January 2023

New Products

• Opicapone (Ongentys) is a peripheral, selective and reversible catechol‑O‑methyltransferase (COMT) inhibitor endowed with a high binding affinity (sub‑picomolar) that translates into a slow complex dissociation rate constant and a long duration of action (>24 hours) in vivo. In the presence of a DOPA decarboxylase inhibitor (DDCI), COMT becomes the major metabolising enzyme for levodopa, catalysing its conversion to 3‑O‑methyldopa (3‑OMD) in the brain and periphery. In patients taking levodopa and a peripheral DDCI, such as carbidopa or benserazide, opicapone increases levodopa plasma levels thereby improving the clinical response to levodopa. Ongentys is indicated as adjunctive therapy to preparations of levodopa/ DDCIs in adult patients with Parkinson’s disease and end‑of‑dose motor fluctuations who cannot be stabilised on those combinations. Ongentys is contraindicated in phaeochromocytoma, paraganglioma, or other catecholamine secreting neoplasms; history of neuroleptic malignant syndrome and/or non‑traumatic rhabdomyolysis; and concomitant use with monoamine oxidase (MAO‑A and MAO‑B) inhibitors (e.g. phenelzine, tranylcypromine and moclobemide) other than those for the treatment of Parkinson’s disease. Ongentys capsules contain opicapone 50 mg and are available in packs of 30.

New Indications

• Durvalumab (Imfinzi) now has provisional approval, in combination with pemetrexed and either cisplatin or carboplatin, for the first‑line treatment of patients with unresectable malignant pleural mesothelioma with epithelioid histology.
   
• Migalastat (hydrochloride) (Galafold) is now indicated for long‑term treatment of adult and adolescent patients 12 years and older with a confirmed diagnosis of Fabry disease (α‑galactosidase A deficiency) and who have an amenable mutation.
   
• Pembrolizumab (Keytruda) is now indicated for the adjuvant treatment of adult and adolescent (12 years and older) patients with Stage IIB, IIC, or III melanoma who have undergone complete resection.
   
• Zanubrutinib (Brukinsa) now has provisional approval for the treatment of adult patients with marginal zone lymphoma who have received at least one prior anti‑CD20‑based therapy.

New Contraindications

• Captopril (Capoten) is now contraindicated with concomitant use of aliskiren‑containing products in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m²); and with concomitant sacubitril/valsartan therapy (captopril must not be initiated earlier than 36 hours after the last dose of sacubitril/valsartan).
   
• Ropinirole (hydrochloride) (Repreve) is now contraindicated in severe renal impairment (creatinine clearance < 30 mL/min) without regular haemodialysis; and severe hepatic impairment.

Safety Related Changes

• Meningococcal oligosaccharide conjugate a, c, y and w‑135 vaccine (Menveo) is no longer available in any presentations containing dry natural rubber, so it is no longer contraindicated in known hypersensitivity to latex.

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.