Brineura
Named-patient access overview. Brineura is coordinated by Reserve Meds for international patients via physician-led cross-border sourcing.
Quick orientation
Brineura (cerliponase alfa) is a recombinant human tripeptidyl peptidase-1 enzyme replacement therapy developed by BioMarin. It is approved by the US FDA for late infantile neuronal ceroid lipofuscinosis type 2 (CLN2 disease, TPP1 deficiency) in patients 3 years and older to slow loss of ambulation. The standard regimen is 300 mg every 14 days via implanted intracerebroventricular reservoir over approximately 4.5 hours. Brineura is available in the global pharmaceutical supply chain in 300 mg per 10 mL vial for intracerebroventricular infusion.
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How Reserve Meds coordinates Brineura
- Patient or treating physician submits an intake at the patient portal.
- Reserve Meds clinical team verifies appropriateness for the patient and destination country.
- Treating physician issues prescription and clinical justification.
- Country-specific named-patient documentation is prepared.
- Brineura is sourced from a DSCSA-compliant US specialty wholesaler with full serial traceability.
- Shipment is coordinated to the patient's physician or hospital pharmacy with appropriate handling.
Access by country
Reserve Meds publishes a detailed country deep-dive for Brineura in every market we coordinate. Each page below covers the destination-country regulatory pathway, real costs, indicative timelines, physician-credential requirements, and handling notes. Tap any country to read the full deep-dive.
Start a request for Brineura
Submit a 60-second intake. The clinical team will follow up within 24 hours with case-specific feasibility, timeline, and a formal quote.
Frequently asked questions
How can I get Brineura if it is not approved or available in my country?
Reserve Meds coordinates US-sourced Brineura for patients through a physician-led, named-patient cross-border pathway. Your treating physician provides the prescription and clinical justification; Reserve Meds prepares the named-patient documentation for your country and arranges DSCSA-compliant US sourcing and delivery to your physician or hospital pharmacy.
Can I access Brineura through named-patient or compassionate-use import?
Yes. Named-patient access (also called compassionate use or personal import) is the core route Reserve Meds operates for Brineura. Eligibility and paperwork depend on the regulator in your country, and Reserve Meds maps the specific pathway for each market it coordinates.
Do I need a prescription to access Brineura through Reserve Meds?
Yes. Reserve Meds is not a pharmacy and does not prescribe. A valid prescription and clinical justification from your treating physician are required, and all clinical decisions remain with your physician.
How does Reserve Meds deliver Brineura to a patient?
Reserve Meds sources Brineura from a DSCSA-compliant US specialty supplier with full traceability and coordinates delivery to your treating physician or hospital pharmacy, with appropriate handling for the product.
How long does it take, and what does Brineura cost through Reserve Meds?
After a short intake, the clinical team responds within one business day with case-specific feasibility, an indicative timeline, and a formal written quote. Cost depends on the destination, the prescribed regimen, and the duration of therapy, and is confirmed in writing before anything proceeds.
How do I start a request for Brineura?
Submit a 60-second intake through the Reserve Meds patient portal, or message the concierge team on WhatsApp. A named coordinator follows up within 24 hours.