"Nov. 6, 2012 -- The FDA has approved Pfizer's Xeljanz (tofacitinib), a first-of-its-kind treatment for rheumatoid arthritis.
Xeljanz is approved for use by patients not helped by methotrexate, the usual first treatment for RA. It's a "...
(golimumab) Injection, for Subcutaneous Use
SIMPONI (golimumab) is a human IgG1κ monoclonal antibody specific for human tumor necrosis factor alpha (TNFα) that exhibits multiple glycoforms with molecular masses of approximately 150 to 151 kilodaltons. SIMPONI was created using genetically engineered mice immunized with human TNF, resulting in an antibody with human-derived antibody variable and constant regions. SIMPONI 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.
The SIMPONI drug product is a sterile solution of the golimumab antibody supplied as either a single dose prefilled syringe (with a passive needle safety guard) or a single dose prefilled autoinjector. The Type 1 glass syringe has a coated stopper. The fixed stainless steel needle (5 bevel, 27G, half-inch) is covered with a needle shield to prevent leakage of the solution through the needle and to protect the needle during handling prior to administration. The needle shield is made of a dry natural rubber containing latex.
SIMPONI does not contain preservatives. The solution is clear to slightly opalescent, colorless to light yellow with a pH of approximately 5.5. SIMPONI is provided in one strength: 50 mg of the golimumab antibody in 0.5 mL of solution. Each 0.5 mL of SIMPONI contains 50 mg of the golimumab antibody, 0.44 mg of L-histidine and L-histidine monohydrochloride monohydrate, 20.5 mg of sorbitol, 0.08 mg of polysorbate 80, and Water for Injection.
What are the possible side effects of golimumab (Simponi, Simponi SmartJect)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
- fever, night sweats, weight loss, tiredness;
- feeling full after eating only a small amount;
- pain in your upper stomach that may spread to your shoulder;
- easy bruising or bleeding, pale skin, feeling light-headed or short of breath, rapid heart rate; or
- nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the...
What are the precautions when taking golimumab injection (Simponi Injection)?
See also Warnings section.
Before using golimumab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as natural rubber/latex), 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: an active infection, TB infection, fungal infections (such as histoplasmosis, coccidioidomycosis), heart disease (congestive heart failure), lupus, recurrent infections, hepatitis B infection, decreased bone marrow function, seizures, certain brain/spinal cord disorders (such as multiple sclerosis), history of cancer (such as lymphoma), scheduled...
Last reviewed on RxList: 5/17/2013
This monograph has been modified to include the generic and brand name in many instances.
Additional Simponi Injection Information
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