Golimumab injection (subcutaneous or intravenous use)

What is this medication?

GOLIMUMAB (goe LIM ue mab) is used to treat rheumatoid arthritis, psoriatic arthritis, polyarticular juvenile idiopathic arthritis, and ankylosing spondylitis. It is also used to treat ulcerative colitis.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Simponi, SIMPONI ARIA

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• cancer
• diabetes
• Guillain-Barre syndrome
• heart failure
• hepatitis B or history of hepatitis B infection
• immune system problems
• infection or history of infections
• low blood counts like low white cell, platelet, or red cell counts
• multiple sclerosis
• psoriasis
• recently received or scheduled to receive a vaccine
• tuberculosis, a positive skin test for tuberculosis or have recently been in close contact with someone who has tuberculosis
• an unusual reaction to golimumab, other medicines, latex, rubber, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

This medicine is for infusion into a vein or for injection under the skin. Infusions are given by a health care professional in a hospital or clinic setting. If you are to give your own medicine at home, you will be taught how to prepare and give this medicine under the skin. Use exactly as directed. Take your medicine at regular intervals. Do not take your medicine more often than directed.

It is important that you put your used injectors, needles and syringes in a special sharps container. Do not put them in a trash can. If you do not have a sharps container, call your pharmacist or healthcare provider to get one.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 2 years for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you give your medicine by injection under the skin: If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses. Call your doctor or health care professional if you are not sure how to handle a missed dose.

If you are to be given an infusion: It is important not to miss your dose. Call your doctor or health care professional if you are unable to keep an appointment.

What may interact with this medication?

Do not take this medicine with any of the following medications:

• abatacept
• adalimumab
• anakinra
• certolizumab
• etanercept
• infliximab
• live virus vaccines
• rituximab
• rilonacept
• tocilizumab

This medicine may also interact with the following medications:

• cyclosporine
• theophylline
• vaccines
• warfarin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your doctor or health care professional for regular checks on your progress. Tell your doctor or healthcare professional if your symptoms do not start to get better or if they get worse.

You will be tested for tuberculosis (TB) before you start this medicine. If your doctor prescribes any medicine for TB, you should start taking the TB medicine before starting this medicine. Make sure to finish the full course of TB medicine.

Call your doctor or health care professional if you get a cold or other infection while receiving this medicine. Do not treat yourself. This medicine may decrease your body's ability to fight infection.

Talk to your doctor about your risk of cancer. You may be more at risk for certain types of cancers if you take this medicine.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• breathing problems
• changes in vision
• chest pain
• joint or muscle pain
• mouth sores
• numbness or tingling in any part of your body
• red, scaly patches or raised bumps on the skin
• signs and symptoms of infection like fever or chills; cough; sore throat; pain or trouble passing urine
• signs and symptoms of liver injury like dark yellow or brown urine; general ill feeling or flu-like symptoms; light-colored stools; loss of appetite; nausea; right upper belly pain; unusually weak or tired; yellowing of the eyes or skin
• swelling of the legs or ankles
• swollen lymph nodes in the neck, underarm, or groin areas
• unexplained weight loss
• unusual bleeding or bruising
• unusually weak or tired

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• dizziness
• increased blood pressure
• loss of appetite
• nausea, vomiting
• redness, itching, swelling, or bruising at site where injected
• runny nose

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Infusions will be given in a hospital or clinic and will not be stored at home.

Storage for syringes or injectors given under the skin and stored at home:

Keep out of the reach of children. Store in a refrigerator between 2 and 8 degrees C (36 and 46 degrees F). If needed, the syringes or injectors may be stored at room temperature up to 25 degrees C (77 degrees F) for up to 30 days. Do not put the medicine back in the refrigerator after it reaches room temperature. Keep this medicine in the original container. Protect from light. Do not freeze. Do not shake. Throw away any medicine that has been kept at room temperature for 30 days and has not been used. Throw away any unused medicine after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.