Notice: Prescription Drug List (PDL): Multiple additions

August 26, 2016
Our file number: 16-109523-230

The purpose of this Notice of Amendment is to notify the additions of Asunaprevir, Bilastine, Daratumumab, Elotuzumab, Idarucizumab, Ixekizumab, Olaparib, Osimertinib, Palbociclib, Velpatasvir and Vorapaxar sulfate to the Human and Veterinary Prescription Drug Lists (PDL). Derquantel will be added only to the Veterinary Prescription Drug List. 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.

Asunaprevir (SUNVEPRA) is indicated in combination with other agents for the treatment of chronic hepatitis C (CHC) in adult patients with hepatitis C virus (HCV) genotypes 1 or 4 and compensated liver disease, including cirrhosis. Treatment with Asunaprevir should be initiated and monitored by a physician experienced in the treatment of CHC.

Bilastine (BLEXTEN) is indicated for the treatment of Seasonal Allergic Rhinitis (SAR) and Chronic Idiopathic Urticaria (CIU).Although, a patient with SAR or CIU may be uniquely suffering from such medical conditions it is also possible and even likely in many cases that these are manifestations of other associated conditions which should be under a practitioner’s supervision.

Daratumumab (DARZALEX) is indicated for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD), or who are double-refractory to a PI and an IMiD. Practitioner expertise is necessary to administer Daratumumab as it is an anti-neoplastic agent that may cause serious adverse reactions within its therapeutic dose range.

Derquantel (STARTECT) oral solution is indicated for the treatment and control of gastro-intestinal nematode and lungworm infections and associated diseases of sheep. Practitioner supervision is necessary to determine the type and severity of infestation, timing of treatment and selection of treatment animals in order to minimize the risk of adverse events occurring as a result of the application of this therapy.

Elotuzumab (EMPLICITI) is indicated for the treatment of patients with multiple myeloma who have received one to three prior therapies. The diagnosis of multiple myeloma requires the use of specialised laboratory techniques and clinical expertise in the diagnosis and treatment of multiple myeloma and potential infusion related reactions.

Idarucizumab (PRAXBIND), is an antidote, specific for Dabigatran etexilate, and is indicated for adult patients treated with Dabigatran etexilate when rapid specific reversal of the anticoagulant effects of Dabigatran etexilate is required for emergency surgery/urgent procedures and life-threatening or uncontrolled bleeding. Idarucizumab must be prescribed by a physician and administered into blood vessels by healthcare providers.

Ixekizumab (TALTZ) is indicated for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Plaque psoriasis is a chronic skin disorder and practitioner expertise is necessary to determine the need for administration of the drug.

Olaparib (LYNPARZA) is indicated for monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed breast cancer susceptibility gene (BRCA) mutated high grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response to platinum-based chemotherapy. Treatment with Olaparib should be initiated and supervised by a physician experienced in the use of anticancer medicinal products.

Osimertinib (TAGRISSO) is indicated for the treatment of patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation positive Non-small cell lung cancer (NSCLC) who have progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy. Osimertinib should only be prescribed by a qualified physician who is experienced in the use of antineoplastic therapy.

Palbociclib (IBRANCE) is indicated in combination with letrozole for the treatment of postmenopausal women with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer as initial endocrine-based therapy for their metastatic disease. Administration under the supervision of a qualified physician who is experienced in the use of anti-cancer agents is recommended.

Velpatasvir (EPCLUSA) is indicated for the treatment of pangenotypic chronic hepatitis C virus infection in adults with compensated cirrhosis. The diagnosis of HCV infection, and further tests to determine genotype, are performed by health care practitioners.

Vorapaxar sulfate (ZONTIVITY) in combination with aspirin and/or clopidogrel, is indicated for the secondary prevention of cardiovascular events in patients with a history of myocardial infarction. Determination of the appropriate drug regimen that needs to be assigned to a patient to prevent reoccurrence also requires a physician’s assessment of the patient.

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

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