Approved Drug Label (PDF)
Boxed Warning
Box
Warning has been revised; see full information below:
WARNING:
SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS
(MACE), AND THROMBOSIS
See
full prescribing information for complete boxed warning.
•
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
stroke) with XELJANZ vs. TNF blockers in RA patients. (5.4)
•
Thrombosis has occurred in patients treated with XELJANZ. Increased incidence
of pulmonary embolism, venous and arterial thrombosis with XELJANZ vs. TNF
blockers in RA patients. (5.5)
5
Warnings and Precautions
5.2 Mortality
Additions and/or
revisions underlined:
Rheumatoid arthritis patients 50 years of age and
older with at least one cardiovascular risk factor treated with XELJANZ 5 mg
twice a day or XELJANZ 10 mg twice a day had a higher observed rate
of all-cause mortality, including sudden cardiovascular death, compared
to those treated with TNF blockers in a large, randomized, postmarketing
safety study (RA Safety Study 1). The incidence rate of all-cause
mortality per 100 patient-years was 0.88 for XELJANZ 5 mg twice a day,
1.23 for XELJANZ 10 mg twice a day, and 0.69 for TNF blockers [see Clinical Studies (14.5)]. Consider
the benefits and risks for the individual patient prior to initiating or
continuing therapy with XELJANZ/XELJANZ XR/XELJANZ Oral Solution.
A XELJANZ/XELJANZ Oral Solution 10 mg twice daily (or
a XELJANZ XR 22 mg once daily) dosage is not recommended for the
treatment of RA or PsA [see Dosage and
Administration (2.2)].
For the treatment of UC, use XELJANZ/XELJANZ XR
at the lowest effective dose and for the shortest duration needed to
achieve/maintain therapeutic response [see
Dosage and Administration (2.3)].
5.3 Malignancy and Lymphoproliferative Disorders
Additions and/or
revisions underlined:
Malignancies,
including lymphomas and solid cancers, were observed in clinical studies of
XELJANZ [see Adverse Reactions (6.1)].
In RA Safety Study
1, a higher rate of malignancies (excluding non-melanoma skin cancer (NMSC))
was observed in patients treated with XELJANZ 5 mg twice a day or XELJANZ 10 mg
twice a day as compared with TNF blockers. The incidence rate of malignancies
(excluding NMSC) per 100 patient-years was 1.13 for XELJANZ 5 mg twice a day,
1.13 for XELJANZ 10 mg twice a day, and 0.77 for TNF blockers. Patients who are
current or past smokers are at additional increased risk [see Clinical Studies (14.5)].
Lymphomas and lung
cancers, which are a subset of all malignancies in RA Safety Study 1, were
observed at a higher rate in patients treated with XELJANZ 5 mg twice a day and
XELJANZ
10
mg twice a day compared to those treated with TNF blockers. The incidence rate
of lymphomas per 100 patient-years was 0.07 for XELJANZ 5 mg twice a day, 0.11
for XELJANZ 10 mg twice a day, and 0.02 for TNF blockers. The incidence rate of
lung cancers per
100
patient-years among current and past smokers was 0.48 for XELJANZ 5 mg twice a
day,
0.59
for XELJANZ 10 mg twice a day, and 0.27 for TNF blockers [see Clinical Studies (14.5)].
Consider
the benefits and risks for the individual patient prior to initiating or
continuing therapy with XELJANZ/XELJANZ XR/XELJANZ Oral Solution,
particularly in patients with a known malignancy (other than a successfully
treated NMSC), patients who develop a malignancy while on treatment, and
patients who are current or past smokers. A XELJANZ/XELJANZ Oral Solution 10
mg twice daily (or a XELJANZ XR 22 mg once daily) dosage is not recommended for
the treatment of RA or PsA [see
Dosage and Administration (2.2)].
In Phase 2B, controlled
dose-ranging trials in de-novo renal
transplant patients, all of whom received induction therapy with basiliximab,
high-dose corticosteroids, and mycophenolic acid products, Epstein Barr
Virus-associated post-transplant lymphoproliferative disorder was observed in 5
out of 218 patients treated with XELJANZ (2.3%) compared to 0 out of
111
patients treated with cyclosporine.
Other
malignancies were observed in clinical studies and the postmarketing setting,
including, but not limited to, lung cancer, breast cancer, melanoma, prostate
cancer, and pancreatic cancer.
Non-Melanoma Skin
Cancer
Non-melanoma skin
cancers (NMSCs) have been reported in patients treated with XELJANZ. Periodic
skin examination is recommended for patients who are at increased risk for skin
cancer. In the UC population, treatment with XELJANZ 10 mg twice daily was
associated with greater risk of NMSC.
5.4 Major Adverse Cardiovascular Events
Newly
added subsection:
In
RA Safety Study 1, RA patients who were 50 years of age and older with at least
one cardiovascular risk factor treated with XELJANZ 5 mg twice daily or XELJANZ
10 mg twice daily had a higher rate of major adverse cardiovascular events
(MACE) defined as cardiovascular death, non-fatal myocardial infarction (MI),
and non-fatal stroke, compared to those treated with TNF blockers. The
incidence rate of MACE per 100 patient-years was 0.91 for XELJANZ 5 mg twice a
day, 1.11 for XELJANZ 10 mg twice a day, and 0.79 for TNF blockers. The
incidence rate of fatal or non-fatal myocardial infarction per 100
patient-years was 0.36 for XELJANZ 5 mg twice a day, 0.39 for XELJANZ 10 mg
twice a day, and 0.20 for TNF blockers [see
Clinical Studies (14.5)]. Patients who are current or past smokers are at
additional increased risk.
Consider
the benefits and risks for the individual patient prior to initiating or
continuing therapy with XELJANZ/XELJANZ XR/XELJANZ Oral Solution, particularly
in patients who are current or past smokers and patients with other
cardiovascular risk factors. Patients should be informed about the symptoms of
serious cardiovascular events and the steps to take if they occur. Discontinue
XELJANZ/XELJANZ XR/XELJANZ Oral Solution in patients that have experienced a
myocardial infarction or stroke. A XELJANZ/XELJANZ Oral Solution 10 mg twice
daily (or a XELJANZ XR 22 mg once daily) dosage is not recommended for the
treatment of RA or PsA [see Dosage and
Administration (2.2)].
5.5 Thrombosis
Additions and/or
revisions underlined:
Thrombosis,
including pulmonary embolism (PE), deep venous thrombosis (DVT),
and arterial thrombosis, have occurred in patients treated with XELJANZ and
other Janus kinase (JAK) inhibitors
used to treat inflammatory conditions. Many of these events were serious and
some resulted in death [see Warnings and
Precautions (5.2)].
Patients with
rheumatoid arthritis 50 years of age and older with at least one cardiovascular
risk factor treated with XELJANZ at both 5 mg or 10 mg twice daily compared to
TNF blockers in RA Safety Study 1 had an observed increase in incidence of
these events. The incidence rate of DVT per 100 patient-years was 0.22 for
XELJANZ 5 mg twice a day, 0.28 for XELJANZ 10 mg twice a day, and 0.16 for TNF
blockers. The incidence rate of PE per 100 patient-years was 0.18 for XELJANZ 5
mg twice a day, 0.49 for XELJANZ 10 mg twice a day, and 0.05 for TNF blockers [see Clinical Studies (14.5)].
A XELJANZ/XELJANZ
Oral Solution 10 mg twice daily (or a XELJANZ XR 22 mg once daily)
dosage is not recommended for the treatment of RA or PsA [see Dosage and Administration (2.2)].
In a long-term
extension study in patients with UC, five cases of pulmonary embolism
were reported in patients taking XELJANZ 10 mg twice daily, including one death
in a patient with advanced cancer.
Promptly evaluate
patients with symptoms of thrombosis and discontinue XELJANZ/XELJANZ XR/XELJANZ
Oral Solution in patients with symptoms of thrombosis.
Avoid
XELJANZ/XELJANZ XR/XELJANZ Oral Solution in patients that may be at increased
risk of thrombosis. For the treatment of UC, use XELJANZ/XELJANZ XR at
the lowest effective dose and for the shortest duration needed to
achieve/maintain therapeutic response [see
Dosage and Administration (2.3)].
6
Adverse Reactions
Addition of the
following to the bulleted line listing:
6.1 Clinical Trials Experience
Additions and/or
revisions underlined:
Because clinical studies are conducted under widely
varying conditions, adverse reaction rates observed in the clinical studies of
a drug cannot be directly compared to rates in the clinical studies of another
drug and may not predict the rates observed in a broader patient population in
clinical practice.
Rheumatoid Arthritis
The clinical studies described in the following sections
were conducted using XELJANZ. Although other doses of XELJANZ have been
studied, the recommended dose of XELJANZ is 5 mg twice daily. The recommended
dose for XELJANZ XR is 11 mg once daily. A dosage of XELJANZ 10 mg twice daily
or XELJANZ XR 22 mg once daily is not a recommended regimen for the treatment
of rheumatoid arthritis [see Dosage and
Administration (2.2)]. In RA Safety Study 1, 1455 patients were treated
with XELJANZ 5 mg twice daily, 1456 patients were treated with 10 mg twice
daily, and 1451 patients were treated with a TNF blocker for a median of
4.0 years [see
Clinical Studies (14.5)].
…
During the 2 PsA controlled clinical trials, there
were 3 malignancies (excluding NMSC) in 474 patients receiving XELJANZ plus
non-biologic DMARD (6 to 12 months exposure) compared with 0 malignancies in
236 patients in the placebo plus non-biologic DMARD group (3 months exposure)
and 0 malignancies in 106 patients in the adalimumab plus non-biologic DMARD
group (12 months exposure). No lymphomas were reported.
Malignancies have also been observed in the long-term extension study in
psoriatic arthritis patients treated with XELJANZ.
…
In the long-term extension study, malignancies
(including solid cancers, lymphomas and NMSC) were observed in patients treated
with XELJANZ 5 mg and 10 mg twice daily [see
Warnings and Precautions (5.3)]. Five cases of pulmonary embolism were
reported in patients taking XELJANZ 10 mg twice daily, including one fatality
in a patient with advanced cancer [see
Warnings and Precautions (5.5)].
…
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
MEDICATION GUIDE
Extensive changes; please refer
to label
PATIENT COUNSELING INFORMATION
Additions and/or
revisions underlined:
Advise
the patient to read the FDA-approved patient labeling (Medication Guide and
Instructions for Use).
Serious Infections
Inform
patients that XELJANZ/XELJANZ XR/XELJANZ Oral Solution may lower the ability of
their immune system to fight infections. Advise patients not to start taking
XELJANZ/XELJANZ XR/XELJANZ Oral Solution if they have an active infection.
Instruct patients to contact their healthcare provider immediately during
treatment if symptoms suggesting infection appear in order to ensure rapid
evaluation and appropriate treatment [see
Warnings and Precautions (5.1)].
Advise
patients that the risk of herpes zoster, some cases of which can be serious, is
increased in patients treated with XELJANZ/XELJANZ XR [see Warnings and Precautions (5.1)].
Malignancies and
Lymphoproliferative Disorders
Inform
patients that XELJANZ/XELJANZ XR/XELJANZ Oral Solution may increase their risk
of certain cancers, and that lymphoma and other cancers have been observed in
patients taking XELJANZ. Instruct patients to inform their healthcare provider
if they have ever had any type of cancer [see
Warnings and Precautions (5.3)].
Major
Adverse Cardiovascular Events
Inform
patients that XELJANZ/XELJANZ XR/XELJANZ Oral Solution may increase their risk
of major adverse cardiovascular events (MACE) defined as myocardial infarction,
stroke, and cardiovascular death. Instruct all patients, especially current or
past smokers or patients with other cardiovascular risk factors, to be alert
for the development of signs and symptoms of cardiovascular events [see Warnings and Precautions (5.4)].
Thrombosis
Advise
patients to stop taking XELJANZ/XELJANZ XR/XELJANZ Oral Solution and to call
their healthcare provider right away if they experience any symptoms of
thrombosis (sudden shortness of breath, chest pain worsened with breathing,
swelling of leg or arm, leg pain or tenderness, red or discolored skin in the
affected leg or arm) [see Warnings and Precautions
(5.5)].
Hypersensitivity
Advise
patients to stop taking XELJANZ/XELJANZ XR/XELJANZ Oral Solution and to call
their healthcare provider right away if they experience any symptoms of
allergic reactions while taking XELJANZ/XELJANZ XR/XELJANZ Oral Solution [see Warnings and Precautions (5.7)].
Important
Information on Laboratory Abnormalities
Inform
patients that XELJANZ/XELJANZ XR/XELJANZ Oral Solution may affect certain lab
test results, and that blood tests are required before and during
XELJANZ/XELJANZ
XR/XELJANZ Oral Solution treatment [see
Warnings and Precautions (5.8)].
Pregnancy
Advise
pregnant women and females of reproductive potential of the potential risk to a
fetus. Advise females to inform their prescriber of a known or suspected
pregnancy. Inform patients that Pfizer has a registry for pregnant women who
have taken
XELJANZ/XELJANZ
XR/XELJANZ Oral Solution during pregnancy. Advise patients to contact the
registry at 1-877-311-8972 to enroll [see
Use in Specific Populations (8.1)].
Lactation
Advise
women not to breastfeed during treatment with XELJANZ/XELJANZ XR/XELJANZ Oral
Solution and for at least 18 hours after the last dose of XELJANZ/XELJANZ Oral
Solution or 36 hours after the last dose of XELJANZ XR [see Use in Specific Populations (8.2)].
Infertility
Advise
females of reproductive potential that XELJANZ/XELJANZ XR/XELJANZ Oral Solution
may impair fertility [see Use in Specific
Populations (8.3), Nonclinical Toxicology (13.1)]. It is not known if this
effect is reversible.
Residual
Tablet Shell
Patients
receiving XELJANZ XR may notice an inert tablet shell passing in the stool or
via colostomy. Patients should be informed that the active medication has
already been absorbed by the time the patient sees the inert tablet shell.
Approved Drug Label (PDF)
Boxed Warning
(addition underlined)
…
Reported
infections include:
Active
tuberculosis, which may present with pulmonary or extrapulmonary disease.
Patients should be tested for latent tuberculosis before XELJANZ/XELJANZ XR use
and during therapy. Treatment for latent
infection should be initiated prior to XELJANZ/XELJANZ XR use.
Invasive
fungal infections, including cryptococcosis and pneumocystosis. Patients with
invasive fungal infections may present with disseminated, rather than
localized, disease.
Bacterial,
viral, including herpes zoster, and other infections due to
opportunistic pathogens.
…
5
Warnings and Precautions
5.2 Malignancy and Lymphoproliferative Disorders
(additions underlined)
…
In the 2 controlled Phase 3 clinical trials in
patients with active psoriatic arthritis, there were 3 malignancies (excluding
NMSC) in 474 patients receiving XELJANZ plus non-biologic
DMARD (6 to 12 months exposure) compared with 0
malignancies in 236 patients in the placebo plus non-biologic DMARD group (3 months
exposure) and 0 malignancies in 106 patients in the adalimumab plus
non-biologic DMARD group (12 months exposure). No lymphomas were reported.
Malignancies have also been observed in the long-term extension study in
psoriatic arthritis patients treated with XELJANZ.
…
6
Adverse Reactions
6.1 Clinical Trial Experience
(additions underlined)
…
Rheumatoid Arthritis
The clinical studies described in the following
sections were conducted using XELJANZ. Although other doses of XELJANZ have
been studied, the recommended dose of XELJANZ is 5 mg twice daily.
The recommended dose for XELJANZ XR is 11 mg once
daily.
…
Psoriatic Arthritis
XELJANZ 5 mg twice daily and 10 mg twice daily were
studied in 2 double-blind Phase 3 clinical trials in patients with active psoriatic
arthritis (PsA).
Study PsA-I (NCT01877668) had a duration of 12
months and enrolled patients who had an inadequate response to a nonbiologic
DMARD and who were naïve to treatment with a TNF-inhibitor (TNFi). Study PsA-I
included a 3-month placebo-controlled period and also included adalimumab 40 mg
subcutaneously once every 2 weeks for 12 months.
Study PsA-II (NCT01882439) had a duration of 6
months and enrolled patients who had an inadequate response to at least one
approved TNFi. This clinical trial included a 3-month placebo controlled
period.
In these combined Phase 3 clinical trials, 238
patients were randomized and treated with XELJANZ 5 mg twice daily and 236
patients were randomized and treated with XELJANZ 10 mg twice daily. All
patients in the clinical trials were required to receive treatment with a
stable dose of a nonbiologic DMARD [the majority (79%) received methotrexate].
The study population randomized and treated with XELJANZ (474 patients)
included 45 (9.5%) patients aged 65 years or older and 66 (13.9%) patients with
diabetes at baseline.
The safety profile observed in patients with active
psoriatic arthritis treated with XELJANZ was consistent with the safety profile
observed in rheumatoid arthritis patients.
7
Drug Interactions
7.4 Immunosuppressive Drugs
(additions underlined)
There is a risk of added immunosuppression when
XELJANZ/XELJANZ XR is coadministered with potent immunosuppressive drugs (e.g.,
azathioprine, tacrolimus, cyclosporine). Combined use of multiple-dose XELJANZ/XELJANZ
XR with potent immunosuppressants has not been studied in rheumatoid arthritis and
psoriatic arthritis. Use of XELJANZ/XELJANZ XR in combination with biologic
DMARDs or potent immunosuppressants such as azathioprine and cyclosporine is
not recommended.
8
Use in Specific Populations
8.5 Geriatric Use
(additions underlined)
Of the 3315 patients who enrolled in rheumatoid
arthritis Studies I to V, a total of
505 rheumatoid arthritis patients were 65 years of
age and older, including 71 patients 75 years and older. The frequency of
serious infection among XELJANZ-treated subjects 65 years of age and older was
higher than among those under the age of 65.
As there is a higher incidence of infections in the
elderly population in general, caution should be used when treating the
elderly.
8.8 Renal Impairment
(additions underlined)
XELJANZ-treated patients with moderate and severe
renal impairment had greater tofacitinib blood levels than XELJANZ-treated
patients with normal renal function; therefore, the recommended dose is XELJANZ
5 mg once daily in patients with moderate and severe renal impairment [see Dosage and Administration (2.5)].
In clinical trials, XELJANZ/XELJANZ XR was not evaluated in rheumatoid
arthritis patients with baseline creatinine clearance values (estimated by the
Cockroft-Gault equation) less than 40 mL/ min (or in patients with active
psoriatic arthritis with creatinine clearance values less than 50 mL/min).
No dose adjustment is required in patients with mild renal impairment.
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
MEDICATION GUIDE
(additions underlined)
…
You should not start taking XELJANZ/XELJANZ XR 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).
…
Approved Drug Label (PDF)
5
Warnings and Precautions
5.1 Serious Infections
(additions
underlined)
Serious
and sometimes fatal infections due to bacterial, mycobacterial, invasive
fungal, viral, or other opportunistic pathogens have been reported in
rheumatoid arthritis patients receiving XELJANZ. The most common serious
infections reported with XELJANZ included pneumonia, cellulitis, herpes zoster,
urinary tract infection, diverticulitis, and appendicitis. Among
opportunistic infections, tuberculosis and other mycobacterial infections,
cryptococcosis, esophageal candidiasis, pneumocystosis, multidermatomal herpes
zoster, cytomegalovirus infections, BK virus infection, and
listeriosis were reported with XELJANZ. Some patients have presented with
disseminated rather than localized disease, and were often taking concomitant
immunomodulating agents such as methotrexate or corticosteroids.
Other
serious infections that were not reported in clinical studies may also occur
(e.g., histoplasmosis and coccidioidomycosis).
![]()
…
Caution
is also recommended in patients with a history of chronic lung disease, or in
those who develop interstitial lung disease, as they may be more prone to
infections.
Risk
of infection may be higher with increasing degrees of lymphopenia and
consideration should be given to lymphocyte counts when assessing individual
patient risk of infection. Discontinuation and monitoring criteria for
lymphopenia are discussed in Dosage Modifications due to Serious Infections and
Cytopenias.
![]()
Tuberculosis
Patients
should be evaluated and tested for latent or active infection prior to and
per applicable guidelines during administration of XELJANZ /XELJANZ XR.
…
5.2 Malignancy and Lymphoproliferative Disorders
![]()
…
Other
malignancies were observed in clinical studies and the post-marketing setting,
including, but not limited to, lung cancer, breast cancer, melanoma, prostate
cancer, and pancreatic cancer.
5.5 Vaccinations
(additions
underlined)
![]()
Avoid use of live vaccines concurrently with XELJANZ/XELJANZ XR. The
interval between live vaccinations and initiation of tofacitinib therapy should
be in accordance with current vaccination guidelines regarding
immunosuppressive agents.
A
patient experienced dissemination of the vaccine strain of varicella zoster
virus, 16 days after vaccination with live attenuated (Zostavax) virus vaccine
and 2 days after treatment start with tofacitinib 5 mg twice daily. The patient
was varicella virus naïve, as evidenced by no previous history of varicella infection
and no anti-varicella antibodies at baseline. Tofacitinib was discontinued and
the patient recovered after treatment with standard doses of antiviral
medication.
Update
immunizations in agreement with current immunization guidelines prior to initiating
XELJANZ/XELJANZ XR therapy.
8
Use in Specific Populations
8.1 Pregnancy
(PLLR
conversion; please refer to label)
8.2 Lactation Risk
(PLLR
conversion)
Summary
It
is not known whether tofacitinib is excreted in human milk. Additionally, there
are no data to assess the effects of the drug on the breastfed child. However,
tofacitinib is excreted in rat milk at concentrations higher than in maternal
serum [see Data]. Women should not
breastfeed while treated with XELJANZ/XELJANZ XR. A decision should be made
whether to discontinue breastfeeding or to discontinue XELJANZ/XELJANZ XR.
Data
Human Data
There
are no adequate and well-controlled studies of XELJANZ/XELJANZ XR use during
breastfeeding.
Animal Data
Following
administration of tofacitinib to lactating rats, concentrations of tofacitinib
in milk over time paralleled those in serum, and were approximately 2 times
higher in milk relative to maternal serum at all time points measured.
8.3 Females and Males of Reproductive Potential
(PLLR
conversion)
Contraception
Females
Embryofetal
toxicity including malformations occurred in embryofetal development studies in
rats and rabbits.
Females
of reproductive potential should be advised to use effective contraception
during treatment with XELJANZ/XELJANZ XR and for at least 4 weeks after the
last dose. Advise females to contact their healthcare provider if they become
pregnant, or if pregnancy is suspected, during treatment with XELJANZ/XELJANZ
XR.
Infertility
Females
Based
on findings in rats, treatment with XELJANZ/XELJANZ XR may result in reduced
fertility in females of reproductive potential.
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
Medication Guide
(additions
underlined)
What is the most important
information I should know about XELJANZ/XELJANZ XR? XELJANZ/XELJANZ XR may
cause serious side effects including:
1. Serious infections.
XELJANZ/XELJANZ
XR is a medicine that affects your immune system. XELJANZ/XELJANZ XR can lower
the ability of your immune system to fight infections. Some people can have
serious infections while taking XELJANZ/XELJANZ XR, 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 and
during treatment.
…
Before starting
XELJANZ/XELJANZ XR, tell your healthcare provider if you:
…
PATIENT COUNSELING INFORMATION
(additions
underlined)
…
Pregnancy
Inform
patients that XELJANZ/XELJANZ XR should not be used during pregnancy unless
clearly necessary, and advise patients to inform their doctors right away if
they become pregnant while taking XELJANZ/XELJANZ XR. Inform patients that
Pfizer has a registry for pregnant women who have taken XELJANZ/XELJANZ XR
during pregnancy. Advise patients to contact the registry at 1-877-311-8972 to
enroll. Women of reproductive potential should be advised to use effective
contraception during treatment with XELJANZ/XELJANZ XR and for at least 4 weeks
after the last dose. Inform patients
that they should not breastfeed while taking XELJANZ/XELJANZ XR.
…
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