Notice: Prescription Drug List (PDL): Multiple Additions 

February 13, 2020
Our file number: 20-102134-993

The purpose of this Notice of Amendment is to notify about the additions of gemtuzumab ozogamacin, gilteritinib, icosapent ethyl, tafamidis, trifarotine and upadacitinib to the Prescription Drug List (PDL) for human and/or veterinary use.

The new drugs will be added to the PDL as the following:

These additions are effective at the time of posting.

Rationale:

A scientific review of these drugs against the criteria set out in C.01.040.3 of the Food and Drug Regulations indicates that these drugs require prescription status.

AKLIEF (trifarotene 50 mcg/g) topical cream is indicated for the topical treatment of acne vulgaris of the face and/or trunk in patients 12 years of age and older.

MYLOTARG (gemtuzumab ozogamicin for injection) is indicated for:

• Combination therapy with daunorubicin (DNR) and cytarabine (AraC) for the treatment of adult patients with previously untreated, de novo CD33-positive acute myeloid leukemia (AML), except acute promyelocytic leukemia.

RINVOQ (upadacitinib) is indicated for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. RINVOQ may be used as monotherapy or in combination with methotrexate or other non-biologic disease-modifying antirheumatic drug (DMARDs).

VASCEPA (icosapent ethyl) is indicated to reduce the risk of cardiovascular events (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, coronary revascularization or hospitalization for unstable angina) in statin-treated patients with elevated triglycerides, who are at high risk of cardiovascular events due to:

• established cardiovascular disease, or
• diabetes, and at least one other cardiovascular risk factor.

VYNDAQEL (tafamidis meglumine) is indicated for the treatment of adult patients with cardiomyopathy due to transthyretin-mediated amyloidosis, wild type or hereditary, to reduce cardiovascular mortality and cardiovascular-related hospitalization.

XOSPATA (gilteritinib tablets) is indicated for:

• the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FMS-like tyrosine kinase 3 (FLT3) mutation. A validated test is required to confirm the FLT3 mutation status of AML.

Additional information on how Health Canada determines prescription status (or non-prescription status) is available in the Guidance Document: Determining Prescription Status for Human and Veterinary Drugs.

Should you have any questions on these amendments to the Prescription Drug List please contact:

Health Canada
Prescription Drug Status Committee
Address Locator 3102C3
Holland Cross, Tower B
1600 Scott Street
Ottawa, Ontario
K1A 0K9

Email: hc.drug.prescription.status-statut.dordonnance.des.drogues.sc@canada.ca
Telephone: 343-998-9304
Facsimile: 613-941-1812