POTELIGEO 4 MG — DIN 02527715
MOGAMULIZUMAB : 4 MG · KYOWA KIRIN, INC. · SOLUTION · wholesale supply in Canada
Health Canada status: MARKETED
What is POTELIGEO?
POTELIGEO 4 MG contains MOGAMULIZUMAB : 4 MG. It is listed in the Health Canada Drug Product Database under DIN 02527715, held by KYOWA KIRIN, INC., supplied as SOLUTION for INTRAVENOUS administration. Health Canada currently lists it as marketed, status dated 27-Mar-2024. 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 POTELIGEO used for?
POTELIGEO (mogamulizumab for injection) is indicated for the treatment of adult patients with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) after at least one prior systemic therapy.
Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.
How much does Mogamulizumab cost around the world?
Mogamulizumab is listed on 9 of the national price registers Nexara ingests. Each country publishes on a different basis, so figures are not comparable with one another — or with a Canadian wholesale price.
What a market publishes matters more than the number it publishes. Australia publishes a ex-manufacturer; Czechia publishes a max producer price (ex-factory); Greece publishes a producer price (ex-factory). Comparing an ex-factory ceiling against a pharmacy public price tells you nothing about either, and comparing either against a Canadian landed cost tells you less.
| Market | Price basis published there | Brands | Packs listed |
|---|---|---|---|
| Australia | ex-manufacturer | 1 | 4 |
| Czechia | max producer price (ex-factory) | 1 | 1 |
| Greece | producer price (ex-factory) | 1 | 1 |
| Iceland | max wholesale | 1 | 1 |
| Italy | ex-factory (classe H) | 1 | 1 |
| Norway | max AUP (pharmacy retail) | 1 | 1 |
| Romania | max producer price | 1 | 1 |
| Saudi Arabia | public | 1 | 1 |
| Slovakia | categorised final price | 1 | 1 |
12 pack listings across 9 brand entries and 9 price bases, refreshed 08 Sep 2026. Ranges span every Mogamulizumab pack in that market, so a high figure is usually a larger pack rather than the same product.
Canada publishes no comparable public list price. For a delivered Canadian price on a licensed account, verify your licence — it takes about a minute.
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 | 4 MG |
|---|---|
| Dosage form | SOLUTION |
| Route | INTRAVENOUS |
| Pack configuration (monograph) | 20 mg/5 mL single-use vial. Vials are individually packaged in a carton. |
| Storage | POTELIGEO vials must be stored in the original carton until the time of use under refrigerated conditions at 2°C to 8°C. Keep POTELIGEO vial in the original carton to protect from light until time of use. Do not freeze or shake POTELIGEO. Do not use POTELIGEO beyond the expiration date stamped on the carton/vial. POTELIGEO vials are single-use only. Discard any unused product. After opening, the medicinal product should be diluted and infused immediately. After preparation of infusion, if not infused immediately, in-use storage times and conditions prior to use must not be longer than a total of 24 hours at 2°C – 8°C provided that dilution has taken place under controlled and validated aseptic conditions. |
| Shipping class | Cold chain — validated shipper with temperature monitoring |
Before an order line is unambiguous Nexara needs the strength, the pack size and the presentation.
Cold chain. This product is stored refrigerated. Nexara ships it on a validated cold chain with temperature monitoring; a delivery address that cannot receive and store it at 2–8 °C on arrival must be flagged before the order is placed.
Substance and classification
| Active substance | Mogamulizumab |
|---|---|
| ATC code | L01FX09 |
| 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) | 02527715 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2527715 |
| Brand name | POTELIGEO |
| Generic / active ingredient | MOGAMULIZUMAB : 4 MG |
| Market authorization holder | KYOWA KIRIN, INC. |
| Health Canada schedule | Schedule D |
| ATC code | L01FX09 |
| ATC anatomical main group | L — Antineoplastic and immunomodulating agents |
| ATC therapeutic subgroup | L01FX |
| Current status | MARKETED |
| Status date | 27-Mar-2024 |
| Original market date | 2024-03-27 00:00:00 |
| Status source | Live Health Canada DPD sync |
Verify on the primary sources
How is it administered?
The recommended dose of POTELIGEO is 1 mg/kg administered as an intravenous infusion over at least 60 minutes. Administer on days 1, 8, 15, and 22 of the first 28-day cycle, then on days 1 and 15 of each subsequent 28-day cycle. Treatment should be continued until disease progression or unacceptable toxicity. Do not administer POTELIGEO subcutaneously or by rapid intravenous administration. Premedication with diphenhydramine and acetaminophen is recommended for the first POTELIGEO infusion and subsequent infusions, if an infusion reaction occurs. If a dose is missed, administer within 2 days of the scheduled dose, or as soon as possible and resume the dosing schedule. For infusion reactions, temporarily interrupt the infusion for mild to severe reactions and treat symptoms. Reduce the infusion rate by at least 50% when restarting. Permanently discontinue for life-threatening (Grade 4) infusion reactions. For dermatologic toxicity, permanently discontinue for life-threatening (Grade 4) rash or any Stevens Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN). For moderate or severe (Grades 2 or 3) rash, interrupt POTELIGEO and treat appropriately until rash improves to Grade 1 or less, then resume treatment.
Included because it drives pack selection and wastage. Consult the monograph.
Contraindications
POTELIGEO is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
Warnings and precautions
Fatal and life-threatening immune-mediated complications have been reported, including myositis, myocarditis, hepatitis, pneumonitis, and Guillain-Barré syndrome. Permanently discontinue POTELIGEO for life-threatening (Grade 4) infusion reactions or severe dermatologic toxicities like SJS or TEN. Interrupt for moderate to severe rash. Complications of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) including severe acute graft versus host disease (GVHD) and transplant-related death have been reported in patients who received allogeneic HSCT after POTELIGEO, especially if administered within 50 days prior to HSCT. Serious skin reactions, including SJS and TEN, have been reported, some fatal. Fatal and serious infections (pneumonia, cellulitis, sepsis) have been reported. Fatal and life-threatening infusion-related reactions (IRRs) have been reported. Patients should be cautioned not to drive or operate dangerous machinery if they experience fatigue.
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 L01FX
| Molecule | Canadian brands | DINs | Marketed | Sourceable |
|---|---|---|---|---|
| Polatuzumab Vedotin | POLIVY | 2 | 2 | Yes |
| Teclistamab | TECVAYLI | 2 | 2 | Yes |
| Belantamab Mafodotin | BLENREP | 2 | 2 | Yes |
| Glofitamab | COLUMVI | 2 | 2 | Yes |
| Talquetamab | TALVEY | 2 | 2 | Yes |
| Tarlatamab | IMDELLTRA | 2 | 2 | Yes |
| Elranatamab | ELREXFIO | 2 | 2 | Yes |
| Enfortumab Vedotin | PADCEV | 2 | 2 | Yes |
| Epcoritamab | EPKINLY | 2 | 2 | Yes |
| Blinatumomab | BLINCYTO | 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 L01F
| ATC subgroup | Molecules | DINs | Marketed |
|---|---|---|---|
| L01FD | Pertuzumab · Trastuzumab · Trastuzumab Deruxtecan · Trastuzumab Emtansine | 18 | 16 |
| L01FG | Bevacizumab · Ramucirumab | 14 | 14 |
| L01FF | Atezolizumab · Avelumab · Cemiplimab · Dostarlimab · Durvalumab · +3 more | 14 | 12 |
| L01FA | Obinutuzumab · Ofatumumab · Rituximab | 11 | 8 |
| L01FC | Daratumumab · Isatuximab | 5 | 5 |
| L01FY | Nivolumab And Relatlimab · Pertuzumab And Trastuzumab | 4 | 4 |
| L01FE | Cetuximab · Necitumumab · Panitumumab | 5 | 3 |
| L01FB | Inotuzumab Ozogamicin | 1 | 1 |
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 POTELIGEO called?
Also recorded in Canada as: 5 ML mogamulizumab-kpkc 4 MG/ML Injection [Poteligeo] (US), 5 ML mogamulizumab-kpkc 4 MG/ML Injection (US), MOGAMULIZUMAB-KPKC (US), MOGAMULIZUMAB (GLOBAL).
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.