INLYTA 5 MG — DIN 02389649
AXITINIB : 5 MG · PFIZER CANADA ULC · TABLET · wholesale supply in Canada
Health Canada status: MARKETED
What is INLYTA?
INLYTA 5 MG contains AXITINIB : 5 MG. It is listed in the Health Canada Drug Product Database under DIN 02389649, held by PFIZER CANADA ULC, supplied as TABLET for ORAL administration. Health Canada currently lists it as marketed, status dated 17-Aug-2012. 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 INLYTA used for?
INLYTA (axitinib) is indicated for the treatment of patients with metastatic renal cell carcinoma (RCC) of clear cell histology after failure of prior systemic therapy with either a cytokine or the VEGFR-TKI, sunitinib. INLYTA, in combination with pembrolizumab, is indicated for the treatment of adult patients with advanced or metastatic renal cell carcinoma (RCC) with no prior systemic therapy for metastatic RCC.
Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.
How much does Axitinib cost around the world?
Axitinib is listed on 15 of the national price registers Nexara ingests. Each country publishes on a different basis, so those 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; Austria publishes a KVP (Kassenverkaufspreis); Bahrain publishes a retail (max). 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 | Range |
|---|---|---|---|---|
| Sweden | AIP (pharmacy purchase price) | 6 | 28 | SEK███.██ |
| Greece | producer price (ex-factory) | 16 | 16 | EUR███.██ |
| Italy | ex-factory (classe H) | 9 | 16 | EUR███.██ |
| Austria | KVP (Kassenverkaufspreis) | 8 | 8 | EUR███.██ |
| Luxembourg | reimbursement | 7 | 7 | EUR███.██ |
| Hungary | producer price (ex-factory) | 6 | 6 | HUF███.██ |
| Romania | max producer price | 5 | 6 | RON███.██ |
| Australia | ex-manufacturer | 1 | 4 | AUD███.██ |
| Czechia | max producer price (ex-factory) | 2 | 4 | CZK███.██ |
| United Kingdom | hospital | 4 | 4 | GBP███.██ |
| Iceland | max wholesale | 2 | 4 | ISK███.██ |
| United Arab Emirates | public | 2 | 2 | AED███.██ |
| Bahrain | retail (max) | 1 | 2 | BHD███.██ |
| Saudi Arabia | public | 2 | 2 | SAR███.██ |
| South Africa | single exit price | 2 | 2 | ZAR███.██ |
111 pack listings across 73 brand entries and 13 price bases, refreshed 08 Sep 2026. Ranges span every Axitinib 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.
Is there a generic Axitinib in Canada, and who makes it?
Every market authorization holder with a Canadian DIN for this molecule, and how many of their listings Health Canada currently shows as marketed.
Only one market authorization holder has a Canadian DIN containing Axitinib — 4 DINs, of which 2 are currently marketed. There is no second Canadian source today, so a supply interruption on this holder has no domestic substitute at the same molecule.
| Market authorization holder | DINs | Marketed | Brand names | Position |
|---|---|---|---|---|
| PFIZER CANADA ULC | 4 | 2 | INLYTA | Sourceable in Canada |
Health Canada’s Drug Product Database does not flag which listing is the originator and which are subsequent-entry products, so Nexara does not label them here. Interchangeability is determined provincially, not federally — confirm for your province before a formulary switch. Nexara can confirm which of these is actually obtainable, and on what lead time, per order.
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 | 5 MG |
|---|---|
| Dosage form | TABLET |
| Route | ORAL |
| Pack configuration (monograph) | INLYTA 1 mg tablets: bottles of 60; foil/foil blister packs containing 28 ([14 tabs/blister] x [2 blisters]), or 56 ([14 tabs/blister] x [4 blisters]) tablets. INLYTA 3 mg tablets: bottles of 60; foil/foil blister packs containing 28 ([14 tabs/blister] x [2 blisters]), or 56 ([14 tabs/blister] x [4 blisters]) tablets. INLYTA 5 mg tablets: bottles of 60; foil/foil blister packs containing 28 ([14 tabs/blister] x [2 blisters]), or 56 ([14 tabs/blister] x [4 blisters]) tablets. INLYTA 7 mg tablets: bottles of 60; foil/foil blister packs containing 28 ([14 tabs/blister] x [2 blisters]), or 56 ([14 tabs/blister] x [4 blisters]) tablets. |
| Storage | Store at a controlled room temperature of 25°C; excursions permitted to 15-30°C. Store in the original package. Do not use after the expiry date (EXP) shown on the outer pack and label. Do not use any pack that is damaged or shows signs of tampering. |
Before an order line is unambiguous Nexara needs the strength, the pack size and the presentation.
Substance and classification
| Active substance | Axitinib |
|---|---|
| ATC code | L01EK01 |
| 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) | 02389649 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2389649 |
| Brand name | INLYTA |
| Generic / active ingredient | AXITINIB : 5 MG |
| Market authorization holder | PFIZER CANADA ULC |
| Health Canada schedule | Prescription |
| ATC code | L01EK01 |
| ATC anatomical main group | L — Antineoplastic and immunomodulating agents |
| ATC therapeutic subgroup | L01EK |
| Current status | MARKETED |
| Status date | 17-Aug-2012 |
| Status source | Live Health Canada DPD sync |
Verify on the primary sources
How is it administered?
The recommended oral starting dose of INLYTA is 5 mg twice daily. INLYTA may be taken with or without food. INLYTA should be swallowed whole with a glass of water. Dose increase or reduction is recommended based on individual safety and tolerability. Patients who tolerate the INLYTA starting dose of 5 mg twice daily with no adverse reactions >Grade 2 (according Common Toxicity Adverse Event Criteria [CTCAE]) for two consecutive weeks, are normotensive, and are not receiving anti-hypertension medication, may have their dose increased to 7 mg twice daily. Subsequently, using the same criteria, patients who tolerate the INLYTA dose of 7 mg twice daily, may have their dose increased to a maximum of 10 mg twice daily. Management of some adverse drug reactions may require temporary or permanent discontinuation and/or dose reduction of INLYTA therapy. When dose reduction is necessary, the INLYTA dose may be reduced from 5 mg twice daily to 3 mg twice daily and further to 2 mg twice daily. For INLYTA in combination with Pembrolizumab: Pembrolizumab 200 mg administered as an intravenous infusion over 30 minutes once every 3 weeks until unacceptable toxicity, disease progression, or for up to 24 months or 35 doses, whichever is longer, in combination with INLYTA – 5 mg orally twice daily until unacceptable toxicity or disease progression. Dose escalation may be considered for patients who tolerated the initial 5 mg INLYTA dose at intervals of six weeks or longer (i.e., at least 2 treatment cycles).
Included because it drives pack selection and wastage. Consult the monograph.
Contraindications
INLYTA (axitinib tablets) is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container. For a complete listing, see the DOSAGE FORMS, COMPOSITION AND PACKAGING section of the product monograph.
Warnings and precautions
Serious Warnings and Precautions: INLYTA should be prescribed by a qualified healthcare professional who is experienced in the use of anti-neoplastic therapy. INLYTA has not been studied in patients with severe hepatic impairment. The following are clinically significant adverse events: • Hypertension and Hypertensive Crisis • Arterial Thromboembolism, including deaths • Venous Thromboembolism, including deaths • Hemorrhage (including gastrointestinal, cerebral and respiratory tract) • Gastrointestinal perforation, including death and gastrointestinal fistulas • Reversible posterior leukoencephalopathy syndrome • Congestive heart failure/Cardiomyopathy, including deaths General: INLYTA contains lactose and should not be taken by patients with hereditary problems of lactose intolerance. Drug-Drug Interactions: Co-administration of INLYTA with strong inhibitors of CYP3A4/5 is not recommended as this may increase axitinib concentrations and drug toxicity. If a strong CYP3A4/5 inhibitor must be co-administered a dose reduction of INLYTA is recommended. Co-administration with strong inducers of CYP3A4/5 should be avoided due to the risk of reduced effectiveness of the drug. Moderate CYP3A4/5 inducers may also reduce the plasma exposure of axitinib and should be avoided if possible.
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.
1 · Same molecule, other Canadian presentations
2 of 4 Canadian DINs for this molecule are currently marketed. Marketed products are listed first.
| Product | Strength | Form | Holder | Health Canada status | DIN |
|---|---|---|---|---|---|
| INLYTA | 1 MG | TABLET | PFIZER CANADA ULC | MARKETED | 02389630 |
| INLYTA | 3 MG | TABLET | PFIZER CANADA ULC | CANCELLED PRE MARKET | 02422883 |
| INLYTA | 7 MG | TABLET | PFIZER CANADA ULC | CANCELLED PRE MARKET | 02422891 |
2 · Same class — other molecules in ATC L01EK
| Molecule | Canadian brands | DINs | Marketed | Sourceable |
|---|---|---|---|---|
| Axitinib | INLYTA | 4 | 2 | Yes |
| Fruquintinib | FRUZAQLA | 2 | 2 | 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 L01E
| ATC subgroup | Molecules | DINs | Marketed |
|---|---|---|---|
| L01EX | Avapritinib · Cabozantinib · Capivasertib · Capmatinib · Entrectinib · +17 more | 80 | 64 |
| L01EA | Asciminib · Bosutinib · Dasatinib · Imatinib · Nilotinib · +1 more | 73 | 57 |
| L01EB | Afatinib · Dacomitinib · Erlotinib · Gefitinib · Lazertinib · +1 more | 40 | 23 |
| L01EF | Abemaciclib · Palbociclib · Ribociclib | 17 | 14 |
| L01ED | Alectinib · Brigatinib · Ceritinib · Crizotinib · Lorlatinib | 10 | 10 |
| L01EJ | Fedratinib · Momelotinib · Ruxolitinib | 8 | 8 |
| L01EE | Binimetinib · Cobimetinib · Selumetinib · Trametinib | 8 | 7 |
| L01EN | Erdafitinib · Infigratinib · Pemigatinib | 11 | 6 |
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 INLYTA called?
Also recorded in Canada as: axitinib 1 MG Oral Tablet [Inlyta] (US), axitinib 5 MG Oral Tablet [Inlyta] (US), axitinib 1 MG Oral Tablet (US), axitinib 5 MG Oral Tablet (US), AXITINIB (US), axitinib (GLOBAL), axitinib (UK), Axinit (IN).
The same molecule, Axitinib, 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 |
|---|---|---|
| Inlyta® | Latin | Sweden |
| Axitinib Accord | Latin | Czechia, Sweden |
| Axitinib Sandoz | Latin | Sweden |
| Axitinib STADA | Latin | Sweden |
| Axitinib Teva | Latin | Sweden |
| Axitinib Avansor | Latin | Sweden |
| Axitinib WH | Latin | Iceland |
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.