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Overview: Golimumab is medicine used for many inflammatory or immune problems, such as certain types of arthritis or ulcerative colitis. Infection is a common side effect. If you get this medicine injected under your skin, you may also have redness, itching, swelling, or pain at the site. Contact your healthcare provider right away if you notice any signs of an infection or increased bleeding or bruising.

Uses

What is golimumab used for?

Golimumab is commonly used for the following inflammatory or immune conditions.

Golimumab may also be used for other conditions as determined by your healthcare provider.

How does golimumab work (mechanism of action)?

Tissue necrosis factor (TNF) is a natural chemical in your body that is involved in normal inflammatory and immune activity. In many types of arthritis and ulcerative colitis, higher than normal TNF levels may exist. Golimumab works by blocking some forms of TNF. By blocking TNF, golimumab may reduce inflammation and immune activity, to provide relief in these conditions.

How is golimumab supplied (dosage forms)?

Brands and other names

  • Simponi
  • Simponi Aria

Dosage forms and strengths

  • 50 mg/0.5mL, 100 mg/mL autoinjector
  • 50 mg/0.5mL, 100 mg/mL prefilled syringe
  • 50 mg/4 mL single-dose vial

How should I store golimumab?

Golimumab should be stored in the original carton to protect it from light. Keep the medicine in the refrigerator between 36 F and 46 F (2 C to 8 C). If needed, it can be stored at room temperature, up to 77 F (25 C), for up to 30 days. If golimumab has been stored at room temperature, it should not be put back in the refrigerator. If it is not used within 30 days once stored at room temperature, it should be thrown away. Do not freeze or shake golimumab.

Side Effects

What are the most common side effects of golimumab?

The most common side effects of golimumab are listed below. Tell your healthcare provider if you have any of these side effects that bother you.

  • Infection in the nose or throat, sore throat, or common cold symptoms
  • Pain, rash, itching, and swelling at the injection site (injection under the skin)
  • Abnormal liver tests
  • Blood disorders (see below)
  • Bronchitis
  • High blood pressure
  • Rash

There may be other side effects of golimumab that are not listed here. Contact your healthcare provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of golimumab?

While less common, the most serious side effects of golimumab are described below, along with what to do if they happen.

Severe Allergic Reactions. Golimumab may cause allergic reactions, which can be serious. Stop using golimumab and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching, skin rash, or pale red bumps on the skin called hives
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Infections. Golimumab can increase your risk of infections, including serious infections. Some of these infections can lead to death. Call your healthcare provider right away if you have an infection or any of the following symptoms.

  • Burning or stinging when you pee 
  • Cough or coughing up blood
  • Fever, sweats, chills, or muscle aches
  • Shortness of breath
  • Diarrhea or stomach pain
  • Weight loss
  • Warm, red, or painful skin

Cancer. Golimumab can cause a new cancer to develop or cause a previously treated cancer to recur. Children, teenagers, and young adults or anyone with severe arthritis may be at higher risk, especially for lymphomas. Some of these cancers may lead to death. Keep any appointments to get your skin checked. Tell your healthcare provider about any new symptoms that you may get. 

Reactivated Infections. Some types of microbes that cause infections (such as bacteria or viruses) can remain in the body after you recover from that infection. When a microbe stays in the body but does not cause an infection, it is called a “latent” microbe. Golimumab may increase your risk of a latent microbe becoming active again, causing an infection. Keep all appointments, including lab appointments before starting and while taking golimumab. Before you start treatment with golimumab, tell your healthcare provider if you have ever had tuberculosis (TB), hepatitis B, or any other serious infections.

Nerve Damage. In rare cases, golimumab may cause damage to the protective covering that surrounds the nerves (demyelinating disease). Tell your healthcare provider if you already have a demyelinating disease before starting golimumab, such as multiple sclerosis or optic neuritis, or if you have seizures. Once you have started using golimumab, tell your healthcare provider right away if you have any of the following symptoms.

  • Changes in mental function
  • Muscle weakness
  • Numbness or tingling
  • Poor coordination or dizziness
  • Trouble walking
  • Vision changes or vision loss

Blood Disorders. Golimumab can cause blood disorders, such as agranulocytosis, aplastic anemia, low platelet levels (thrombocytopenia), and low white blood cell levels (leukopenia or neutropenia). Stop using golimumab and get help right away if you have any of the following symptoms of blood disorders.

  • Fever
  • Shortness of breath
  • Pale or yellowish skin
  • Easy bruising or bleeding
  • Frequent infection
  • Unusual weakness or tiredness
  • Dizziness, lightheadedness, or feeling like you are about to pass out
  • Headache
  • Fast or abnormal heartbeat

Heart Failure. Golimumab may lead to or worsen heart failure. Tell your healthcare provider right away if you have any of the following symptoms of heart failure.

  • Shortness of breath or trouble breathing, especially while lying down
  • Swelling in your feet, ankles, or legs
  • Unusually fast weight gain
  • Unusual tiredness

Immune System Reactions. Golimumab can cause inflammation of your liver, blood vessels, or lymph vessels and cause symptoms that look like a condition called lupus. Stop using golimumab and call your healthcare provider right away if you develop any of the following symptoms.

  • Rash
  • New joint or muscle pain
  • Fever
  • Weakness or unusual tiredness
  • Swelling in your feet, ankles, or legs

Liver Damage. Liver damage, also called hepatotoxicity, can happen when using golimumab. Call your healthcare provider right away if you have any of the following symptoms of liver damage.

  • Nausea or vomiting
  • Stomach or belly pain
  • Fever
  • Weakness or unusual tiredness
  • Itching
  • Loss of appetite
  • Light-colored poop
  • Dark-colored urine (pee)
  • Your skin or the whites of your eyes turning yellowish in color (also called jaundice)

Skin Problems. Golimumab may cause or worsen a skin condition known as psoriasis. Tell your healthcare provider if you have any of the following symptoms of psoriasis.

  • Red patches that may be scaly
  • Pus-filled bumps on your skin

Warnings & Precautions

Who should not use golimumab?

Allergies to Ingredients. People who are allergic to any of the following should not use golimumab.

  • Golimumab
  • Simponi
  • Simponi Aria
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in the specific golimumab products they stock.

What should I know about golimumab before using it?

Do not use golimumab unless it has been prescribed to you by a healthcare provider. Use it as prescribed. This medicine is injected under the skin. Make sure that you or a caregiver understands how to properly prepare and use golimumab. Read and follow the “Instructions for Use” that come with your golimumab. If you have any questions, talk to your pharmacist or other healthcare provider.

Do not share golimumab with other people, even if they have the same condition as you. It may harm them.

Keep golimumab out of the reach of children. Since this medicine should be kept in a refrigerator, take special precautions to keep it away from children who also use the refrigerator.

Do not inject golimumab in the exact same spot every time. You should rotate where you give golimumab injections. Do not inject it in areas that are bruised, red, hard, or tender. If you need to give more than one injection at a time, give the injections at different places on your body. 

What should I tell my healthcare provider before using golimumab?

Tell your healthcare provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if golimumab is right for you.

In particular, make sure that you discuss any of the following.

Vaccines. Talk with your healthcare provider about any vaccines that you may need. You should not receive certain vaccines right before or while using golimumab. Tell your healthcare provider about any vaccines you have recently received or have scheduled.

Latex Allergy. The golimumab needle cover contains dry natural rubber, which is related to latex. Tell your healthcare provider if you have a latex allergy. 

Current and Past Health Conditions. Tell your healthcare provider if you have any of the following.

  • Think you have an infection, are being treated for an infection, or get infections often
  • Skin problems, such as open sores or cuts or psoriasis
  • Have or had cancer, including skin cancers or lymphomas
  • Heart failure
  • Nerve problems, including multiple sclerosis, Guillain-Barre syndrome, or optic neuritis
  • Liver problems
  • Diabetes
  • Blood disorders
  • Immune system problems, including HIV
  • Chronic obstructive pulmonary disease (COPD)
  • Tuberculosis (TB), or close contact with someone who has it
  • Traveled to or lived in areas where the risk of tuberculosis is high
  • Live or lived in areas (such as the Ohio or Mississippi River valleys) where there is an increased risk for certain fungal infections (histoplasmosis, coccidioidomycosis, or blastomycosis)
  • Have or had hepatitis B

Other Medicines and Supplements. Golimumab may interact with other medicines and supplements. Before using golimumab, tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

Pregnancy. It is not known if or how golimumab could affect pregnancy or harm an unborn baby. Tell your healthcare provider if you are or plan to become pregnant. Your healthcare provider will advise you if you should use golimumab while you are pregnant or trying to get pregnant. If you use golimumab while you are pregnant, tell your baby’s healthcare provider before your baby gets any vaccines in their first six months of life.

Breastfeeding. It is not known if golimumab passes into breast milk. Tell your healthcare provider if you are breastfeeding or plan to breastfeed. Your healthcare provider will advise you if you should use golimumab while breastfeeding.

Interactions

Does golimumab interact with foods or drinks?

There are no known interactions between golimumab and foods or drinks.

It is unknown if drinking alcohol will affect golimumab.

Does golimumab interact with other medicines (drug interactions)?

Always tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

In particular, make sure that you discuss if you are using or have recently used any of the following before using golimumab.

  • Azathioprine (Imuran), which is a medicine used for rheumatoid arthritis
  • 6–mercaptopurine (Purinethol), which is a medicine used for certain types of cancer
  • A medicine used to treat autoimmune conditions, such as tocilizumab (Actemra), etanercept (Enbrel), adalimumab (Humira), infliximab (Remicade), rituximab (Rituxan), abatacept (Orencia), anakinra (Kineret), certolizumab (Cimzia), golimumab (Simponi), ustekinumab (Stelara), secukinumab (Cosentyx), vedolizumab (Entyvio), or ixekizumab (Taltz)
  • Cyclosporine (Gengraf, Neoral, Sandimmune, and others), which is a medicine that suppresses your immune system
  • Warfarin, which is a blood thinner
  • Theophylline (Theo-24, Elixophyllin), which is a medicine for asthma or certain other breathing problems
  • Bacillus Calmette-Guerin (BCG), which is used for bladder cancer

Golimumab may alter the blood levels of some other medicines. Tell your healthcare provider about all medicines that you take or have recently taken.

This may not be a complete list of medicines that can interact with golimumab. Always check with your healthcare provider.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much golimumab?

If you or someone else has used too much golimumab, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of golimumab?

Infusions. Golimumab intravenous (IV) infusions are usually given by a healthcare provider in a hospital or clinic. Your healthcare provider will make sure you are receiving golimumab as scheduled. If you miss an appointment to get your golimumab infusion, call to make another appointment as soon as possible. 

Injections. It is important not to miss doses of golimumab injections under the skin. If you miss a dose, use it as soon as you remember it. Then, use your next dose when you normally would. Do not use double or extra doses.