September 2015September 2015
Safety Related Changes
Hydopa (methyldopa) is now also contraindicated with a catecholamine secreting tumour such as phaeochromocytoma or paraganglioma and with porphyria.
Kineret (anakinra) treatment is now also contraindicated and must not be initiated in patients with neutropenia (ANC < 1.5 x 109/L).
Kineret is now also indicated in adult and paediatric patients aged 8 months and older with a bodyweight of 10 kg or above for the treatment of cryopyrin associated periodic syndromes including neonatal onset multisystem inflammatory disease/ chronic infantile neurological, cutaneous, articular syndrome, Muckle‑Wells syndrome, and familial cold autoinflammatory syndrome.
Somatuline Autogel (lanreotide acetate) is now also indicated in the treatment of gastroenteropancreatic neuroendocrine tumours (GEP‑NETs) in adults with unresectable locally advanced or metastatic disease.
Stribild (tenofovir disoproxil fumarate, emtricitabine, elvitegravir, cobicistat) is now also contraindicated with the anticonvulsants carbamazepine, phenobarbitone and phenytoin.
Stribild is now also indicated in certain virologically suppressed (HIV1 RNA < 50 copies/mL) adults on a stable antiretroviral regimen at start of therapy in order to replace their current antiretroviral treatment regimen. Patients must not have a history of treatment failure or known mutations associated with resistance to the antiretroviral components of Stribild.
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