Type of medicine: monoclonal antibody for tumor necrosis factor (TNF)
Generic and brand names: golimumab, injection; Simponi
This medicine is given by subcutaneous injection (just under the skin) to treat:
It may be used for other conditions as determined by your healthcare provider.
This medicine may be used alone or along with another medicine.
Before taking this medicine, tell your healthcare provider if you have ever had:
Tell your healthcare provider if you currently have an infection such as the flu or an open cut or sore, or if you often have infections that come back. Also tell your healthcare provider if you:
Some infections are more likely to occur in certain parts of the country. Tell your provider where you have lived or recently traveled or where you plan to travel to during treatment.
Tell your provider if you take any other medicines for RA or JIA, especially anakinra (Kineret), certolizumab (Cimzia), etanercept (Enbrel), golimumab (Simponi), adalimumab (Humira), rituximab (Rituxan), infliximab (Remicade), or tocilizumab (Actemra).
Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant. Do not breast-feed while taking this medicine without your healthcare provider's approval.
If you have a baby and you were using his medicine during your pregnancy, tell your baby's healthcare provider before your baby receives any vaccine. Your baby may have an increased chance of getting an infection for up to 6 months after birth.
Read the Medication Guide that comes in the medicine package when you start taking this medicine and each time you get a refill.
This medicine comes in a single-use prefilled syringe or a single-use autoinjector. This medicine is given by subcutaneous injection (just under the skin). If your healthcare provider is giving you the shots, keep all your appointments. You will get a dose one time each month.
Sometimes you can give yourself these shots or have someone at home give them to you. You should receive training on how to prepare and give yourself these shots. Check the label on the medicine for directions about your specific dose. Be sure you know how and when to have shots and how much medicine to use. The shots should not be given into areas where the skin is tender, bruised, or red, or where you have scars or stretch marks. Allow the medicine to sit at room temperature outside the carton for 30 minutes before injecting it.
Use each prefilled syringe or autoinjector only once and dispose of them safely, following your healthcare provider's instructions. Do not use the medicine if it becomes cloudy or contains particles.
Carefully read and follow the directions that come in the package of medicine for preparing the shots. Wash your hands before using this medicine.
If you are not sure of how to give yourself the shots, ask your healthcare provider or pharmacist for help.
Do not stop using this medicine without your healthcare provider's approval.
If you miss a dose, use it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and use the next one as directed. Do not use double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.
Symptoms of an acute overdose have not been reported.
This medicine increases your risk for serious or life-threatening infections. Stay away from people with colds, flu, or other infections. Contact your healthcare provider right away if you develop a fever or ANY other symptoms of infection. Also, do not have any vaccines without getting your healthcare provider's approval first.
Your healthcare provider will check you regularly to see how this medicine affects you. Keep all appointments.
This medicine may make you dizzy or cause vision changes. Do not drive or operate machinery unless you are fully alert and can see clearly.
Rarely, this medicine causes a condition called lupuslike syndrome. Its symptoms include a rash on your face or other parts of your body, chest pain or discomfort that doesn’t go away, new joint pain, shortness of breath, and sensitivity to sunlight. Talk to your healthcare provider about this.
This medicine may increase your risk for lymphoma, leukemia, and other cancers. Talk to your healthcare provider about this.
This medicine may also increase the risk of developing psoriasis or worsen psoriasis. Contact your provider if you notice red scaly patches or raised bumps on the skin that are filled with pus.
If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.
Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.
Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).
Serious (report these to your healthcare provider right away): Yellow skin or eyes; dark urine; severe stomach pain, diarrhea, or vomiting; loss of appetite; fever; unexplained weight loss; night sweats; unexplained weight loss; extreme tiredness; lupuslike syndrome (rash, sensitivity to sunlight, chest pain, new joint or muscle pain); seizures; dry cough; increased shortness of breath; unexplained swelling; weakness in the arms or legs; dizziness; unusual bleeding or bruising; numbness or tingling in your hands or feet; sinus or chest infection; sudden changes in vision; pain when urinating or urinating more often than normal.
Other: Runny nose, headache, stomach pain, nausea; redness, swelling, or bruising around the area where you received the shot.
When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking any other medicines.
If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.
Store this medicine in the refrigerator. Do not let it freeze. Protect it from heat, high humidity, and bright light.
This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.
Keep all medicines out of the reach of children.
Do not share medicines with other people.
