March 2024

New Products

• Nirsevimab (Beyfortus) is a recombinant neutralising human IgG1ĸ long‑acting monoclonal antibody to the prefusion conformation of the respiratory syncytial virus (RSV) F protein which has been modified with a triple amino acid substitution (YTE) in the Fc region to extend serum half‑life. Nirsevimab binds to a highly conserved epitope in antigenic site Ø on the prefusion protein with dissociation constants KD = 0.12 nM and KD = 1.22 nM for RSV subtype A and B strains, respectively. Nirsevimab inhibits the essential membrane fusion step in the viral entry process, neutralising the virus and blocking cell‑to‑cell fusion.  Beyfortus is indicated for the prevention of RSV lower respiratory tract disease in neonates, infants born during or entering their first RSV season and in children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season in accordance with official recommendations. Beyfortus solution for injection contains nirsevimab 50 mg per 0.5 mL or 100 mg per 1 mL in a pre‑filled syringe and is available in packs of 1.

New Indications

• Brentuximab vedotin (Adcetris) is now indicated for treatment of patients with previously untreated CD30+ stage III or IV Hodgkin lymphoma in combination with doxorubicin, vinblastine, and dacarbazine.
   
• Dostarlimab (Jemperli) is now indicated in combination with carboplatin and paclitaxel for the treatment of adult patients with primary advanced or recurrent mismatch repair deficient/ microsatellite instability-high endometrial cancer.
   
• Nivolumab (Opdivo) is now indicated as monotherapy for the adjuvant treatment of adults and adolescent patients 12 years and older with completely resected Stage IIB, IIC, III or IV melanoma.
   
• Pneumococcal 20 valent polysaccharide conjugate vaccine (Prevenar 20) is now indicated for active immunisation to prevent pneumococcal disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F in individuals from 6 weeks of age and older in accordance with official recommendations.
   
• Ravulizumab (rch) (Ultomiris 100 mg/mL) is now indicated for the treatment of adult patients with Neuromyelitis Optica Spectrum Disorder (NMOSD) who are anti-aquaporin 4 antibody-positive. Ultomiris is not intended for the acute treatment of an NMOSD relapse.
   
• Relugolix, estradiol and norethisterone acetate (Ryeqo) is now indicated for symptomatic treatment of endometriosis in adult women of reproductive age with a history of previous medical or surgical treatment for their endometriosis.

New Contraindications

• Apomorphine hydrochloride hemihydrate (Movapo, Movapo Pen and Movapo PFS) is now contraindicated for concomitant use with 5HT₃ antagonists including antiemetics (for example ondansetron, granisetron, palonosetron).
   
• Clomifene citrate (Clomid) is now contraindicated in patients with known history of significant, medically confirmed vision disorders related to the use of Clomid (prior or ongoing treatment).
   
• Factor VIII inhibitor bypassing fraction (Feiba NF) is now contraindicated in acute myocardial infarction, unless indicated in life-threatening bleeding events. 
   
• Itraconazole (Lozanoc) is now contraindicated for concomitant use with apixaban, rivaroxaban, dabigatran, mobocertinib, finerenone and voclosporin, including 2 weeks after itraconazole treatment, and in chronic lymphocytic leukaemia/ small lymphocytic lymphoma patients during the dose initiation, titration, and ramp-up phases of venetoclax treatment.

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.