Regulatory Alerts
Keep up-to-date with key announcements and guidance from organisations including NICE, DHSC and MHRA.
Dolutegravir (Tivicay▼, Triumeq▼, Juluca▼): updated advice on increased risk of neural tube defects
Inform women of the potential risk of neural tube defects with dolutegravir and discuss the benefits and risks of continuing treatment if a woman plans pregnancy.
Niraparib (Zejula▼): reports of severe hypertension and posterior reversible encephalopathy syndrome (PRES), particularly in early treatment
Monitor blood pressure at least weekly for 2 months from initiation and then monthly afterwards for the first year and periodically thereafter during treatment
Flucytosine (Ancotil): new contraindication in patients with DPD deficiency
New contraindication for patients with complete DPD deficiency due to risk of life-threatening toxicity.
Regulatory Alerts, Cancer, Oncology, Breast cancer, Gastrointestinal cancer, Head and neck cancer, Oncology Room
5-fluorouracil (intravenous), capecitabine, tegafur: DPD testing recommended before initiation to identify patients at increased risk of severe and fatal toxicity
Patients with complete or partial dihydropyrimidine dehydrogenase (DPD) deficiency are at increased risk of severe and fatal toxicity during treatment with these medicines.
Pembrolizumab recommended for head and neck cancer
Treatment recommended as monotherapy for untreated metastatic or unresectable recurrent HNSCC, in NICE final draft guidance.
SMC accepts treatment for eosinophilic oesophagitis
Only for patients unsuccessfully treated with proton pump inhibitors.
SMC accepts meropenem/vaborbactam for restricted use within NHS Scotland
For adults with confirmed carbapenem-resistant Enterobacteriaceae.
SMC accepts two neurology treatments
Medicines indicated in multiple sclerosis and CLN2 disease within NHS Scotland.