What is the most important information I should know about golimumab?
Serious and sometimes fatal infections may occur during treatment with golimumab. Stop using this medicine and call your doctor right away if you have signs of infection such as: fever, chills, muscle aches, feeling very tired, cough, shortness of breath, sweating, skin sores, diarrhea, stomach pain, weight loss, increased urination, or burning when you urinate.
If you have ever had tuberculosis or hepatitis B, golimumab can cause these conditions to come back or get worse. You should be tested for these conditions before you start using golimumab.
What is golimumab?
Golimumab reduces the effects of a substance in the body that can cause inflammation.
Golimumab is used to treat rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or ulcerative colitis. Golimumab is sometimes used with another medicine called methotrexate (Rheumatrex, Trexall).
Golimumab may also be used for purposes not listed in this medication guide.
What should I discuss with my healthcare provider before using golimumab?
You should not use golimumab if you are allergic to it.
Tell your doctor if you have ever had tuberculosis, if anyone in your household has tuberculosis, or if you have recently traveled to an area where certain infections are common (Ohio River Valley, Mississippi River Valley, and the Southwest).
To make sure golimumab is safe for you, tell your doctor if you have:
- an active or recent infection, or chronic infections that come and go;
- hepatitis B (or if you are a carrier of the virus);
- diabetes;
- a personal or family history of skin cancer;
- a weak immune system, HIV or AIDS;
- a nerve-muscle disease such as multiple sclerosis or Guillain-Barre syndrome;
- a history of cancer or lymphoma;
- a history of congestive heart failure;
- an allergy to latex rubber;
- if you are also using abatacept (Orencia) or anakinra (Kineret); or
- if you are scheduled to receive any vaccine.
Using golimumab may increase your risk of developing autoimmune disorders or cancer, including skin cancer. Talk to your doctor about this risk and what symptoms to watch for.
Some people using golimumab have developed a rare fast-growing type of lymphoma (cancer) that affects the liver, spleen, and bone marrow, and it can be fatal. This has occurred mostly in teenage boys and young men using golimumab or similar medicines to treat Crohn's disease or ulcerative colitis. However, people with autoimmune disorders (including rheumatoid arthritis, Crohn's disease, ankylosing spondylitis, and psoriasis) may have a higher risk of lymphoma.
Golimumab is not expected to harm an unborn baby. However, a newborn baby may have an increased risk of infection for up to 6 months if the mother uses golimumab during pregnancy. Tell your doctor if you are pregnant or plan to become pregnant.
It is not known whether golimumab passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.
Do not give this medication to anyone under 18 years old without medical advice.
How should I use golimumab?
Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.
If you have ever had tuberculosis or hepatitis B, golimumab can cause these conditions to come back or get worse. You should be tested for these conditions before you start using golimumab.
Golimumab is sometimes injected into a vein through an IV. A healthcare provider will give you this type of injection once every 4 to 8 weeks.
Golimumab may also be injected under the skin once every 2 to 4 weeks. You may be shown how to use injections at home. Do not self-inject this medicine if you do not understand how to give the injection and properly dispose of used needles and syringes.
Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.
Your care provider will show you the best places on your body to inject golimumab. Use a different place each time you give an injection. Do not inject into the same place two times in a row.
Each single-use prefilled syringe or auto-injector device is for one use only. Throw away after one use, even if there is still some medicine left in it after injecting your dose.
Use a disposable needle and syringe only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.
Store in the refrigerator, do not freeze. Protect from light. Keep the medication in its original carton until you are ready to give an injection.
Take the prefilled syringe or auto-injector out of the refrigerator and place it at room temperature for 30 minutes before giving your injection. Do not warm the medication with water or heat.
Golimumab can weaken your immune system. Your blood will need to be tested often.
What happens if I miss a dose?
Use the missed dose as soon as you remember, and then go back to your regular injection schedule. Do not use extra medicine to make up the missed dose.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while using golimumab?
Do not receive a "live" vaccine while using golimumab, and avoid coming into contact with anyone who has recently received a live vaccine. There is a chance that the virus could be passed on to you. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.
If you use golimumab during pregnancy, your baby should not receive a live vaccine for the first 6 months after birth.
Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.
What are the possible side effects of golimumab?
Get emergency medical help if you have signs of an allergic reaction: hives, itching; nausea; chest pain, difficulty breathing; swelling of your face, lips, tongue, or throat.
Serious and sometimes fatal infections may occur during treatment with golimumab. Stop using this medicine and call your doctor right away if you have signs of infection such as:
- fever, chills, muscle aches, feeling very tired;
- cough, shortness of breath;
- sweating, skin sores;
- diarrhea, stomach pain, weight loss;
- increased urination, or burning when you urinate.
Call your doctor at once if you have any of these other side effects:
- skin growths or changes in skin appearance;
- shortness of breath with swelling of your ankles or feet;
- pale skin, easy bruising or bleeding;
- vision changes, neck stiffness, seizure;
- numbness or tingly feeling, weakness in your arms or legs;
-
liver problems --upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
-
lupus-like syndrome --muscle or joint pain, chest pain, patchy skin color, skin rash over your cheeks and nose (worsens in sunlight); or
-
signs of psoriasis --red or scaly patches of skin, flaking, pus.
Common side effects may include:
- cold symptoms such as stuffy nose, sneezing, sore throat;
- flu symptoms, cold sores; or
- pain, itching, redness, or swelling where you injected the medicine.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect golimumab?
Tell your doctor about all your current medicines and any you start or stop using, especially:
- any other medicines to treat rheumatoid arthritis, such as adalimumab, certolizumab, etanercept, infliximab, rituximab, or tocilizumab.
This list is not complete. Other drugs may interact with golimumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.
Where can I get more information?
Your pharmacist can provide more information about golimumab.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
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