Approved Drug Label (PDF)
5
Warnings and Precautions
5.1 Serious Infections
Additions
and/or revisions underlined:
… Opportunistic infections due to
bacterial, mycobacterial, invasive fungal, viral, or parasitic organisms including
aspergillosis, blastomycosis, candidiasis, coccidioidomycosis, cryptococcosis,
histoplasmosis, legionellosis, listeriosis, pneumocystosis, salmonellosis
and tuberculosis have been reported with TNF-blockers …
6
Adverse Reactions
6.2 Postmarketing Experience
Additions
and/or revisions underlined:
… serious infections, malignancies,
including leukemia, melanoma, Merkel cell carcinoma …
Infusion-related Reactions
… cases of anaphylactic reactions,
including anaphylactic shock, laryngeal/pharyngeal edema …
Approved Drug Label (PDF)
5
Warnings and Precautions
5.2 Malignancies
(Additions and/or revisions are underlined)
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 and
cervical cancer cannot be excluded. Periodic screening should continue in women
treated with REMICADE.
5.4 Hepatotoxicity
(Additions
and/or revisions are underlined)
…
If jaundice and/or marked liver enzyme elevations (e.g., greater than or
equal to 5 times the upper limit of normal) develop…
5.7 Hypersensitivity
(Additions
and/or revisions are underlined)
REMICADE
has been associated with hypersensitivity reactions that vary in their time of
onset and required hospitalization in some cases. Most hypersensitivity
reactions, which include anaphylaxis, urticaria, dyspnea, and/or
hypotension, have occurred during or within 2 hours of REMICADE infusion.
5.8 Cardiovascular and Cerebrovascular Reactions During and After Infusion
(Newly added
subsection)
Serious
cerebrovascular accidents, myocardial ischemia/infarction (some fatal),
hypotension, hypertension, and arrhythmias have been reported during and within
24 hours of initiation of REMICADE infusion. Cases of transient visual loss
have been reported during or within 2 hours of infusion of REMICADE. 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
6.1 Clinical Trials Experience
(Additions
and/or revisions are underlined)
Other Adverse Reactions
…Adverse
reactions reported in greater than or equal to 5% of all patients with
rheumatoid arthritis receiving 4 or more infusions are in Table 2…
The
most common serious adverse reactions observed in clinical trials were
infections. Other serious, medically relevant adverse reactions greater than
or equal to 0.2%...
Adverse
Reactions in Pediatric Patients
Pediatric
Crohn’s Disease
Elevations
of ALT up to 3 times the upper limit of normal (ULN) were seen in 18% of
pediatric patients in Crohn’s disease clinical trials; 4% had ALT elevations greater
than or equal to 3 x ULN, and 1% had elevations greater than or equal to
5 x ULN. (Median follow-up was 53 weeks.)
6.2 Postmarketing Experience
(Additions
and/or revisions are underlined)
Adverse
reactions have been identified during post approval use of REMICADE in
adult and pediatric patients. Because these reactions are reported
voluntarily from a population of uncertain size, it is not always possible to
reliably estimate their frequency or establish a causal relationship to drug
exposure.
The
following adverse reactions, some with fatal outcome, have been reported during
post- approval use of REMICADE: neutropenia, agranulocytosis (including
infants exposed in utero to
infliximab), interstitial lung disease (including pulmonary
fibrosis/interstitial pneumonitis and rapidly progressive disease), idiopathic
thrombocytopenic purpura, thrombotic thrombocytopenic purpura, pericardial
effusion, systemic and cutaneous vasculitis, erythema multiforme,
Stevens-Johnson Syndrome, toxic epidermal necrolysis, peripheral demyelinating
disorders (such as Guillain- Barré syndrome, chronic inflammatory demyelinating
polyneuropathy, and multifocal motor neuropathy), new onset and worsening
psoriasis (all subtypes including pustular, primarily palmoplantar), transverse
myelitis, and neuropathies (additional neurologic reactions have also been
observed), acute liver failure, jaundice, hepatitis, and cholestasis, serious
infections, malignancies, including melanoma, Merkel cell carcinoma, and
cervical cancer …
Infusion-related
Reactions
Cases of transient
visual loss have been reported in association with REMICADE 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
(Additions and/or revisions are underlined)
(Additions
and/or revisions are underlined)
Juvenile Rheumatoid
Arthritis (JRA)
…Concurrent
use of folic acid, oral corticosteroids (less than or equal to 0.2
mg/kg/day of prednisone or equivalent),
NSAIDs,
and/or disease modifying antirheumatic drugs (DMARDs) was permitted.
8.1 Pregnancy
(Additions
and/or revisions are underlined)
…At
least a six month waiting period following birth is recommended before the administration
of live vaccines (e.g., BCG vaccine or other live vaccines, such as the rotavirus
vaccine) to these infants . 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 REMICADE(Rem-eh-kaid) (infliximab)
(Additions and/or revisions are underlined)
Risk of Cancer
• Patients with Chronic Obstructive
Pulmonary Disease (COPD), a specific type of lung disease), may have an
increased risk for getting cancer while being treated with REMICADE.
• Some women being treated for
rheumatoid arthritis with REMICADE have developed cervical cancer. For women
receiving REMICADE, including those over 60 years of age, your doctor may
recommend that you continue to be regularly screened for cervical cancer.
Tell
your doctor about all the medicines you take, including prescription and over-the-counter
medicines, vitamins, and herbal supplements. These include any other medicines to
treat Crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis,
psoriatic arthritis or psoriasis.
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 REMICADE. 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
Nervous System Disorders
Some patients have experienced a stroke within approximately
24 hours of their infusion with REMICADE. Tell your doctor right away if you have
symptoms of a stroke which may include: numbness or weakness of the face, arm or
leg, especially on one side of the body; sudden confusion, trouble speaking or understanding;
sudden trouble seeing in one or both
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