UPDATED INFORMATION - July 6, 2022 A new PAXLOVID dose pack for use in patients with moderate renal impairment (eGFR ≥30 to <60 mL/min) is now available with a distinct DIN : 02527804 . Pfizer has introduced this new packaging configuration to mitigate dosing errors, given that these patients require a reduced daily dose of nirmatrelvir. Each carton of the new dose pack contains 20 tablets divided in 5 daily-dose blister cards. Each daily blister card contains 2 nirmatrelvir tablets (150 mg each) and 2 ritonavir tablets (100 mg each), which are separated into morning and evening doses (see images in Appendix B). The original dose pack (DIN: 02524031), introduced on January 17, 2022, should be used for patients with normal renal function or mild renal impairment (eGFR ≥60 mL/min). This packaging configuration consists of 30 tablets divided in 5 daily-dose blister cards. Each daily blister card contains 4 nirmatrelvir tablets (150 mg each) and 2 ritonavir tablets (100 mg each) separated into morning and evening doses (see images in Appendix A). In the event that the new dose pack is not available, healthcare professionals should refer to the instructions provided in the January 17, 2022 communication (see the Information for healthcare professionals section) for dispensing PAXLOVID to patients with moderate renal impairment. Similar to the original dose pack, Pfizer is introducing the new dose pack with the US Emergency Use label, in English-only, for a period of time. As a result, important Canadian-specific information is absent from the carton and blister labels (see the January 17, 2022 communication for more information). When indicated, PAXLOVID should be initiated as soon as possible after a diagnosis of COVID-19 has been made, and within 5 days of symptom onset . It is recommended that all prescriptions specify the dose and the number of tablets for each active ingredient (see the table in the January 17, 2022 communication). PAXLOVID is not recommended in patients with severe renal impairment (eGFR <30 mL/min). January 17, 2022 PAXLOVID (nirmatrelvir and ritonavir) was authorized by Health Canada on January 17, 2022. PAXLOVID is not recommended in patients with severe renal impairment and requires a dosage reduction in patients with moderate renal impairment. PAXLOVID may also interact with various medications, which could result in serious or life-threatening adverse reactions, or a loss of therapeutic effect and possible development of viral resistance. In order to provide rapid access to PAXLOVID, Pfizer will distribute product cartons and blisters labelled in English-only for a period of time. As a result, important Canadian-specific information is absent from these labels.
RecallTracker