PAXLOVID- nirmatrelvir and ritonavir kit

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

NIRMATRELVIR (UNII: 7R9A5P7H32) (NIRMATRELVIR - UNII:7R9A5P7H32)

Beszerezhető a:

Pfizer Laboratories Div Pfizer Inc

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the emergency use of PAXLOVID for the treatment of adults and pediatric patients (12 years of age and older weighing at least 40 kg) with mild-to-moderate coronavirus disease 2019 (COVID-19) and who are at high risk1 for progression to severe COVID-19, including hospitalization or death. LIMITATIONS OF AUTHORIZED USE PAXLOVID is not authorized for use as pre-exposure or post-exposure prophylaxis for prevention of COVID-19 [see Clinical Studies (14.3)] . PAXLOVID may be prescribed for an individual patient by physicians, advanced practice registered nurses, and physician assistants that are licensed or authorized under state law to prescribe drugs. PAXLOVID may also be prescribed for an individual patient by a state-licensed pharmacist under the following conditions: The state-licensed pharmacist should refer an individual patient for clinical evaluation (e.g., telehealth, in-person visit) with a physician, advanced

Termék összefoglaló:

      How Supplied PAXLOVID is nirmatrelvir tablets co-packaged with ritonavir tablets. It is supplied in different Dose Packs (two-dose blister cards or single-dose blister cards). The FDA has extended the expiration date (shelf-life) for some lots of PAXLOVID. To find the extended expiration date, enter the lot number found on the side of carton or bottom of blister pack at this website: https://www.paxlovidlotexpiry.com/. Information on the authorized shelf-life extensions for PAXLOVID may also be found at https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/expiration-dating-extension. Nirmatrelvir tablets and ritonavir tablets are supplied in separate blister cavities within the same child-resistant blister card. Two-dose Blister Card Presentation Dose Pack Content NDC Description 300 mg nirmatrelvir; 100 mg ritonavir Each Carton Contains: 30 tablets divided in 5 daily-dose blister cards 0069-1085-30 Nirmatrelvir tablets: Oval, pink immediate-release, film-coated tablets debossed with "PFE" on one side and "3CL" on the other side. Ritonavir tablets: White film-coated ovaloid tablets debossed with the "a" logo and the code NK. Or 0069-0345-30 Nirmatrelvir tablets: Oval, pink immediate-release, film-coated tablets debossed with "PFE" on one side and "3CL" on the other side. Ritonavir tablets: White to off-white, capsule-shaped, film-coated tablets debossed with "H" on one side and "R9" on the other side. Each Blister Card * Contains: 4 nirmatrelvir tablets (150 mg each) and 2 ritonavir tablets (100 mg each) 0069-1085-06 Nirmatrelvir tablets: Oval, pink immediate-release, film-coated tablets debossed with "PFE" on one side and "3CL" on the other side. Ritonavir tablets: White film-coated ovaloid tablets debossed with the "a" logo and the code NK. Or 0069-0345-06 Nirmatrelvir tablets: Oval, pink immediate-release, film-coated tablets debossed with "PFE" on one side and "3CL" on the other side. Ritonavir tablets: White to off-white, capsule-shaped, film-coated tablets debossed with "H" on one side and "R9" on the other side. 150 mg nirmatrelvir; 100 mg ritonavir Each Carton Contains: 20 tablets divided in 5 daily-dose blister cards 0069-1101-20 Nirmatrelvir tablets: Oval, pink immediate-release, film-coated tablets debossed with "PFE" on one side and "3CL" on the other side. Ritonavir tablets: White film-coated ovaloid tablets debossed with the "a" logo and the code NK. Each Blister Card * Contains: 2 nirmatrelvir tablets (150 mg each) and 2 ritonavir tablets (100 mg each) 0069-1101-04 Nirmatrelvir tablets: Oval, pink immediate-release, film-coated tablets debossed with "PFE" on one side and "3CL" on the other side. Ritonavir tablets: White film-coated ovaloid tablets debossed with the "a" logo and the code NK. Single-dose Blister Card Presentation Dose Pack Content NDC Description 300 mg nirmatrelvir; 100 mg ritonavir Each Carton Contains: 30 tablets divided in 10 blister cards 0069-5001-30 Nirmatrelvir tablets: Oval, pink immediate‑release, film‑coated tablets debossed with "PFE" on one side and "3CL" on the other side. Ritonavir tablets: White film-coated ovaloid tablets debossed with the “a” logo and the code NK. Or 0069-5045-30 Nirmatrelvir tablets: Oval, pink immediate‑release, film‑coated tablets debossed with "PFE" on one side and "3CL" on the other side. Ritonavir tablets: White to off-white, capsule‑shaped, film‑coated tablets debossed with “H” on one side and “R9” on the other side. Or 0069-5321-30 Nirmatrelvir tablets: Oval, pink immediate‑release, film‑coated tablets debossed with "PFE" on one side and "3CL" on the other side. Ritonavir tablets: White film-coated ovaloid tablets debossed with “NK” on one side. Each Blister Card Contains: 2 nirmatrelvir tablets (150 mg each) and 1 ritonavir tablet (100 mg) 0069-5001-06 Nirmatrelvir tablets: Oval, pink immediate‑release, film‑coated tablets debossed with "PFE" on one side and "3CL" on the other side. Ritonavir tablets: White film-coated ovaloid tablets debossed with the “a” logo and the code NK. Or 0069-5045-06 Nirmatrelvir tablets: Oval, pink immediate‑release, film‑coated tablets debossed with "PFE" on one side and "3CL" on the other side. Ritonavir tablets: White to off-white, capsule‑shaped, film‑coated tablets debossed with “H” on one side and “R9” on the other side. Or 0069-5321-03 Nirmatrelvir tablets: Oval, pink immediate‑release, film‑coated tablets debossed with "PFE" on one side and "3CL" on the other side. Ritonavir tablets: White film-coated ovaloid tablets debossed with “NK” on one side. 150 mg nirmatrelvir; 100 mg ritonavir Each Carton Contains: 20 tablets divided in 10 blister cards 0069-5017-20 Nirmatrelvir tablets: Oval, pink immediate‑release, film‑coated tablets debossed with "PFE" on one side and "3CL" on the other side. Ritonavir tablets: White film-coated ovaloid tablets debossed with the “a” logo and the code NK. Or 0069-5317-20 Nirmatrelvir tablets: Oval, pink immediate‑release, film‑coated tablets debossed with "PFE" on one side and "3CL" on the other side. Ritonavir tablets: White film-coated ovaloid tablets debossed with “NK” on one side. Each Blister Card Contains: 1 nirmatrelvir tablet (150 mg) and 1 ritonavir tablet (100 mg) 0069-5017-04 Nirmatrelvir tablets: Oval, pink immediate‑release, film‑coated tablets debossed with "PFE" on one side and "3CL" on the other side. Ritonavir tablets: White film-coated ovaloid tablets debossed with the “a” logo and the code NK. Or 0069-5317-02 Nirmatrelvir tablets: Oval, pink immediate‑release, film‑coated tablets debossed with "PFE" on one side and "3CL" on the other side. Ritonavir tablets: White film-coated ovaloid tablets debossed with “NK” on one side. Storage and Handling Store at USP controlled room temperature 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F).

Termékjellemzők

PAXLOVID- NIRMATRELVIR AND RITONAVIR
PFIZER LABORATORIES DIV PFIZER INC
----------
FACT SHEET FOR HEALTHCARE PROVIDERS:
EMERGENCY USE AUTHORIZATION FOR PAXLOVID™
HIGHLIGHTS OF EMERGENCY USE
AUTHORIZATION (EUA)
THESE HIGHLIGHTS OF THE EUA DO NOT
INCLUDE ALL THE INFORMATION NEEDED TO USE
PAXLOVID UNDER THE EUA. SEE THE
FULL FACT SHEET FOR HEALTHCARE
PROVIDERS FOR PAXLOVID.
PAXLOVID (NIRMATRELVIR TABLETS; RITONAVIR
TABLETS), CO-PACKAGED FOR ORAL USE
ORIGINAL EUA AUTHORIZED DATE: 12/2021
REVISED EUA AUTHORIZED DATE: 11/2023
PAXLOVID is authorized only for the
duration of the declaration that
circumstances exist justifying the
authorization of the emergency use of
PAXLOVID under section 564(b)(1) of
the Act, 21 U.S.C. § 360bbb-3(b)(1),
unless the authorization is terminated
or revoked sooner.
See Full Fact Sheet for Healthcare
Providers for the justification for
emergency use of drugs during the
COVID-19 pandemic, information on
available alternatives, and additional
information on COVID-19.
WARNING: SIGNIFICANT DRUG
INTERACTIONS WITH PAXLOVID
_SEE FULL PRESCRIBING INFORMATION FOR_
_COMPLETE BOXED WARNING._
--------DOSAGE AND
ADMINISTRATION--------
•
•
•
PAXLOVID is nirmatrelvir tablets co-
packaged with ritonavir tablets. (2.1)
Nirmatrelvir must be co-administered
with ritonavir. (2.1)
•
•
•
•
•
•
--------DOSAGE FORMS AND
STRENGTHS--------
•
--------RECENT MAJOR CHANGES--------
Limitations of Authorized Use (1):
updated
11/2023
How Supplied (16): updated
11/2023
Patient Counseling Information
(17): updated
11/2023
Boxed Warning: added
05/2023
Limitations of Authorized Use (1):
updated
05/2023
Contraindications (4): add
rifapentine
05/2023
Warnings and Precautions (5.1,
5.2): updated
05/2023
Adverse Reactions (6.1, 6.2):
updated
05/2023
TM
PAXLOVID INCLUDES RITONAVIR, A
STRONG CYP3A INHIBITOR, WHICH MAY
LEAD TO GREATER EXPOSURE OF CERTAIN
CONCOMITANT MEDICATIONS, RESULTING IN
POTENTIALLY SEVERE, LIFE-THREATENING,
OR FATAL EVENTS. _(4, 5.1, 7)_
PRIOR TO PRESCRIBING PAXLOVID: 1)
REVIEW ALL MEDICAT