Corifact: how international patients access US-sourced specialty supply
Corifact (Factor XIII concentrate (plasma-derived, human)) is coordinated by Reserve Meds for international patients through US-sourced, named-patient cross-border supply, working with your treating doctor.
This page is informational, not medical advice. Always work with a licensed treating physician on prescribing decisions. Reserve Meds does not make insurance or pharmacy-assistance-program promises.
Ask about Corifact
Tell us the medicine and your country. We reply within one business day. On WhatsApp we usually reply the same day.
Quick orientation
Corifact (Factor XIII concentrate (plasma-derived, human)) is sponsored by CSL Behring and received first US FDA approval in 2011. It is delivered as intravenous infusion, monthly prophylaxis. The US label covers routine prophylactic treatment of congenital Factor XIII deficiency and peri-operative management of surgical bleeding in adults and pediatric patients with congenital Factor XIII deficiency. Mechanistically, Corifact is a pasteurized concentrate of human Factor XIII purified from pooled plasma.
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Annual medicine cost depends on weight and dosing cadence. Medicine price: quote on request. You get a written custom quote for your case before you commit.
Mechanism of action
Corifact is a pasteurized concentrate of human Factor XIII purified from pooled plasma. It restores plasma Factor XIII activity in patients with congenital deficiency, allowing fibrin clots to be properly cross-linked and stable. Because it contains both A and B subunits, it covers the broader congenital Factor XIII deficiency population beyond isolated A-subunit deficiency.
Why Corifact routes via cross-border NPP internationally
Congenital Factor XIII deficiency is extremely rare and most regional hemophilia treatment centers across MENA and South Asia carry limited supply of dedicated Factor XIII concentrate. Off-label cryoprecipitate or fresh-frozen plasma is sometimes used regionally as a substitute, with meaningful clinical drawbacks. Patients who require dedicated Factor XIII concentrate for prophylaxis or peri-operative cover typically route via named-patient import.
The patterns that produce cross-border demand for Corifact are consistent across destination countries: meaningful registration lag relative to the US label, indication-specific dosing complexity that makes substitution clinically risky, payer denial patterns that exclude newer or expanded indications, and the global specialty distribution model in which the originator manufacturer routes specialty supply through a small number of authorized US wholesalers. Reserve Meds sits inside that authorized supply lane, not outside it.
How Reserve Meds coordinates supply
Every Corifact case follows the same doctor-directed, document-first workflow:
- The treating physician issues a prescription and clinical justification letter.
- Reserve Meds clinical and regulatory review assesses indication fit and destination-country pathway eligibility.
- Country-specific named-patient or personal-import documentation is prepared, translated where required, and submitted to the destination-country regulator under the local lawful import framework.
- Supply is sourced from a US-licensed pharmaceutical wholesale partner with full serial traceability (a federal track-and-trace requirement) and unbroken chain of custody from US warehouse forward.
- Cold-chain handling is validated where applicable; temperature is monitored end-to-end with audit logs.
- Shipment is coordinated to the patient's treating physician or hospital pharmacy, not directly to consumers.
Reserve Meds does not handle controlled substances. We do not promise pharmacy assistance program enrollment, manufacturer copay support, or insurance reimbursement; those are different commercial frameworks aimed at US-domiciled patients.
Common cross-border destinations
Corifact cross-border demand concentrates in markets where US specialty supply is the most reliable path to the labeled indication. We publish destination-country deep-dives for selected countries; every other destination is coordinated case by case on the same workflow, with your treating doctor.
Across each of these destinations, three structural patterns repeat. First, the local regulator maintains a named-patient or personal-import framework precisely so clinicians can reach a labeled US therapy for individual patients whose case cannot wait for full local registration. Second, that framework is document-driven, which means the work of cross-border access is the work of preparing a defensible clinical and regulatory dossier rather than chasing inventory. Third, the destination-country specialist (the treating physician) signs the case in; Reserve Meds operates on top of that signature, not in place of it.
Real cost picture
Annual medicine cost depends on body weight and dosing cadence. Medicine price: quote on request. Cold-chain logistics, customs, IOR, and translation costs apply. Reserve Meds quotes firm pricing after the hemophilia-center dossier and labs plan are reviewed.
A formal Reserve Meds quote breaks out: drug cost; cold-chain 3PL handling where applicable; IOR, customs, and destination-country regulatory fees; certified translation of physician documentation; and the Reserve Meds coordination fee, quoted in writing for your case before you commit. No hidden charges. A written custom quote is issued after physician documentation is reviewed, before you commit.
Reserve Meds does not charge intake deposits. Patients pay the firm-quoted amount in full only after accepting the quote, with a defined refund posture for procurement failure or gross negligence as set out in the engagement documentation. Delivery or transit-failure outcomes are handled via insurance and replacement coordination rather than refund, because once a US procurement chain is committed, the drug is committed.
Manufacturer context and global distribution
Corifact is manufactured by CSL Behring. Like most US specialty therapies, it is routed through a narrow set of authorized specialty wholesalers under DSCSA (Drug Supply Chain Security Act) track-and-trace rules. That is the same supply lane US specialty pharmacies use; cross-border named-patient access works by attaching destination-country regulatory documentation to a shipment that originates inside that authorized lane, not by sourcing outside it. Counterfeit and parallel-trade exposure is concentrated outside that lane, which is precisely why Reserve Meds will not source from secondary or grey-market channels regardless of price.
Serial-number traceability is preserved end-to-end. Every Corifact pack or vial carries the US wholesaler's lot and serial-number documentation forward into the destination-country regulatory submission, which is what allows the destination regulator to verify provenance on inspection.
What your physician provides
For Reserve Meds to coordinate Corifact, the treating physician provides a treating-hematologist prescription, a clinical justification letter documenting confirmed congenital Factor XIII deficiency and bleeding history, Factor XIII activity assay results, an infusion plan, and license verification. Reserve Meds does not substitute for treating-physician judgment, does not prescribe, and does not advise on individual patient suitability; that is the treating physician's role.
Common questions
How is Corifact different from Tretten?
Corifact is plasma-derived and covers the broader Factor XIII deficiency population (A- or B-subunit). Tretten is recombinant A-subunit only.
Is there a pathogen-safety concern with plasma-derived product?
Corifact undergoes pasteurization and pathogen-reduction steps; the regulatory safety profile is well-characterized. Inhibitor and viral-serology surveillance is part of monitoring.
Does Corifact require cold chain?
Yes. Refrigerated storage is required until reconstitution.
How often is Corifact given?
Monthly IV prophylaxis is the standard regimen; peri-operative dosing is calculated separately.
Is FFP or cryoprecipitate a real substitute?
They can provide some Factor XIII activity but are not equivalent on dose precision or pathogen-safety profile and are not a long-term prophylaxis solution.
Indicative timing
Time-to-first-dose for Corifact is dominated by destination-country regulatory turnaround on the named-patient or personal-import submission, not by US procurement (which is typically days, not weeks, for an authorized specialty wholesaler with serialized stock). In every market, a dossier that is complete on first submission avoids the most common delays. We give you a written timeline estimate for your case before you commit. Reserve Meds frames every Corifact timeline as an indicative range with a defined gating event (regulator acknowledgement), not as a guaranteed delivery date.
Subsequent cycles are materially faster than the first cycle because the regulatory file, physician credentials, and import authorization are already on record. For chronic-use therapies like Corifact, the first cycle carries the regulatory overhead; the rest is logistics.
Where Reserve Meds fits in
Reserve Meds is the named cross-border coordinator. A dedicated patient coordinator owns the case from intake through delivery, the clinical and regulatory teams handle the document chain, and a DSCSA-compliant specialty wholesaler is the source of every vial or pack. We work in service of the treating-physician relationship, not around it.
Patients deal with one case coordinator from intake through delivery. Physicians deal with a clinical-and-regulatory contact who speaks the language of the destination regulator and of US specialty pharmacy. That single-point-of-contact structure is deliberate: cross-border specialty access fails most often at the seams between parties, not inside any single step, and Reserve Meds is built to own the seams.
Next step
Send us the medicine and your country. We reply within one business day with case-specific feasibility, a country pathway, an indicative timeline, and a formal quote.
For broader disease context, see our Factor XIII Deficiency overview.
Clinical trials and expanded access
On 17 October 2026 we searched ClinicalTrials.gov, the clinical study registry of the US National Library of Medicine, for studies that list factor XIII as an intervention. The search found studies that are recruiting or not yet recruiting. See the current list on ClinicalTrials.gov.
Whether a patient can join a trial or an expanded access program is decided by the study team or the manufacturer, together with the treating doctor. Reserve Meds does not run trials or supply investigational medicines. We can help you and your doctor read a listing and understand the route.
Frequently asked questions
How can I get Corifact if it is not approved or available in my country?
Reserve Meds coordinates US-sourced Corifact for patients through a legal named-patient pathway, working with your treating doctor. 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 Corifact through a named-patient import?
Often, yes. Named-patient access (sometimes called personal import) is the legal route we use for FDA-approved medicines such as Corifact. It is different from compassionate use, which covers investigational medicines through the manufacturer's own program; we do not supply investigational medicines. 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 Corifact 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 Corifact to a patient?
Medicines are supplied through a US-licensed pharmaceutical wholesale partner, and Reserve Meds coordinates delivery of Corifact to your treating physician or hospital pharmacy, with appropriate handling for the product.
How long does it take, and what does Corifact 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 Corifact?
Submit a 60-second intake through the Reserve Meds patient portal, or message our team on WhatsApp. We reply within one business day. On WhatsApp we usually reply the same day.