Approved Drug Label (PDF)
4
Contraindications
Additions and revisions underlined:
The use of RENFLEXIS at doses >5 mg/kg
is contraindicated in patients with moderate or severe heart failure [see Warnings and Precautions (5.5) and
Adverse Reactions (6.1)].
RENFLEXIS is contraindicated in patients with
a previous severe
hypersensitivity reaction to infliximab products or any of the inactive ingredients of RENFLEXIS or any murine proteins
[severe hypersensitivity reactions have included anaphylaxis, hypotension, and
serum sickness] [see Warnings and
Precautions (5.7) and Adverse Reactions (6.1)].
5
Warnings and Precautions
5.13 Vaccinations and Use of Live Vaccines/Therapeutic Infectious Agents
Newly added information:
Vaccinations
Prior to initiating RENFLEXIS in pediatric and adult patients, update vaccinations in accordance with current vaccination
guidelines.
5.5 Heart Failure
Additions and revisions underlined:
The use of RENFLEXIS at doses >5 mg/kg is
contraindicated in patients with moderate or severe heart failure. A randomized,
double-blind, placebo-controlled study evaluated the use of infliximab (5 mg/kg or 10 mg/kg at Weeks 0, 2,
and 6) in patients with moderate or severe
heart failure [New York Heart Association (NYHA) Functional Class
III/IV]. Compared to patients who received placebo, there was a higher rate
of mortality and a higher risk of hospitalization at Week 28 due to heart
failure in patients who received the 10 mg/kg infliximab dose,
and higher rates of cardiovascular adverse events in patients who received
infliximab doses of 5 mg/kg and 10 mg/kg.
There have been post-marketing reports of new
onset and worsening heart failure, with and without identifiable precipitating
factors (e.g., pre-existing cardiovascular disease), in patients treated
with infliximab products. Some of these
patients have been under 50 years
of age.
If a decision is made to administer RENFLEXIS (< or =5
mg/kg) to patients with moderate or severe heart failure or to administer RENFLEXIS (any approved dose)
to patients with mild
heart failure, they should be
closely monitored during therapy,
and RENFLEXIS should be discontinued if new or worsening symptoms of heart failure
appear [see Contraindications (4) and Adverse
Reactions (6.1)].
6
Adverse Reactions
6.1 Clinical Trials Experience
Extensive changes; please refer to label
6.2 Immunogenicity
Extensive changes; please refer to label
6.3 Postmarketing Experience
Extensive changes; please refer to label
7
Drug Interactions
7.1 Other Biological Products
Newly added subsection:
The
combination of RENFLEXIS with other biological products used to treat the same
conditions as RENFLEXIS is not recommended [see Warnings
and Precautions (5.10)].
8
Use in Specific Populations
8.1 Pregnancy
Extensive changes; please refer to label
8.5 Geriatric Use
Extensive changes; please refer to label
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
Medication Guide
Additions and revisions underlined:
It is not known if RENFLEXIS is safe and effective in children under 6 years of age.
What should I tell my doctor
before starting treatment with RENFLEXIS?
Your doctor will assess your health before
each treatment.
Tell your doctor
about all of your medical
conditions, including if you:
have an infection (see “What is the most important
information I should know about RENFLEXIS?”).
have other liver problems
including liver failure.
have heart failure or other heart conditions. If you
have heart failure,
it may get worse while you receive RENFLEXIS.
have or have had any type of cancer.
have had phototherapy (treatment with ultraviolet light or sunlight
along with a medicine to make
your skin sensitive to light) for psoriasis. You may have a higher chance of
getting skin cancer while receiving RENFLEXIS.
have COPD, a specific
type of lung disease. Patients
with COPD may have an increased risk of
getting cancer while receiving RENFLEXIS.
have or have had a condition
that affects your nervous system
such as:
multiple sclerosis, or Guillain-Barré syndrome, or
if you experience any numbness
or tingling, or
if you have had a seizure.
have recently received or are
scheduled to receive a vaccine. Adults and
children receiving RENFLEXIS should not receive live vaccines (for example, the
Bacille Calmette-Guérin [BCG] vaccine) or treatment with a weakened bacteria (such
as BCG for bladder cancer). Adults and children should have all of their vaccines brought
up to date before starting
treatment with RENFLEXIS.
are pregnant or plan to become pregnant, are breastfeeding or plan to breastfeed. You and your doctor should decide if you should
receive RENFLEXIS while you are pregnant or breastfeeding.
What are the possible
side effects of RENFLEXIS?
RENFLEXIS can cause
serious side effects,
including:
See “What is the most important information I should know about RENFLEXIS?”. Serious Infections
Some patients, especially those 65 years and older have had serious
infections while receiving infliximab
products, such as RENFLEXIS. These serious infections include TB and infections
caused by viruses, fungi, or bacteria that have spread throughout the body or
cause infections in certain areas (such as skin).
PATIENT COUNSELING INFORMATION
Extensive changes; please refer to label
Approved Drug Label (PDF)
6
Adverse Reactions
6.1 Clinical Trials Experience
(extensive additions, please refer to label)
8
Use in Specific Populations
8.4 Pediatric Use
(additions
underlined)
The
safety and effectiveness of infliximab products have been established in
pediatric patients 6 to 17 years of age for induction and maintenance treatment
of Crohn’s disease or ulcerative colitis. However, infliximab products
have not been studied in children with Crohn’s disease or ulcerative colitis
<6 years of age.
…
Pediatric
Ulcerative Colitis
The
safety and effectiveness of infliximab products for reducing signs and symptoms
and inducing and maintaining clinical remission in pediatric patients aged 6
years and older with moderately to severely active ulcerative colitis who have
had an inadequate response to conventional therapy are supported by evidence
from adequate and well-controlled studies of infliximab in adults. Additional
safety and pharmacokinetic data were collected in 60 pediatric patients aged 6
years and older. The effectiveness of infliximabin inducing and maintaining
mucosal healing could not be established. Although 41 patients had a Mayo
endoscopy subscore of 0 or 1 at the Week 8 endoscopy, the induction phase was
open-label and lacked a control group. Only 9 patients had an optional
endoscopy at Week 54.
In
the pediatric UC trial, approximately half of the patients were on concomitant
immunomodulators (AZA, 6-MP, MTX) at study start. Due to the risk of HSTCL, a
careful risk-benefit assessment should be made when RENFLEXIS is used in
combination with other immunosuppressants.
The
longer term (greater than 1 year) safety and effectiveness of infliximab
products in pediatric ulcerative colitis patients have not been established in
clinical trials.
…
Approved Drug Label (PDF)
5
Warnings and Precautions
5.1
Serious Infections
Addition
of the following to the Opportunistic infections listing:
Cryptococcosis,
salmonellosis
5.2 Malignancies
Addition of the
following:
Cervical Cancer
A
population-based retrospective cohort study using data from Swedish national
health registries found a 2 to 3-fold increase in the incidence of invasive
cervical cancer in women with rheumatoid arthritis treated with infliximab
compared to biologics-naïve patients or the general population, particularly
those over 60 years of age. A causal relationship between infliximab products
and cervical cancer cannot be excluded. Periodic screening should continue in
women treated with RENFLEXIS.
5.7
Hypersensitivity
Addition of the
following to Most hypersensitivity reactions sentence:
Anaphylaxis
Newly added
subsection:
5.8 Cardiovascular
and Cerebrovascular Reactions During and After Infusion
Serious
cerebrovascular accidents, myocardial ischemia/infarction (some fatal),
hypotension, hypertension, and arrhythmias have been reported during and within
24 hours of initiation of infliximab infusion. Cases of transient visual loss
have been reported during or within 2 hours of infusion of infliximab. Monitor
patients during infusion and if serious reaction occurs, discontinue infusion.
Further management of reactions should be dictated by signs and symptoms.
6
Adverse Reactions
6.2 Post-Marketing Experience
Additions and/or
revisions underlined:
…
The following adverse reactions, some with fatal outcome, have been reported
during post- approval use of infliximab products: neutropenia, agranulocytosis
(including infants exposed in utero to
infliximab products), interstitial lung disease … serious infections [see Warnings and Precautions (5.1)],
malignancies, including leukemia, melanoma , Merkel cell carcinoma, and
cervical cancer.
Infusion-related
Reactions
In
post-marketing experience, cases of anaphylactic reactions, including anaphylactic
shock, laryngeal/pharyngeal edema …
…
Cases of transient visual loss have been reported in association with
infliximab products during or within 2 hours of infusion. Cerebrovascular
accidents, myocardial ischemia/infarction (some fatal), and arrhythmia
occurring within 24 hours of initiation of infusion have also been reported.
8
Use in Specific Populations
8.1 Pregnancy
Clinical
Considerations
Fetal/Neonatal
adverse reactions
Addition of the
following sentence to the end of this section:
Cases
of agranulocytosis in infants exposed in
utero have also been reported.
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
MEDICATION GUIDE
Newly added
information following Heart Failure:
Other Heart
Problems
Some
patients have experienced a heart attack (some of which led to death), low
blood flow to the heart, or abnormal heart rhythm within 24 hours of beginning
their infusion of an infliximab product. Symptoms may include chest discomfort
or pain, arm pain, stomach pain, shortness of breath, anxiety, lightheadedness,
dizziness, fainting, sweating, nausea, vomiting, fluttering or pounding in your
chest, and/or a fast or a slow heartbeat. Tell your doctor right away if you
have any of these symptoms.
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