(goe LIM ue mab) Brand: Simponi, Simponi SmartJect
• You must not use golimumab if you are also using abatacept or anakinra.
• Till you start treatment with golimumab, speak 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.
• Serious and sometimes fatal infections may occur during treatment with golimumab, especially if you also use another medications that can weaken your immune system.
• Stop using golimumab and call your doctor right away if you have signs of infection such as: fever, chills, sore throat, stomach pain, diarrhea, muscle aches, skin redness, headache, dry cough, coughing up blood or mucus, chest discomfort, rapid heart course, white patches in your mouth or throat, or pain when swallowing.
• Some people using golimumab have developed a rare fast-growing type of lymphoma (cancer) that affects the liver, spleen, and bone marrow, and it can be fatal. This has occurred mostly in teenage boys and young men using golimumab.
• Golimumab is a tumor necrosis factor (TNF) blocker. It works by reducing the effects of a stuff in the body that can reason inflammation.
• Golimumab is used to treat rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and ulcerative colitis. Golimumab is sometimes used with other medicine called methotrexate (Rheumatrex, Trexall).
• Golimumab may also be used for purposes not listed in this medicine guide.
• You must not use this medication if you are allergic to golimumab, or if you are also using abatacept or anakinra.
• Golimumab can weaken your immune system. Serious and sometimes fatal infections may occur during treatment, especially if you also use another medications that can weaken your immune system.
• Using golimumab may magnify your risk of determined types of cancer, including lymphoma (cancer of the lymph nodes) or melanoma (a tumor that generally affects the skin). This risk may be greater in children and young adults. You may also develop an autoimmune mess such as a lupus-like syndrome. Conversation with your doctor about your specific risk.
• Some people using this medication have developed a rare fast-growing type of lymphoma (cancer) that affects the liver, spleen, and bone marrow, and it can be fatal. This has occurred mostly in teenage boys and young men using golimumab or similar medicines to treat Crohn's malady or ulcerative colitis. However, people with autoimmune disorders (including rheumatoid arthritis, Crohn's malady, ankylosing spondylitis, and psoriasis) may have a higher risk of lymphoma.
• Till you start treatment with golimumab, speak 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 determined areas of the world. Speak your doctor where you live and where you have recently traveled or plan to travel to during treatment.
• To create certain golimumab is safety for you, speak your doctor if you have:
· an active or last infection (including flu symptoms, diarrhea, skin infection, bladder infection, or lung infection);
· chronic infections that come and go;
· hepatitis B, or another liver problem;
· a history of cancer or lymphoma;
· a history of congestive heart failure;
· diabetes;
· HIV, or a weak immune system;
· a malady that affects the nerves or muscles, such as multiple sclerosis;
· an allergy to latex rubber;
· if you have ever had Guillain-Barre syndrome; or
· if you are scheduled to receive any vaccine.
• FDA pregnancy category B. This medicine is not expected to be deleterious to an unborn child. However, a newborn child may have an heighten risk of infection for up to 6 months if the mother uses golimumab during pregnancy. Speak your doctor if you are pregnant or plan to become pregnant while using golimumab.
• It is not known whether golimumab passes into breast milk or if it could harm a nursing child. You must not breast-feed while using this medicine.
• Do not give this medicine to anyone under 18 years old without medical advice.
• Follow all directions on your prescription label. Do not use this medication in larger or less amounts or for longer than recommended.
• Golimumab is injected under the skin. You may be shown how to use injections at house. Do not self inject this medication if you do not fully understand how to give the injection and properly dispose of used needles and syringes.
• Golimumab comes with patient instructions for safety and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.
• Do not shake the prefilled syringe or you may ruin the medication. Prepare your doze only when you are ready to give an injection. Do not use if the medication has changed colors or has particles in it. Call your pharmacist for new medicine.
• Use a various seat on your stomach, thigh, or upper hand every time you give the injection. Your care provider will show you the excellent places on your body to inject the medicine. Do not inject into the same seat two times in a row. Avoid injecting golimumab into skin that is scarred, bruised, red, tender, or hard.
• Every single-use vial (bottle) of this medication is for one use only. Throw away after one use, even if there is still some medication left in it after injecting your dose.
• Use a disposable needle and syringe only once, then throw away in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Hold this container out of the reach of children and pets.
• Store this medication in the refrigerator but do not let it to freeze. Hold the medicine in its original carton and protect from light.
• Take the prefilled syringe or autoinjector out of the refrigerator and seat it at room temperature for 30 minutes till giving your injection. Do not warm the medicine with water or heat.
• Golimumab can lower blood cells that help your body fight infections and help your blood to clot. This can create it easier for you to bleed from an injury or get sick from being near others who are ill. Your blood may need to be tested often.
• If you have hepatitis B you may develop liver symptoms after you stop taking this medicine, even months after stopping. Your doctor may want to check your liver function for different months after you stop using golimumab.
• Use the medicine as soon as you remember, and then go back to your regular injection schedule. Do not use extra medication to create up the missed dose.
• Search abnormal medical attention or call the Poison Help line at 1-800-222-1222.
• Do not receive a "live" vaccine while you are being treated with golimumab. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.
• If you use this medicine during pregnancy, your child must not receive a live vaccine for the first 6 months after birth.
• Avoid being around people who are sick or have infections. Speak your doctor at once if you develop signs of infection.
• Get abnormal medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your person, lips, tongue, or throat.
• Stop using golimumab and call your doctor right away if you have any of these symptoms, some of which may be signs of infection or lymphoma:
· fever, chills, night sweats, sore throat, headache, diarrhea, muscle aches, weight loss, tiredness;
· skin rash or redness, light bruising or bleeding, pale skin, feeling light-headed or short of breath, rapid heart course;
· nausea, feeling full after eating only a little amount;
· pain in your upper stomach that may spread to your shoulder;
· loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
· dry cough, coughing up blood or mucus, chest discomfort; or
· white patches in your mouth or throat, or pain when swallowing.
• Call your doctor at once if you have any of these another side effects:
· skin growths or changes in skin appearance;
· shortness of breath with swelling of your ankles or feet;
· cool sores;
· vision changes, neck stiffness, seizure;
· numbness or tingly feeling, weakness in your arms or legs;
· patchy skin color, red spots, or a butterfly-shaped skin rash over your cheeks and nose (worsens in sunlight); or
· signs of psoriasis (raised, silvery, flaking of the skin).
• General side effects may include:
· cool symptoms such as stuffy nose, sneezing;
· dizziness; or
· pain, itching, redness, or swelling 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 message side effects to FDA at 1-800-FDA-1088.
• Speak your doctor about all medicines you use, and those you start or stop using during your treatment with golimumab, especially:
· alfentanil, fentanyl;
· ergotamine, dihydroergotamine;
· paclitaxel;
· phenytoin;
· pimozide;
· quinidine;
· rituximab;
· theophylline;
· thioridazine;
· tizanidine;
· tocilizumab;
· warfarin, Coumadin;
· medication to prevent organ transplant rejection--azathioprine, cyclosporine, sirolimus, tacrolimus; or
· another TNF blockers--adalimumab, certolizumab, etanercept, infliximab.
• Your pharmacist can provide more information about golimumab.
Remember, hold this and all another medicines out of the reach of children, never share your medicines with others, and use this medicine only for the indication prescribed.
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