Remicade, Humira, Cimzia Informed Consent

 

Click here to Download and print in WORD

Judy J. Davis, M.D., F.A.A.P.

1095 E Warner Ave #102

Fresno, CA 93710

(559) 412-8184 Fax (559) 438-1174

Informed Consent for Treatment With Remicade (infliximab),

Humira (adalimumab),Cimzia (certolizumab)



Remicade, Humira and Cimzia have been approved by the Food and Drug Administration (FDA) to inhibit the progression of Rheumatoid arthritis, psoriasis and treat ulcerative colitis, and Crohn’s disease with and without fistulas.  They block the activity of an inflammatory agent called tumor necrosis factor (TNF). TNF is a key ingredient in the inflammatory process. Because they block TNF in these patients, they are known as “anti-TNF” antibody agents.

These agents all have the same side effects. The following warnings ascribed to Remicade also occur with the other agents.


Warnings


Remicade has been associated with hypersensitivity reactions that vary in their time of onset. Urticaria (hives), dyspnea (difficulty breathing) and hypotension (low blood pressure) have occurred during or within 2 hours of infusion. In some cases, serum sickness-like reactions have been observed in patients 312 days after therapy was reinstituted following an extended period without Remicade. Symptoms include fever, rash, headache, sore throat, muscle aches, joint pain, hand and facial swelling and/or difficulty breathing.


Precautions


AntiTNF therapy mediates inflammation and modulates cellular immune response; therefore, the possibility

exists for antiTNF therapies, including Remicade, to affect normal immune responses.  AntiTNF therapy may result in the formation of autoimmune antibodies and rarely, in the development of a lupuslike syndrome. In clinical trials, patients who developed symptoms suggestive of a lupuslike syndrome have had resolution of symptoms after the medication was discontinued. 


Patients with long duration of inflammatory bowel disease (i.e. Crohn’s and ulcerative colitis) and chronic exposure to immunosuppressant therapies are more prone to develop lymphomas and infections. The impact of Remicade on these

is unknown. Potential longterm side effects such as lymphoma, other tumors or other serious infections cannot be predicted.


Treatment with Remicade can be associated with the development of antibodies to the drug.  Patients who were antibody positive were more likely to experience an infusion reaction. Antibody development was lower among RA and inflammatory bowel disease (IBD) patients receiving immunosuppressant medications.


Specific studies on drug interactions with Remicade have not been conducted. The majority of patients in RA and IBD clinical trials received one or more concomitant medications. In RA, concomitant medications besides methotrexate were nonsteroidal antiinflammatories, folic acid, corticosteroids and/or narcotics. In IBD concomitant medications were antibiotics, anti-virals, corticosteroids, 6-MP/AZA, and aminosalicylates. Patients receiving immunosuppressants tended to experience fewer infusion reactions as compared to patients on no immunosuppressants. It is not known whether Remicade can cause fetal harm when administered during pregnancy or if it can affect reproductive capacity. It is not known whether Remicade is excreted in human milk or absorbed systemically after ingestion. Because of the potential for serious adverse reactions in nursing infants, women should either discontinue nursing before

receiving the drug or not be administered the medication while nursing.

Click here to download and print in WORDRemicade,_Humira,_Cimzia_Informed_Consent_files/Remicade,Humira,Cimzia%20consent.docx
Please click here to return to the Table of ContentsTable_of_Contents.html