Patients treated with golimumab are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.
Reported infections include:
The risks and benefits of treatment with golimumab should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection.
Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with golimumab, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy.
Tuberculosis, invasive fungal infections, and other opportunistic infections, some fatal, have been observed in patients receiving golimumab. Patients should be evaluated for tuberculosis risk factors and be tested for latent tuberculosis infection prior to initiating golimumab and during therapy. Treatment of latent tuberculosis infection should be initiated prior to therapy with golimumab. Monitor patients receiving golimumab for signs and symptoms of infection including tuberculosis in patients who tested negative for latent tuberculosis infection. Lymphoma and other malignancies, some fatal, have been reported in children and adolescents treated with TNF blockers, of which golimumab is a member .
Commonly used brand name(s):
In the U.S.
Available Dosage Forms:
Therapeutic Class: Immune Modulator
Pharmacologic Class: Tumor Necrosis Factor Inhibitor
Golimumab injection is used 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. Psoriatic arthritis usually occurs with a skin condition called psoriasis. Golimumab may be used alone or in combination with other arthritis medicines, such as methotrexate (Rheumatrex®, Trexall®), sulfasalazine (Azulfidine®), hydroxychloroquine (Plaquenil®), corticosteroids (cortisone-like medicines), or nonsteroidal antiinflammatory drugs (NSAIDs).
golimumab 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 golimumab, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to golimumab 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, golimumab causes more infections 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.
Using golimumab 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.
The presence of other medical problems may affect the use of golimumab. Make sure you tell your doctor if you have any other medical problems, especially:
golimumab is given as a shot under your skin. Golimumab may sometimes be given at home to patients who do not need to be in the hospital or clinic. If you are using golimumab 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.
golimumab comes with a Medication Guide and patient information insert. Read and follow the instructions carefully. Ask your doctor if you have any questions.
If you use golimumab 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.
golimumab is available in 2 forms. You may use a prefilled syringe or a prefilled SmartJect™ autoinjector.
The needle cover of the prefilled syringe and SmartJect™ autoinjector contains 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 golimumab.
To use the injection:
The dose of golimumab 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 golimumab. 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 golimumab, 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.
Store in the refrigerator. Do not freeze.
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.
If you will be using golimumab 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 take it. Blood tests may be needed to check for unwanted effects.
You will need to have a skin test for tuberculosis before you start using golimumab. Tell your doctor if you or anyone in your home has ever had a positive reaction to a tuberculosis 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®), or rituximab (Rituxan®). Using any of these together with golimumab may increase your chance of having serious side effects.
Check with your doctor right away if you have more than one of these symptoms: 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 with 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 who have used golimumab have developed certain types of cancer. Some patients also developed a rare type of cancer called 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.
Do not change or stop using golimumab without checking with your doctor first. Your doctor may want you to gradually reduce the amount you are using before stopping it completely.
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:More common
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:Less common
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.
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