45 mg / 0.45 ml solution for injection in a pre-filled pen
For pediatric patients under 40 kg, golimumab
What Simponi is and what it is used for
Simponi contains the active substance golimumab.
Simponi belongs to a group of medicines called “TNF inhibitors”. It is used in children 2 years and older for the treatment of polyarticular juvenile idiopathic arthritis.
Simponi works by blocking the function of a protein called “tumor necrosis factor alpha” (TNFα). This protein participates in inflammatory processes in the body and by blocking it, inflammation in the body can be reduced.
Polyarticular juvenile idiopathic arthritis
Polyarticular juvenile idiopathic arthritis is an inflammatory disease that causes pain and swelling in the joints in children. If you have polyarticular juvenile idiopathic arthritis, you will first be given other medicines. If you do not get enough of these medicines, you will be given Simponi in combination with methotrexate to treat the disease.
What you need to know before using Simponi
Do not use Simponi
- if you are allergic (hypersensitive) to golimumab or any of the other ingredients of this medicine (listed in section 6).
- if you have tuberculosis (TB) or any other serious infection.
- if you have heart failure that is moderate or severe.
If you are not sure if any of the above applies to you, talk to your doctor, pharmacist, or nurse before using Simponi.
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before using Simponi.
Infection is
Tell your doctor immediately if you have or experience symptoms of infection during or after your Simponi treatment. Such symptoms include fever, cough, shortness of breath, flu-like signs, diarrhea, sores, dental problems, or a burning sensation when urinating.
- You can more easily get an infection when you use Simponi.
- Infections can develop faster and can be more serious. In addition, previous infections may return.
Tuberculosis (TBC)Tell your doctor immediately if symptoms of TB occur during or after treatment. Symptoms of TB include persistent cough, weight loss, tiredness, fever, or night sweats.- Cases of TB have been reported in patients treated with Simponi, in rare cases also in patients treated with anti-TB drugs. Your doctor will check if you have TB. Your doctor will note the examinations on your patient card.
- You must tell your doctor if you have ever had TB or if you have been in close contact with someone who has had or has TB.
- If your doctor thinks you are at risk for TB, you can get TB medicine before you start using Simponi.Hepatitis B virus (HBV)
- Tell your doctor if you are a carrier or if you have or have had the hepatitis B virus before receiving Simponi.
- Tell your doctor if you think you are at risk of getting HBV.
- Your doctor will test you for HBV.
- Treatment with TNF inhibitors such as Simponi can reactivate the hepatitis B virus in patients carrying this virus, which in some cases can be life-threatening. Invasive fungal infections tell your doctor immediately if you have lived in or traveled to areas where the infection is caused by a specific type of fungus that can attack the lungs or other parts of the body ( histoplasmosis, coccidioidomycosis, or blastomycosis ) are common. Ask your doctor if you do not know if these infections are common in areas you have lived in or traveled to.
Cancer and lymphoma
Tell your doctor if you have ever had lymphoma (a type of blood cancer) or any other cancer before using Simponi.
- If you are being treated with Simponi or another TNF inhibitor, you may be at increased risk of developing lymphoma or any other cancer.
- Patients with severe rheumatoid arthritis and other inflammatory diseases who have had the disease for a long time may be at a higher risk than generally developing lymphoma.
- There have been cases of cancer, including rare types, in children and adolescents receiving TNF -suppressants, which have sometimes led to death.
- In rare cases, a specific and severe type of lymphoma called T-cell lymphoma in the liver and spleen has been observed in patients taking other TNF inhibitors. Most of these patients were adolescents or younger adult men. This type of cancer has usually led to death. Almost all of these patients had also been given medicines called azathioprine or 6-mercaptopurine. Tell your doctor if you are taking azathioprine or 6-mercaptopurine with Simponi.
- Patients with severe persistent asthma, chronic obstructive pulmonary disease (COPD), or who are heavy smokers may be at increased risk of cancer when treated with Simponi. If you have severe persistent asthma, COPD, or are a heavy smoker, you should discuss with your doctor whether treatment with a TNF inhibitor is suitable for you.
- Some patients treated with golimumab have developed certain types of skin cancer. Tell your doctor if there are any changes in the appearance of the skin or growths on the skin during or after the treatment.
Heart failure
Tell your doctor immediately if you get new or worsening signs of heart failure. Such symptoms include shortness of breath or swollen feet.
- New or worsening heart failure has been reported with TNF inhibitors, including Simponi. Some of these patients died.
- If you have mild heart failure and are being treated with Simponi, you will be closely monitored by your doctor.
Diseases of the nervous system
Tell your doctor immediately if you have ever been diagnosed with or developed symptoms of a demyelinating disease such as multiple sclerosis. Such symptoms may include altered vision, weakness in the arms or legs, and numbness or tingling in any part of the body. Your doctor will decide if you should receive Simponi.
Operations or dental treatments
- Tell your doctor if you are going to have any surgery or dental treatment.
- Tell the doctor or dentist who will perform the procedure that you are being treated with Simponi by showing your patient card.
Autoimmune disease
Tell your doctor if you develop symptoms of a disease called lupus. Such symptoms include persistent itching, fever, joint pain, and fatigue.
- In rare cases, people treated with TNF -antagonists have developed lupus.
Blood disease
In some patients, the body may have difficulty producing enough blood cells to help fight infection or stop bleeding. If you get a fever that does not go away, get bruises or bleed very easily or look very pale, you should contact a doctor immediately. Your doctor may decide to stop treatment.
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Simponi.
Vaccinations
Tell your doctor if you have or are planning to get vaccinated.
- You should not be given certain (live) vaccines during treatment with Simponi.
- Some vaccinations can cause you an infection. If you got Simponi while you were pregnant, your baby may be at a higher risk of getting such an infection for up to about six months after the last dose you received during pregnancy. You must tell your child’s doctor and other healthcare professionals about your use of Simponi so that they can decide when your child should receive a vaccine.
Talk to your child’s doctor regarding your child’s vaccinations. If possible, your child should have received all vaccinations according to the current vaccination program before using Simponi.
Immunotherapy is
Tell your doctor if you have recently received or are planning to receive immunotherapy (such as BCG installation which is used to treat cancer).
Allergic reactions
Tell your doctor immediately if you develop symptoms of an allergic reaction after using Simponi. Symptoms of an allergic reaction may include swelling of the face, lips, mouth, or throat, which may cause difficulty swallowing or breathing, skin rash, hives, swollen hands, feet, or ankles.
- Some of these reactions can be serious, or in rare cases life-threatening.
- Some of these reactions occurred after the first use of Simponi.
Children
Simponi is not recommended for children with polyarticular juvenile idiopathic arthritis who are younger than 2 years as this group has not been studied.
Other medicines and Simponi
- Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines to treat polyarticular juvenile idiopathic arthritis.
- You should not use Simponi with medicines containing the active substance anakinra or abatacept. These drugs are used in the treatment of rheumatic diseases.
- Tell your doctor or pharmacist if you are taking any medicine that affects the immune system.
- You should not be given certain types of (life) vaccines when using Simponi
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using Simponi.
Pregnancy and breastfeeding
Talk to your doctor before using Simponi if:
- You are pregnant or planning to become pregnant while using Simponi. The effect of this drug on pregnant women is not known. The use of Simponi during pregnancy is not recommended. You must avoid becoming pregnant while being treated with Simponi and for at least 6 months after stopping treatment, by using appropriate contraception during this time.
- Before starting breastfeeding, at least 6 months must have passed since the end of Simponi treatment. You must stop breastfeeding if you receive Simponi.
- If you got Simponi during your pregnancy, your baby may be at a higher risk of getting an infection. You must tell your child’s doctor and other healthcare professionals about your use of Simponi before the child receives any vaccine (for more information see the section on vaccinations).
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Simponi has little effect on your ability to cycle, drive vehicles, and use tools or machines. However, dizziness may occur after taking Simponi. If this happens, do not cycle, drive or use any tools or machines.
Simponi contains latex and sorbitol
Sensitivity to latex
Part of the pre-filled pen, the needle guard, contains latex. Because latex can cause severe allergic reactions, talk to your doctor before taking Simponi if you or your healthcare provider are allergic to latex.
Hypersensitivity to sorbitol
This medicine contains 18.45 mg sorbitol (E420) in each pre-filled pen. Every 0.05 ml of the drug contains 2.05 mg of sorbitol (E420).
How to use Simponi
Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Amount of Simponi given
Polyarticular juvenile idiopathic arthritis in children 2 years and older:
- Children weighing less than 40 kg: The recommended dose of Simponi for children weighing less than 40 kg depends on their weight and height. Your doctor will tell you the correct dose to use. The dose should be given once a month, on the same date each month.
- Children weighing at least 40 kg: For children with a body weight of at least 40 kg, a pre-filled pen or pre-filled syringe with a fixed dose of 50 mg is available. For a 50 mg dose, see section 3 “How to use Simponi” in the package leaflet for Simponi 50 mg pre-filled pen or pre-filled syringe.
- Talk to your child’s doctor before your child takes the fourth dose. Your child’s doctor will decide if the child should continue Simponi treatment.
How Simponi is given
- Simponi is injected under the skin ( subcutaneously ).
- To begin with, a doctor or nurse may inject one with Simponi. However, you and your doctor may decide that you can inject yourself or inject your child with Simponi. In that case, you will be taught how to inject Simponi yourself.
Talk to your doctor if you have any questions about injecting Simponi yourself. There is a detailed “Instructions for use” in this leaflet.
If you use more Simponi than you should
If you have used or taken too much Simponi (either injected too much on a single occasion or used it too often) talk to a doctor or pharmacist immediately. Always carry the outer carton, even if it is empty, and this leaflet.
If you forget to use Simponi
If you forget to use Simponi on your scheduled date, take the missed dose as soon as you remember.
Do not take a double dose to make up for a forgotten dose.
Time for next dose:
- If you are less than 2 weeks late, inject the missed dose as soon as you remember and stick to the original schedule.
- If you are more than 2 weeks late, inject the missed dose as soon as you remember and talk to your doctor or pharmacist, and ask when to take the next dose.
If you are not sure, talk to your doctor or pharmacist.
If you stop taking Simponi
If you are considering stopping Simponi, talk to your doctor or pharmacist first.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Some patients may experience serious side effects that require treatment. Side effects can occur up to several months after the last injection.
Tell your doctor immediately if you notice any of the following serious side effects with Simponi such as:
- allergic reactions that can be severe, or rare, life-threatening (rare). Symptoms of an allergic reaction may include swelling of the face, lips, mouth, or throat, which may cause difficulty swallowing or breathing, skin rash, hives, swollen hands, feet, or ankles. Some of these reactions occurred after the first administration of Simponi.
- severe infections (such as tuberculosis, bacterial infections such as severe blood infections and pneumonia, severe fungal infections, and opportunistic infections ) (common). Symptoms of an infection can include fever, fatigue, (persistent) cough, shortness of breath, flu-like symptoms, weight loss, night sweats, diarrhea, sores, dental problems, and burning when urinating.
- reactivation of hepatitis B virus, if you are a carrier or if you have a history of hepatitis B (rare). Symptoms may include yellowing of the skin and eyes, dark brown urine, pain in the right part of the abdomen, fever, nausea, vomiting, and a pronounced feeling of tiredness.
- the disease of the nervous system such as multiple sclerosis (rare). Symptoms of nervous system disease can include altered vision, weakness in the arms and legs, numbness, or tingling in any part of the body.
- lymph node cancer ( rare ). Symptoms of lymphoma may include swollen lymph nodes, weight loss, or fever.
- heart failure (rare). Symptoms of heart failure can be shortness of breath or swollen feet.
- signs of diseases of the immune system called:
- lupus (rare). Symptoms may include joint pain or rash that is sensitive to light on the cheeks or arms.
- sarcoidosis (rare). Symptoms may include persistent cough, shortness of breath, chest pain, fever, swelling of lymph nodes, weight loss, rash, and blurred vision.
- swelling of small blood vessels ( vasculitis ) (rare). Symptoms may include fever, headache, weight loss, night sweats, rash, and nerve problems such as numbness and tingling.
- skin cancer (uncommon). Symptoms of skin cancer can be changes in the appearance of the skin or growths on the skin.
- blood disease (common). Symptoms of blood disease can be fever that does not go away, bruising or easy bleeding, or significant pallor.
- blood cancer ( leukemia ) (rare). Symptoms of leukemia can include fever, tiredness, frequent infections, bruising, and night sweats.
Tell your doctor immediately if you notice any of the above symptoms.
The following additional side effects have been observed with Simponi:
Very common side effects (may affect more than 1 user in 10):
- upper respiratory tract infection, sore throat or hoarseness, runny nose
Common side effects (may affect up to 1 in 10 people):
- abnormal liver values (increase in liver enzyme values), according to blood tests taken by a doctor
- dizziness
- headache
- numbness or stinging sensation
- superficial fungal diseases
- boil
- bacterial infections (such as cellulite )
- the low number of red blood cells
- low white blood cell count
- positive blood test for lupus
- allergic reactions
- indigestion
- abdominal pain
- nausea
- influenza
- tracheal catarrh
- sinusitis
- cold sores
- high blood pressure
- fever
- asthma, shortness of breath, wheezing
- gastrointestinal disorders that include inflammation of the gastric mucosa and colon, which can cause fever
- pain and sores in the mouth
- injection site reactions (includes redness, hardness, pain, bruising, itching, tingling, and irritation)
- hair loss
- skin rash and itching
- difficulty sleeping
- Depression
- feeling weak
- fracture
- chest discomfort
Uncommon side effects (may affect up to 1 in 100 people):
- kidney infection
- cancers, such as skin cancer and other non-cancerous growths or lumps, including skin blemishes
- skin blisters
- severe infection of the body (sepsis), sometimes with low blood pressure ( septic shock )
- psoriasis (also on the palms and/or soles of the feet and/or in the form of blisters)
- low platelet count
- combination of low platelet counts, red and white blood cells
- thyroid problems
- elevated blood sugar levels
- elevated cholesterol levels
- balance disorders
- visual disturbances
- inflammation of the eye ( conjunctivitis )
- eye allergy
- the feeling of the heart beating irregularly
- narrowing of the blood vessels in the heart
- blood clots
- hemorrhage
- constipation
- chronic inflammatory conditions of the lungs
- acid reflux
- gallstone
- liver problems
- chest problems
- menstrual disorders
Rare side effects (may affect up to 1 in 1,000 people):
- the inability of bone marrow to produce blood cells
- severely decreased white blood cell count
- infection in the joints or the tissue one around them
- impaired healing
- inflammation of blood vessels in internal organs
- leukemia
- melanoma (a type of skin cancer)
- Merkel cell carcinoma (a type of skin cancer)
- lichenoid reactions (itchy reddish-purple rash and/or filamentous white-gray lines on mucous membranes)
- scaly, flaky skin
- immune disorders that can affect the lungs, skin, and lymph nodes (usually manifests as sarcoidosis )
- pain in and discolored fingers or toes
- taste disorders
- bladder problems
- kidney problems
- inflammation of the blood vessels of the skin that causes rashes
Side effects are where the frequency is not known:
- an unusual blood cancer that mostly affects young people (T-cell lymphoma in the liver and spleen )
- Kaposi’s sarcoma, rare cancer associated with human herpes virus infection 8. Kaposi’s sarcoma usually appears as purple spots on the skin
- worsening of a condition called dermatomyositis (which manifests itself as a skin rash accompanied by muscle weakness)
How to store Simponi
- Keep this medicine out of the sight and reach of children.
- Do not use this medicine after the expiry date which is stated on the label and the carton after “EXP”. The expiration date is the last day of the specified month.
- Store in a refrigerator (2 ° C – 8 ° C). Do not freeze.
- Keep the pre-filled pen in the outer carton. Sensitive to light.
- This medicine can also be stored outside the refrigerator at temperatures up to a maximum of 25 ° C for a single period of no more than 30 days, but without exceeding the original expiry date printed on the carton. Write the new expiration date with day/month/year on the box (maximum 30 days after removal from the refrigerator). After storage at room temperature, this medicine must not be stored in the refrigerator again. Discard this medicine if it is not being used by the new expiration date or the expiration date printed on the carton, whichever comes first.
- Do not use this medicine if you notice that the solution is not clear to pale yellow, cloudy, or contains foreign particles.
- Medicines should not be disposed of via wastewater or household waste. Ask your doctor or pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the packaging and other information
Content declaration
The active substance is golimumab. A 0.45 ml pre-filled pen contains 45 mg golimumab. 1 ml contains 100 mg golimumab.
The other ingredients are sorbitol (E420), histidine, histidine hydrochloride monohydrate, polysorbate 80, and water for injections. For more information on sorbitol (E420), see section 2.
What the medicine looks like and the contents of the pack
Simponi is supplied as a solution for injection in a pre-filled disposable pen, VarioJect. Simponi is available in packs of 1 pre-filled pen.
The solution is clear to slightly opalescent (has a pearlescent luster), colorless to pale yellow, and may contain a few small transparent or white particles of protein. Simponi should not be used if the solution is discolored, cloudy, or contains visible foreign particles.
Marketing Authorization Holder and Manufacturer
Janssen Biologics BV
Einsteinweg 101
2333 CB Leiden
Netherlands
Contact the representative of the marketing authorization holder to find out more about this medicine:
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