Tretten: how international patients access US-sourced specialty supply
Tretten (catridecacog (recombinant Factor XIII A-subunit)) 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 Tretten
Tell us the medicine and your country. We reply within one business day. On WhatsApp we usually reply the same day.
Quick orientation
Tretten (catridecacog (recombinant Factor XIII A-subunit)) is sponsored by Novo Nordisk and received first US FDA approval in 2013. It is delivered as intravenous infusion, monthly prophylaxis. The US label covers routine prophylaxis of bleeding in patients with congenital Factor XIII A-subunit deficiency. Mechanistically, Tretten replaces the missing recombinant A-subunit of Factor XIII, the clotting factor that cross-links fibrin to stabilize clots.
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Medicine price: quote on request. You get a written quote for your case before you commit.
Mechanism of action
Tretten replaces the missing recombinant A-subunit of Factor XIII, the clotting factor that cross-links fibrin to stabilize clots. Without Factor XIII, clots form but do not hold, producing severe bleeding from minor injuries or spontaneously. Monthly IV dosing maintains plasma activity above the protective threshold.
Why Tretten routes via cross-border NPP internationally
Congenital Factor XIII A-subunit deficiency is extraordinarily rare (estimated 1 in 1 to 3 million globally). Most MENA and South Asian hemophilia treatment centers carry pooled-plasma Factor XIII concentrate (Corifact) where they carry anything at all; the recombinant A-subunit product (Tretten) is rarely on a local formulary. Patients who require recombinant therapy specifically (immune-system considerations, plasma-derived avoidance, supply continuity) route via named-patient import.
The patterns that produce cross-border demand for Tretten 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 Tretten 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
Tretten 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
Medicine price: quote on request. You get a written quote for your case before you commit. Cold-chain logistics, IOR, customs, and translation costs apply on top. Reserve Meds quotes firm pricing post-hemophilia-center document review.
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
Tretten is manufactured by Novo Nordisk. 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 Tretten 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 Tretten, the treating physician provides a treating-hematologist prescription from a recognized hemophilia treatment center, a clinical justification letter documenting confirmed congenital Factor XIII A-subunit deficiency and bleeding history, Factor XIII activity assay results, an infusion plan, and license verification accepted by the destination regulator. 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
Is Tretten interchangeable with Corifact?
No. Tretten is recombinant A-subunit only and is labeled for congenital A-subunit deficiency. Corifact is plasma-derived and covers a broader Factor XIII deficiency population.
How often is Tretten given?
Monthly IV prophylaxis is the standard regimen.
Does Tretten require cold chain?
Yes. It is refrigerated until reconstitution at the infusion center.
Is this product appropriate for B-subunit deficiency?
No. B-subunit deficiency is not covered by the Tretten label. Plasma-derived Factor XIII concentrate is the appropriate product in that population.
Are antibody monitoring labs required?
Yes. Inhibitor (anti-A-subunit antibody) surveillance is part of standard monitoring.
Indicative timing
Time-to-first-dose for Tretten 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 Tretten 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 Tretten, 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 Tretten if it is not approved or available in my country?
Reserve Meds coordinates US-sourced Tretten 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 Tretten 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 Tretten. 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 Tretten 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 Tretten to a patient?
Medicines are supplied through a US-licensed pharmaceutical wholesale partner, and Reserve Meds coordinates delivery of Tretten to your treating physician or hospital pharmacy, with appropriate handling for the product.
How long does it take, and what does Tretten 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 Tretten?
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.