Simponi (golimumab) is a tumor necrosis factor (TNF) blocker. It works by reducing the effects of a substance in the body that can cause inflammation.
Simponi is used to treat rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. Simponi is sometimes used with another medication called methotrexate (Rheumatrex, Trexall).
You should not use Simponi if you are allergic to golimumab, or if you are already using adalimumab (Humira), certolizumab (Cimzia), etanercept (Enbrel), or infliximab (Remicade). Some people using Simponi have developed a rare fast-growing type of lymphoma (cancer). This condition affects the liver, spleen, and bone marrow, and it can be fatal. This has occurred mainly in teenagers and young adults using Simponi or similar medicines to treat Crohn’s disease or ulcerative colitis.
However, people with autoimmune disorders (including rheumatoid arthritis, Crohn’s disease, ankylosing spondylitis, and psoriasis) may have a higher risk of lymphoma. Talk to your doctor about your individual risk.
Before using Simponi, tell your doctor if you have ever had tuberculosis, if anyone in your household has tuberculosis, or if you have recently traveled to an area where tuberculosis is common.
Some infections are more likely to occur in certain areas of the world. Tell your doctor where you live and where you have recently traveled or plan to travel to during treatment.
To make sure you can safely use Simponi, tell your doctor if you have any of these other conditions:
- an active or recent infection;
- hepatitis B;
- congestive heart failure;
- cancer, HIV, or a weak immune system;
- an allergy to latex rubber;
- a disease that affects the nerves or muscles, such as multiple sclerosis;
- if you have recently been vaccinated with BCG (Bacille Calmette-Guerin); or
- if you are scheduled to receive any vaccines.
FDA pregnancy category B. Simponi is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether golimumab passes into breast milk. Do not use Simponi without first talking to your doctor if you are breast-feeding a baby.
Get emergency medical help if you have any of these signs of an allergic reaction to Simponi: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using Simponi and call your doctor right away if you have any of these symptoms of lymphoma:
- 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 skin or eyes).
Stop using Simponi and call your doctor at once if you have any of these other serious side effects:
- signs of infection (fever, chills, sore throat, flu symptoms, stomach pain, diarrhea, muscle aches);
- shortness of breath with swelling of your ankles or feet;
- chest pain, ongoing cough, coughing up mucus or blood;
- cold sores;
- vision changes, neck stiffness, seizure;
- numbness or tingly feeling, weakness in your legs;
- loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
- joint pain or swelling with fever, swollen glands, muscle aches, nausea, vomiting, chest pain, unusual thoughts or behavior, and/or seizure (convulsions); or
- patchy skin color, red spots, or a butterfly-shaped skin rash over your cheeks and nose (worsens in sunlight).
Less serious Simponi side effects may include:
- cold symptoms such as stuffy nose, sneezing, sore throat;
- dizziness; or
- redness where you injected the medicine.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.