Generic Name: Golimumab

  • What is Simponi?

    Simponi is a medicine used to treat moderate to severe rheumatoid arthritis, ankylosing spondylitis, or psoriatic arthritis. Simponi is administered subcutaneously (just below the skin).

  • What is the most important information I should know about Simponi?

    Simponi can make you more likely to get infections or make any infection you have worse. Tell your doctor if you experience fever, sweating, chills, muscle aches, cough, shortness of breath, blood in your phlegm, weight loss, skin reactions, diarrhea, stomach pain, pain on urination, urinating more often, or feel tired.

    Your doctor will test you for tuberculosis (a bacterial infection that affects the lungs) before starting Simponi and will monitor you closely for signs and symptoms of tuberculosis during treatment with Simponi. Tell your doctor if you have tuberculosis, have been in close contact with someone with tuberculosis, or have or have had hepatitis B virus infection. Also, tell your doctor if you live, have lived, or have traveled to certain parts of the country; some areas can increase your chance of getting certain kinds of fungal infections.

    Simponi can affect your immune system and can increase your risk of certain cancers. Tell your doctor if you have ever had any type of cancer. Also, this medication can cause lupus (disease that affects the immune system).

  • Who should not take Simponi?

    Do not use Simponi if you are allergic to it or any of its ingredients.

  • What should I tell my doctor before I take the first dose of Simponi?

    Tell your doctor about all prescription, over-the-counter, and herbal medications you are taking before beginning treatment with Simponi. Also, talk to your doctor about your complete medical history, especially if you have an infection (including tuberculosis or hepatitis B), a weak immune system, diabetes, cancer, liver problems, heart failure or other heart conditions, blood disorders, nervous system problems, scheduled to receive a vaccine, are allergic to rubber or latex, or are pregnant, plan to become pregnant, or are breastfeeding.

  • What is the usual dosage?

    The information below is based on the dosage guidelines your doctor uses. Depending on your condition and medical history, your doctor may prescribe a different regimen. Do not change the dosage or stop taking your medication without your doctor's approval.

    Adults: The recommended dose is 50 milligrams (mg) once a month.

  • How should I take Simponi?

    Use Simponi exactly as prescribed by your doctor.

    Allow Simponi to sit at room temperature outside the carton for 30 minutes. You can inject Simponi into your middle thighs, lower part of your abdomen, or outer area of your upper arm. Wash your hands and wipe the site of injection with alcohol. Inject Simponi within 5 minutes after the cap or needle cover has been removed. Pinch and hold the skin at the injection site.

    If you are using the Smartject autoinjector, push the open end of the Smartject autoinjector firmly against your skin at a 90-degree angle. Press the front raised part of the button with your fingers or thumb. Wait for 2 "click" sounds; the second "click" sound means that the injection is finished and the needle has pulled back into the Smartject autoinjector. If you have hearing problems, count for 15 seconds from the time you pressed the button and then lift the Smartject autoinjector from the injection site. Check the viewing window to see the yellow indicator, which means the autoinjector has worked the right way.

    If you are using the prefilled syringe, push the open end of the prefilled syringe firmly against your skin at a 45-degree angle. Push in the plunger until the plunger head is completely between the needle guard wings. Take the needle out of the skin and let go of the skin. Slowly take your thumb off the plunger head. The empty syringe will move up until the entire needle is covered by the needle guard.

    Dispose the used Smartject autoinjector or prefilled syringe into a closable puncture-resistant container. Press a cotton ball or gauze over the injection site for 10 seconds; do not rub the site.

    Rotate the sites of injection to avoid injection-site reactions (such as itching, redness, or pain).

    Your doctor will show you and/or your caregiver how to inject this medicine, as well as how to properly dispose the needle. Please review the instructions that came with your prescription on how to properly inject Simponi.

  • What should I avoid while taking Simponi?

    Do not shake the Smartject autoinjector at any time. Do not inject the Simponi solution if it is cloudy or contains particles.

    Do not warm the Smartject autoinjector in any other way, including in a microwave or in hot water.

    Do not remove the cap or the needle cover until you are ready to inject Simponi.

    Do not inject into areas where the skin is tender, bruised, red, scaly, or hard. Avoid areas with scars or stretch marks.

    Do not miss any doses of Simponi. Also, do not miss your scheduled follow-up appointments with your doctor.

  • What are possible food and drug interactions associated with Simponi?

    If Simponi is used with certain drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with your doctor before combining Simponi with the following: blood thinners (such as warfarin), certain other medicines to treat certain inflammatory disorders (such as abatacept, adalimumab, anakinra, certolizumab, etanercept, infliximab, rituximab, or tocilizumab), cyclosporine, live vaccines, or theophylline.

  • What are the possible side effects of Simponi?

    Side effects cannot be anticipated. If any develop or change in intensity, tell your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking this drug.

    Side effects may include: abdominal pain, allergic reactions, bleed or bruise very easily, chest discomfort or pain, cold sores, fever, flu, infections, injection-site reactions, joint or muscle pain, numbness or tingling, pale skin, shortness of breath, skin rash or itching, sore throat, swelling of your lower legs or feet, tiredness, upper respiratory tract infection, vision changes, weakness in your arms or legs, yellowing of your skin or whites of your eyes

  • Can I receive Simponi if I am pregnant or breastfeeding?

    The effects of Simponi during pregnancy and breastfeeding are unknown. Tell your doctor immediately if you are pregnant, plan to become pregnant, or are breastfeeding.

  • What should I do if I miss a dose of Simponi?

    If you miss a dose of Simponi, inject it as soon as you remember. However, if it is almost time for your next dose, skip the one you missed and return to your regular dosing schedule. Do not inject two doses at once.

  • How should I store Simponi?

    Store in the refrigerator. Do not freeze. Protect from light.