Raxtozinameran (Comirnaty Omicron XBB.1.5) is a nucleoside‑modified messenger RNA formulated in lipid nanoparticles, which enable delivery of the non‑replicating RNA into host cells to direct transient expression of the SARS‑CoV‑2 spike (S) antigen. Comirnaty elicits both neutralising antibody and cellular immune responses to the antigen, which may contribute to protection against COVID‑19. Comirnaty Omicron XBB.1.5 is indicated for active immunisation to prevent COVID‑19 in individuals 5 years of age and older in accordance with official recommendations. Comirnaty Omicron XBB.1.5 suspension for injection contains raxtozinameran 10 mcg per 0.3 mL (single dose vial with light blue cap) or 30 mcg per 0.3 mL (six‑dose vial with dark grey cap) and is available in packs of 10 or 195 vials.
New Indications
Incobotulinumtoxin A (Xeomin) is now indicated in adults for the treatment of chronic sialorrhoea due to neurological disorders; and in children and adolescents aged 2 to 17 years for the symptomatic treatment of chronic sialorrhoea due to neurological/neurodevelopmental disorders and spasticity of the lower and/or upper limbs.
Olaparib (Lynparza) indications for use in breast and prostate cancer have been extended. It is now indicated as monotherapy for adjuvant treatment of adult patients who have HER2‑negative, high‑risk early breast cancer with a deleterious or suspected deleterious germline BRCA mutation (gBRCAm), for which they have previously been treated with neoadjuvant or adjuvant chemotherapy; for treatment of adult patients who have HER2‑negative metastatic breast cancer with a deleterious or suspected deleterious gBRCAm, for which they have previously been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting; and for the treatment of adult patients who have metastatic castration‑resistant prostate cancer (mCRPC) with a deleterious or suspected deleterious BRCA mutation (germline or somatic), which has progressed following prior therapy that included a new hormonal agent. It is indicated in combination with abiraterone and either prednisone or prednisolone for the treatment of adult patients who have mCRPC with a deleterious or suspected deleterious BRCA mutation (germline or somatic).
New Contraindications
Romosozumab (Evenity)is now contraindicated in patients with a history of myocardial infarction or stroke.
Trimethoprim and sulfamethoxazole (Septrin Sugar Free Oral Liquid)is now contraindicated in patients with documented megaloblastic anaemia due to folate deficiency, evidence of marked parenchymal damage or blood dyscrasia; in pregnancy (any stage) and in nursing mothers.
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.
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