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Aflibercept/propranolol Lack of efficacy and acute ischaemic cerebrovascular stroke secondary to off-label use: case report

A 42-week-old (post menopausal age) male infant exhibited lack of efficacy of propranolol, indicated for hypertension. Additionally, at an approximate post menopausal age of 51 weeks, he developed acute ischaemic cerebrovascular stroke, during an off-label treatment with aflibercept for aggressive posterior retinopathy of prematurity (ROP) [not all routes and dosages stated; outcome not stated]. The preterm male infant with a gestational age of 34 weeks (36 weeks postmenstrual age (PMA)) was admitted to the neonatal ICU with respiratory distress syndrome, and treated with intratracheal surfactant. For neonatal jaundice, he received phototherapy and responded well. He additionally developed hypertension. Therefore, he started receiving propranolol. Later, at the PMA of 41 weeks, he presented with ROP for the first time. He showed ROP in zone 1–2. At 42 weeks PMA, he was admitted with uncontrolled hypertension, despite receiving treatment with propranolol. Cardiac workup was normal. In 43 weeks PMA, he was admitted for nephrology workup. CT angiography and Colour Doppler sonography confirmed renal artery stenosis. The male infant was treated with amlodipine. In 48 weeks PMA, he suffered from an episode of tonic-clonic seizure. An electroencephalography showed no abnormalities. He was then treated with phenobarbital and phenytoin. He was discharged with controlled BP (in the setting of treatment with amlodipine and enalapril). One day after discharge, he visited hospital (at his 50 weeks PMA), and received off-label treatment with bilateral intravitreal aflibercept 1 mg/0.025mL [Eylea; Regeneron] injection for aggressive posterior ROP, under unspecified topical anaesthesia. Additionally, he received topical chloramphenicol, in order to prevent infection. One week following the administration of aflibercept, he presented to the emergency department with hypertension crisis and a decrease in left upper and lower extremities’ motion and agitation. Subsequently, he was admitted. Based on neurologic examination, CT scan and MRI, acute ischaemic cerebrovascular stroke at the occipital lobe, parietal lobe, and splenium of the corpus callosum at territories of posterior cerebral and middle cerebral artery was confirmed. His systemic workup for antiphospholipid and anticardiolipin antibodies were normal. He was discharged with phenytoin, aspirin, phenobarbital, enalapril and amlodipine. Due to uncontrolled hypertension and suspicion for vascular anomaly, thoracic and abdominal CTangiography, cervical color Doppler sonography and transoesophageal echocardiography were performed. However, no apparent vascular involvement except for the right renal artery stenosis was observed. Serial nephrology and cardiac workups, till 75 weeks PMA showed no further abnormality. His BP was controlled with amlodipine and enalapril. Fundoscopies performed after intravitreal aflibercept injection showed a complete stop