Product Details

Xeljanz XR

Tofacitinib Citrate
11 mg
ER Tablet


DIN/PIN/NPN

02470608

Manufacturer

Pfizer Canada Inc.

Formulary Listing Date

2019-08-30  

Unit Price

49.5467

Amount MOH Pays

49.5467

Coverage Status

Limited Use Product

ODB Formulary Therapeutic Classification

Therapeutic Note

NO

ATC Code

L04AA29

Interchangeable Products

NO  

LU Clinical Criteria

LU Code Auth. Period Clinical Criteria
565 1 year

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.

 

EAP Criteria

NO

Product Monograph

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