Simponi injection contains the active ingredient golimumab, which is a type of medicine called a human monoclonal antibody. It works by suppressing part of the immune system and modifying the process of inflammation.
What is Simponi used for?
- Moderate to severe rheumatoid arthritis in adults.
Golimumab is used in combination with methotrexate, when other DMARDs, for example sulfasalazine, methotrexate have not been effective. It can also be used for people with severe active progressive rheumatoid arthritis who have not previously been treated with methotrexate.
- A form of arthritis that affects the joints of the spine (ankylosing spondylitis).
Golimumab is used for adults who have severe symptoms and who have responded inadequately to conventional therapy.
- A form of arthritis in adults called axial spondyloarthritis, in people without X-ray evidence of ankylosing spondylitis.
This condition also affects the spine. Golimumab is used for people with this condition whose back pain is not relieved by non-steroidal anti-inflammatory drugs such as diclofenac or indometacin, as well as for people who can't take this kind of painkiller.
- A form of arthritis called psoriatic arthritis that can occur in people with the skin condition psoriasis.
Golimumab is used for adults with active progressive disease that has not responded adequately to treatment with disease modifying antirheumatic drugs (DMARDs, eg sulfasalazine, methotrexate). It can be used in combination with methotrexate, or on its own for people who cannot take methotrexate.
- Moderate to severe active ulcerative colitis in adults.
Golimumab is used for people with this condition who have not responded well to conventional therapy, including corticosteroids and 6-mercaptopurine or azathioprine, or who cannot take these medicines.
How does Simponi work?
- Simponi injection contains the active ingredient golimumab, which is a type of medicine called a human monoclonal antibody. It works by suppressing part of the immune system and modifying the process of inflammation.
- Golimumab works in a similar way to the natural antibodies produced by our immune system. Our natural antibodies recognise foreign invaders and bind to them, helping our immune systems to attack them and protect us from infections. Monoclonal antibodies like golimumab are made in laboratories and are designed to recognise particular proteins in a similar way.
- Golimumab specifically recognises and binds to a protein produced by the body called tumour necrosis factor alpha (TNF alpha). TNF alpha is involved in producing inflammation. It controls the activity of other inflammatory chemicals.
- TNF alpha is found in increased levels in various inflammatory conditions. It is found in the inflamed joints of people with rheumatoid arthritis and in the joints of people who have a type of arthritis affecting the spine, called ankylosing spondylitis. It is also found in increased levels in skin affected by psoriasis, as well as in the joints of people who have a type of arthritis called psoriatic arthritis, which can occur in people with psoriasis. TNF alpha is also found in the inflamed bowel lining of people with ulcerative colitis.
- By binding to TNF alpha, golimumab prevents the inflammatory responses it causes. In all the conditions mentioned, it reduces the inflammation and related symptoms.
- In arthritic conditions, treatment with golimumab reduces the movement of inflammatory cells into inflamed areas of the joints. This reduces the signs and symptoms of the arthritis, improves physical function of the joints and reduces the rate of joint damage. When treating arthritis, golimumab is referred to as a disease-modifying antirheumatic drug (DMARD).
- Golimumab is only prescribed by specialists experienced in treating these conditions. It is administered as an injection under the skin (subcutaneously) once every month.
- Improvements in symptoms should be seen within 12 to 14 weeks of starting treatment.
How is Simponi given?
- Your doctor or consultant will administer your first Simponi injection. You may be taught how to use the injection yourself, so that you can administer the next injection yourself and do not have to visit the clinic. Make sure you understand what to do and ask questions if you don't. You should make sure you read and understand all the instructions for administration provided in the package leaflet.
- Simponi injections are given under the skin (subcutaneously).
- For arthritis, the injections are given once a month, on the same day each month. After your third injection your doctor will assess your symptoms before continuing the treatment.
- For ulcerative colitis, Simponi treatment is started with two injections given two weeks apart. After this the injection is given every four weeks.
- If you forget to take your injection on the planned date you should not inject a double dose to make up for it. If the missed injection is less than two weeks late, you should administer it and then use your next scheduled injection as normal, on your normal date. If the missed injection is more than two weeks late, you should administer it and then start a new monthly schedule from the date of this injection. Speak with your doctor if you are confused about what to do.
Simponi should be used with caution in
- Elderly people.
- People with decreased kidney function.
- People with decreased liver function.
- People with a history of hepatitis B.
- People with dormant (currently inactive) tuberculosis infection.
- People with a history of long-term or recurrent infections.
- People with low levels of white blood cells or platelets in their blood.
- People who are or who have recently been receiving treatment that suppresses the activity of the immune system, eg long-term corticosteroids, chemotherapy, radiotherapy, medicines to prevent transplant rejection.
- People with a history of or current cancer.
- Heavy smokers.
- People with chronic obstructive lung disease (COPD).
- People with mild heart failure.
- People with any nerve disease in which the myelin sheath around the nerves becomes damaged (demyelinating disorders), such as multiple sclerosis.
- People who are allergic to latex (the needle cover of the syringe contains latex).
Simponi should not be used in
- People with active tuberculosis.
- People with severe active infections, such as abscesses, leg ulcers, blood-poisoning (sepsis).
- People with infections due to lowered resistance of the body.
- People with moderate to severe heart failure.
- This medicine is not recommended for children and adolescents under 18 years of age.
- Simponi injections contain sorbitol and should not be used by people with rare hereditary problems of fructose intolerance.
- This medicine should not be used if you are allergic to any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.
If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.
Pregnancy and breastfeeding
- There is no information about the safety of this medicine during pregnancy. It is not recommended for use during pregnancy as it could potentially be harmful to a developing baby. Women who could get pregnant should use an effective method of contraception to prevent pregnancy, both during treatment and for at least six months after their last injection. If you think you could be pregnant at any point during treatment you should tell your doctor straight away. Seek further medical advice from your doctor.
- It is not known if this medicine passes into breast milk. However, as antibodies produced naturally by the mother do pass into breast milk, it is likely that it does. Women should not breastfeed during treatment with this medicine, or for six months after their last dose. Seek further medical advice from your doctor.
Side effects of Simponi
- Upper respiratory tract infections such as cough and cold.
- Inflammation of the nose and throat (nasopharyngitis).
- Sore throat or hoarseness.
- Chest infections such as bronchitis, penumonia.
- Viral infections such as flu and cold sores.
- Bacterial infections such as infections in the tissues under the skin (cellulitis), abscesses.
- Fungal infections of the skin.
- Low red blood cells count (anaemia).
- Alteration in results of liver function tests.
- Difficulty sleeping (insomnia).
- Sensation of pins and needles.
- High blood pressure .
- Disturbances of the gut such as indigestion, constipation, nausea or abdominal pain.
- Inflammation of the lining of the mouth (stomatitis).
- Inflammation of the stomach (gastritis) or colon (colitis).
- Skin reactions such as itching, rash and dermatitis.
- Hair loss.
- Reactions at the site of injection, such as redness, pain, itching or bruising.
- Weakness or loss of strength (asthenia).
- Chest problems such as asthma, wheezing or shortness of breath.
- Bone fractures.
The side effects listed above may not include all of the side effects reported by the medicine's manufacturer. For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.
How can Simponi affect other medicines?
It is important to tell your doctor or pharmacist what medicines you are already taking, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while having treatment with this one, to make sure that the combination is safe.
- Golimumab is not recommended for use in combination with anakinra or abatacept, as this combination may increase the risk of serious infections, without an increase in effectiveness against the disease treated.
- Golimumab is also not recommended for use in combination with other medicines that are known as biological immunosuppressants, such as adalimumab, etanercept, infliximab, infliximab or certolizumab.
This medicine suppresses part of the immune system. This means that vaccines may potentially be less effective if given during treatment, and live vaccines may cause serious infections. Live vaccines include: measles, mumps, rubella, MMR, oral polio, oral typhoid and yellow fever. It is recommended that live vaccines are not given to people being treated with this medicine.