Notice: Prescription Drug List (PDL): Multiple Additions
Date: September 8, 2020
Our file number: 20-112398-776
The purpose of this Notice of Amendment is to notify about the additions of amifampridine, cedazuridine (when used in combination with another drug), etomidate, fedratinib, lefamulin, obiltoxaximab, polatuzumab vedotin, ripretinib, satralizumab and sonidegib to the Prescription Drug List (PDL) for human and/or veterinary use.
The new drugs will be added to the PDL as the following:
| Drugs containing any of the following | Including (but not limited to) | Qualifier |
|---|---|---|
| Amifampridine or its salts or derivatives | - | - |
| Cedazuridine | - | When used in combination with another drug |
| Etomidate or its salts | - | - |
| Fedratinib or its salts | - | - |
| Lefamulin or its salts | - | - |
| Obiltoxaximab | - | - |
| Polatuzumab vedotin | - | - |
| Ripretinib or its salts | - | - |
| Satralizumab | - | - |
| Sonidegib or its salts | - | - |
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.
ANTHIM (obiltoxaximab for injection) is indicated:
- In adult and pediatric patients for the treatment of inhalational anthrax due to Bacillus anthracis in combination with appropriate antibacterial drugs
- For prophylaxis of inhalational anthrax due to B. anthracis when alternative therapies are not available or not appropriate.
ENSPRYNG (satralizumab) is indicated as monotherapy or in combination with immunosuppressive therapy (IST) for the treatment of neuromyelitis optica spectrum disorders (NMOSD) in adult and adolescent patients who are anti-aquaporin 4 (AQP4) seropositive.
FIRDAPSE (amifampridine) is indicated for the symptomatic treatment of Lambert-Eaton Myasthenic Syndrome (LEMS) in adults.
INQOVI (cedazuridine and decitabine) is indicated for treatment of adult patients with myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and secondary MDS of all French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System (IPSS) groups.
INREBIC (fedratinib) is indicated for the treatment of splenomegaly and/or disease related symptoms in adult patients with primary myelofibrosis, post-polycythemia vera myelofibrosis or post-essential thrombocythemia myelofibrosis, including patients who have been previously exposed to ruxolitinib.
ODOMZO (sonidegib) is indicated for the treatment of adult patients with histologically confirmed locally advanced basal cell carcinoma (laBCC) that is not amenable to radiation therapy or curative surgery.
POLIVY (polatuzumab vedotin) in combination with bendamustine and rituximab is indicated for the treatment of adult patients with diffuse large B-cell lymphoma, not otherwise specified, who are not eligible for autologous stem cell transplant and have received at least one prior therapy.
QINLOCK (ripretinib) is a kinase inhibitor indicated for the treatment of patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with imatinib, sunitinib, and regorafenib.
RUZURGI (amifampridine) is indicated for the symptomatic treatment of Lambert-Eaton myasthenic syndrome (LEMS) in patients 6 years of age and older.
TOMVI (etomidate) is indicated for:
- The induction of general anesthesia
- The supplementation of subpotent anesthetic agents, such as nitrous oxide in oxygen, during maintenance of anesthesia for short operative procedures.
XENLETA (lefamulin acetate) is indicated for community-acquired pneumonia (CAP) caused by: Streptococcus pneumoniae including multi-drug resistant S. pneumoniae (MDRSPFootnote *), Staphylococcus aureus (methicillin-susceptible isolates), Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, Legionella pneumophila, Mycoplasma pneumoniae, and Chlamydophila pneumoniae.
- Footnote *
-
*MDRSP refers to isolates resistant to two or more of the following antibiotics/antibiotic classes: Penicillins, cephalosporins, macrolides, tetracyclines, lincosamides, fluoroquinolones and folate-synthesis inhibitors.
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
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