Notice: Prescription Drug List (PDL): Multiple additions

Date: November 1, 2018
Our file number: 18-116661-578

The purpose of this Notice of Amendment is to notify about the additions of Cabozantinib, Doravirine, Inotersen, Lanadelumab, Patiromer, Telotristat, and Zaleplon to the Prescription Drug List (PDL) for human and veterinary use.

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.

CABOMETYX (cabozantinib) is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) who have received prior vascular endothelial growth factor (VEGF)-targeted therapy.

PIFELTRO (doravirine) is indicated, in combination with other antiretroviral medicinal products, for the treatment of adults infected with HIV-1 without past or present evidence of viral resistance to doravirine.

TEGSEDI (inotersen solution for subcutaneous injection) is indicated for the treatment of stage 1 or stage 2 polyneuropathy in adult patients with hereditary transthyretin amyloidosis (hATTR).

TAKHZYRO (lanadelumab injection) is indicated for routine prevention of attacks of hereditary angioedema (HAE) in adolescents and adults. TAKHZYRO is not intended for acute treatment of HAE attacks.

VELTASSA (patiromer as patiromer sorbitex calcium) is indicated for the treatment of hyperkalemia in adults with chronic kidney disease (eGFR ≥15mL/min/1.73m2).

XERMELO (telotristat ethyl) is indicated for the treatment of refractory carcinoid syndrome diarrhea, in combination with somatostatin analogue (SSA) therapy, in patients inadequately controlled by SSA therapy alone.

STARNOC (zaleplon) is indicated for the short-term treatment and symptomatic relief of insomnia in patients who have difficulty falling asleep.

Additional information on how Health Canada 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

Email: hc.drug.prescription.status-statut.dordonnance.des.drogues.sc@canada.ca
Telephone: 343-998-9304
Facsimile: 613-941-1812