FIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.4 Pediatric Use
8.5 Geriatric Use
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
14.1 Crohn’s Disease
14.2 Pediatric Crohn’s Disease
14.3 Ulcerative Colitis
14.4 Rheumatoid Arthritis
14.5 Ankylosing Spondylitis
14.6 Psoriatic Arthritis
14.7 Plaque Psoriasis
15 REFERENCES
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
17.1 Patient Counseling
*Sections or subsections omitted from the full prescribing information are notlisted.
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FULL PRESCRIBING INFORMATION
WARNING: SERIOUS INFECTIONS and MALIGNANCY
SERIOUS INFECTIONS
Patients treated with infliximab products are at increased risk for developing seriousinfections that may lead to hospitalization or death [see Warnings and Precautions (5.1)
and Adverse Reactions (6.1)]. Most patients who developed these infections were takingconcomitant immunosuppressants such as methotrexate or corticosteroids.
RENFLEXIS should be discontinued if a patient develops a serious infection or sepsis.
Reported infections include:
• Active tuberculosis, including reactivation of latent tuberculosis. Patients withtuberculosis have frequently presented with disseminated or extrapulmonarydisease. Patients should be tested for latent tuberculosis before RENFLEXIS useand during therapy.1,2 Treatment for latent infection should be initiated prior toRENFLEXIS use.
• Invasive fungal infections, including histoplasmosis, coccidioidomycosis,candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients withhistoplasmosis or other invasive fungal infections may present withdisseminated, rather than localized, disease. Antigen and antibody testing forhistoplasmosis may be negative in some patients with active infection. Empiricanti-fungal therapy should be considered in patients at risk for invasive fungalinfections who develop severe systemic illness.
• Bacterial, viral and other infections due to opportunistic pathogens, includingLegionella and Listeria.
The risks and benefits of treatment with RENFLEXIS should be carefully consideredprior to initiating therapy in patients with chronic or recurrent infection.
Patients should be closely monitored for the development of signs and symptoms ofinfection during and after treatment with RENFLEXIS, including the possible
development of tuberculosis in patients who tested negative for latent tuberculosisinfection prior to initiating therapy.
MALIGNANCY
Lymphoma and other malignancies, some fatal, have been reported in children andadolescent patients treated with TNF blockers, including infliximab products [see
Warnings and Precautions (5.2)].
Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-celllymphoma, have been reported in patients treated with TNF blockers including
infliximab products. These cases have had a very aggressive disease course and havebeen fatal. Almost all patients had received treatment with azathioprine or 6-
mercaptopurine concomitantly with a TNF-blocker at or prior to diagnosis. Themajority of reported cas |
