Vistogard (uridine triacetate)

Antidote for 5‑FU/capecitabine overdose · Oncology

FDA approved unverified Accessible via NPP

About Vistogard

Vistogard (uridine triacetate) is a unverified manufactured by Wellstat Therapeutics, used in the treatment of Antidote for 5‑FU/capecitabine overdose. It received FDA approval in unverified under the unverified pathway.

Note: Fatima list; ex-US detail unverified.

Accessing Vistogard through Reserve Meds

We help patients in the Middle East, India, Africa, and other regions access Vistogard via established Named Patient Program (NPP) and personal-import pathways. Every order requires a prescription from a licensed physician in the destination country.

What we need from you

  • A prescription from a licensed physician in your country of residence.
  • A clinical justification from the prescribing physician (why Vistogard for this patient).
  • Destination-country NPP or personal-import paperwork (we help prepare these).
  • Patient consent for cross-border drug import under the applicable pathway.

Typical timeline

From request to delivery, most orders for Vistogard are completed in 2-6 weeks. Timing varies by destination country regulatory review speed and physician documentation turnaround.

Indication context

Vistogard is indicated for Antidote for 5‑FU/capecitabine overdose. The condition falls within Oncology. For patients with this condition in countries where Vistogard is not yet registered, NPP access is typically the primary legal pathway for obtaining treatment.

About the manufacturer

Vistogard is manufactured by Wellstat Therapeutics. We source drug supply exclusively through DSCSA-compliant US specialty wholesalers, ensuring every unit is authentic, serialized, and chain-of-custody documented.

International regulatory status

  • United States: FDA approved (unverified).
  • EMA (EU): Status unknown.
  • MHRA (UK): Status unknown.
  • Other countries: Approval status varies. Reserve Meds coordinates access under each destination country's NPP pathway.

Start a request for Vistogard

If you or a family member needs Vistogard and it is not available in your country, submit a request. Our clinical team will review eligibility and respond within one business day.

Request Vistogard

Vistogard — country access pages

Information on how patients in different countries access Vistogard through Named Patient Program pathways.

  • Vistogard in United Arab Emirates — The UAE recognises a formal Named Patient / compassionate-use pathway via MOHAP and the Department of Health Abu Dhabi (DoH). Physicians apply on behalf of individual patients for drugs not registered in-country.
  • Vistogard in Saudi Arabia — The Saudi Food and Drug Authority (SFDA) operates a Personal Import / Unregistered Medicine pathway for named patients, typically requiring physician justification and hospital ethics-committee review.
  • Vistogard in India — India's CDSCO permits import of unapproved drugs under Rule 36 for personal use by patients with a prescription from a registered medical practitioner. Named Patient import is common for rare-disease indications.
  • Vistogard in Kuwait — Kuwait's Ministry of Health operates a Personal Import pathway for specialty drugs not registered locally, typically through a hospital pharmacy with physician attestation.
  • Vistogard in Qatar — Qatar's MoPH permits unregistered drug import under a named-patient pathway with physician and MoPH approval; Hamad Medical Corp frequently sponsors.
  • Vistogard in Bahrain — Bahrain's NHRA accepts named-patient import requests for rare-disease and specialty drugs not registered locally.

Safety, interactions, and handling

Drug interactions: Before dispatch, our clinical team reviews every patient's full medication list against published FDA drug-interaction data. If a significant interaction is identified, we notify the prescribing physician and hold shipment until an alternative dose or timing is confirmed.

Contraindications: This medication is not appropriate for every patient. Refer to the US FDA label for full contraindication list. Patients with active infection, pregnancy, known hypersensitivity, or specific organ-system comorbidities may be excluded. Prescribing-physician judgement applies.

Cold chain and storage: Biologics, monoclonals, and cell/gene therapies require validated cold-chain shipping (2-8°C) with continuous temperature monitoring. On arrival we document temperature logs; out-of-spec shipments are flagged and replaced.

Adverse event reporting: Any adverse event should be reported to both the local national regulator and to Reserve Meds's pharmacovigilance team at [email protected]. We forward serious events to the US manufacturer within 15 days per ICH E2D guidance.

Last medically reviewed: 2026-04-22 by AI Clinical Review Agent (see Trust & Compliance).

AI disclosure & medical review. Content on this page is reviewed by Reserve Meds's AI clinical and regulatory review agents. A US-licensed human pharmacist (dispensed by Altima Care, US-licensed specialty pharmacy) reviews every prescription before dispensing. Regulatory posture is AI-summarized and not legal advice; case-specific questions route to retained outside counsel. Last medically reviewed: .
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