Notice: Prescription Drug List (PDL): Multiple additions

June 26, 2015

Our file number: 15-107450-164

The purpose of this Notice of Amendment is to notify the addition of Carglumic acid, Levomilnacipran hydrochloride, Naloxegol oxalate, Pembrolizumab and Sodium nitrite injection 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.

Carglumic Acid (CARBAGLU) is indicated as an adjunctive therapy in pediatric and adult patients for the treatment of acute hyperammonemia due to the deficiency of the hepatic enzyme N-acetylglutamate synthase (NAGS). Management of hyperammonemia due to NAGS deficiency should be done in coordination with medical personnel experienced in metabolic disorders.

Levomilnacipran hydrochloride (FETZIMA) is indicated for the symptomatic relief of major depressive disorder (MDD). FETZIMA should only be prescribed by physicians who are experienced in the diagnosis and management of Major Depressive Disorder. Individualized instruction, direct practitioner supervision, and regular monitoring of treatment response and tolerability/adverse events are required.

Naloxegol oxalate (MOVANTIK) is indicated for the treatment of opioid-induced constipation (OIC) patients taking opioid analgesics for pain. Practitioner expertise is necessary to administer Naloxegol oxalate and oversee administration due to contraindications in patients with renal insufficiency, gastrointestinal obstruction/risk of recurrent obstruction and for patients concomitantly taking CYP3A4 inhibitors.

Pembrolizumab (KEYTRUDA) is used for the treatment of unresectable or metastatic melanoma that has progressed on or after at least one other anti-cancer treatment and thus requires careful diagnosis by a medical oncologist. A qualified health practitioner is necessary to determine the specific weight based dosing of KEYTRUDA as well as to determine the need for dose holding that may be required based on adverse events.

Sodium nitrite injection is indicated for sequential use with sodium thiosulfate for the treatment of acute cyanide poisoning that is judged to be life-threatening. Cyanide poisoning is a treatable condition and needs direct practitioner supervision for treatment and monitoring.

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: 613-941-6458
e-mail: drug_prescription_status-statut_d'ordonnance_des_drogues@hc-sc.gc.ca

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