wild-type serum TTR protein levels. Amvuttra is indicated for the treatment of hereditary TTR-mediated amyloidosis in adult patients with stage 1 or stage 2 polyneuropathy. Amvuttra solution for injection contains vutrisiran 25 mg per 0.5 mL and is available in packs of 1 prefilled syringe.

New Presentations

• Alteplase (rch) (Actilyse Cathflo) is now available in a strength specifically indicated for use in occluded central venous access devices. It is indicated for the thrombolytic treatment of occluded central venous access devices including those used for haemodialysis. Actilyse Cathflo powder for injection contains alteplase 2 mg and is available in packs of 5 vials.
   
• Aripiprazole (as monohydrate) (Abilify Asimtufii) is now available as prolonged release suspension for injection every 2 months. Abilify Asimtufii is indicated as monotherapy in adult patients, who have been treated with Abilify Maintena in the prior month and whose tolerability to aripiprazole has been established, for the maintenance treatment of schizophrenia to prevent the recurrence of manic or mixed episodes of bipolar I disorder. Abilify Asimtufii prolonged release suspension for injection contains aripiprazole 720 mg per 2.4 mL or 960 mg per 3.2 mL and is available in packs of 1 prefilled syringe.

New Indications

• Amivantamab (Rybrevant) is now indicated in combination with lazertinib for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 19 deletions or exon 21 L858R substitution mutations.
   
• Bimekizumab (Bimzelx) is now indicated for the treatment of adult patients with moderate to severe hidradenitis suppurativa (HS) with an inadequate response to conventional systemic HS therapy.
   
• Durvalumab (Imfinzi) is now indicated in combination with carboplatin and paclitaxel, followed by Imfinzi monotherapy, for the first-line treatment of patients with primary advanced or recurrent endometrial cancer.
  
  Recombinant respiratory syncytial virus (RSV) pre-fusion F protein vaccine (Arexvy) is now also indicated for adults 50 through 59 years of age who are at increased risk for RSV disease.
   
• Tislelizumab (Tevimbra) is now indicated in combination with platinum and fluoropyrimidine-based chemotherapy for the first-line treatment of adult patients with HER-2 negative locally advanced unresectable or metastatic gastric or gastro-oesophageal junction adenocarcinoma with a PD-L1 expression ≥ 1%.

New Contraindications

• Dactylis glomerata, Poa pratensis, Lolium perenne, Anthoxanthum odoratum, Phleum pratense pollen (Alustal Pollen Extract of Five Grasses) and European (Dermatophagoides pteronyssinus), American (Dermatophagoides farinae) house dust mite allergen extracts (Alustal House Dust Mites Extract) are now contraindicated in patients with active or poorly controlled autoimmune disease, immune defects, immunodeficiencies, immunosuppression or malignant neoplastic diseases with current disease relevance; in patients with severe, uncontrolled asthma (FEV1 < 70% of predicted value) or severe exacerbation of asthma within the last 3 months; in initiation during pregnancy; and in patients with renal insufficiency.
   
• Naltrexone hydrochloride and bupropion hydrochloride (Contrave 8/90) is now contraindicated in patients treated with opioid agonists used in opioid dependence including buprenorphine.

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.