Simponi SubQ Warnings
This medication can decrease your body's ability to fight an infection. This effect can lead to very serious (possibly fatal) infections (such as fungal infections, bacterial infections including tuberculosis). You should have a tuberculosis (TB) skin test before and during treatment with this medication. Also tell your doctor your medical history, especially of past/recent/current infections. You should also tell your doctor if you have lived or traveled in areas where certain fungal infections (such as coccidioidomycosis, histoplasmosis) are common or if you have been near someone with tuberculosis. Areas where these types of fungal infections are commonly found include the Ohio and Mississippi River valleys and the southwestern United States. See Side Effects section for symptoms of infections to watch out for, and seek immediate medical attention if you develop any of these symptoms.
If you are diagnosed with TB, to prevent the infection from becoming serious you must first be treated for it before you start golimumab.
Though it is very unlikely to happen, there is a risk (especially in children/teens/young adults) of developing cancer (such as lymphoma, skin) due to this medication or due to your medical condition. Discuss the risks and benefits of treatment with your doctor. Tell your doctor immediately if you develop symptoms such as unusual lumps/growths, swollen glands, swollen or painful abdomen, unexplained weight loss, persistent fever or night sweats.
Simponi SubQ Uses
This medication is used to reduce pain and swelling due to certain types of arthritis (such as rheumatoid, psoriatic, and ankylosing spondylitis). It works by blocking a protein (tumor necrosis factor or TNF) found in the body's immune system that causes joint swelling and damage. By reducing joint swelling, the medication helps to reduce further joint damage and preserve joint function. Depending on the type of arthritis that is being treated, this drug may be used alone or in combination with another drug called methotrexate.How to use Simponi SubQ
Read the Medication Guide and, if available, the Patient Information Leaflet provided by your pharmacist before you start using golimumab and each time you get a refill. If you have any questions regarding the information, consult your doctor or pharmacist.
Use this medication exactly as prescribed. This drug is given by injection under the skin of the thigh, abdomen, or upper arm, usually once a month, or as directed by your doctor. Learn all preparation and usage instructions in the product package. Never shake this product. Doing so may decrease the effectiveness of the drug.
Remove this medication from the refrigerator and leave it at room temperature for 30 minutes before injecting. Do not warm up this medication any other way such as by heating in the microwave or placing in hot water.
Before using, check this product visually for particles or discoloration. The liquid is usually colorless to pale yellow and may contain tiny particles that are white or that you can see through. If the liquid is any darker than pale yellow, if it is discolored in any other way, or if it contains large particles, do not use the liquid.
Before injecting each dose, clean the injection site with rubbing alcohol.
It is important to change the injection site with each dose. Do not inject into any areas of skin that are sore, bruised, red, scaly, or hard.
Use this medication regularly to get the most benefit from it. To help you remember, mark the day on the calendar when you need to receive the medication.
Learn how to store and discard needles and medical supplies safely. Never reuse syringes or needles. Consult your pharmacist.
Tell your doctor if your condition persists or worsens.
Simponi SubQ Side Effects
Redness, itching, pain, or swelling at the injection site may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor immediately if any of these unlikely but serious side effects occur: fast/irregular/pounding heartbeat, stomach pain, blood in the stools, mental/mood changes, severe headache, easy bruising/bleeding, dark urine, yellowing eyes/skin, leg pain/swelling, numbness/tingling of the hands/feet, unsteadiness, unexplained muscle weakness, vision changes, extreme fatigue, joint pain, butterfly-shaped rash on the nose and cheeks.
Tell your doctor immediately if you develop signs of infection while using this drug, such as: fever, chills, persistent sore throat, persistent cough, night sweats, trouble breathing, painful/frequent urination, unusual vaginal discharge, white patches in the mouth (oral thrush).
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Simponi SubQ Precautions
See also Warnings section.
Before using golimumab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as natural rubber/latex), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: an active infection, TB infection, fungal infections (such as histoplasmosis, coccidioidomycosis), heart disease (congestive heart failure), lupus, recurrent infections, hepatitis B infection, decreased bone marrow function, seizures, certain brain/spinal cord disorders (such as multiple sclerosis), history of cancer (such as lymphoma), scheduled surgery.
Do not have immunizations/vaccinations without the consent of your doctor and avoid contact with people who have recently received oral polio vaccine. Consult your doctor about the risks of exposure to chickenpox and other infections.
Older adults may be more sensitive to the effects of this drug, especially the risk of infections.
During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.
Simponi SubQ Interactions
Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
Some of the products that may interact with this drug include: abatacept, live vaccines, other TNF-blockers (such as adalimumab, certolizumab, etanercept, infliximab), other arthritis drugs (such as anakinra, methotrexate, prednisone, leflunomide, tofacitinib), drugs that suppress the immune system (such as cyclosporine).
Simponi SubQ Overdose
If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.NOTES:
Do not share this medication with others.
Laboratory and/or medical tests (such as complete blood counts, liver function) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.
This medication has been prescribed for your current condition only. Do not use it later for another condition unless your doctor directs you to do so. A different medication may be necessary in that case.MISSED DOSE:
If you miss a dose, contact your doctor or pharmacist to establish a new dosing schedule.STORAGE:
Store in the refrigerator between 36-46 degrees F (2-8 degrees C) away from light and moisture. Do not freeze. Discard any unused portion of this medication. Keep all medicines away from children and pets.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.
MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).
Information last revised March 2013. Copyright(c) 2013 First Databank, Inc.