Notice - Prescription Drug List (PDL): Multiple additions

May 29, 2015

Our file number: 15-106109-614

The purpose of this Notice of Amendment is to notify the addition of Bromfenac, Ceritinib, Idealisib, Ponatinib Hydrochloride, Secukinumab and Tedizolid phosphate, 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.

Bromfenac (PROLENSA) is indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery. Ocular surgery may lead to complications that require the ongoing monitoring of a physician to prevent and mitigate them.

Ceritinib (ZYKADIA) is indicated for the treatment of patients with locally advanced or metastatic Non-Small Cell Lung Cancer who have received prior treatment with an anaplastic lymphoma kinase inhibitor. Ceritinib must only be prescribed by qualified physicians experienced in the use of anticancer agents and who are aware of the serious nature and potential of these risks to lead to permanent discontinuation, dose interruption, dose reduction and/or death.

Idealisib (ZYDELIG) is indicated for the treatment of patients with Chronic Lymphocytic Leukemia (CLL) and indolent non-Hodgkin Lymphoma (iNHL). The diagnosis and management of patients with CLL or iNHL require a specialized team of health care professionals. Practitioner expertise in necessary to select dose, monitor efficacy and manage the side effects of Idealisib in individual patients.

Ponatinib Hydrochloride (ICLUSIG) is indicated for the treatment of adult patients with chronic myeloid leukemia (CML) or Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ALL). Due to the serious risks of vascular occlusion, thromboembolism and cardiac failure associated with this medication, the cardiovascular status of the patient should be established and monitored by a physician who is experienced in the use of antineoplastic therapy and in the treatment of CML and Ph+ALL.

Secukinumab (COSENTYX) is indicated for the treatment of moderate to severe plaque psoriasis in adult patients who suffer from Chronic Plaque Psoriasis and Atopic Eczema. The diagnosis and management of patients with these conditions require physician diagnosis and oversight.

Tedizolid phosphate (SIVEXTRO) is indicated for the treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI) caused by susceptible strains of gram-positive microorganisms in adults 18 years of age and older. ABSSSI are not self-diagnosed conditions, they require diagnosis, treatment and ongoing monitoring by a physician.

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