Minimum Product Information
BRINEURA cerliponase alfa (rch)
Indications: neuronal ceroid lipofuscinosis type 2 (CLN2) disease, also known as tripeptidyl peptidase 1 (TPP1) deficiency.
Contraindications: life-threatening anaphylactic reaction to active substance or any excipients, if re-challenge unsuccessful; CLN2 patients with ventriculo-peritoneal shunts, signs of acute intracerebroventricular (ICV) access device leakage, device failure, or device-related infection.
Precautions: device-related complications; clinical and laboratory monitoring; anaphylactic reactions; paediatric use in patients < 2 years.
Adverse Effects: bradycardia, gastrointestinal disorders (e.g. vomiting, constipation, diarrhoea, dysphagia, abdominal pain), pyrexia, gait disturbance, feeling jittery, pain, hypersensitivity, infections and infestations (e.g. upper respiratory tract infection, nasopharyngitis, rhinitis, viral infection, gastroenteritis, pharyngitis, viral upper respiratory tract infection, tonsillitis, conjunctivitis, device related infection), fall, nervous system disorders (e.g. seizure, epilepsy, generalised tonic-clonic seizure, myoclonus, tremor, petit mal epilepsy, dystonia, extensor plantar response, headache, CSF pleocytosis, dropped head syndrome), needle issue, device leakage, occlusion or dislocation, insomnia, irritability, cough, rash, urticaria.
Dosage and Administration: treatment given only by trained healthcare professional knowledgeable in ICV administration in a healthcare setting. Recommended dose is 300 mg once every other week by ICV infusion. Lower doses recommended in patients < 2 years. Pre-treatment with antihistamines with or without antipyretics recommended.
Before prescribing, please review Product Information available from BioMarin Pharmaceutical Australia Pty Ltd, 1800 387 876.
PBS Information: This product is not listed on the PBS. Brineura is indicated for the treatment of Late-Infantile Onset Batten disease (CLN2) and is listed on the Life Saving Drugs Program.
Date of preparation: 30 October 2019. Based on approved Product Information 18 October 2019.