XELJANZ XR provides adult patients living
with moderately to severely active UC the first and only once-daily
JAK inhibitor for managing their disease
Pfizer Inc. (NYSE:PFE) announced today that the
U.S. Food and Drug Administration (FDA) has approved XELJANZ® XR
(tofacitinib) extended-release 11 mg and 22 mg tablets for the
once-daily treatment of adult patients with moderately to severely
active ulcerative colitis (UC), after an inadequate response or
intolerance to TNF blockers.
“Ulcerative colitis is a chronic inflammatory disease of the
colon that can significantly affect a patient’s quality of life and
be emotionally burdensome due to symptoms, flares and
complications,” said Michael Corbo, Chief Development Officer,
Inflammation & Immunology, Pfizer Global Product Development.
“We are pleased to now offer patients with moderately to severely
active ulcerative colitis and their healthcare providers a
convenient once-daily dosing option with XELJANZ.”
XELJANZ/XELJANZ XR is indicated for the treatment of adult
patients with moderately to severely active UC, who have had an
inadequate response or who are intolerant to TNF blockers. Use of
XELJANZ/XELJANZ XR in combination with biological therapies for UC
or with potent immunosuppressants such as azathioprine and
cyclosporine is not recommended. XELJANZ 10 mg twice daily or
XELJANZ XR 22 mg once daily may be given for eight weeks or up to a
maximum of 16 weeks as induction therapy. Following, XELJANZ 5 mg
twice daily or XELJANZ XR 11 mg once daily may be given as
maintenance treatment. For patients with loss of response during
maintenance treatment, XELJANZ 10 mg twice daily or XELJANZ XR 22
mg once daily may be considered and limited to the shortest
duration, with careful consideration of benefits and risks to the
individual patient. Use the lowest effective dose needed to
maintain response. Dosage adjustment is needed in patients with
moderate and severe renal impairment or moderate hepatic
impairment. For dosing adjustments, refer to the XELJANZ/XELJANZ XR
Full Prescribing Information at:
https://labeling.pfizer.com/ShowLabeling.aspx?id=959.
About XELJANZ® (tofacitinib) XELJANZ® (tofacitinib) is
approved in the U.S. for adult patients in three indications:
moderately to severely active rheumatoid arthritis (RA) after
methotrexate failure, active psoriatic arthritis (PsA) after
disease modifying antirheumatic drug (DMARD) failure and moderately
to severely active ulcerative colitis (UC) after tumor necrosis
factor inhibitor (TNFi) failure. XELJANZ has been studied in more
than 50 clinical trials worldwide, including more than 20 trials in
RA patients, and prescribed to over 208,000 adult patients (the
majority of whom were RA patients) worldwide in the last seven
years.
As the developer of tofacitinib, Pfizer is committed to
advancing the science of JAK inhibition and enhancing understanding
of tofacitinib through robust clinical development programs in the
treatment of immune-mediated inflammatory conditions.
Please see XELJANZ/XELJANZ XR Full Prescribing Information at
https://labeling.pfizer.com/ShowLabeling.aspx?id=959.
INDICATIONS
Rheumatoid Arthritis
- XELJANZ/XELJANZ XR (tofacitinib) is indicated for the treatment
of adult patients with moderately to severely active rheumatoid
arthritis who have had an inadequate response or intolerance to
methotrexate. It may be used as monotherapy or in combination with
methotrexate or other nonbiologic disease-modifying antirheumatic
drugs (DMARDs).
- Limitations of Use: Use of XELJANZ/XELJANZ XR in combination
with biologic DMARDs or with potent immunosuppressants such as
azathioprine and cyclosporine is not recommended.
Psoriatic Arthritis
- XELJANZ/XELJANZ XR (tofacitinib) is indicated for the treatment
of adult patients with active psoriatic arthritis who have had an
inadequate response or intolerance to methotrexate or other
disease-modifying antirheumatic drugs (DMARDs).
- Limitations of Use: Use of XELJANZ/XELJANZ XR in combination
with biologic DMARDs or with potent immunosuppressants such as
azathioprine and cyclosporine is not recommended.
Ulcerative Colitis
- XELJANZ/XELJANZ XR is indicated for the treatment of adult
patients with moderately to severely active ulcerative colitis
(UC), who have had an inadequate response or who are intolerant to
TNF blockers.
- Limitations of Use: Use of XELJANZ/XELJANZ XR in combination
with biological therapies for UC or with potent immunosuppressants
such as azathioprine and cyclosporine is not recommended.
IMPORTANT SAFETY INFORMATION
SERIOUS INFECTIONS
Patients treated with XELJANZ/XELJANZ XR are at increased
risk for developing serious infections that may lead to
hospitalization or death. Most patients who developed these
infections were taking concomitant immunosuppressants, such as
methotrexate or corticosteroids.
If a serious infection develops, interrupt XELJANZ/XELJANZ XR
until the infection is controlled.
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.
The most common serious infections reported with XELJANZ
included pneumonia, cellulitis, herpes zoster, urinary tract
infection, diverticulitis, and appendicitis. Avoid use of
XELJANZ/XELJANZ XR in patients with an active, serious infection,
including localized infections, or with chronic or recurrent
infection.
In the UC population, XELJANZ 10 mg twice daily was associated
with greater risk of serious infections compared to 5 mg twice
daily. Opportunistic herpes zoster infections (including
meningoencephalitis, ophthalmologic, and disseminated cutaneous)
were seen in patients who were treated with XELJANZ 10 mg twice
daily.
The risks and benefits of treatment with XELJANZ/XELJANZ XR
should be carefully considered prior to initiating therapy in
patients with chronic or recurrent infection, or those who have
lived or traveled in areas of endemic TB or mycoses. Viral
reactivation including herpes virus and hepatitis B reactivation
have been reported. Screening for viral hepatitis should be
performed in accordance with clinical guidelines before starting
therapy.
Patients should be closely monitored for the development of
signs and symptoms of infection during and after treatment with
XELJANZ/XELJANZ XR, including the possible development of
tuberculosis in patients who tested negative for latent
tuberculosis infection prior to initiating therapy.
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 infection.
MORTALITY
Rheumatoid arthritis (RA) patients 50 years of age and older
with at least one cardiovascular (CV) risk factor treated with
XELJANZ 10 mg twice a day had a higher rate of all-cause mortality,
including sudden CV death, compared to those treated with XELJANZ 5
mg given twice daily or TNF blockers in a large, ongoing,
postmarketing safety study.
XELJANZ 10 mg twice daily or XELJANZ XR 22 mg once daily is not
recommended for the treatment of RA or PsA. For UC, use XELJANZ at
the lowest effective dose and for the shortest duration needed to
achieve/maintain therapeutic response.
MALIGNANCIES
Lymphoma and other malignancies have been observed in
patients treated with XELJANZ. Epstein Barr Virus-associated
post-transplant lymphoproliferative disorder has been observed at
an increased rate in renal transplant patients treated with XELJANZ
and concomitant immunosuppressive medications.
Consider the risks and benefits of XELJANZ/XELJANZ XR treatment
prior to initiating therapy in patients with a known malignancy
other than a successfully treated non-melanoma skin cancer (NMSC)
or when considering continuing XELJANZ/XELJANZ XR in patients who
develop a malignancy.
Malignancies (including solid cancers and lymphomas) were
observed more often in patients treated with XELJANZ 10 mg twice
daily dosing in the UC long-term extension study.
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.
NMSCs have been reported in patients treated with XELJANZ. In the
UC population, treatment with XELJANZ 10 mg twice daily was
associated with greater risk of NMSC. Periodic skin examination is
recommended for patients who are at increased risk for skin
cancer.
THROMBOSIS
Thrombosis, including pulmonary embolism, deep venous
thrombosis, and arterial thrombosis have occurred in patients
treated with XELJANZ and other Janus kinase inhibitors used to
treat inflammatory conditions. RA patients who were 50 years of age
and older with at least one CV risk factor treated with XELJANZ 10
mg twice daily compared to XELJANZ 5 mg twice daily or TNF blockers
in a large, ongoing postmarketing safety study had an observed
increase in incidence of these events. Many of these events were
serious and some resulted in death. Avoid XELJANZ/XELJANZ XR in
patients at risk. Discontinue XELJANZ/XELJANZ XR and promptly
evaluate patients with symptoms of thrombosis. For patients with
UC, use XELJANZ at the lowest effective dose and for the shortest
duration needed to achieve/maintain therapeutic response.
XELJANZ 10 mg twice daily or XELJANZ XR 22 mg once daily is not
recommended for the treatment of RA or PsA. In a long-term
extension study in UC, four cases of pulmonary embolism were
reported in patients taking XELJANZ 10 mg twice a day, including
one death in a patient with advanced cancer.
GASTROINTESTINAL PERFORATIONS
Gastrointestinal perforations have been reported in XELJANZ
clinical trials, although the role of JAK inhibition is not known.
In these studies, many patients with rheumatoid arthritis were
receiving background therapy with Nonsteroidal Anti-Inflammatory
Drugs (NSAIDs). There was no discernable difference in frequency of
gastrointestinal perforation between the placebo and the XELJANZ
arms in clinical trials of patients with UC, and many of them were
receiving background corticosteroids. XELJANZ/XELJANZ XR should be
used with caution in patients who may be at increased risk for
gastrointestinal perforation (e.g., patients with a history of
diverticulitis or taking NSAIDs).
HYPERSENSITIVITY
Angioedema and urticaria that may reflect drug hypersensitivity
have been observed in patients receiving XELJANZ/XELJANZ XR and
some events were serious. If a serious hypersensitivity reaction
occurs, promptly discontinue tofacitinib while evaluating the
potential cause or causes of the reaction.
LABORATORY ABNORMALITIES
Lymphocyte Abnormalities: Treatment with XELJANZ was
associated with initial lymphocytosis at one month of exposure
followed by a gradual decrease in mean lymphocyte counts. Avoid
initiation of XELJANZ/XELJANZ XR treatment in patients with a count
less than 500 cells/mm3. In patients who develop a confirmed
absolute lymphocyte count less than 500 cells/mm3, treatment with
XELJANZ/XELJANZ XR is not recommended. 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. Monitor lymphocyte counts at baseline
and every 3 months thereafter.
Neutropenia: Treatment with XELJANZ was associated with
an increased incidence of neutropenia (less than 2000 cells/mm3)
compared to placebo. Avoid initiation of XELJANZ/XELJANZ XR
treatment in patients with an ANC less than 1000 cells/mm3. For
patients who develop a persistent ANC of 500-1000 cells/mm3,
interrupt XELJANZ/XELJANZ XR dosing until ANC is greater than or
equal to 1000 cells/mm3. In patients who develop an ANC less than
500 cells/mm3, treatment with XELJANZ/XELJANZ XR is not
recommended. Monitor neutrophil counts at baseline and after 4-8
weeks of treatment and every 3 months thereafter.
Anemia: Avoid initiation of XELJANZ/XELJANZ XR treatment
in patients with a hemoglobin level less than 9 g/dL. Treatment
with XELJANZ/XELJANZ XR should be interrupted in patients who
develop hemoglobin levels less than 8 g/dL or whose hemoglobin
level drops greater than 2 g/dL on treatment. Monitor hemoglobin at
baseline and after 4-8 weeks of treatment and every 3 months
thereafter.
Liver Enzyme Elevations: Treatment with XELJANZ was
associated with an increased incidence of liver enzyme elevation
compared to placebo. Most of these abnormalities occurred in
studies with background DMARD (primarily methotrexate) therapy. If
drug-induced liver injury is suspected, the administration of
XELJANZ/XELJANZ XR should be interrupted until this diagnosis has
been excluded. Routine monitoring of liver tests and prompt
investigation of the causes of liver enzyme elevations is
recommended to identify potential cases of drug-induced liver
injury.
Lipid Elevations: Treatment with XELJANZ was associated
with dose-dependent increases in lipid parameters, including total
cholesterol, low-density lipoprotein (LDL) cholesterol, and
high-density lipoprotein (HDL) cholesterol. Maximum effects were
generally observed within 6 weeks. There were no clinically
relevant changes in LDL/HDL cholesterol ratios. Manage patients
with hyperlipidemia according to clinical guidelines. Assessment of
lipid parameters should be performed approximately 4-8 weeks
following initiation of XELJANZ/XELJANZ XR therapy.
VACCINATIONS
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. Update
immunizations in agreement with current immunization guidelines
prior to initiating XELJANZ/XELJANZ XR therapy.
PATIENTS WITH GASTROINTESTINAL NARROWING
Caution should be used when administering XELJANZ XR to patients
with pre-existing severe gastrointestinal narrowing. There have
been rare reports of obstructive symptoms in patients with known
strictures in association with the ingestion of other drugs
utilizing a non-deformable extended release formulation.
HEPATIC and RENAL IMPAIRMENT
Use of XELJANZ/XELJANZ XR in patients with severe hepatic
impairment is not recommended.
For patients with moderate hepatic impairment or with moderate
or severe renal impairment taking XELJANZ 5 mg twice daily, reduce
to XELJANZ 5 mg once daily.
For UC patients with moderate hepatic impairment or with
moderate or severe renal impairment taking XELJANZ 10 mg twice
daily, reduce to XELJANZ 5 mg twice daily.
ADVERSE REACTIONS
The most common serious adverse reactions were serious
infections. The most commonly reported adverse reactions during the
first 3 months in controlled clinical trials in patients with RA
with XELJANZ 5 mg twice daily and placebo, respectively, (occurring
in greater than or equal to 2% of patients treated with XELJANZ
with or without DMARDs) were upper respiratory tract infection,
nasopharyngitis, diarrhea, headache, and hypertension. The safety
profile observed in patients with active PsA treated with XELJANZ
was consistent with the safety profile observed in RA patients.
Adverse reactions reported in ≥5% of patients treated with
either 5 mg or 10 mg twice daily of XELJANZ and ≥1% greater than
reported in patients receiving placebo in either the induction or
maintenance clinical trials for UC were: nasopharyngitis, elevated
cholesterol levels, headache, upper respiratory tract infection,
increased blood creatine phosphokinase, rash, diarrhea, and herpes
zoster.
USE IN PREGNANCY
Available data with XELJANZ/XELJANZ XR use in pregnant women are
insufficient to establish a drug associated risk of major birth
defects, miscarriage or adverse maternal or fetal outcomes. There
are risks to the mother and the fetus associated with rheumatoid
arthritis and UC in pregnancy. In animal studies, tofacitinib at
6.3 times the maximum recommended dose of 10 mg twice daily
demonstrated adverse embryo-fetal findings. The relevance of these
findings to women of childbearing potential is uncertain. Consider
pregnancy planning and prevention for females of reproductive
potential.
Please see full Prescribing Information, including BOXED WARNING
for XELJANZ/XELJANZ XR available at:
http://labeling.pfizer.com/ShowLabeling.aspx?id=959.
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DISCLOSURE NOTICE: The information contained in this release is
as of December 12, 2019. Pfizer assumes no obligation to update
forward-looking statements contained in this release as the result
of new information or future events or developments.
This release contains forward-looking information about XELJANZ
(tofacitinib) and XELJANZ (tofacitinib) extended release (XR),
including their potential benefits, that involves substantial risks
and uncertainties that could cause actual results to differ
materially from those expressed or implied by such statements.
Risks and uncertainties include, among other things, the
uncertainties inherent in research and development, including the
ability to meet anticipated clinical endpoints, commencement and/or
completion dates for our clinical trials, as well as the
possibility of unfavorable new clinical data and further analyses
of existing clinical data; risks associated with interim data; the
risk that clinical trial data are subject to differing
interpretations and assessments by regulatory authorities; whether
regulatory authorities will be satisfied with the design of and
results from our clinical studies; uncertainties regarding the
commercial success of XELJANZ and XELJANZ XR; uncertainties
regarding the commercial impact of the update to the U.S.
prescribing information for XELJANZ and XELJANZ XR; uncertainties
regarding the commercial impact of the Committee for Medicinal
Products for Human Use (CHMP) final opinion and the final decision
to be issued by the European Commission, which may vary from the
CHMP final opinion, as well as any potential actions by other
regulatory authorities based on analysis of clinical trial A3921133
or other data, which will depend, in part, on labeling
determinations; whether and when any applications that may be
pending or filed for any potential indications for XELJANZ or
XELJANZ XR in any jurisdictions may be approved by regulatory
authorities, which will depend on myriad factors, including making
a determination as to whether the product’s benefits outweigh its
known risks and determination of the product’s efficacy, and, if
approved, whether they will be commercially successful; decisions
by regulatory authorities impacting labeling, safety, manufacturing
processes and/or other matters that could affect the availability
or commercial potential of XELJANZ and XELJANZ XR; and competitive
developments.
A further description of risks and uncertainties can be found in
Pfizer’s Annual Report on Form 10-K for the fiscal year ended
December 31, 2018 and in its subsequent reports on Form 10-Q,
including in the sections thereof captioned “Risk Factors” and
“Forward-Looking Information and Factors That May Affect Future
Results”, as well as in its subsequent reports on Form 8-K, all of
which are filed with the U.S. Securities and Exchange Commission
and available at www.sec.gov and www.pfizer.com.
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