Simponi

This medication belongs to a family of medications known as biological response modifiers ("biologics") or tumour necrosis factor (TNF) blockers. It is used in combination with another medication, methotrexate, to reduce the symptoms and slow down the damage to the affected joints for adults with moderately to severely active rheumatoid arthritis (RA).

It is also used alone or in combination with methotrexate to treat moderately to severely active psoriatic arthritis (PsA). Used alone, golimumab also treats active ankylosing spondylitis (AS). It is also used to treat severe active non-radiographic axial spondyloarthitis, an inflammatory disease of the spine. Golimumab is also used with other medications to reduce signs and symptoms of ulcerative colitis (UC) for adults who have moderately to severely active UC. When effective in creating remission of the disease, it can then be continued to maintain remission.

The intravenous form of this medication may be used alone or with other medications to treat polyarticular juvenile idiopathic arthritis (pJIA) for children 2 years of age and older.

For people with these conditions, their bodies overproduce a protein called tumour necrosis factor (TNF), which causes pain, inflammation, and damage. Golimumab blocks the production of TNF and decreases the inflammation in the joints and the digestive system. By reducing the inflammation, it also slows down how quickly permanent damage to the affected areas occurs. You may start to notice an improvement in symptoms about 14 to 16 weeks after starting treatment.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are being given this medication, speak to your doctor. Do not stop using this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to use this medication if their doctor has not prescribed it.

The usual recommended dose for the treatment of RA, PsA, AS, or non-radiographic axial spondyloarthritis is 50 mg once a month, on the same day each month.

The usual recommended dose for the treatment of UC is 200 mg given at week 0, followed by 100 mg given at week 2, and then 50 mg every 4 weeks.

This medication is given as an injection under the skin. A doctor can train you to give yourself the injection at home. Do not attempt to inject this medication on your own until you completely understand how to inject a dose. If you are unsure of how to prepare or administer a dose, ask a health care professional for advice. Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are using the medication without consulting your doctor.

Before injecting the medication, check the solution to ensure that it is clear, colourless and has no particles in it. If the solution is not clear and colourless, discard the syringe safely and use a new one.

If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication in the refrigerator, protect it from light, and keep it out of the reach of children. Do not freeze it or shake it.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Prefilled syringes

Each single-use prefilled syringe of sterile solution contains 50 mg of golimumab per 0.5 mL syringe. Nonmedicinal ingredients: L-histidine, L-histidine hydrochloride, polysorbate 80, sorbitol, and water for injection. Supplied as a single-use, sterile solution in a glass syringe with a fixed stainless-steel needle. The needle shields are manufactured using a dry natural rubber containing latex.

Autoinjector

Each single-use autoinjector contains 50 mg of golimumab per 0.5 mL in an autoinjector. Nonmedicinal ingredients: L-histidine, L-histidine hydrochloride, polysorbate 80, sorbitol, and water for injection. Supplied as a single-use, sterile solution in a glass syringe with a fixed stainless-steel needle. The needle shields are manufactured using a dry natural rubber containing latex.

Solution for Infusion

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

Do not use golimumab if you:

• are allergic to 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

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 this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. 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
• cough
• dizziness
• fever
• hair loss

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 anemia (low red blood cells; e.g., dizziness, pale skin, unusual tiredness or weakness, shortness of breath)
• 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 liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
• 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 this medication.

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 this medication.

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 this medication.

Bleeding: This medication 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 this medication.

Cancer risks: People taking this medication 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 golimumab or other medications in the same family as 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 this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, 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: This medication may cause dizziness. Do not drive or operate heavy machinery until you know how it affects you.

Hepatitis B: 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 this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Immune system problems: In rare instances, people taking medications in the same family as 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 this medication 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 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.

Serious infections: 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 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 this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, 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: 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 golimumab.

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

Vaccinations: People taking this medication should not receive certain vaccines. Talk to your doctor about whether any vaccines you are scheduled to take may be used with this medication.

Pregnancy: 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 golimumab is taken to avoid causing harm to an unborn baby. If you become pregnant while taking this medication, contact your doctor immediately.

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

Children: The safety and effectiveness of using the subcutaneous form of this medication have not been established for children. Children 2 years of age and over may use the intravenous form of golimumab to treat pJIA. Children less than 18 years of age may be at an increased risk of developing certain blood cancers.

There may be an interaction between golimumab and any of the following:

• medications that suppress the immune system:
• corticosteroids (e.g., dexamethasone, hydrocortisone, prednisone)
• medications used to treat conditions such as cancer, inflammatory bowel disease, multiple sclerosis, psoriasis, rheumatoid arthritis, or medications used after a transplant

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 this medication. 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.

All material copyright MediResource Inc. 1996 – 2024. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Simponi