ISTODAX 10 MG — DIN 02414295
ROMIDEPSIN : 10 MG · BRISTOL-MYERS SQUIBB CANADA · KIT ; POWDER FOR SOLUTION · wholesale supply in Canada
Health Canada status: MARKETED
What is ISTODAX?
ISTODAX 10 MG contains ROMIDEPSIN : 10 MG. It is listed in the Health Canada Drug Product Database under DIN 02414295, held by BRISTOL-MYERS SQUIBB CANADA, supplied as KIT ; POWDER FOR SOLUTION for INTRAVENOUS administration. Health Canada currently lists it as marketed, status dated 04-Nov-2025. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.
What is ISTODAX used for?
Treatment of relapsed/refractory peripheral T-cell lymphoma (PTCL) in patients not eligible for transplant who have received at least one prior systemic therapy. (Authorized with conditions).
Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.
How is it supplied and stored?
Pack configuration, storage class and the handling constraints that drive cold-chain planning. One DIN can cover more than one pack size, and the pack — not the DIN — is what gets priced, shipped and invoiced.
| Strength on the label | 10 MG |
|---|---|
| Dosage form | KIT ; POWDER FOR SOLUTION |
| Route | INTRAVENOUS |
| Pack configuration (monograph) | Kit containing two vials: one 10 mg single-use vial of romidepsin and one vial of diluent (2.4 mL). |
| Storage | Reconstituted solution stable for 8 hours at room temperature; diluted solution stable for 24 hours at room temperature. |
Before an order line is unambiguous Nexara needs the strength, the pack size and the presentation.
Substance and classification
| Active substance | Romidepsin |
|---|---|
| ATC code | L01XH02 |
| AHFS class | 10:00.00 |
| Biosimilar biologic | No |
Health Canada record and identifiers
The regulatory facts straight from the Drug Product Database, plus every identifier form Nexara accepts on a purchase order. A DIN written without its leading zeros is the commonest reason an order line fails to match.
| DIN (8-digit, as used in ordering) | 02414295 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2414295 |
| Brand name | ISTODAX |
| Generic / active ingredient | ROMIDEPSIN : 10 MG |
| Market authorization holder | BRISTOL-MYERS SQUIBB CANADA |
| Health Canada schedule | Prescription |
| ATC code | L01XH02 |
| ATC anatomical main group | L — Antineoplastic and immunomodulating agents |
| ATC therapeutic subgroup | L01XH |
| Current status | MARKETED |
| Status date | 04-Nov-2025 |
| Original market date | 2014-02-05 00:00:00 |
| Status source | Live Health Canada DPD sync |
Verify on the primary sources
How is it administered?
14 mg/m2 IV over 4 hours on days 1, 8, and 15 of a 28-day cycle. Premedication with antiemetics is recommended. Potassium and magnesium must be in normal range before administration.
Included because it drives pack selection and wastage. Consult the monograph.
Contraindications
Hypersensitivity to romidepsin or to any ingredient in the formulation.
Warnings and precautions
Pancytopenia, QT interval prolongation, fatal infections, tumor lysis syndrome, potential fetal harm, and hepatic impairment. Available only through Restricted Access Program.
What can be used instead?
Alternatives on every axis a buyer actually considers — the same molecule in another presentation, the same class, an adjacent class, or a fixed-dose combination. Every row is led by the marketed DIN count, because that is what can be bought this week.
2 · Same class — other molecules in ATC L01XH
| Molecule | Canadian brands | DINs | Marketed | Sourceable |
|---|---|---|---|---|
| Romidepsin | ISTODAX | 1 | 1 | Yes |
| Vorinostat | ZOLINZA | 1 | 1 | Yes |
A molecule with zero marketed DINs cannot be sourced domestically, however many approvals it holds — if one of these sits on a formulary or in an older protocol, that is the line to check.
3 · Adjacent classes in ATC L01X
| ATC subgroup | Molecules | DINs | Marketed |
|---|---|---|---|
| L01XX | Aflibercept · Altretamine · Amsacrine · Anagrelide · Arsenic Trioxide · +13 more | 48 | 23 |
| L01XG | Bortezomib · Carfilzomib · Ixazomib | 30 | 18 |
| L01XA | Carboplatin · Cisplatin · Oxaliplatin | 45 | 12 |
| L01XK | Niraparib · Niraparib And Abiraterone · Olaparib · Talazoparib | 12 | 7 |
| L01XL | Axicabtagene Ciloleucel · Brexucabtagene Autoleucel · Ciltacabtagene Autoleucel · Idecabtagene Vicleucel · Lifileucel · +2 more | 8 | 5 |
| L01XJ | Glasdegib · Sonidegib · Vismodegib | 4 | 4 |
| L01XD | Aminolevulinic Acid · Methyl Aminolevulinate · Porfimer Sodium | 5 | 3 |
| L01XF | Tretinoin | 2 | 2 |
Not clinical advice. These tables describe what can be supplied in Canada, not what should be prescribed. Substitution within or across classes is a prescriber and pharmacist decision, and interchangeability is determined provincially.
What else is ISTODAX called?
The same molecule, Romidepsin, is registered under other names elsewhere. Buyers and prescribers searching from outside Canada — or working from a foreign prescription or tender document — often know it by one of these:
| Name | Script | Registered in |
|---|---|---|
| ROMIDEPSIN-REACH | Latin | Australia |
Names are taken from national medicine registers and published price lists. A product registered abroad is not authorized for sale in Canada unless it holds its own DIN; import is possible only through the routes Health Canada permits.
How can I get it?
Nexara Health supplies this product to licensed Canadian buyers — pharmacies, hospitals, clinics, licensed distributors, and clinical trial sponsors or their CROs. We confirm stock, pack size, expiry and pricing at the time of quotation. If the product is on backorder or in shortage, we identify equivalent alternatives and import options where permitted.
Ordering questions
Who can buy this from Nexara?
Licensed entities only. Nexara holds Health Canada establishment licence DEL 3-002896-A and ships only to a licensed address. Patients and unlicensed buyers are routed to a partner pharmacy.
Is there a minimum order?
Yes, set per product line and per pack multiple rather than on the order total, so you are never asked to buy a part-pack. The minimum for this line is confirmed with your quote.
What is the lead time?
Confirmed per order at quotation, and it depends on current stock position and whether the product is in shortage.
Why is there no price on this page?
Nexara quotes a delivered Canadian price per order, against a verified licence. Foreign list prices are published on incompatible bases and are not a guide to what any buyer can obtain here, so this page shows which markets list the molecule and on what basis, and nothing more.
Can Nexara supply this for a clinical trial?
Yes — comparator and background-therapy supply, including sourcing from other markets where a Canadian pack will not satisfy the protocol. Clinical trial supply.