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What should I discuss with my healthcare provider before using golimumab (Simponi, Simponi SmartJect)?
You should not use this medication if you are allergic to golimumab, or if you are already using adalimumab (Humira), certolizumab (Cimzia), etanercept (Enbrel), or infliximab (Remicade).
Some people using golimumab 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 golimumab 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 golimumab, 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 golimumab, tell your doctor if you have any of these other conditions:
FDA pregnancy category B. This medication 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 golimumab without first talking to your doctor if you are breast-feeding a baby.
How should I use golimumab (Simponi, Simponi SmartJect)?
Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Golimumab is usually given once per month. Follow the directions on your prescription label.
Golimumab comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.
Before you start treatment with golimumab, your doctor may perform tests to make sure you do not have tuberculosis or other infections.
Golimumab is injected under the skin. You may be shown how to use injections at home. Do not self inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.
Do not shake the golimumab prefilled syringe. Vigorous shaking can ruin the medicine. Do not use the medication if it has changed colors, is cloudy, or has any particles in it. Call your doctor for a new prescription.
Use a different place on your stomach, thigh, or upper arm each time you give the injection. Your care provider will show you the best places on your body to inject the medication. Do not inject into the same place two times in a row. Avoid injecting golimumab into skin that is scarred, bruised, red, tender, or hard.
Each single-use pre-filled syringe of golimumab is for one use only. Throw away the auto-injector after one use, even if there is still some medicine left in it after injecting your dose.
Throw away used needles and syringes in a puncture-proof container. If your medicine does not come with such a container, ask your pharmacist where you can get one. Keep this container out of the reach of children and pets. Your pharmacist can tell you how to properly dispose of the container.
Golimumab can lower blood cells that help your body fight infections. Your blood may need to be tested often. Avoid being near people who are sick or have infections. Avoid activities that may increase your risk of bleeding injury. Serious and sometimes fatal infections may occur during treatment with golimumab. Contact your doctor right away if you have signs of infection such as: fever, chills, sore throat, flu symptoms, stomach pain, diarrhea, or muscle aches.
If you have hepatitis B you may develop liver symptoms after you stop taking this medication, even months after stopping. Your doctor may want to check your liver function for several months after you stop using golimumab. Visit your doctor regularly.
Store this medication in the refrigerator but do not allow it to freeze. Keep the medication in its original carton and protect from light.
You may take the prefilled syringe or autoinjector out of the refrigerator and place it at room temperature for 30 minutes before giving your injection. Do not warm the medication with water or heat.
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.
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