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Brineura
cerliponase alfa
Black Box Warnings .
Hypersensitivity Reaction
life-threatening reactions including anaphylaxis have occurred; anaphylaxis has occurred during early tx and after extended tx duration; administer where appropriate medical support including cardiopulmonary resuscitation equip. available; D/C immediately and start appropriate tx if severe reaction occurs; counsel patients on signs/symptoms and to seek immediate medical attention if they occur at any time
Adult Dosing .
Adult dosing is currently unavailable or not applicable for this drug.
Peds Dosing .
- Dosage forms: INJ
neuronal ceroid lipofuscinosis type 2
- [<6 mo, postmenstrual age >37 wk, >2.5 kg]
- Dose: 100 mg intracerebroventricularly every other week; Start: 5-7 days after intraventricular access device implantation; Info: premed with antihistamines with or without antipyretics or corticosteroids 30-60 min prior to infusion; give intracerebroventricular electrolytes immediately after infusion
- [6-11 mo]
- Dose: 150 mg intracerebroventricularly every other week; Start: 5-7 days after intraventricular access device implantation; Info: premed with antihistamines with or without antipyretics or corticosteroids 30-60 min prior to infusion; give intracerebroventricular electrolytes immediately after infusion
- [12-23 mo]
- Dose: 300 mg intracerebroventricularly every other week; Start: 200 mg intracerebroventricularly every other week x4 doses, then 300 mg intracerebroventricularly every other week; 5-7 days after intraventricular access device implantation; Info: premed with antihistamines with or without antipyretics or corticosteroids 30-60 min prior to infusion; give intracerebroventricular electrolytes immediately after infusion
- [2 yo and older]
- Dose: 300 mg intracerebroventricularly every other week; Start: 5-7 days after intraventricular access device implantation; Info: premed with antihistamines with or without antipyretics or corticosteroids 30-60 min prior to infusion; give intracerebroventricular electrolytes immediately after infusion
renal dosing
- [not defined]
- renal impairment: not defined
- HD/PD: not defined
hepatic dosing
- [not defined]