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TOFACITINIB CITRATE

All products: Limited Use (codes 565)

Other products in the same Health Canada class (L04A, L04AF) — coverage varies; not interchangeable

  • Tofacitinib (Xeljanz): limited Use 480, 589, 743, Limited Use 589
  • Upadacitinib (Rinvoq): limited Use 637, 684, Limited Use 684
  • Adalimumab (Hyrimoz): limited Use 600, 601, 602, 603, 604, 605, 606, 607, 609, 611, Limited Use 600, 602, 603, 604, 605, 606, 607, 609, 633, 634
  • Etanercept (Erelzi): limited Use 498, 499, 514, 563, 591, Limited Use 512, 513, 514, 563, 591
  • Infliximab (Remdantry): limited Use 468, 469, 470, 471, 477, 478, 479, Limited Use 541, 542, 543, 544, 545, 546, 547, Limited Use 592, 593, 594, 595, 596, 597, 598, Limited Use 715, 716, 718
  • Tocilizumab (Tyenne): limited Use 697, 698, 720, Limited Use 697, 698, 720, 721

1 more in the class list below

Xeljanz XR · DIN 02470608 · 11mg · extended release tablet

Limited Use — Reason for Use code 565 requiredMarketed · checked 2026-09-19
StatusLimited Use — Reason for Use code 565 required
Write on scriptLU code 565 (patient must meet the criteria below)
Patient paysPatient pays: program not supplied; amount cannot be determined.
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ontario Limited Use criteria — code 565
Reason for Use code 565 For the treatment of rheumatoid arthritis (RA) in patients who have severe active disease (greater than or equal to 5 swollen joints and rheumatoid factor positive and/or, anti-CCP positive, and/or radiographic evidence of rheumatoid arthritis) and have experienced failure, intolerance, or have a contraindication to adequate trials of disease-modifying anti-rheumatic drugs (DMARDs) treatment regimens, such as one of the following combinations of treatments: A. i) Methotrexate (20mg/week) for at least 3 months, AND ii) leflunomide (20mg/day) for at least 3 months, in addition to iii) an adequate trial of at least one combination of DMARDs for 3 months; OR B. i) Methotrexate (20mg/week) for at least 3 months, AND ii) leflunomide in combination with methotrexate for at least 3 months; OR C. i) Methotrexate (20mg/week), sulfasalazine (2g/day) and hydroxychloroquine (400mg/day) for at least 3 months. (Hydroxychloroquine is based by weight up to 400mg per day.) Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For renewals beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. The recommended dosing regimen is 11mg once daily. Coverage limit: LU Authorization Period: 1 year
1 brand, same coverage
Xeljanz XR · DIN 02470608 Manufacturer: Pfizer Canada Inc.; listing date 2019-08-30 Health Canada: Marketed since 2018-03-29 · brand XELJANZ XR · ATC L04AF01 TOFACITINIB · form Tablet (extended-release) · route Oral · ingredients TOFACITINIB (TOFACITINIB CITRATE) 11 MG · company Pfizer canada ulc · schedule Prescription
Check this DIN again · Health Canada product record

Ministry pays: $27.2507 per source unit.

Source explanation: The formulary price is what ODB pays; the cash price at the counter is set by the pharmacy.

Formulary data: Ontario extract of Aug 26, 2026 · Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=95960 · Verify on the e-Formulary ↗ (DIN 02470608)

Source record
DIN 02470608: Xeljanz XR Raw flags: sec12=Y, sec3=Y Item: 923600015; group id 1040; item number 2391; lccId 00320; manufacturer id PFI Source form: ER Tab; strength: 11mg Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $49.5467; ministry $27.2507 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02470608 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=95960
Interchangeable products
Taro-Tofacitinib XR · DIN 02553988 · $27.2507
Shortage status: not checked (no credentials)
Other drugs in the same formulary class (92:36 Disease-Modifying Antirheumatic Agents) and how they are covered

Matched class: 92:36 Disease-Modifying Antirheumatic Agents

Drug-class inventory only. Lists recorded Ontario formulary products, not every Canadian medication; does not recommend treatment. No displayed product is listed as a general benefit in this extract. Check its listing requirements below. 92:36 Disease-Modifying Antirheumatic Agents

TOFACITINIB

· 10 products · Limited Use, codes 480, 589, 743 (6), Limited Use, codes 589 (4) · strengths: 5mg, 10mg · Tab

UPADACITINIB

· 3 products · Limited Use, codes 637, 684 (1), Limited Use, codes 684 (2) · strengths: 15mg, 30mg, 45mg · ER Tab

ADALIMUMAB

· 30 products · Limited Use, codes 600, 601, 602, 603, 604, 605, 606, 607, 609, 611 (23), Limited Use, codes 600, 602, 603, 604, 605, 606, 607, 609, 633, 634 (7) · strengths: 20mg/0.2mL, 40mg/0.4mL, 20mg/0.4mL, 40mg/0.8mL, 80mg/0.8mL · Inj Sol-0.2mL Pref Syr (Preservative-Free), Inj Sol-0.4mL Autoinj (Preservative-Free), Inj Sol-0.4mL Pref Autoinj Pen (Preservative-Free), Inj Sol-0.4mL Pref Autoinj Syr (Preservative-Free), Inj Sol-0.4mL Pref Pen (Preservative-Free), Inj Sol-0.4mL Pref Syr (Preservative-Free), Inj Sol-0.8mL Pref Autoinj (Preservative-Free), Inj Sol-0.8mL Pref Pen (Preservative-Free), Inj Sol-0.8mL Pref Syr (Preservative-Free)

ETANERCEPT

· 7 products · Limited Use, codes 512, 513, 514, 563, 591 (3), Limited Use, codes 498, 499, 514, 563, 591 (4) · strengths: 25mg/0.5mL, 50mg/mL · Inj Sol-0.5mL Pref Syr Pk, Inj Sol-1mL Pref Syr Pk, Inj Sol-1mL Prefilled SensoReady Pen Pk, Inj Sol-Pref Autoinj Pen, Inj Sol-Pref Syr, Sol- Pref AutoInj

INFLIXIMAB

· 6 products · Limited Use, codes 468, 469, 470, 471, 477, 478, 479 (2), Limited Use, codes 541, 542, 543, 544, 545, 546, 547 (1), Limited Use, codes 715, 716, 718 (2), Limited Use, codes 592, 593, 594, 595, 596, 597, 598 (1) · strengths: 100mg/Vial, 120mg/mL · Inj Pd-Vial Pk, Inj Sol-1mL Pref Pen Pk (Preservative-Free), Inj Sol-1mL Pref Syr Pk (Preservative-Free), Pd for Sol-Vial Pk

TOCILIZUMAB

· 10 products · Limited Use, codes 697, 698, 720 (6), Limited Use, codes 697, 698, 720, 721 (4) · strengths: 200mg/10mL, 400mg/20mL, 80mg/4mL, 162mg/0.9mL · Inj Sol-10mL Vial Pk, Inj Sol-10mL Vial Pk (Preservative-Free), Inj Sol-20mL Vial Pk, Inj Sol-20mL Vial Pk (Preservative-Free), Inj Sol-4mL Vial Pk, Inj Sol-4mL Vial Pk (Preservative-Free), Inj Sol-Pref Autoinj, Inj Sol-Pref Autoinj (Preservative-Free), Inj Sol-Pref Syr, Inj Sol-Pref Syr (Preservative-Free)

APREMILAST

· 12 products · Off-Formulary Interchangeable, not an ODB benefit · strengths: 30mg, 10mg & 20mg & 30mg · Tab, Tab-27 Blister Starter Pk Source: formulary-ed43-front-matter.txt Part V; ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26; class 92:36
Full class listing Related classes: 92:20 Biologic Response Modifiers, 92:44 Immunosuppressive Agents, 92:92 Other Miscellaneous Therapeutic Agents Same formulary class, not same indication: class membership alone does not establish equivalent uses.
Other drugs whose Health Canada label lists a similar indication: active ankylosing spondylitis, active polyarticular juvenile arthritis, moderately to severely active ulcerative colitis, reducing the signs and symptoms of psoriatic arthritis, reducing the signs and symptoms of rheumatoid arthritis
From Health Canada product monographs; label wording only, not a treatment recommendation. Matching is lexical and uses one held product label per generic; formulations and qualifying criteria may differ. No displayed matched alternative is a general benefit. TOFACITINIB · Limited Use, codes 480, 589, 743 (6), Limited Use, codes 589 (4) Indications Rheumatoid Arthritis XELJANZ/XELJANZ XR (tofacitinib), in combination with methotrexate (MTX), is indicated for reducing the signs and symptoms of rheumatoid arthritis (RA) in adult patients with moderately to severely active RA who have had an inadequate response to MTX and to one or more disease-modifying anti-rheumatic drugs (DMARDs). PM: https://pdf.hres.ca/dpd_pm/00084246.PDF; date 2026-04-09; DIN 02423898; fetched 2026-09-10 Product monograph Psoriatic Arthritis XELJANZ (tofacitinib), in combination with methotrexate (MTX) or another conventional synthetic disease- modifying antirheumatic drug (DMARD), is indicated for reducing the signs and symptoms of psoriatic arthritis (PsA) in adult patients with active PsA when the response to previous DMARD therapy has been inadequate. PM: https://pdf.hres.ca/dpd_pm/00084246.PDF; date 2026-04-09; DIN 02423898; fetched 2026-09-10 Product monograph Ankylosing Spondylitis XELJANZ (tofacitinib) is indicated for the treatment of adult patients with active ankylosing spondylitis (AS) who have responded inadequately to a biologic DMARD or when use of those therapies is inadvisable. PM: https://pdf.hres.ca/dpd_pm/00084246.PDF; date 2026-04-09; DIN 02423898; fetched 2026-09-10 Product monograph Ulcerative Colitis XELJANZ (tofacitinib) is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) with an inadequate response, loss of response or intolerance to either conventional UC therapy or a TNF inhibitor. PM: https://pdf.hres.ca/dpd_pm/00084246.PDF; date 2026-04-09; DIN 02423898; fetched 2026-09-10 Product monograph Active Juvenile Idiopathic Arthritis (JIA) XELJANZ (tofacitinib) is indicated for the treatment of active polyarticular juvenile idiopathic arthritis (pJIA; rheumatoid factor positive [RF+] or negative [RF-] polyarthritis, extended oligoarthritis, and systemic JIA without systemic manifestations), and juvenile psoriatic arthritis (jPsA) in children weighing ≥40 kg, who have responded inadequately or are intolerant to tumour necrosis factor (TNF) inhibitors or when use of those therapies is inadvisable. PM: https://pdf.hres.ca/dpd_pm/00084246.PDF; date 2026-04-09; DIN 02423898; fetched 2026-09-10 Product monograph GUSELKUMAB · Limited Use, codes 658 (guselkumab injection/guselkumab for injection) is indicated for: • the treatment of adult patients with moderately to severely active ulcerative colitis. 1.1 Pediatrics Plaque Psoriasis • (6 years to 17 years): TREMFYA (guselkumab injection) is indicated for the treatment of pediatric patients 6 years of age and older with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy (see 4.1 Dosing Considerations). PM: https://pdf.hres.ca/dpd_pm/00085777.PDF; date 2026-08-14; DIN 02469758; fetched 2026-09-10 Product monograph IXEKIZUMAB · Limited Use, codes 526 Ankylosing Spondylitis TALTZ is indicated for the treatment of adult patients with active ankylosing spondylitis who have responded inadequately to, or are intolerant to conventional therapy. PM: https://pdf.hres.ca/dpd_pm/00080067.PDF; date not captured; DIN 02455102; fetched 2026-09-10 Product monograph RISANKIZUMAB · Limited Use, codes 574 • the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, loss of response, or were intolerant to conventional therapy, a biologic treatment, or a Janus kinase (JAK) inhibitor. PM: https://pdf.hres.ca/dpd_pm/00085642.PDF; date 2026-07-08; DIN 02519283; fetched 2026-09-10 Product monograph SECUKINUMAB · Limited Use, codes 476 Axial spondyloarthritis (axSpA) Ankylosing spondylitis (AS, radiographic axial spondyloarthritis) COSENTYX is indicated for the treatment of adult patients with active ankylosing spondylitis who have responded inadequately to conventional therapy (see 14.1.3 Axial spondyloarthritis (axSpA), Ankylosing spondylitis). PM: https://pdf.hres.ca/dpd_pm/00080972.PDF; date not captured; DIN 02529653; fetched 2026-09-10 Product monograph UPADACITINIB · Limited Use, codes 637, 684 (1), Limited Use, codes 684 (2) RINVOQ (upadacitinib) Page 5 of 108 Unclassified / Non classifié Ulcerative Colitis RINVOQ is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have demonstrated prior treatment failure, i.e., an inadequate response to, loss of response to, or intolerance to at least one of conventional, and/or biologic therapy. PM: https://pdf.hres.ca/dpd_pm/00085368.PDF; date 2026-07-14; DIN 02495155; fetched 2026-09-10 Product monograph USTEKINUMAB · Limited Use, codes 669, 670, 671, 672 (5), Limited Use, codes 668, 669, 671, 672 (6), Limited Use, codes 669, 671, 672, 733 (3), Limited Use, codes 669, 671, 672, 742 (2), Limited Use, codes 671, 672 (4) (ustekinumab) is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic or have medical contraindications to such therapies. 1.1 Pediatrics Pediatrics (6-17 years of age): Jamteki (ustekinumab) is indicated for the treatment of chronic moderate to severe plaque psoriasis in pediatric patients (children and adolescents) from 6 to 17 years of age, who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies. PM: https://pdf.hres.ca/dpd_pm/00077781.PDF; date November 9, 2023; DIN 02543036; fetched 2026-09-10 Product monograph Coverage source: ON formulary extract 2026-08-26
What the Health Canada label says it is for
1. Indications Rheumatoid Arthritis XELJANZ/XELJANZ XR (tofacitinib), in combination with methotrexate (MTX), is indicated for reducing the signs and symptoms of rheumatoid arthritis (RA) in adult patients with moderately to severely active RA who have had an inadequate response to MTX and to one or more disease-modifying anti-rheumatic drugs (DMARDs). In cases of intolerance to MTX and other DMARDs, physicians may consider the use of XELJANZ/XELJANZ XR (tofacitinib) as monotherapy. Psoriatic Arthritis XELJANZ (tofacitinib), in combination with methotrexate (MTX) or another conventional synthetic disease- modifying antirheumatic drug (DMARD), is indicated for reducing the signs and symptoms of psoriatic arthritis (PsA) in adult patients with active PsA when the response to previous DMARD therapy has been inadequate. Ankylosing Spondylitis XELJANZ (tofacitinib) is indicated for the treatment of adult patients with active ankylosing spondylitis (AS) who have responded inadequately to a biologic DMARD or when use of those therapies is inadvisable. Ulcerative Colitis XELJANZ (tofacitinib) is indicated for the treatment of adult patients with moderately to severely active ulcerative … https://pdf.hres.ca/dpd_pm/00084246.PDF PM date: 2026-04-09 Source product: XELJANZ XR; DIN 02470608; fetched 2026-09-10 Product monograph posted by Health Canada; excerpt for lookup only.