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Golimumab (Intravenous, Subcutaneous)

Generic name: golimumab [ goe-LIM-ue-mab ]
Brand names: Simponi, Simponi Aria
Drug class: TNF alfa inhibitors

Medically reviewed by Drugs.com. Last updated on Nov 24, 2023.

Intravenous route(Solution)

Serious Infections and Malignancy

Serious infections leading to hospitalization or death including tuberculosis (TB), bacterial sepsis, invasive fungal (such as 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 TNF blockers, of which golimumab is a member .

Subcutaneous route(Solution)

Serious Infections and Malignancy

Serious infections leading to hospitalization or death including tuberculosis (TB), bacterial sepsis, invasive fungal (such as 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 TNF blockers, of which golimumab is a member .

Uses for golimumab

Golimumab injection is used together with other medicines (eg, methotrexate) to treat moderate to severe rheumatoid arthritis. 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. This medicine is also used to treat ankylosing spondylitis (arthritis in the spine or backbone) and polyarticular juvenile idiopathic arthritis.

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.

Before using golimumab

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:

Allergies

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.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of Simponi® in the pediatric population. Safety and efficacy have not been established.

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Simponi Aria® in children 2 years of age and older with polyarticular juvenile idiopathic arthritis and psoriatic arthritis. However, safety and efficacy have not been established in children with other conditions.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of golimumab injection in the elderly. However, elderly patients are more likely to have serious infections, which may require caution in patients receiving golimumab injection.

Breast Feeding

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.

Interactions with Medicines

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.

Interactions with Food/Tobacco/Alcohol

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:

Proper use of golimumab

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 into one of your veins. It 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 these 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 exactly 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:

Dosing

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.

Missed Dose

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.

Storage

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. You may also store the medicine in the original carton at room temperature for 30 days, as needed. Do not put it back in the refrigerator once you have stored it at room temperature, and throw it away after 30 days.

Throw away used syringes or autoinjectors in a hard, closed container where the needles cannot poke through. Keep this container away from children and pets.

Precautions while using golimumab

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and requires immediate medical attention. 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. Tell your doctor if you have a baby and you have received this medicine while you are pregnant. Tell your child's doctor before your child receives a vaccine. This medicine may increase the risk for infections in children for up to 6 months after birth.

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 pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

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, swelling of the face, fingers, feet, or lower legs, tightness in the chest, trouble breathing, or weight gain. 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, forgetfulness, 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).

This medicine may increase your risk of getting certain types of cancer, including lymphoma, leukemia, skin cancer, and colon cancer. Some teenagers and young adults with Crohn's disease or ulcerative colitis developed a rare type of cancer called hepatosplenic T-cell lymphoma (HSTCL). Check with your doctor right away if you have unusual bleeding, bruising, or weakness, swollen lymph nodes in the neck, underarms, or groin, or unexplained weight loss.

This medicine may increase your risk of having a lupus-like syndrome. Check with your doctor right away if you have chest pain, fever or chills, a general feeling of discomfort, illness, or weakness, joint pain, a rash on the cheeks or arms that is worse in the sun, or severe tiredness.

This medicine may make your skin more sensitive to sunlight. Wear sunscreen. Do not use sunlamps or tanning beds.

Side Effects of golimumab

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

Less common

Rare

Incidence not known

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.

Commonly used brand name(s)

In the U.S.

Available Dosage Forms:

Therapeutic Class: Immune Modulator

Pharmacologic Class: Tumor Necrosis Factor Inhibitor

Frequently asked questions

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.