Revuforj (revumenib)
R/R KMT2A-rearranged acute leukemia (adult+ped >=1 yr) ยท Oncology (Leukemia)
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About Revuforj
Revuforj (revumenib) is a specialty medicine manufactured by Syndax, used in the treatment of R/R KMT2A-rearranged acute leukemia (adult+ped >=1 yr). It received FDA approval in 2024 under the FDA approved pathway.
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Accessing Revuforj through Reserve Meds
We help patients in the Middle East, India, Pakistan, Africa, and other regions access Revuforj 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 Revuforj 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
We give you a written timeline estimate for your case before you commit. Timing varies by destination country regulatory review speed and physician documentation turnaround.
Indication context
Revuforj is indicated for R/R KMT2A-rearranged acute leukemia (adult+ped >=1 yr). The condition falls within Oncology (Leukemia). For patients with this condition in countries where Revuforj is not yet registered, NPP access is typically the primary legal pathway for obtaining treatment.
About the manufacturer
Revuforj is manufactured by Syndax. We source drug supply exclusively through a US-licensed pharmaceutical wholesale partner, ensuring every unit is authentic, serialized, and chain-of-custody documented.
International regulatory status
- United States: FDA approved (2024).
- EMA (EU): Not approved.
- MHRA (UK): Not approved.
- Other countries: Approval status varies. Reserve Meds coordinates access under each destination country's NPP pathway.
Start a request for Revuforj
If you or a family member needs Revuforj and it is not available in your country, submit a request. Our clinical team will review eligibility and reach out within one business day.
Revuforj, country access pages
Information on how patients in different countries access Revuforj through Named Patient Program pathways.
- Revuforj 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.
- Revuforj 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.
- Revuforj 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.
- Revuforj 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.
- Revuforj in Qatar, Qatar's MoPH permits unregistered drug import under a named-patient pathway with physician and MoPH approval; Hamad Medical Corp frequently sponsors.
- Revuforj 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 pv@reservemeds.com. We forward serious events to the US manufacturer within 15 days per ICH E2D guidance.
Last medically reviewed: 2026-04-22 (see Trust & Compliance).
Access by country
Reserve Meds publishes a detailed country deep-dive for Revuforj in every market we coordinate. Each page below covers the destination-country regulatory pathway (named-patient framework), how quotes work, indicative timelines, physician-credential requirements, and cold-chain handling for the route into that country. Tap any country to read the full deep-dive.