Notice: Prescription Drug List (PDL): Multiple Additions

Date: October 7, 2019
Our file number: 19-119291-196

The purpose of this Notice of Amendment is to notify about the additions of acalabrutinib, galcanezumab, larotrectinib, mannitol, neratinib, niraparib, ravulizumab, romosozumab, and sodium zirconium cyclosilicate 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.

CALQUENCE (acalabrutinib) is indicated for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.

EMGALITY (galcanezumab) is indicated for the prevention of migraine in adults who have at least 4 migraine days per month. EMGALITY should be initiated by physicians experienced in the diagnosis and treatment of migraine.

VITRAKVI (larotrectinib) is indicated for the treatment of adult and pediatric patients with solid tumours that:

• have a Neurotrophic Tyrosine Receptor Kinase (NTRK) gene fusion without a known acquired resistance mutation,
• are metastatic or where surgical resection is likely to result in severe morbidity, and
• have no satisfactory treatment options.

ARIDOL (mannitol inhalation powder) is indicated for the assessment of bronchial hyper-responsiveness in patients 6 years and over who do not have clinically apparent asthma.

NERLYNX (neratinib) is indicated for the extended adjuvant treatment of women with early-stage hormone receptor positive, HER2-overexpressed/amplified breast cancer within one year after completion of trastuzumab-based adjuvant therapy.

ZEJULA (niraparib capsules) is indicated as monotherapy for the maintenance treatment of female adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.

ULTOMIRIS (ravulizumab for injection) is indicated for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH).

EVENITY (romosozumab injection) is indicated for the treatment of osteoporosis in postmenopausal women at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture.

LOKELMA (sodium zirconium cyclosilicate) is indicated for the treatment of hyperkalemia in adult patients.

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