Generic Name: golimumab (goe-LIM-ue-mab)
Brand Name: Simponi
Serious and sometimes fatal infections, including tuberculosis (TB), a fungal infection, and other types of infection, have occurred in patients using Simponi. Most patients who developed these infections were taking medicines that suppressed their immune system (eg, methotrexate, corticosteroids).
TB may be caused by a new infection or by reactivation of a previous infection. Patients should receive a TB skin test before using Simponi. Patients who test positive for TB should begin treatment for TB before starting Simponi. All patients should also be monitored for signs of TB while using Simponi, even if their TB test is negative. Contact your doctor immediately if you develop symptoms of TB or any other infection (eg, persistent cough or sore throat, muscle weakness, weight loss, fever, chills, unusual vaginal discharge, painful or frequent urination, persistent feeling of being unwell).
Simponi is a tumor necrosis factor (TNF) blocker. Lymphoma and other types of cancer have been reported in children and teenagers treated with TNF blockers. This has been fatal in some cases. Talk with your doctor for more information.
Simponi is used for:
Treating moderate to severe rheumatoid arthritis (RA) in certain patients when used along with methotrexate. It is also used to treat psoriatic arthritis alone or with methotrexate. It may also be used to treat ankylosing spondylitis, moderate to severe ulcerative colitis, or for other conditions as determined by your doctor.
Simponi is a TNF blocker. It works by blocking a protein (TNF-alpha) found in the body that causes inflammation.
Do NOT use Simponi if:
- you are allergic to any ingredient in Simponi
- you have a severe infection (eg, sepsis) or any other active infection
- you are using abatacept, adalimumab, anakinra, canakinumab, certolizumab, etanercept, infliximab, rilonacept, rituximab, tocilizumab, or tofacitinib
Contact your doctor or health care provider right away if any of these apply to you.
Before using Simponi:
Some medical conditions may interact with Simponi. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances, including rubber or latex
- if you have a history of infections or an infection that keeps coming back; TB infection or positive TB skin test; hepatitis B infection or other liver problems; heart problems (eg, heart failure); low blood platelets, white blood cell counts, or hemoglobin; asthma; diabetes; HIV; lymphoma or another type of cancer; or numbness, tingling, or other nervous system problems (eg, multiple sclerosis, Guillain-BarrÃ© syndrome)
- if you have an autoimmune disorder (eg, lupus) or other immune system problems, have recently received a vaccine, are scheduled to receive a vaccine, or are scheduled to have surgery
- if you have open cuts or sores on your body, have flu-like symptoms or other signs of infection (eg, fever; chills; cough; warm, red, or painful skin), or are using medicine to treat an infection
- if you have ever lived in or traveled to an area where TB is common, or if you have come into close contact with a person with active TB
- if you live, have lived, or traveled to certain parts of the country (eg, Ohio or Mississippi river valleys and the Southwest) where certain types of fungal infections (eg, histoplasmosis, coccidioidomycosis, blastomycosis) are common. Check with your doctor if you are not sure if you have lived or traveled in an area where these infections are common
- if you take medicine that may decrease your immune system (eg, cyclosporine), or if you have recently received rituximab
Some MEDICINES MAY INTERACT with Simponi. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Abatacept, adalimumab, anakinra, canakinumab, certolizumab, corticosteroids (eg, prednisone), etanercept, infliximab, rilonacept, rituximab , tocilizumab, or tofacitinib because the risk of serious infection may be increased
- Anticoagulants (eg, warfarin), cyclosporine, or theophylline because their effectiveness may be decreased by Simponi
This may not be a complete list of all interactions that may occur. Ask your health care provider if Simponi may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Simponi:
Use Simponi as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Simponi comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Simponi refilled.
- Simponi is given as an injection under the skin. A health care provider will teach you how to use it. Be sure you understand how to use Simponi. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
- Simponi should be colorless to slightly yellow in appearance. Do not use Simponi if it contains particles, is cloudy or discolored, or if the syringe or autoinjector is cracked or damaged.
- Do not shake Simponi before use.
- Allow the prefilled syringe or autoinjector to sit out at room temperature for 30 minutes before using. Do not warm Simponi in any other way. Do not remove the needle cover or the cap on the autoinjector until right before use.
- Use the proper technique taught to you by your doctor. Inject deep under the skin, NOT into muscle.
- Rotate injection sites. New injections should be given at least 1 inch from an old site. Do not inject into areas where the skin is tender, bruised, red, scaly, or hard, or where you have scars or stretch marks.
- Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
- If you miss a dose of Simponi, use it as soon as you remember. Then go back to your regular dosing schedule. If you are not sure when to use Simponi, check with your doctor or pharmacist.
Ask your health care provider any questions you may have about how to use Simponi.
Important safety information:
- Simponi may cause dizziness or vision changes. These effects may be worse if you take it with alcohol or certain medicines. Use Simponi with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Do NOT use more than the recommended dose or use for longer than prescribed without checking with your doctor.
- Simponi may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection such as fever, sore throat, rash, or chills.
- Simponi may increase the risk of developing certain types of cancer (eg, leukemia, lymphoma, skin cancer). This may be fatal in some cases. Discuss any questions or concerns with your doctor. Tell your doctor if you have ever had cancer. Contact your doctor right away if you develop symptoms of leukemia or lymphoma, such as unusual bruising, unusual lumps or swelling (eg, in your neck, armpit, or groin), night sweats, recurring fever, unusual tiredness or weakness, persistent unexplained itching, or unexplained weight loss.
- A rare type of cancer called HSTCL has been reported in patients using TNF blockers. These cases have been fatal. Most of these cases occurred in teenagers or young adults. Most of these patients had Crohn disease or ulcerative colitis. Patients who developed this cancer were usually using Simponi along with certain other medicines (azathioprine, 6-mercaptopurine). Tell your doctor if you have or have ever had any type of cancer. Tell your doctor right away if you develop stomach pain or tenderness, fever, night sweats, or unexplained weight loss.
- New or worsening nervous system problems (eg, multiple sclerosis, Guillain-BarrÃ© syndrome, seizures) have occurred with TNF blockers. Tell your doctor if you have a condition that affects your nervous system. Discuss any questions or concerns with your doctor.
- Patients with inflammatory diseases (eg, RA) who use Simponi, especially those with more severe inflammatory diseases, have an increased risk of developing lymphoma. Talk with your doctor if you have questions about your risk of developing any type of cancer while using Simponi.
- Some patients who use Simponi have developed new or worsening psoriasis. Tell your doctor right away if you notice any new or worsening skin problems (eg, red, flaky, or itchy skin patches).
- Tell your doctor or dentist that you take Simponi before you receive any medical or dental care, emergency care, or surgery.
- Simponi may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.
- Do not receive a live vaccine (eg, measles, mumps) while you are taking Simponi. Talk with your doctor before you receive any vaccine.
- Lab tests, including TB, liver function, and complete blood cell counts, may be performed while you use Simponi. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Use Simponi with caution in the ELDERLY; they may be more sensitive to its side effects, especially an increased risk of infection.
- Simponi should be used with extreme caution in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: If you receive Simponi while pregnant, your baby may be at a higher risk of getting an infection. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Simponi while you are pregnant. It is not known if Simponi is found in breast milk. Do not breast-feed while taking Simponi.
Possible side effects of Simponi:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Cold sores; dizziness; hoarseness; mild itching, pain, redness, or swelling at the injection site; mild sore throat; runny or stuffy nose.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood in the urine or stools; butterfly-shaped rash on the nose and cheeks; change in the appearance of the skin; chest pain; diarrhea; eye pain; fainting; fast or irregular heartbeat; increased sensitivity to the sun; mental or mood changes; muscle pain or weakness; new or worsening joint pain; new or worsening red, scaly patches or raised bumps filled with pus on the skin; numbness, burning, or tingling; open sore that does not heal; red, swollen, blistered, or peeling skin; seizures; severe or persistent headache or dizziness; severe or persistent pain, swelling, or redness at the injection site; severe or persistent stomach pain; shortness of breath; signs of infection (eg, fever, chills, or persistent cough or sore throat; flu-like symptoms; muscle aches; warm, red, or painful skin or sores; increased or painful urination; night sweats; unexplained weight loss; blood in the mucus; tooth pain); swelling of the ankles, hands, or feet; symptoms of liver problems (eg, yellowing of the skin or eyes, dark urine, pale stools, unusual nausea, loss of appetite); unexplained weight loss; unusual bruising or bleeding; unusual lumps or skin growth; unusual tiredness or weakness; unusually pale skin; vision changes (including vision loss); vomiting; weakness in the arms or legs.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.Proper storage of Simponi:
Store Simponi in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Protect from light. Store in the original container until ready to use. If you need to take Simponi with you, such as when traveling, store it in a cool carrier with an ice pack and protect it from light. Do not use after the expiration date on the prefilled syringe or autoinjector. Do not use Simponi if it has ever been frozen or heated. Keep Simponi out of the reach of children and away from pets.
- If you have any questions about Simponi, please talk with your doctor, pharmacist, or other health care provider.
- Simponi is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take Simponi or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Simponi. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Simponi. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using Simponi.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.