Notice - Prescription Drug List (PDL): Multiple additions

March 26, 2015

Our file number: 15-103382-697

The purpose of this Notice of Amendment is to notify the addition of Dapagliflozin, Deferiprone, Ombitasvir, Dasabuvir, Paritaprevir, Sodium phenylbutyrate, Pradofloxacin and Vedolizumab to both the Human and Veterinary Prescription Drug List (PDL). The existing Qualifier listing for Alpha Hydroxy Acids on both the Human and Veterinary Prescription Drug List will be amended. 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.

Dapagliflozin (FORXIGA) is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus for whom metformin is inappropriate due to contraindications or intolerance. Patients receiving dapagliflozin require monitoring for adverse effects on renal function, adequate glycemic control and hypoglycemia, and regular multifaceted assessment and monitoring of their diabetes.

Deferiprone (FERRIPROX) is indicated for the treatment of patients with transfusional iron overload due to thalassemia syndromes when current chelation therapy is inadequate. Management is optimally conducted by a specialized team of healthcare professionals.

Ombitasvir is one of the direct acting antiviral agents in a fixed dose combination (HOLKIRA PAK), which has been developed for the treatment of chronic hepatitis C (HCV) infection with compensated liver disease, including cirrhosis. HOLKIRA PAK must be administered by physicians experienced in the management of chronic hepatitis C infections.

Dasabuvir is one of the direct acting antiviral agents in a fixed dose combination (HOLKIRA PAK), which has been developed for the treatment of chronic hepatitis C (HCV) infection with compensated liver disease, including cirrhosis. HOLKIRA PAK must be administered by physicians experienced in the management of chronic hepatitis C infections.

Paritaprevir is one of direct acting antiviral agents in a fixed dose combination (HOLKIRA PAK), which has been developed for the treatment of chronic hepatitis C (HCV) infection with compensated liver disease, including cirrhosis. HOLKIRA PAK must be administered by physicians experienced in the management of chronic hepatitis C infections.

Sodium phenylbutyrate (PHEBURANE) is indicated as adjunctive therapy in the chronic management of urea acid cycle disorders. These disorders require highly specialized diagnostic testing by an appropriately trained health professional and the patient should receive a comprehensive medical evaluation.

Pradofloxacin (VERALFLOX) is a third generation fluoroquinolone, a class of antibiotics important to human and public health and its use can cause bone marrow suppression resulting in varying degrees of leukopenia, anemia and thrombocytopenia, therefore it needs to be administered by an appropriately trained health professional.

Vedolizumab (ENTYVIO) is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, loss of response to or were intolerant to ether conventional therapy or Inflixumab. Vedolizumab is administered by a healthcare professional prepared to manage anaphylaxis.

The Qualifier for the existing Human and Veterinary PDL listing for Alpha Hydroxy Acids will be amended to exempt topical formulations when sold for the treatment of warts, corns or calluses. This exemption was unintentionally omitted on the December 25, 2014 list.

Additional information on how Health Canada now 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

Telephone: 613-957-1058
Facsimile: 613-941-5035
E-mail: drug_prescription_status-statut_d'ordonnance_des_drogues@hc-sc.gc.ca