April 2025

New Products

• Momelotinib (as dihydrochloride monohydrate) (Omjjara) and its major circulating metabolite (M21) are inhibitors of wild type Janus Kinase 1 and 2 (JAK1/JAK2) and mutant JAK2V617F, which contribute to signalling of a number of cytokines and growth factors that are important for haematopoiesis and immune function. JAK1 and JAK2 recruit and activate signal transducer and activator of transcription proteins that control gene transcription impacting inflammation, haematopoiesis, and immune regulation. Momelotinib and M21, additionally inhibit activin A receptor type 1 which subsequently down regulates liver hepcidin expression resulting in increased iron availability and red blood cell production. Momelotinib and M21 potentially inhibit additional kinases, such as other JAK family members, IκB kinase, interleukin-1 receptor-associated kinase 1, and others. Omjjara is indicated for the treatment of disease-related splenomegaly or symptoms in adult patients with moderate to severe anaemia who have primary myelofibrosis, post-polycythaemia vera myelofibrosis or post-essential thrombocythaemia myelofibrosis and who are JAK inhibitor naïve or have been treated with ruxolitinib. Omjjara is contraindicated in pregnancy and breastfeeding. Omjjara tablets contain momelotinib 100 mg, 150 mg or 200 mg and are available in packs of 30.
  

New Indications

• Amivantamab (Rybrevant) is now also indicated in combination with carboplatin and pemetrexed for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor, and as first-line treatment of adult patients with locally advanced or metastatic NSCLC, with activating EGFR exon 20 insertion mutations.
   
• Dupilumab (Dupixent) is now indicated as an add-on maintenance treatment for uncontrolled chronic obstructive pulmonary disease, characterised by raised blood eosinophils, in adults on a stable combination of an inhaled corticosteroid (ICS), a long-acting beta2-agonist (LABA), and a long-acting muscarinic antagonist (LAMA), or on a combination of a LABA and a LAMA if ICS is not appropriate.
   
• Durvalumab (Imfinzi) is now indicated as monotherapy for the treatment of adult patients with limited-stage small cell lung cancer whose disease has not progressed following platinum-based chemoradiation therapy.

• Enfortumab vedotin (Padcev), in combination with pembrolizumab, is now indicated for the first-line treatment of adult patients with locally advanced or metastatic urothelial cancer.

• Enzalutamide (Xtandi) is now indicated for the treatment of patients with non-metastatic hormone-sensitive prostate cancer with biochemical recurrence at high-risk for metastasis.

• Nivolumab (rch) (Opdivo), in combination with platinum-doublet chemotherapy, is now also indicated for the neoadjuvant treatment of adult patients with resectable (tumours ≥ 4 cm or node positive) non-small cell lung cancer and no known epidermal growth factor receptor mutations or anaplastic lymphoma kinase rearrangements, followed by Opdivo as a single agent in the adjuvant setting after surgical resection.

• Pembrolizumab (rch) (Keytruda) is now indicated in combination with enfortumab vedotin, for the first-line treatment of adult patients with locally advanced or metastatic urothelial carcinoma; in combination with carboplatin and paclitaxel, followed by Keytruda as a single agent, for the treatment of adult patients with primary advanced or recurrent endometrial carcinoma; and in combination with chemoradiotherapy, for the treatment of patients with high-risk, locally advanced cervical cancer (FIGO 2014 Stage IB2-IIB and node-positive, or Stage III-IVA).

New Contraindications

• Metronidazole (Flagyl) is now contraindicated in patients with Cockayne syndrome.
   
• Obeticholic acid (Ocaliva) is now contraindicated in patients with compensated cirrhosis who have evidence of portal hypertension (e.g. ascites, gastroesophageal varices, persistent thrombocytopenia).
  

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.