GOLIMUMAB (Simponi®) INFORMATION SHEET

Developed by Andy Thompson MD FRCPC

What is Golimumab?

Golimumab is a biologic agent specifically engineered to treat inflammation. It is used for the treatment of Rheumatoid arthritis, Psoriatic arthritis, and Ankylosing spondylitis.

How does Golimumab work?

In some people with arthritis, a protein called Tumour Necrosis Factor (TNF) is present in the blood and joints in excessive amounts where it increases inflammation (pain & swelling). Golimumab is another type of protein (antibody) called a TNF blocker which blocks the action of TNF. By blocking TNF, Golimumab works by suppressing the body’s immune system. Although this suppression can make it slightly harder for you to fight off infections, it also helps to stabilize an overactive immune system.`

Why am I taking Golimumab?

Your doctor has prescribed this medicine to help with the following:

1. Reduce the pain and swelling (inflammation) in your joints.
2. Improve your day to day function.
3. Prevent any long-term damage from the joint inflammation.

What is the usual dose of Golimumab?

Golimumab is taken by injection under the skin. The standard dose of each injection is 50 mg.

How often do I take Golimumab?

Golimumab is usually taken ONCE A MONTH.

Who should NOT take Golimumab?

• Patients who have had a previous serious allergic reaction to Golimumab.
• Women who are pregnant, planning on becoming pregnant in the near future, or currently breast feeding.
• Possibly patients who have cancer or have had a past history of certain cancers.
• Patients who have severe or uncontrolled congestive heart failure.
• Patients who have multiple sclerosis.
• Patients with active infections (such as tuberculosis).

When will I start to feel the effects of Golimumab?

Golimumab will take about 2 weeks before you start to feel the effects. It may take 4 to 12 weeks before you feel the maximum effect.

What should I AVOID while taking Golimumab?

• You should discuss all vaccinations with your doctor as some vaccines are not advisable while you are taking Golimumab.
• If you are scheduled for surgery, please tell your doctor.

When should I NOT TAKE my Golimumab?

You should contact your doctor before missing a dose of Golimumab. However, in the following situations, it would be advisable to stop the Golimumab:

• If you have a fever.
• If you have or think you have an infection.
• If you are taking antibiotics.
  
• If you think you are pregnant.

Which Medications are safe to take with Golimumab?

Your rheumatologist may decide to add other medications to treat your arthritis. Most medications may be taken safely with Adalimumab. For example, some of the other medications which may be safely added to Golimumab include: Acetaminophen (Tylenol), Prednisone, and Other DMARDs (i.e. Methotrexate).

What are the side-effects of Golimumab?

MORE COMMON side-effects include:

• Mild skin reaction at the injection site (itchiness, redness, and mild swelling).
• Nausea, abdominal pain
• Headache
• Rash
• Upper respiratory tract infections (such as sinusitis).

RARE side-effects include:

• Infection – There is an increased risk of serious infections associated with the use of Golimumab. Any infections or fevers should be taken very seriously and reviewed by your doctor.
• Nervous System – There have been rare reports of some patients developing disorders that affect the nervous system (multiple sclerosis, seizures, or inflammation of the nerves of the eye) while taking Golimumab. Fortunately, these reports are exceedingly rare.
• Heart – Inform your doctor if you have congestive heart failure as Golimumab may make it worse.
• Blood Counts – Golimumab can cause a drop in the numbers of white blood cells (which are needed to fight infection) or red blood cells (which carry oxygen). This is very rare and it is unusual for this to be a serious problem.
• Malignancy – Golimumab has been associated with a small increased risk of developing cancer (<1%).

How can I help to minimize the side-effects of Golimumab?

Take your Golimumab as prescribed by your doctor.

Do I need to have regular blood tests while taking Golimumab?

Blood tests are not routinely required while you are taking Golimumab. However, your doctor will likely order periodic blood tests to check your blood counts and follow the activity of your arthritis.

How do I stop the Golimumab?

You do not need to wean yourself off the Golimumab. It can simply be stopped. However, your arthritis will likely “flare” after you stop the medicine.

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

If you forget to take your Golimumab, take your next dose right away. Then take your next dose when your next scheduled dose is due. This will put you back on schedule.

Is Golimumab safe in pregnancy?

• Golimumab is a new medication and it is unknown if it is safe to use in pregnancy. Therefore, you should AVOID PREGNANCY while on Golimumab.
• All women of child bearing potential taking Golimumab must use reliable contraception.
• If you become pregnant while taking Golimumab NOTIFY YOUR DOCTOR IMMEDIATELY.
• You should not breast feed while taking Golimumab.