UK Medicines Information
Nusinersen (Spinraza▼): reports of communicating hydrocephalus; discuss symptoms with patients and carers and investigate urgently
Information type:
Safety alerts
Source:
Medicines and Healthcare products Regulatory Agency
Specialities:
Musculo-skeletal disorders | Neurological disorders | Paediatric and neonatal medicine
Summary
Following 5 cases of communicating hydrocephalus, MHRA is advising urgent medical attention if any signs/symptoms develop during nusinersen therapy (include persistent vomiting or headache, decreased consciousness, or rapid increase in head size in children).
UKMi comment
Advice for healthcare professionals:
communicating hydrocephalus has been rarely reported during treatment with nusinersen; most cases developed after 2 to 4 loading doses
discuss the risk of communicating hydrocephalus and its clinical features with patients and their caregivers
advise them to seek urgent medical attention if any possible symptoms or signs develop including: persistent vomiting or headache, decreased consciousness, or a rapid increase in head size in children
consider communicating hydrocephalus in the differential diagnosis of any patient with suggestive symptoms and signs and investigate them urgently
refer patients with hydrocephalus to a neurosurgeon as soon as possible as they may require treatment with a CSF shunt
if a CSF shunt is considered necessary, prescribers should inform patients and their carers that the benefits and risks of continued nusinersen treatment in patients with CSF shunts are not known (see below)
report any suspected adverse drug reactions to nusinersen on a
Yellow Card
, including hydrocephalus or any problems after insertion of a CSF shunt
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