IMPORTANT SAFETY INFORMATION AND
INDICATIONS
INDICATIONS
SERIOUS INFECTIONS
Patients treated with infliximab products 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. Discontinue
INFLECTRA® (infliximab-dyyb) if a patient
develops a serious infection or sepsis.
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. Discontinue
INFLECTRA® (infliximab-dyyb) if a patient
develops a serious infection or sepsis.
Reported infections include:
-
Active tuberculosis (TB), including reactivation
of latent TB. Patients frequently presented
with disseminated or extrapulmonary disease.
Patients should be tested for latent TB before
INFLECTRA® use and during therapy.1,2
Treatment for latent infection should be
initiated prior to INFLECTRA® use. -
Invasive fungal infections including
histoplasmosis, coccidioidomycosis,
candidiasis, aspergillosis, blastomycosis and
pneumocystosis. Patients may present with
disseminated, rather than localized, disease.
Empiric anti-fungal therapy should be
considered in patients at risk for invasive
fungal infections who develop severe systemic
illness. -
Bacterial, viral, and other infections due to
opportunistic pathogens, including Legionella
and Listeria.
The risks and benefits of treatment with
INFLECTRA® should be carefully considered prior
to initiating therapy in patients with chronic or
recurrent infection. Patients should be closely
monitored for the development of signs and
symptoms of infection during and after
treatment with INFLECTRA®, including the
possible development of TB in patients who
tested negative for latent TB infection prior to
initiating therapy, who are on treatment for
latent TB, or who were previously treated for TB
infection.
INFLECTRA® should be carefully considered prior
to initiating therapy in patients with chronic or
recurrent infection. Patients should be closely
monitored for the development of signs and
symptoms of infection during and after
treatment with INFLECTRA®, including the
possible development of TB in patients who
tested negative for latent TB infection prior to
initiating therapy, who are on treatment for
latent TB, or who were previously treated for TB
infection.
Risk of infection may be higher in patients greater
than 65 years of age, pediatric patients, patients
with co-morbid conditions and/or patients taking
concomitant immunosuppressant therapy. In
clinical trials, other serious infections observed in
patients treated with infliximab products included
pneumonia, cellulitis, abscess, and skin ulceration.
than 65 years of age, pediatric patients, patients
with co-morbid conditions and/or patients taking
concomitant immunosuppressant therapy. In
clinical trials, other serious infections observed in
patients treated with infliximab products included
pneumonia, cellulitis, abscess, and skin ulceration.
MALIGNANCIES
Lymphoma and other malignancies, some fatal,
have been reported in children and adolescent
patients treated with TNF blockers, including
infliximab products. Approximately half of these
cases were lymphomas, including Hodgkin's and
non-Hodgkin's lymphoma. The other cases
represented a variety of malignancies, including
rare malignancies that are usually associated with
immunosuppression and malignancies that are not
usually observed in children and adolescents. The
malignancies occurred after a median of 30
months after the first dose of therapy. Most of the
patients were receiving concomitant
immunosuppressants.
have been reported in children and adolescent
patients treated with TNF blockers, including
infliximab products. Approximately half of these
cases were lymphomas, including Hodgkin's and
non-Hodgkin's lymphoma. The other cases
represented a variety of malignancies, including
rare malignancies that are usually associated with
immunosuppression and malignancies that are not
usually observed in children and adolescents. The
malignancies occurred after a median of 30
months after the first dose of therapy. Most of the
patients were receiving concomitant
immunosuppressants.
Postmarketing cases of hepatosplenic T-cell
lymphoma, a rare type of T-cell lymphoma, have
been reported in patients treated with TNF
blockers, including infliximab products. These
cases have had a very aggressive disease course
and have been fatal. The majority of reported
cases have occurred in patients with Crohn's
disease or ulcerative colitis and most were in
adolescent and young adult males. Almost all
patients had received treatment with
azathioprine or 6-mercaptopurine concomitantly
with a TNF-blocker at or prior to diagnosis.
Carefully assess the risks and benefits of
treatment with INFLECTRA®, especially in these
patient types.
lymphoma, a rare type of T-cell lymphoma, have
been reported in patients treated with TNF
blockers, including infliximab products. These
cases have had a very aggressive disease course
and have been fatal. The majority of reported
cases have occurred in patients with Crohn's
disease or ulcerative colitis and most were in
adolescent and young adult males. Almost all
patients had received treatment with
azathioprine or 6-mercaptopurine concomitantly
with a TNF-blocker at or prior to diagnosis.
Carefully assess the risks and benefits of
treatment with INFLECTRA®, especially in these
patient types.
In clinical trials of all TNF inhibitors, more cases of
lymphoma were observed compared with controls
and the expected rate in the general population.
However, patients with Crohn’s disease,
rheumatoid arthritis, or plaque psoriasis may be at
higher risk for developing lymphoma. In clinical
trials of some TNF inhibitors, including infliximab
products, more cases of other malignancies were
observed compared with controls. The rate of these
malignancies among patients treated with
infliximab products was similar to that expected in
the general population, whereas the rate in control
patients was lower than expected. Cases of acute
and chronic leukemia have been reported with
postmarketing TNF-blocker use. As the potential
role of TNF inhibitors in the development of
malignancies is not known, caution should be
exercised when considering treatment of patients
with a current or a past history of malignancy or
other risk factors such as chronic obstructive
pulmonary disease (COPD).
lymphoma were observed compared with controls
and the expected rate in the general population.
However, patients with Crohn’s disease,
rheumatoid arthritis, or plaque psoriasis may be at
higher risk for developing lymphoma. In clinical
trials of some TNF inhibitors, including infliximab
products, more cases of other malignancies were
observed compared with controls. The rate of these
malignancies among patients treated with
infliximab products was similar to that expected in
the general population, whereas the rate in control
patients was lower than expected. Cases of acute
and chronic leukemia have been reported with
postmarketing TNF-blocker use. As the potential
role of TNF inhibitors in the development of
malignancies is not known, caution should be
exercised when considering treatment of patients
with a current or a past history of malignancy or
other risk factors such as chronic obstructive
pulmonary disease (COPD).
Melanoma and Merkel cell carcinoma have been
reported in patients treated with TNF-blocker
therapy, including infliximab products. Periodic skin
examination is recommended for all patients,
particularly those with risk factors for skin cancer.
reported in patients treated with TNF-blocker
therapy, including infliximab products. Periodic skin
examination is recommended for all patients,
particularly those with risk factors for skin cancer.
CONTRAINDICATIONS
INFLECTRA® is contraindicated in patients with
moderate to severe (NYHA Class III/IV) congestive
heart failure (CHF) at doses greater than 5 mg/kg.
Higher mortality rates at the 10 mg/kg dose and
higher rates of cardiovascular events at the 5
mg/kg dose have been observed in these patients.
INFLECTRA® should be used with caution and only
after consideration of other treatment options.
Patients should be monitored closely. Discontinue
INFLECTRA® if new or worsening CHF symptoms
appear. INFLECTRA® should not be
(re)administered to patients who have experienced
a severe hypersensitivity reaction or to patients
with hypersensitivity to murine proteins or other
components of the product.
moderate to severe (NYHA Class III/IV) congestive
heart failure (CHF) at doses greater than 5 mg/kg.
Higher mortality rates at the 10 mg/kg dose and
higher rates of cardiovascular events at the 5
mg/kg dose have been observed in these patients.
INFLECTRA® should be used with caution and only
after consideration of other treatment options.
Patients should be monitored closely. Discontinue
INFLECTRA® if new or worsening CHF symptoms
appear. INFLECTRA® should not be
(re)administered to patients who have experienced
a severe hypersensitivity reaction or to patients
with hypersensitivity to murine proteins or other
components of the product.
HEPATITIS B REACTIVATION
TNF inhibitors, including infliximab products, have
been associated with reactivation of hepatitis B
virus (HBV) in patients who are chronic carriers.
Some cases were fatal. Patients should be tested
for HBV infection before initiating INFLECTRA®. For
patients who test positive, consult a physician with
expertise in the treatment of hepatitis B. Exercise
caution when prescribing INFLECTRA® for patients
identified as carriers of HBV and monitor closely for
active HBV infection during and following
termination of therapy with INFLECTRA®.
Discontinue INFLECTRA® in patients who develop
HBV reactivation and initiate antiviral therapy with
appropriate supportive treatment. Exercise caution
when considering resumption of INFLECTRA® and
monitor patients closely.
been associated with reactivation of hepatitis B
virus (HBV) in patients who are chronic carriers.
Some cases were fatal. Patients should be tested
for HBV infection before initiating INFLECTRA®. For
patients who test positive, consult a physician with
expertise in the treatment of hepatitis B. Exercise
caution when prescribing INFLECTRA® for patients
identified as carriers of HBV and monitor closely for
active HBV infection during and following
termination of therapy with INFLECTRA®.
Discontinue INFLECTRA® in patients who develop
HBV reactivation and initiate antiviral therapy with
appropriate supportive treatment. Exercise caution
when considering resumption of INFLECTRA® and
monitor patients closely.
HEPATOTOXICITY
Severe hepatic reactions, including acute liver
failure, jaundice, hepatitis, and cholestasis have
been reported rarely in patients receiving infliximab
products postmarketing. Some cases were fatal or
required liver transplant. Aminotransferase
elevations were not noted prior to discovery of liver
injury in many cases. Patients with symptoms or
signs of liver dysfunction should be evaluated for
evidence of liver injury. If jaundice and/or marked
liver enzyme elevations (eg, ≥5 times the upper
limit of normal) develop, INFLECTRA® should be
discontinued, and a thorough investigation of the
abnormality should be undertaken.
failure, jaundice, hepatitis, and cholestasis have
been reported rarely in patients receiving infliximab
products postmarketing. Some cases were fatal or
required liver transplant. Aminotransferase
elevations were not noted prior to discovery of liver
injury in many cases. Patients with symptoms or
signs of liver dysfunction should be evaluated for
evidence of liver injury. If jaundice and/or marked
liver enzyme elevations (eg, ≥5 times the upper
limit of normal) develop, INFLECTRA® should be
discontinued, and a thorough investigation of the
abnormality should be undertaken.
HEMATOLOGIC EVENTS
Cases of leukopenia, neutropenia,
thrombocytopenia, and pancytopenia (some fatal)
have been reported in patients receiving infliximab
products. The causal relationship to infliximab
therapy remains unclear. Exercise caution in
patients who have ongoing or a history of
significant hematologic abnormalities. Advise
patients to seek immediate medical attention if
they develop signs and symptoms of blood
dyscrasias or infection. Consider discontinuation of
INFLECTRA® in patients who develop significant
hematologic abnormalities.
thrombocytopenia, and pancytopenia (some fatal)
have been reported in patients receiving infliximab
products. The causal relationship to infliximab
therapy remains unclear. Exercise caution in
patients who have ongoing or a history of
significant hematologic abnormalities. Advise
patients to seek immediate medical attention if
they develop signs and symptoms of blood
dyscrasias or infection. Consider discontinuation of
INFLECTRA® in patients who develop significant
hematologic abnormalities.
HYPERSENSITIVITY
Infliximab products have been associated with
hypersensitivity reactions that differ in their time
of onset. Acute urticaria, dyspnea, and hypotension
have occurred in association with infusions of
infliximab products. Serious infusion reactions
including anaphylaxis were infrequent. Medications
for the treatment of hypersensitivity reactions
should be available.
hypersensitivity reactions that differ in their time
of onset. Acute urticaria, dyspnea, and hypotension
have occurred in association with infusions of
infliximab products. Serious infusion reactions
including anaphylaxis were infrequent. Medications
for the treatment of hypersensitivity reactions
should be available.
NEUROLOGIC EVENTS
TNF inhibitors, including infliximab products, have
been associated in rare cases with CNS
manifestation of systemic vasculitis, seizure, and
new onset or exacerbation of CNS demyelinating
disorders, including multiple sclerosis and optic
neuritis, and peripheral demyelinating disorders,
including Guillain-Barré syndrome. Exercise caution
when considering INFLECTRA® in patients with
these disorders and consider discontinuation if
these disorders develop.
been associated in rare cases with CNS
manifestation of systemic vasculitis, seizure, and
new onset or exacerbation of CNS demyelinating
disorders, including multiple sclerosis and optic
neuritis, and peripheral demyelinating disorders,
including Guillain-Barré syndrome. Exercise caution
when considering INFLECTRA® in patients with
these disorders and consider discontinuation if
these disorders develop.
AUTOIMMUNITY
Treatment with infliximab products may result in
the formation of autoantibodies and, rarely, in the
development of a lupus-like syndrome. Discontinue
treatment with INFLECTRA® if symptoms of a
lupus-like syndrome develop.
the formation of autoantibodies and, rarely, in the
development of a lupus-like syndrome. Discontinue
treatment with INFLECTRA® if symptoms of a
lupus-like syndrome develop.
ADVERSE REACTIONS
In clinical trials with infliximab products, the most
common adverse reactions occurring in >10% of
patients included infections (eg, upper respiratory,
sinusitis, and pharyngitis), infusion-related
reactions, headache, and abdominal pain.
common adverse reactions occurring in >10% of
patients included infections (eg, upper respiratory,
sinusitis, and pharyngitis), infusion-related
reactions, headache, and abdominal pain.
USE WITH OTHER DRUGS
Concomitant use of INFLECTRA® with anakinra,
abatacept, tocilizumab, or other biologics used to
treat the same conditions as INFLECTRA® is not
recommended because of the possibility of an
increased risk of infection. Care should be taken
when switching from one biologic to another, since
overlapping biological activity may further increase
the risk of infection.
abatacept, tocilizumab, or other biologics used to
treat the same conditions as INFLECTRA® is not
recommended because of the possibility of an
increased risk of infection. Care should be taken
when switching from one biologic to another, since
overlapping biological activity may further increase
the risk of infection.
LIVE VACCINES/THERAPEUTIC INFECTIOUS AGENTS
Live vaccines or therapeutic infectious agents
should not be given with INFLECTRA® due to the
possibility of clinical infections, including
disseminated infections.
should not be given with INFLECTRA® due to the
possibility of clinical infections, including
disseminated infections.
Bring pediatric patients up to date with all
vaccinations prior to initiating INFLECTRA®. At
least a 6-month waiting period following birth is
recommended before the administration of any
live vaccine to infants exposed in utero to
infliximab products.
vaccinations prior to initiating INFLECTRA®. At
least a 6-month waiting period following birth is
recommended before the administration of any
live vaccine to infants exposed in utero to
infliximab products.
References:
1. American Thoracic Society, Centers for Disease
Control and Prevention. Targeted tuberculin
testing and treatment of latent tuberculosis
infection. Am J Respir Crit Care Med.
2000;161:S221-S247.
Control and Prevention. Targeted tuberculin
testing and treatment of latent tuberculosis
infection. Am J Respir Crit Care Med.
2000;161:S221-S247.
2. See latest Centers for Disease Control guidelines
and recommendations for tuberculosis testing in
immunocompromised patients.
and recommendations for tuberculosis testing in
immunocompromised patients.
INDICATIONS
Crohn's Disease
-
Reducing signs and symptoms and inducing and
maintaining clinical remission in adult patients
with moderately to severely active Crohn's
disease (CD) who have had an inadequate
response to conventional therapy -
Reducing the number of draining
enterocutaneous and rectovaginal fistulas and
maintaining fistula closure in adult patients with
fistulizing CD
Pediatric Crohn's Disease
-
Reducing signs and symptoms and inducing and
maintaining clinical remission in pediatric
patients 6 years of age and older with
moderately to severely active Crohn’s disease
who have had an inadequate response to
conventional therapy
Ulcerative Colitis
-
Reducing signs and symptoms, inducing and
maintaining clinical remission and mucosal
healing, and eliminating corticosteroid use in
adult patients with moderately to severely active
ulcerative colitis who have had an inadequate
response to conventional therapy
Rheumatoid Arthritis
-
Reducing signs and symptoms, inhibiting the
progression of structural damage, and improving
physical function in patients with moderately to
severely active rheumatoid arthritis, in
combination with methotrexate
Ankylosing Spondylitis
-
Reducing signs and symptoms in patients with
active ankylosing spondylitis
Psoriatic Arthritis
-
Reducing signs and symptoms of active arthritis,
inhibiting the progression of structural damage,
and improving physical function in patients with
psoriatic arthritis
Plaque Psoriasis
-
Treatment of adult patients with chronic severe
(ie, extensive and/or disabling) plaque psoriasis
who are candidates for systemic therapy and
when other systemic therapies are medically less
appropriate -
INFLECTRA® should only be administered to
patients who will be closely monitored and have
regular follow-up visits with a physician
Please see full Prescribing Information, including
BOXED WARNING and Medication Guide, for
INFLECTRA.
BOXED WARNING and Medication Guide, for
INFLECTRA.
INFLECTRA® is a trademark of Hospira UK, a Pfizer
company.
Remicade is a registered trademark of Janssen
Biotech Inc.
company.
Remicade is a registered trademark of Janssen
Biotech Inc.
PP-IFA-USA-0110-02
© 2017 Pfizer Inc. All rights reserved.
© 2017 Pfizer Inc. All rights reserved.