LORBRENA 100 MG — DIN 02485974
LORLATINIB : 100 MG · PFIZER CANADA ULC · TABLET · wholesale supply in Canada
Health Canada status: MARKETED
What is LORBRENA?
LORBRENA 100 MG contains LORLATINIB : 100 MG. It is listed in the Health Canada Drug Product Database under DIN 02485974, held by PFIZER CANADA ULC, supplied as TABLET for ORAL administration. Health Canada currently lists it as marketed, status dated 22-Apr-2019. 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 LORBRENA used for?
LORBRENA (lorlatinib) is indicated as: • monotherapy for the first-line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC) • monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) who have progressed on: crizotinib and at least one other ALK inhibitor, or patients who have progressed on ceritinib or alectinib. The marketing authorization for the second and later line indication was based on a primary efficacy endpoint of tumor objective response rate and duration of response; no overall survival benefit has been demonstrated (see 14 CLINICAL TRIALS).
Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.
How much does Lorlatinib cost around the world?
Lorlatinib is listed on 14 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 |
|---|---|---|---|---|
| Norway | max AUP (pharmacy retail) | 1 | 7 | NOK███.██ |
| United Arab Emirates | public | 2 | 2 | AED███.██ |
| Austria | KVP (Kassenverkaufspreis) | 2 | 2 | EUR███.██ |
| Australia | ex-manufacturer | 1 | 2 | AUD███.██ |
| Bahrain | retail (max) | 1 | 2 | BHD███.██ |
| Czechia | max producer price (ex-factory) | 1 | 2 | CZK███.██ |
| Greece | producer price (ex-factory) | 2 | 2 | EUR███.██ |
| Hungary | producer price (ex-factory) | 2 | 2 | HUF███.██ |
| Iceland | max wholesale | 1 | 2 | ISK███.██ |
| Italy | ex-factory (classe H) | 2 | 2 | EUR███.██ |
| Luxembourg | reimbursement | 2 | 2 | EUR███.██ |
| Romania | max producer price | 2 | 2 | RON███.██ |
| Saudi Arabia | public | 1 | 2 | SAR███.██ |
| Slovakia | categorised final price | 2 | 2 | EUR███.██ |
33 pack listings across 22 brand entries and 12 price bases, refreshed 08 Sep 2026. Ranges span every Lorlatinib 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 Lorlatinib 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 Lorlatinib — 2 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 | 2 | 2 | LORBRENA | 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 | 100 MG |
|---|---|
| Dosage form | TABLET |
| Route | ORAL |
| Pack configuration (monograph) | 25 mg: high density polyethylene bottles containing 30, 60, or 100 tablets; aluminum foil blisters with aluminum foil backing containing 120 tablets (12 cards of 10 tablets)§ 100 mg: high density polyethylene bottles containing 30, 60, or 100 tablets; aluminum foil blisters with aluminum foil backing containing 30 tablets (3 cards of 10 tablets)§ § not commercially available in Canada |
| Storage | Store at 15°C to 30°C in the original package to protect from light. |
Before an order line is unambiguous Nexara needs the strength, the pack size and the presentation, because this listing covers more than one of them.
Substance and classification
| Active substance | Lorlatinib |
|---|---|
| ATC code | L01ED05 |
| 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) | 02485974 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2485974 |
| Brand name | LORBRENA |
| Generic / active ingredient | LORLATINIB : 100 MG |
| Market authorization holder | PFIZER CANADA ULC |
| Health Canada schedule | Prescription |
| ATC code | L01ED05 |
| ATC anatomical main group | L — Antineoplastic and immunomodulating agents |
| ATC therapeutic subgroup | L01ED |
| Current status | MARKETED |
| Status date | 22-Apr-2019 |
| Original market date | 2019-04-22 00:00:00 |
| Status source | Live Health Canada DPD sync |
Verify on the primary sources
How is it administered?
The recommended dose of LORBRENA is 100 mg taken orally once daily continuously. Continue treatment with LORBRENA until disease progression or unacceptable toxicity. LORBRENA may be taken with or without food (see 10 CLINICAL PHARMACOLOGY). Pediatric patients (<18 years): The safety and efficacy of LORBRENA in pediatric patients have not been established. Health Canada has not authorized an indication for pediatric use. Geriatrics (≥ 65 years): No clinically important differences in safety or efficacy were observed between patients aged 65 years or older and younger patients (see 10 CLINICAL PHARMACOLOGY). Dose Modifications: Dosing interruption and/or dose reduction may be required based on individual safety and tolerability. Dose reduction levels are summarized below. • First dose reduction: LORBRENA 75 mg taken orally once daily • Second dose reduction: LORBRENA 50 mg taken orally once daily LORBRENA should be permanently discontinued if the patient is unable to tolerate LORBRENA 50 mg taken orally once daily. Dose modification recommendations for toxicities are provided in Table 1. Dose modification recommendations for patients who develop first-degree, second-degree, or complete atrioventricular (AV) block are provided in Table 2. Administration: Patients should be encouraged to take their dose of LORBRENA at approximately the same time each day. Tablets should be swallowed whole (tablets should not be chewed, crushed or split prior to swallowing). No tablet should be ingested if it is broken, cracked, or otherwise not intact. Missed Dose: If a dose of LORBRENA is missed, then it should be taken as soon as the patient remembers unless it is less than 4 hours before the next dose, in which case the patient should not take the missed dose. Patients should not take 2 doses at the same time to make up for a missed dose.
Included because it drives pack selection and wastage. Consult the monograph.
Contraindications
LORBRENA (lorlatinib) 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. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. Concomitant use of strong CYP3A inducers with LORBRENA is contraindicated due to the potential for serious hepatotoxicity (aspartate aminotransferase [AST] and alanine aminotransferase [ALT] elevations (see 4 DOSAGE AND ADMINISTRATION and 9 DRUG INTERACTIONS).
Warnings and precautions
Serious Warnings and Precautions: • Hypercholesterolemia/Hypertriglyceridemia (see 7 WARNINGS AND PRECAUTIONS, Metabolism and Endocrine, Hyperlipidemia) • Pneumonitis (see 7 WARNINGS AND PRECAUTIONS, Respiratory, ILD/Pneumonitis) • Hepatotoxicity (see 7 WARNINGS AND PRECAUTIONS, General, Drug-Drug Interactions, Risk of Serious Hepatotoxicity with Concomitant Use of Strong CYP3A Inducers) LORBRENA should only be prescribed and supervised by a qualified physician experienced in the use of antineoplastic agents. Cardiovascular: Atrioventricular (AV) Block: PR interval prolongation and atrioventricular (AV) block events have been reported in patients receiving LORBRENA. For those patients who develop AV block, dose modification may be required. Hypertension: Hypertension can occur in patients receiving LORBRENA. Withhold and resume at a reduced dose or permanently discontinue LORBRENA based on severity. Driving and Operating Machinery: LORBRENA has moderate influence on the ability to drive and use machines. Caution should be exercised when driving or operating machines as patients may experience central nervous system effects. Endocrine and Metabolism: Hyperlipidemia: The use of LORBRENA has been associated with increases in serum cholesterol and triglycerides. Initiation, or increase in the dose, of lipid-lowering agents is recommended. Hyperglycemia: Hyperglycemia can occur in patients receiving LORBRENA. Withhold and resume at a reduced dose or permanently discontinue LORBRENA based on severity. Neurologic: Central Nervous System Effects: Central nervous system (CNS) effects have been observed in patients receiving LORBRENA. These include seizures, psychotic effects and changes in cognitive function, mood (including suicidal ideation), speech, mental status, and sleep. Dose modification may be required for those patients who develop CNS effects. Permanent discontinuation of LORBRENA is recommended in patients diagnosed with Grade 4 CNS effects. Respiratory: ILD/Pneumonitis: Severe or life-threatening pulmonary adverse reactions consistent with pneumonitis have occurred with LORBRENA. Promptly investigate for ILD/pneumonitis in any patient who presents with worsening of respiratory symptoms indicative of ILD/pneumonitis. Immediately withhold LORBRENA in patients with suspected ILD/pneumonitis. Permanently discontinue LORBRENA for treatment-related ILD/pneumonitis of any severity.
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 2 Canadian DINs for this molecule are currently marketed. Marketed products are listed first.
| Product | Strength | Form | Holder | Health Canada status | DIN |
|---|---|---|---|---|---|
| LORBRENA | 25 MG | TABLET | PFIZER CANADA ULC | MARKETED | 02485966 |
2 · Same class — other molecules in ATC L01ED
| Molecule | Canadian brands | DINs | Marketed | Sourceable |
|---|---|---|---|---|
| Brigatinib | ALUNBRIG | 4 | 4 | Yes |
| Crizotinib | XALKORI | 2 | 2 | Yes |
| Lorlatinib | LORBRENA | 2 | 2 | Yes |
| Alectinib | ALECENSARO | 1 | 1 | Yes |
| Ceritinib | ZYKADIA | 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 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 |
| L01EJ | Fedratinib · Momelotinib · Ruxolitinib | 8 | 8 |
| L01EE | Binimetinib · Cobimetinib · Selumetinib · Trametinib | 8 | 7 |
| L01EN | Erdafitinib · Infigratinib · Pemigatinib | 11 | 6 |
| L01EL | Acalabrutinib · Ibrutinib · Zanubrutinib | 10 | 5 |
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 LORBRENA called?
Also recorded in Canada as: lorlatinib 25 MG Oral Tablet [Lorbrena] (US), lorlatinib 100 MG Oral Tablet [Lorbrena] (US), lorlatinib 25 MG Oral Tablet (US), lorlatinib 100 MG Oral Tablet (US), LORLATINIB (US), LORVIQUA (EU), LORVIQUA (UK), LORLATINIB (GLOBAL), LORLATINIB (UK).
The same molecule, Lorlatinib, 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 |
|---|---|---|
| Lorviqua | Latin | Australia, Czechia, Iceland, Norway |
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.