e medically less appropriate. (1.7)
DOSAGE AND ADMINISTRATION
RENFLEXIS is administered by intravenous infusion over a period of not lessthan 2 hours. (2.10)
Crohn’s Disease
5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks. Some adult patientswho initially respond to treatment may benefit from increasing the doseto 10 mg/kg if they later lose their response. (2.1)
Pediatric Crohn’s Disease
5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks. (2.2)
Ulcerative Colitis
5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks. (2.3)
Rheumatoid Arthritis
In conjunction with methotrexate, 3 mg/kg at 0, 2 and 6 weeks, thenevery 8 weeks. Some patients may benefit from increasing the dose upto 10 mg/kg or treating as often as every 4 weeks. (2.4)
Ankylosing Spondylitis
5 mg/kg at 0, 2 and 6 weeks, then every 6 weeks. (2.5)
Psoriatic Arthritis and Plaque Psoriasis
5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks. (2.6) and (2.7)
DOSAGE FORMS AND STRENGTHS
For injection: 100 mg of lyophilized infliximab-abda in a 20 mL vial forintravenous infusion. (3)
CONTRAINDICATIONS
RENFLEXIS doses >5 mg/kg in moderate to severe heart failure. (4)
Previous severe hypersensitivity reaction to infliximab products orknown hypersensitivity to inactive components of RENFLEXIS or toany murine proteins. (4)
WARNINGS AND PRECAUTIONS
• Serious infections – do not give RENFLEXIS during an active infection.
If an infection develops, monitor carefully and stop RENFLEXIS ifinfection becomes serious. (5.1)
• Invasive fungal infections – for patients who develop a systemic illnesson RENFLEXIS, consider empiric antifungal therapy for those whoreside or travel to regions where mycoses are endemic (5.1)
• Malignancies – the incidence of malignancies, including invasivecervical cancer and lymphoma, was greater in TNF blocker treatedpatients than in controls. Due to the risk of HSTCL carefully assess therisk/benefit especially if the patient has Crohn’s disease or ulcerativecolitis, is male, and is receiving azathioprine or 6-mercaptopurinetreatment. (5.2)
• Hepatitis B virus reactivation – test for HBV infection before startingRENFLEXIS. Monitor HBV carriers during and several months aftertherapy. If reactivation occurs, stop RENFLEXIS and begin anti-viraltherapy. (5.3)
• Hepatotoxicity – severe hepatic reactions, some fatal or necessitatingliver transplantation. Stop RENFLEXIS in cases of jaundice and/ormarked liver enzyme elevations. (5.4)
• Heart failure – new onset or worsening symptoms may occur. (4, 5.5)
• Cytopenias – advise patients to seek immediate medical attention ifsigns and symptoms develop, and consider stopping RENFLEXIS. (5.6)
• Hypersensitivity – serious infusion reactions including anaphylaxis orserum sickness-like reactions may occur. (5.7)
• Cardiovascular and Cerebrovascular Reactions – Cerebrovascularaccidents, myocardial infarctions (some fatal), and arrhythmias havebeen reported during and within 24 hours of initiation of RENFLEXISinfusion. Monitor patients during RENFLEXIS infusion and if seriousreaction occurs, discontinue infusion. (5.8)
• Demyelinating disease – exacerbation or new onset may occur. (5.9)
• Lupus-like syndrome – stop RENFLEXIS if syndrome develops. (5.14)
• Live vaccines or therapeutic infectious agents – should no |
