Golimumab

Golimumab is used to treat inflammatory types of arthritis, such as rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS).

For RA and PsA, golimumab may be used as monotherapy or in combination with DMARD therapy, such as methotrexate (MTX).

Golimumab may be used as monotherapy for treatment of AS that has not responded to DMARD therapy.

Golimumab is delivered by subcutaneous (s.c.) injection (meaning in the fatty layer of tissue just under the skin). Golimumab may be also given by infusion to treat RA.

When given by infusion the dose of golimumab is based on your weight. You will receive an initial infusion, then a second infusion four weeks later. Following this you will receive infusions every eight weeks. The medication comes in a single-use vial for administration by infusion. Each infusion lasts about 30 minutes.

When given by s.c. injection the dose of golimumab is 50 mg given once every month. The medication comes as a single-use pre-filled syringe or single-use autoinjector for subcutaneous administration.

Golimumab pre-filled syringes and auto-injectors cannot be used for infusions. Single-use vials for infusions cannot be used for s.c. injections.

In some people with arthritis, a signalling protein called a tumour necrosis factor (TNF) is present in the blood and joint in excessive amounts where it increases inflammation. Golimumab works by suppressing the body’s immune system, specifically it binds to tumour necrosis factor and prevents it from causing inflammation. By doing this, golimumab can help to reduce pain and swelling in the joints, improve day-to-day function, and prevent long term damage to the joints.

As with all of the biologics, you may not feel the effects of the golimumab right away. Some people begin to feel the effects of the medication fairly quickly; however, it may take three to six months to feel its full effect. It is important to be patient and keep taking your medication.

To provide symptom relief while you are waiting for golimumab to take effect, your healthcare provider may recommend taking a steroid, such as prednisone, or a non-steroidal anti-inflammatory drug (NSAID).

Golimumab can make it more difficult for your body to fight infections. Therefore, people with active infections should not take golimumab. If you have a fever, think you have an infection or have been prescribed an antibiotic, contact your healthcare provider. People who have had frequent infections in the past or a history of tuberculosis should discuss the use of golimumab with their healthcare provider. 

Also contact your healthcare provider if you are having surgery as you may need to stop golimumab until you are healed and there is no sign of infection.

Golimumab has not been studied in pregnant people or lactating parents so its effect(s) on pregnant people or nursing babies are unknown. You should tell your doctor if you are pregnant or are planning to become pregnant. Because of the potential for adverse reactions in nursing infants, a decision should be made with your healthcare provider on whether or not to discontinue nursing or the medication, taking into account the importance of the drug to the lactating parent.

Anyone who has had a previous allergic reaction to golimumab should avoid the medication.
People with a history of cancer or nervous system problems, such as multiple sclerosis, should discuss the use of golimumab with their healthcare provider.

Golimumab may make a condition called congestive heart failure worse. Tell your doctor if you have congestive heart failure.

Before starting this medication, you will likely be tested for inactive (“latent”) tuberculosis (TB) and hepatitis B because golimumab can dampen the immune system and cause these infections to become active. If TB or hepatitis is found, it will need to be treated before you start golimumab.    

Ideally, your vaccinations should be up to date prior to starting golimumab. If you have already started therapy with golimumab, your healthcare provider will likely recommend most inactive vaccines (e.g., influenza, pneumococcal). Live vaccines are not recommended due to risk of causing infection. Before receiving any vaccinations while taking golimumab, you should speak with your healthcare provider.

Like all medications, taking golimumab carries some risk of side effects, which must be balanced with the potential benefits. In general, the risk of joint damage and permanent disability (resulting from arthritis) is much greater than the risks of side effects from golimumab. When monitored properly the vast majority of side effects are rare, most improve over time and are reversible.

Golimumab can increase your risk of infections. You should take precautions to minimize your risk of being infected by common contagious infections such as COVID-19, influenzae, pneumonia, and the common cold. 

In rare cases, golimumab can cause an allergic reaction during the infusion (flushing, itching, changes in heart rate and blood pressure, etc.). A healthcare professional will monitor for this reaction during the infusion. 
For people taking the medication by injection, golimumab can in rare circumstances cause a reaction (redness, pain and itching) at the injection site. Talk to your healthcare provider if these symptoms become severe.
In uncommon cases, some people experience headaches while taking golimumab. If this becomes severe, please consult your healthcare provider.

Some people have developed lupus-like symptoms that disappeared after the medication was ceased. If you have chest pains that do not go away, shortness of breath or a rash on your cheeks or arms that gets worse in the sun, call your doctor right away.

There have been rare cases of disorders that affect the nervous system of people taking golimumab or other TNF-blockers. Signs that you could be experiencing a problem affecting your nervous system include numbness or tingling, problems with your vision, weakness in your legs and dizziness.

Golimumab very rarely can cause a drop in blood counts.

Take golimumab as prescribed and contact your healthcare provider if you have any concerns while taking the medication.

If you experience infusion reactions while taking golimumab, prior to your next infusion your prescriber may recommend a medication pre-treatment to help prevent the reaction. Your prescriber may also recommend a longer infusion time.

Keeping yourself well hydrated before getting your infusion and drinking while you get your infusion may also help reduce side effects.

For people taking golimumab via injection, avoid injection site reactions by rotating injection sites and avoid areas where the skin is tender, bruised, red and/or hard.

Blood tests are not routinely required while you are taking golimumab. Your healthcare provider may order periodic blood tests to check your blood count and follow the activity of your arthritis.

Golimumab must be refrigerated at 2 to 8 degrees Celsius and protected from light. Keep the product in the original package and out of the light. It may be stored at room temperature (up to 25 degrees Celsius) for one period of time up to 30 days, once transferred to room temperature, it cannot be returned to the fridge for storage and it must be disposed of after 30 days by returning it to the pharmacy.

Golimumab must be kept cool while travelling. Ask your pharmacist for a cool carrier if you are not able to put the drug in your refrigerator right away.

The patient support program for Simponi is called "Bioadvance." Their phone number is 1-833-972-2420.