Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Simponi (Golimumab).
Birth control: Effective birth control must be used during treatment and for 6 months after stopping therapy. During this time, women will have monthly pregnancy tests to ensure they are not pregnant. Tell your doctor immediately if you become pregnant while using Simponi (Golimumab).
Bleeding: Simponi (Golimumab) may affect your body's ability to produce enough of certain types of blood cells, including the ones that help you stop bleeding. If you experience unusual bruising or bleeding, increased nosebleeds, or bleeding gums, or you notice blood in your urine, contact your doctor as soon as possible. Get medical attention immediately if you notice signs of bleeding in the stomach such as bloody, black, or tarry stools, or vomiting blood or material that looks like coffee grounds.
If you have an increased risk of bleeding, your doctor should closely monitor your blood counts while you are using Simponi (Golimumab).
Cancer risks: People taking Simponi (Golimumab) have a higher risk of Leukemia, lymphoma, or other cancers such as Melanoma. People with rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis are also at a higher risk for lymphoma. Talk to your doctor about cancer screening and your risk of cancer.
Congestive heart failure (CHF): People taking medications in the same family as Simponi (Golimumab) may develop CHF or find that their CHF gets worse.
If you have a history of CHF or are at risk of developing CHF, discuss with your doctor how Simponi (Golimumab) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Simponi (Golimumab), and whether any special monitoring is needed.
If you develop shortness of breath or swelling of the feet or legs (symptoms of CHF), contact your doctor right away.
Dizziness: Simponi (Golimumab) may cause dizziness. Do not drive or operate heavy machinery until you know how it affects you.
Hepatitis B: Simponi (Golimumab), like other tumour necrosis factor blockers, has been associated with reactivation of hepatitis B infections. This can be fatal. If you have a history of hepatitis B infection, discuss with your doctor how Simponi (Golimumab) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Simponi (Golimumab), and whether any special monitoring is needed.
Immune system problems: In rare instances, people taking medications in the same family as Simponi (Golimumab) may develop symptoms similar to the symptoms of lupus (rash on the cheeks or other body areas; sun sensitivity; joint or muscle pain; fatigue; chest pain; shortness of breath; or swelling of the feet, ankles, or legs). Contact your doctor if you develop these symptoms.
Latex allergies: There is dry natural rubber (a form of latex) in the needle covers for both the prefilled syringe and the autoinjector. If you are sensitive to latex, you may have an allergic reaction. Talk to your doctor about how this may affect you.
Liver problems: Some people taking Simponi (Golimumab) have developed liver problems. Contact your doctor right away if you notice symptoms of a liver problem, such as yellowing of the skin and eyes, dark brown-coloured urine, right-sided abdominal pain, fever, nausea, vomiting, and severe fatigue.
Neurological effects: In rare instances, people taking medications in the same family as Simponi (Golimumab) may develop nervous system diseases such as Multiple Sclerosis (MS). Contact your doctor right away if you notice vision changes, arm or leg weakness, or numbness or tingling in any body part.
Psoriasis: Some people taking Simponi (Golimumab) develop psoriasis, or notice that their existing psoriasis has gotten worse. Contact your doctor if this occurs.
Serious infections: Simponi (Golimumab) can affect the way your body's natural defences work to fight infection. This makes the body more likely to develop infections due to bacteria, viruses, and fungi. This effect is increased if you are taking Simponi (Golimumab) with other medications that reduce the body's ability to fight infection. For some people, these infections have been fatal.
If you have a history of chronic or frequent infections, discuss with your doctor how Simponi (Golimumab) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Simponi (Golimumab), and whether any special monitoring is needed.
Stop taking the medication and tell your doctor right away if you notice symptoms of a serious infection, such as fever, chills, headache, flu-like symptoms, feeling tired, cough, blood in the sputum, shortness of breath, night sweats, weight loss, nausea, vomiting, diarrhea, frequency or burning while passing urine, redness or swelling of skin or joint, cold sores, tooth pain, or new or worsening pain in any part of the body.
Severe allergy: Simponi (Golimumab) is known to cause severe allergic reactions. Contact your doctor at once if you experience signs of an allergic reaction, such as skin rash, itching, difficulty breathing, or swelling of the face and throat.
Surgery: If you are scheduled for planned (elective) surgery, be sure to let your surgeon and other health care professionals know that you are using Simponi (Golimumab).
Tuberculosis: Some people who have had tuberculosis (a lung infection) in the past have had this infection return when they are using Simponi (Golimumab). If you have a history of tuberculosis, or have come into recent contact with someone who has tuberculosis, discuss with your doctor how Simponi (Golimumab) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Simponi (Golimumab), and whether any special monitoring is needed.
Vaccinations: People taking Simponi (Golimumab) should not receive certain vaccines. Talk to your doctor about whether any vaccines you are scheduled to take may be used with Simponi (Golimumab).
Pregnancy: Simponi (Golimumab) crosses the placenta and may affect the development of the unborn child if it is used by a woman during pregnancy. Effective birth control must be used to prevent pregnancy and for 6 months after the last dose of Simponi (Golimumab) is taken to avoid causing harm to an unborn baby. If you become pregnant while taking Simponi (Golimumab), contact your doctor immediately.
Breast-feeding: It is not known if Simponi (Golimumab) passes into breast milk. If you are a breast-feeding mother and are taking Simponi (Golimumab), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Children: The safety and effectiveness of using Simponi (Golimumab) have not been established for children. Children less than 18 years of age may be at an increased risk of developing certain blood cancers.
