XELJANZ- tofacitinib tablet, film coated XELJANZ XR- tofacitinib tablet, film coated, extended release XELJANZ- tofacitinib so

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

TOFACITINIB CITRATE (UNII: O1FF4DIV0D) (TOFACITINIB - UNII:87LA6FU830)

Boleh didapati daripada:

Pfizer Laboratories Div Pfizer Inc

INN (Nama Antarabangsa):

TOFACITINIB CITRATE

Komposisi:

TOFACITINIB 5 mg

Laluan pentadbiran:

ORAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

XELJANZ/XELJANZ XR is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more TNF blockers. XELJANZ/XELJANZ XR is indicated for the treatment of adult patients with active psoriatic arthritis (PsA) who have had an inadequate response or intolerance to one or more TNF blockers. XELJANZ/XELJANZ XR is indicated for the treatment of adult patients with active ankylosing spondylitis (AS) who have had an inadequate response or intolerance to one or more TNF blockers. XELJANZ/XELJANZ XR is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC), who have an inadequate response or intolerance to one or more TNF blockers. XELJANZ/XELJANZ Oral Solution is indicated for the treatment of active polyarticular course juvenile idiopathic arthritis (pcJIA) in patients 2 years of age and older who have had an inadequate response or intolerance to one or more TNF

Ringkasan produk:

How supplied information for XELJANZ/XELJANZ XR is shown in Table 22. XELJANZ 5 mg tofacitinib tablets White, round, immediate-release film-coated tablets, debossed with "Pfizer" on one side, and "JKI 5" on the other side 60 NDC 0069-1001-01 XELJANZ 10 mg tofacitinib tablets Blue, round, immediate-release film-coated tablets, debossed with "Pfizer" on one side, and "JKI 10" on the other side 60 NDC 0069-1002-01 XELJANZ XR 11 mg tofacitinib tablets Pink, oval, extended-release film-coated tablets with a drilled hole at one end of the tablet band and "JKI 11" printed on one side of the tablet 30 NDC 0069-0501-30 XELJANZ XR 22 mg tofacitinib tablets Beige, oval, extended-release film-coated tablets with a drilled hole at one end of the tablet band and "JKI 22" printed on one side of the tablet 30 NDC 0069-0502-30 How supplied information for XELJANZ Oral Solution is shown in Table 23. XELJANZ Oral Solution 1 mg/mL tofacitinib oral solution Clear, colorless solution 240 mL NDC 0069-1029-02 XELJANZ/XELJANZ XR Store XELJANZ/XELJANZ XR at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature]. Do not repackage. XELJANZ Oral Solution XELJANZ 1 mg/ mL oral solution is a clear, colorless solution that contains 1 mg of tofacitinib. It is packaged in HDPE bottles as follows: Each bottle is packaged with one press-in bottle adapter and one 5 mL oral dosing syringe with 3.2 mL, 4 mL, and 5 mL gradations. The press-in bottle adapter and oral dosing syringe are not made with natural rubber latex. Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F). [See USP Controlled Room Temperature]. Store in the original bottle and carton to protect from light. Use contents of bottle within 60 days of opening. Discard remaining oral solution after 60 days.

Status kebenaran:

New Drug Application

Risalah maklumat

XELJANZ XR- TOFACITINIB TABLET, FILM COATED, EXTENDED RELEASE
XELJANZ- TOFACITINIB SOLUTION
Pfizer Laboratories Div Pfizer Inc
----------
This Medication Guide has been
approved by the U.S. Food and
Drug Administration.
Revised: December 2021
MEDICATION GUIDE
XELJANZ (ZEL' JANS')
(tofacitinib)
tablets, for oral use
XELJANZ XR (ZEL' JANS' EKS-
AHR)
(tofacitinib)
extended-release tablets, for oral use
XELJANZ (ZEL' JANS')
(tofacitinib)
Oral Solution
What is the most important information I should know about
XELJANZ/XELJANZ XR/XELJANZ Oral
Solution?
XELJANZ/XELJANZ XR/XELJANZ Oral Solution may cause serious side
effects including:
1.
Serious infections. XELJANZ/XELJANZ XR/XELJANZ Oral Solution
is a medicine that affects your immune system. XELJANZ/XELJANZ
XR/XELJANZ Oral Solution can lower the ability of your immune
system to fight infections. Some people can have serious infections
while
taking XELJANZ/XELJANZ XR/XELJANZ Oral Solution, including
tuberculosis (TB), and infections caused by bacteria, fungi, or
viruses
that can spread throughout the body. Some people have died from these
infections.
•
Your healthcare provider should test you for TB before starting
XELJANZ/XELJANZ XR/XELJANZ Oral Solution and during
treatment.
•
Your healthcare provider should monitor you closely for signs and
symptoms of TB infection during treatment with
XELJANZ/XELJANZ XR/XELJANZ Oral Solution.
You should not start taking XELJANZ/XELJANZ XR/XELJANZ Oral
Solution if you have any kind of infection unless your healthcare
provider tells you it is okay. You may be at a higher risk of
developing
shingles (herpes zoster).
People with ulcerative colitis taking the higher dose of XELJANZ (10
mg twice daily) or XELJANZ XR (22 mg one time each day) have a
higher risk of serious infections and shingles.
Before starting XELJANZ/XELJANZ XR/XELJANZ Oral Solution, tell
your healthcare provider if you:
•
think you have an infection or have symptoms of an infection such
as:
o
o
fever,
sweating, or
chills
o
cough
o
blood in
phlegm
o
warm, red,
o

Ciri produk

XELJANZ- TOFACITINIB TABLET, FILM COATED
XELJANZ XR- TOFACITINIB TABLET, FILM COATED, EXTENDED RELEASE
XELJANZ- TOFACITINIB SOLUTION
PFIZER LABORATORIES DIV PFIZER INC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
XELJANZ/XELJANZ
XR/XELJANZ ORAL SOLUTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
XELJANZ/XELJANZ XR/XELJANZ ORAL SOLUTION.
XELJANZ (TOFACITINIB) TABLETS, FOR ORAL USE
XELJANZ XR (TOFACITINIB) EXTENDED-RELEASE TABLETS, FOR ORAL USE
XELJANZ (TOFACITINIB) ORAL SOLUTION
INITIAL U.S. APPROVAL: 2012
WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE
CARDIOVASCULAR EVENTS (MACE), AND THROMBOSIS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
•
•
•
•
•
RECENT MAJOR CHANGES
Boxed Warning
12/2021
Indications and Usage (1)
12/2021
Dosage and Administration (2.2)
12/2021
Warnings and Precautions (5.2)
12/2021
Warnings and Precautions (5.3)
12/2021
Warnings and Precautions (5.4)
12/2021
Warnings and Precautions (5.5)
12/2021
INDICATIONS AND USAGE
XELJANZ/XELJANZ XR/XELJANZ Oral Solution is a Janus kinase (JAK)
inhibitor indicated for:
•
•
®
®
®
INCREASED RISK OF SERIOUS BACTERIAL, FUNGAL, VIRAL, AND OPPORTUNISTIC
INFECTIONS
LEADING TO HOSPITALIZATION OR DEATH, INCLUDING TUBERCULOSIS (TB).
INTERRUPT TREATMENT
WITH XELJANZ/XELJANZ XR/XELJANZ ORAL SOLUTION IF SERIOUS INFECTION
OCCURS UNTIL THE
INFECTION IS CONTROLLED. TEST FOR LATENT TB BEFORE AND DURING THERAPY;
TREAT LATENT TB
PRIOR TO USE. MONITOR ALL PATIENTS FOR ACTIVE TB DURING TREATMENT,
EVEN PATIENTS WITH
INITIAL NEGATIVE LATENT TB TEST. (5.1)
HIGHER RATE OF ALL-CAUSE MORTALITY, INCLUDING SUDDEN CARDIOVASCULAR
DEATH WITH
XELJANZ VS. TNF BLOCKERS IN RHEUMATOID ARTHRITIS (RA) PATIENTS. (5.2)
MALIGNANCIES HAVE OCCURRED IN PATIENTS TREATED WITH XELJANZ. HIGHER
RATE OF
LYMPHOMAS AND LUNG CANCERS WITH XELJANZ VS. TNF BLOCKERS IN RA
PATIENTS. (5.3)
HIGHER RATE OF MACE (DEFINED AS CARDIOVASCULAR DEATH, MYOCARDIAL
INFARCTION, AND
STROK