Notice: Prescription Drug List (PDL): Multiple additions

November 16, 2016
Our file number: 16-112865-923

The purpose of this Notice of Amendment is to notify the additions of Alectinib, Bepotastine besilate, Ixazomib, Nitisinone and Venetoclax to the Human and Veterinary Prescription Drug Lists (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.

Alectinib hydrochloride (ALECENSARO) is indicated as monotherapy for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive, locally advanced or metastatic non-small cell lung cancer (NSCLC) who have failed prior crizotinib therapy. Practitioner supervision is necessary for the proper selection of patients eligible for treatment with this medication.

Bepotastine besilate (BEPREVE) ophthalmic solution 1.5% is indicated for treatment of itching associated with allergic conjunctivitis. Proper diagnosis of allergic conjunctivitis is essential by a trained eye care specialist as other more serious ophthalmic diseases can be mistaken for this disorder.

Ixazomib (NINLARO) is indicated for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. Prescription and administration of ixazomib under the supervision of a qualified physician who is experienced in the use of anti-cancer agents is recommended.

Nitisinone (MDK-Nitisinone) is indicated for the treatment of hereditary tyrosinemia type 1 (HT-1), in combination with dietary restriction of tyrosine and phenylalanine. Use of nitisinone requires monitoring by a suitably qualified health practitioner, in order to titrate dosing and adjust dietary restriction of tyrosine and phenylalanine, as necessary.

Venetoclax (VENCLEXTA) is indicated for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy. Practitioner expertise is necessary to select dose, monitor efficacy and manage the safety profile of venetoclax in individual patients.

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: 613-941-1812
E-mail: drug_prescription_status-statut_d'ordonnance_des_drogues@hc-sc.gc.ca