"(Reuters) - Sanofi SA and Regeneron Pharmaceuticals Inc on Friday said U.S. regulators had declined to approve their experimental treatment for rheumatoid arthritis because of manufacturing deficiencies.
The companies, in a release, s"...
(infliximab) Intravenous Infusion
SERIOUS INFECTIONS and MALIGNANCY
Patients treated with REMICADE are at increased risk for developing serious infections that may lead to hospitalization or death [see WARNINGS AND PRECAUTIONS and ADVERSE REACTIONS]. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.
REMICADE should be discontinued if a patient develops a serious infection or sepsis.
Reported infections include:
- Active tuberculosis, including reactivation of latent tuberculosis. Patients with tuberculosis have frequently presented with disseminated or extrapulmonary disease. Patients should be tested for latent tuberculos is before REMICADE use and during therapy.1,2 Treatment for latent infection should be initiated prior to REMICADE use.
- Invasive fungal infections, including his toplasmosis, coccidioidomycosis, candidiasis, as pergillosis, blastomycosis, and pneumocystosis. Patients with his toplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for his toplasmos is may be negative in some patients with active infection. Empiric anti-fungal therapy should be considered in patients at risk for invasive fungal infections who develop severe systemic illness.
- Bacterial, viral and other infections due to opportunis tic pathogens, including Legionella and Listeria.
The risks and benefits of treatment with REMICADE should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection.
Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with REMICADE, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy.
Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers , including REMICADE [see WARNINGS AND PRECAUTIONS].
Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers including REMICADE. These cases have had a very aggressive disease course and have been fatal. Almost all patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with a TNF-blocker at or prior to diagnosis. The majority of reported REMICADE cases have occurred in patients with Crohn's disease or ulcerative colitis and most were in adolescent and young adult males.
Infliximab, the active ingredient in REMICADE, is a chimeric IgG1κ monoclonal antibody (composed of human constant and murine variable regions) specific for human tumor necrosis factor-alpha (TNFα). It has a molecular weight of approximately 149.1 kilodaltons. Infliximab is produced by a recombinant cell line cultured by continuous perfusion and is purified by a series of steps that includes measures to inactivate and remove viruses.
REMICADE is supplied as a sterile, white, lyophilized powder for intravenous infusion. Following reconstitution with 10 mL of Sterile Water for Injection, USP, the resulting pH is approximately 7.2. Each single-dose vial contains 100 mg infliximab, dibasic sodium phosphate, dihydrate (6.1 mg), monobasic sodium phosphate, monohydrate (2.2 mg), polysorbate 80 (0.5 mg), and sucrose (500 mg). No preservatives are present.
2. See latest Centers for Disease Control guidelines and recommendations for tuberculosis testing in immunocompromised patients.
What are the possible side effects of infliximab (Remicade)?
Some people receiving an infliximab injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel dizzy, nauseated, light-headed, itchy or tingly, swollen, short of breath, or have a headache, fever, chills, flu symptoms, muscle or joint pain, pain or tightness in your throat, chest pain, or trouble swallowing during the injection. Infusion reactions may also occur within 1 or 2 hours after injection.
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult...
What are the precautions when taking infliximab (Remicade)?
Before using infliximab, tell your doctor or pharmacist if you are allergic to it; or to mouse proteins; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: previous severe allergic reaction to this medication, tuberculosis (previous infection or positive skin test), past/recent/current infections (e.g., cold sores, Valley Fever), heart disease (e.g., heart failure), blood/bone marrow disorder (e.g., leukopenia, thrombocytopenia), nervous system disorder (e.g., numbness/tingling, seizures, multiple sclerosis), history of cancer (e.g., breast cancer, skin...
Last reviewed on RxList: 9/19/2016
This monograph has been modified to include the generic and brand name in many instances.
Additional Remicade Information
Remicade - User Reviews
Remicade User Reviews
Now you can gain knowledge and insight about a drug treatment with Patient Discussions.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Get the latest treatment options