Notice: Prescription Drug List (PDL): Multiple additions

October 16, 2015

Our file number: 15-111220-880

The purpose of this Notice of Amendment is to notify the addition of Asfotase alfa, Daclatasvir, Deoxycholic Acid, Empagliflozin, Ramucirumab, and Teduglutide to both the Human and Veterinary Prescription Drug List (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.

Asfotase alfa (STRENSIQ) is indicated as an enzyme replacement therapy in patients with confirmed diagnosis of paediatric-onset Hypophosphatasia, a rare, life threatening disease. Treatment with Asfotase alfa should be initiated by a physician with experience in the management of patients with metabolic bone disorders.

Daclatasvir (DAKLINZA) is indicated in combination with other agents for the treatment of chronic hepatitis C. Daclatasvir must be administered in a primary care setting by practitioners experienced in the management of chronic hepatitis C infections.

Deoxycholic Acid (BELKYRA) is indicated for the improvement in the appearance of moderate to severe convexivity or fullness associated with submental fat (SMF) in adults. Health professionals administering Deoxycholic acid via injection must understand the relevant submental anatomy and associated neuromuscular structures in the area involved and any alterations to the anatomy due to prior surgical or aesthetic procedures.

Empagliflozin (JARDIANCE) is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus.  Patients receiving Empagliflozin require monitoring for adverse effects on renal function, adequate glycemic control and hypoglycemia, and regular multifaceted assessment and monitoring of their diabetes.

Ramucirumab (CYRAMZA) is indicated as a single agent or in combination with paclitaxel for the treatment of patients with advanced or metastatic gastric cancer or gastro-esophageal junction adenocarcinoma. The drug is used to treat patients with advanced stage cancer and is associated with significant adverse reactions, some are fatal. It requires close monitoring by treating physicians.

Teduglutide (REVESTIVE) is indicated for the treatment of adult patients with Short Bowel Syndrome (SBS). Treatment of SBS with Teduglutide should be initiated under the supervision of a medical professional with experience in the treatment of SBS.

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