Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes Simponi IV (Golimumab). If you are concerned about side effects, discuss the risks and benefits of Simponi IV (Golimumab) with your doctor.

The following side effects have been reported by at least 1% of people taking Simponi IV (Golimumab). Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• Cold Sores
• Constipation
• dizziness
• hair loss
• nausea

Check with your doctor as soon as possible if any of the following side effects occur:

• flu-like symptoms (sudden lack of energy, Fever, cough, sore throat)
• high blood pressure
• red scaly patches or raised bumps filled with pus
• redness, pain, swelling, itching, warmth, and bruising at the injection site
• signs of bleeding (e.g., unusual nosebleeds, bruising, blood in urine, coughing blood, bleeding gums, cuts that don't stop bleeding)
• signs of a urinary tract infection such as difficult or painful urination, or blood in the urine
• symptoms of heart failure (shortness of breath or swelling of the feet or legs)
• symptoms of Lupus (rash on the cheeks or other body areas; sun sensitivity; joint or muscle pain; fatigue; chest pain; shortness of breath; or swelling of the feet, ankles, or legs)
• symptoms of nervous system problems (such as arm or leg weakness, vision changes, dizziness, or numbness or tingling in any part of the body)

Stop taking the medication and seek immediate medical attention if any of the following occur:

• signs of bleeding in the stomach (e.g., bloody, black, or tarry stools, spitting up of blood, vomiting blood or material that looks like coffee grounds)
• symptoms of a serious allergic reaction (e.g., Hives, face swelling, difficulty breathing or swallowing)
• symptoms of a serious infection (e.g., fever, chills, headache, flu-like symptoms, feeling tired, cough, blood in sputum, shortness of breath, night sweats, weight loss, nausea or vomiting, Diarrhea, joint swelling, cold sores, tooth pain, new or worsening pain in any part of the body)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking Simponi IV (Golimumab).

Each 4 mL vial of colourless-to-light-yellow solution for infusion contains 50 mg of Simponi IV (Golimumab). Nonmedicinal ingredients: L-histidine, L-histidine monohydrochloride monohydrate, sorbitol, polysorbate 80, and water for injection.

Do not use Simponi IV (Golimumab) if you:

• are allergic to Simponi IV (Golimumab) or any ingredients of the medication
• are allergic to latex or any components of the medication container
• have a serious infection such as sepsis (an infection in the bloodstream), Tuberculosis, an abscess, or an opportunistic infection (a type of infection that affects people with weakened immune systems)
• have moderate to severe Congestive Heart Failure

There may be an interaction between Simponi IV (Golimumab) and any of the following:

• bacillus Calmette-Guérin (BCG)
• Denosumab
• echinacea
• Fingolimod
• immunosuppressants (e.g., Cyclosporine, mycophenolate, Tacrolimus)
• Leflunomide
• medications that weaken the immune system (e.g., medications for cancer or organ transplants)
• other biologics (e.g., Abatacept, Adalimumab, Infliximab, Anakinra)
• Roflumilast
• tacrolimus
• vaccines

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Simponi IV (Golimumab). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Simponi IV (Golimumab).

Birth control: Effective birth control must be used during treatment and for 6 months after stopping therapy. During this time, women will have monthly pregnancy tests to ensure they are not pregnant. Tell your doctor immediately if you become pregnant while using Simponi IV (Golimumab).

Bleeding: Simponi IV (Golimumab) may affect your body's ability to produce enough of certain types of blood cells, including the ones that help you stop bleeding. If you experience unusual bruising or bleeding, increased nosebleeds, or bleeding gums, or you notice blood in your urine, contact your doctor as soon as possible. Get medical attention immediately if you notice signs of bleeding in the stomach such as bloody, black, or tarry stools, or vomiting blood or material that looks like coffee grounds.

If you have an increased risk of bleeding, your doctor should closely monitor your blood counts while you are using Simponi IV (Golimumab).

Cancer risks: People taking Simponi IV (Golimumab) have a higher risk of Leukemia, lymphoma, or other cancers such as Melanoma. People with rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis are also at a higher risk for lymphoma. Talk to your doctor about cancer screening and your risk of cancer.

Congestive heart failure (CHF): People taking medications in the same family as Simponi IV (Golimumab) may develop CHF or find that their CHF gets worse.

If you have a history of CHF or are at risk of developing CHF, discuss with your doctor how Simponi IV (Golimumab) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Simponi IV (Golimumab), and whether any special monitoring is needed.

If you develop shortness of breath or swelling of the feet or legs (symptoms of CHF), contact your doctor right away.

Dizziness: Simponi IV (Golimumab) may cause dizziness. Do not drive or operate heavy machinery until you know how it affects you.

Hepatitis B: Simponi IV (Golimumab), like other tumour necrosis factor blockers, has been associated with reactivation of hepatitis B infections. This can be fatal. If you have a history of hepatitis B infection, discuss with your doctor how Simponi IV (Golimumab) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Simponi IV (Golimumab), and whether any special monitoring is needed.

Immune system problems: In rare instances, people taking medications in the same family as Simponi IV (Golimumab) may develop symptoms similar to the symptoms of lupus (rash on the cheeks or other body areas; sun sensitivity; joint or muscle pain; fatigue; chest pain; shortness of breath; or swelling of the feet, ankles, or legs). Contact your doctor if you develop these symptoms.

Latex allergies: There is dry natural rubber (a form of latex) in the needle covers for both the prefilled syringe and the autoinjector. If you are sensitive to latex, you may have an allergic reaction. Talk to your doctor about how this may affect you.

Liver problems: Some people taking Simponi IV (Golimumab) have developed liver problems. Contact your doctor right away if you notice symptoms of a liver problem, such as yellowing of the skin and eyes, dark brown-coloured urine, right-sided abdominal pain, fever, nausea, vomiting, and severe fatigue.

Neurological effects: In rare instances, people taking medications in the same family as Simponi IV (Golimumab) may develop nervous system diseases such as Multiple Sclerosis (MS). Contact your doctor right away if you notice vision changes, arm or leg weakness, or numbness or tingling in any body part.

Psoriasis: Some people taking Simponi IV (Golimumab) develop psoriasis, or notice that their existing psoriasis has gotten worse. Contact your doctor if this occurs.

Serious infections: Simponi IV (Golimumab) can affect the way your body's natural defences work to fight infection. This makes the body more likely to develop infections due to bacteria, viruses, and fungi. This effect is increased if you are taking Simponi IV (Golimumab) with other medications that reduce the body's ability to fight infection. For some people, these infections have been fatal.

If you have a history of chronic or frequent infections, discuss with your doctor how Simponi IV (Golimumab) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Simponi IV (Golimumab), and whether any special monitoring is needed.

Stop taking the medication and tell your doctor right away if you notice symptoms of a serious infection, such as fever, chills, headache, flu-like symptoms, feeling tired, cough, blood in the sputum, shortness of breath, night sweats, weight loss, nausea, vomiting, diarrhea, frequency or burning while passing urine, redness or swelling of skin or joint, cold sores, tooth pain, or new or worsening pain in any part of the body.

Severe allergy: Simponi IV (Golimumab) is known to cause severe allergic reactions. Contact your doctor at once if you experience signs of an allergic reaction, such as skin rash, itching, difficulty breathing, or swelling of the face and throat.

Surgery: If you are scheduled for planned (elective) surgery, be sure to let your surgeon and other health care professionals know that you are using Simponi IV (Golimumab).

Tuberculosis: Some people who have had tuberculosis (a lung infection) in the past have had this infection return when they are using Simponi IV (Golimumab). If you have a history of tuberculosis, or have come into recent contact with someone who has tuberculosis, discuss with your doctor how Simponi IV (Golimumab) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Simponi IV (Golimumab), and whether any special monitoring is needed.

Vaccinations: People taking Simponi IV (Golimumab) should not receive certain vaccines. Talk to your doctor about whether any vaccines you are scheduled to take may be used with Simponi IV (Golimumab).

Pregnancy: Simponi IV (Golimumab) crosses the placenta and may affect the development of the unborn child if it is used by a woman during pregnancy. Effective birth control must be used to prevent pregnancy and for 6 months after the last dose of Simponi IV (Golimumab) is taken to avoid causing harm to an unborn baby. If you become pregnant while taking Simponi IV (Golimumab), contact your doctor immediately.

Breast-feeding: It is not known if Simponi IV (Golimumab) passes into breast milk. If you are a breast-feeding mother and are taking Simponi IV (Golimumab), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using Simponi IV (Golimumab) have not been established for children. Children less than 18 years of age may be at an increased risk of developing certain blood cancers.