Notice - Prescription Drug List (PDL): Multiple additions

December 5, 2014
Our file number: 14-115019-499

The purpose of this Notice of Amendment is to notify the addition of Agalsidase Beta, Apremilast, Azelastine, Basedoxifene, Ibrutinib and Ledispasvir to both the Human and Veterinary Prescription Drug List (PDL) and Tildipirosin to the Veterinary PDL. 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.

Agalsidase Beta (FABRAZYME) is a recombinant human α-galactosidase A and is indicated for long-term enzyme replacement therapy in patients with a confirmed diagnosis of Fabry disease.

Apremilast (OTEZLA) is indicated for the treatment of adult patients with moderate to severe plaque psoriasis. At normal therapeutic dosage levels, Apremilast has common and potentially serious side effects, therefore practitioner supervision is required for treatment and monitoring.

Azelastine in a nasal spray suspension (DYMISTA) is indicated for the treatment of moderate to severe seasonal allergic rhinitis. Practitioner supervision is required as there is limited market experience with the use of this drug.

Basedoxifene as an active ingredient in DUAVIVE is indicated in women with an intact uterus for the treatment of moderate to severe vasomotor symptoms associated with menopause. Practitioner supervision is required to determine whether a patient is a good candidate for this therapy, taking into consideration medical history and monitoring for serious side effects.

Ibrutinib (IMBRUVICA) is indicated for the treatment of patients with chronic lymphocytic leukemia or small lymphocytic lymphoma. The treatment of patients with this disease is optimally conducted by a specialized team of healthcare professionals.

Ledispasvir as an active ingredient in HARVONI is indicated for the treatment of chronic hepatitis C virus. Treatment of patients with this disease should be initiated and monitored by a physician experienced in the management of chronic hepatitis C.

Tildipirosin (ZUPREVO) is a semi-synthetic macrolide antibiotic for the therapeutic and prophylactic treatment of Bovine Respiratory Disease. Veterinarian supervision is required as therapeutic use of Tildipirosin involves the treatment of individual animals diagnosed with this disease. Health Canada has categorized macrolides as antimicrobials of high importance in human medicine and it is critical to ensure that this class of antibiotics are used appropriately.

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