Serious infections leading to hospitalization or death, including TB, bacterial sepsis, invasive fungal (eg, histoplasmosis), and other opportunistic infections have occurred in patients receiving golimumab. Discontinue golimumab if a patient develops a serious infection or sepsis. Perform test for latent TB; if positive, start treatment for TB prior to starting golimumab. Monitor all patients for active TB during treatment, even if initial latent TB test is negative. Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with tumor necrosis factor (TNF) blockers, of which golimumab is a member .Subcutaneous route(Solution)
Serious infections leading to hospitalization or death, including TB, bacterial sepsis, invasive fungal (eg, histoplasmosis), and other opportunistic infections have occurred in patients receiving golimumab. Discontinue golimumab if a patient develops a serious infection or sepsis. Perform test for latent TB; if positive, start treatment for TB prior to starting golimumab. Monitor all patients for active TB during treatment, even if initial latent TB test is negative. Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with tumor necrosis factor (TNF) blockers, of which golimumab is a member .
Tumor Necrosis Factor Inhibitor
Golimumab injection is used alone or combined with other medicines (eg, methotrexate) to treat the symptoms of moderate-to-severe rheumatoid arthritis and ankylosing spondylitis (arthritis in the spine or backbone). It is also used to treat psoriatic arthritis, which is a type of arthritis that causes pain and swelling in the joints along with patches of scaly skin on some areas of the body.
Golimumab injection is used to treat moderate-to-severe ulcerative colitis in patients who have been treated with other medicines that did not work well.
This medicine is available only with your doctor's prescription.
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies have not been performed on the relationship of age to the effects of golimumab injection in the pediatric population. Safety and efficacy have not been established.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of golimumab injection in the elderly. However, this medicine causes more infections and unwanted side effects in the elderly, which may require caution in patients receiving golimumab injection.
|All Trimesters||B||Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.|
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other medical problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
A nurse or other trained health professional will give you Simponi® Aria™ (together with methotrexate) in a hospital. This medicine is given through a needle placed in one of your veins. The medicine must be injected slowly, so your IV tube will need to stay in place for 30 minutes.
This medicine comes with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.
Simponi® is given as a shot under your skin. It may sometimes be given at home to patients who do not need to be in a hospital or clinic. If you are using this medicine at home, your doctor or nurse will teach you how to prepare and inject the medicine. Be sure that you understand how to use the medicine.
If you use Simponi® at home, you will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. This will help prevent skin problems.
Simponi® is available in 2 forms. You may use a prefilled syringe or a prefilled SmartJect® autoinjector.
The needle covers of the prefilled syringe and SmartJect® autoinjector contain dry natural rubber (a derivative of latex). This may cause allergic reactions in people who are sensitive to latex. Tell your doctor if you have a latex allergy before you start using this medicine.
To use Simponi® injection:
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Store in the refrigerator. Do not freeze.
Protect Simponi® from direct light. Keep the medicine in the original package until you are ready to use it.
If you will be using this medicine for a long time, it is very important that your doctor check you at regular visits. This will allow your doctor to see if the medicine is working properly and to decide whether you should continue to use it. Blood tests may be needed to check for unwanted effects.
This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Stop using this medicine and call your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after you receive this medicine.
You will need to have a skin test for tuberculosis before you start using this medicine. Tell your doctor if you or anyone in your home has ever had a positive reaction to a tuberculosis skin test.
Golimumab can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:
Do not have any live vaccines (immunizations) while you are being treated with golimumab . Check with your doctor before having any vaccines.
Do not take other medicines for arthritis unless you talk to your doctor. This includes abatacept (Orencia®), anakinra (Kineret®), adalimumab (Humira®), certolizumab (Cimzia®), etanercept (Enbrel®), infliximab (Remicade®), rituximab (Rituxan®), or tocilizumab (Actemra®). Using any of these together with this medicine may increase your chance of having serious side effects.
Check with your doctor right away if you have more than one of these symptoms: a fever or chills, a general feeling of discomfort, illness, or weakness, light-colored stools, nausea and vomiting, dark brown-colored urine, right-sided stomach pain, or yellow eyes and skin. These may be signs of serious liver problems.
Check with your doctor right away if you have more than one of these symptoms: chest pain, decreased urine output, dilated neck veins, extreme fatigue, irregular breathing, irregular heartbeat, shortness of breath, swelling of the face, fingers, feet, or lower legs, tightness in the chest, trouble breathing, weight gain, or wheezing. These may be signs of a heart condition called congestive heart failure (CHF).
Check with your doctor right away if you have more than one of these symptoms: blurred vision, difficulty controlling your bladder or bowels, difficulty with walking, feeling sad or depressed, forgetful, muscle cramps, numbness or tingling in your arms, legs, or face, slurred speech or problems with swallowing, or unusual tiredness or weakness. These may be signs of a nervous system disease called multiple sclerosis (MS).
A small number of people (including children and teenagers) who have used this type of medicine have developed certain types of cancer (eg, leukemia, lymphoma). Talk with your doctor if you have unusual bleeding, bruising, or weakness, swollen lymph nodes in the neck, underarms, or groin, or unexplained weight loss. Also, check with your doctor right away if your skin has red, scaly patches, or raised bumps that are filled with pus.
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.