infliximab levels.
This may be related in part to higher antibody rates [see Adverse Reactions (6.1)]. In addition,in a subset of patients who had achieved a response at Week 10, maintenance of responseappears to be greater in patients who received infliximab every 8 weeks at the 5 mg/kg dose.
Regardless of whether the maintenance doses are PRN or every 8 weeks, there is a decline inresponse in a subpopulation of patients in each group over time. The results of Study Ithrough Week 50 in the 5 mg/kg every 8 weeks maintenance dose group were similar to theresults from Study II.
Figure 4 Proportion of patients achieving ≥75% improvement in PASI from baselinethrough Week 50; patients randomized at Week 14Efficacy and safety of infliximab treatment beyond 50 weeks have not been eva luated inpatients with plaque psoriasis.
15 REFERENCES
1. American Thoracic Society, Centers for Disease Control and Prevention. Targetedtuberculin 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 fortuberculosis testing in immunocompromised patients.
3. van der Heijde DM, van Leeuwen MA, van Riel PL, et al. Biannual radiographicassessments of hands and feet in a three-year prospective follow-up of patients with
early rheumatoid arthritis. Arthritis Rheum. 1992;35(1):26-34.
4. van der Linden S, Valkenburg HA, Cats A. eva luation of diagnostic criteria forankylosing spondylitis. A proposal for modification of the New York criteria.
Arthritis Rheum. 1984;27(4):361-368.
5. Schroeder KW, Tremaine WJ, Ilstrup DM. Coated oral 5-aminosalicylic acidtherapy for mildly to moderately active ulcerative colitis. A randomized study. N
Engl J Med. 1987;317(26):1625-1629.
16 HOW SUPPLIED/STORAGE AND HANDLING
Each RENFLEXIS (infliximab-abda) for Injection 100 mg vial is individually packaged in acarton.
NDC 0006-4305-02 100 mg vial
Each single dose vial contains 100 mg of infliximab-abda as a white, lyophilized powder forfinal reconstitution volume of 10 mL.
Storage and Stability
Store unopened RENFLEXIS vials in a refrigerator at 2ºC to 8ºC (36ºF to 46ºF). Do not useRENFLEXIS beyond the expiration date located on the carton and the vial. This productcontains no preservative.
[For storage conditions of the reconstituted product, see Dosage and Administration (2.11)].
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Medication Guide)
17.1 Patient Counseling
Patients or their caregivers should be advised of the potential benefits and risks ofRENFLEXIS. Physicians should instruct their patients to read the Medication Guide beforestarting RENFLEXIS therapy and to reread it each time they receive an infusion. It isimportant that the patient’s overall health be assessed at each treatment visit and that anyquestions resulting from the patient’s or their caregiver’s reading of the Medication Guide bediscussed.
Immunosuppression
Inform patients that RENFLEXIS may lower the ability of their immune system tofight infections. Instruct patients of the importance of contacting their doctors if they
develop any symptoms of an infection, including tuberculosis and reactivation ofhepatitis B virus infections. Patients should be counseled about the risk of lymphoma
and other malignancies while receiving RENFLEXIS.
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