This information from Lexicomp® explains what you need to know about this medication, including what it’s used for, how to take it, its side effects, and when to call your healthcare provider.
Simponi; Simponi Aria
Simponi; Simponi I.V.
- Very bad and sometimes deadly infections have happened in patients who take this drug. Most people who had these infections were taking other drugs to lower the immune system like methotrexate or steroid drugs. If your child has any infection, is taking antibiotics now or in the recent past, or has had many infections, talk with your child’s doctor.
- TB (tuberculosis) has been seen in patients started on this drug. These patients were exposed to TB in the past, but never got the infection. Your child may be tested to see if he/she has been exposed to TB before starting this drug.
- Lymphoma and other cancers have happened in children and teenagers taking this drug or drugs like it. These cancers have also happened in adults. Sometimes, this has been deadly. If you have questions, talk with the doctor.
- A rare type of cancer called hepatosplenic T-cell lymphoma (HSTCL) has happened in people taking drugs like this one. This cancer has been deadly. Almost all cases happened during treatment for Crohn’s disease or ulcerative colitis. Most of these people were male teenagers or young men. Almost all of the people were also taking certain other drugs (azathioprine or 6-mercaptopurine). If you have questions, talk with the doctor.
- It is used to treat some types of arthritis.
- It may be given to your child for other reasons. Talk with the doctor.
Auto-injectors and prefilled pens:
- If your child has been given this form of this drug, talk with the doctor for information about the benefits and risks. Talk with the doctor if you have questions or concerns about giving this drug to your child.
- If your child is allergic to this drug; any part of this drug; or any other drugs, foods, or substances. Tell the doctor about the allergy and what signs your child had.
- If your child has an infection.
- If your child is taking any of these drugs: Abatacept, adalimumab, anakinra, certolizumab, etanercept, infliximab, rituximab, or tocilizumab.
This is not a list of all drugs or health problems that interact with this drug.
Tell the doctor and pharmacist about all of your child’s drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe to give this drug with all of your child’s other drugs and health problems. Do not start, stop, or change the dose of any drug your child takes without checking with the doctor.
- Tell all of your child’s health care providers that your child is taking this drug. This includes your child’s doctors, nurses, pharmacists, and dentists.
- If your child has had hepatitis B before or carries the virus, this drug can cause the virus to become active. This can lead to very bad and sometimes deadly liver problems. Your child will be tested for hepatitis B before starting this drug. You will need to watch for signs of hepatitis while your child takes this drug and for several months after your child stops it. Talk with your child’s doctor.
- Talk with the doctor before your child gets any vaccines. Use of some vaccines with this drug may either raise the chance of very bad infection or make the vaccine not work as well.
- Be sure your child does not get a weakened bacteria like BCG for bladder cancer while using this drug. Talk with the doctor.
- Have blood work checked as you have been told by the doctor. Talk with the doctor.
- Have your child’s skin checked. Tell your child’s doctor if your child has any skin changes like a new wart, skin sore or reddish bump that bleeds or does not heal, or a change in the color or size of a mole.
- Allergic reactions have happened with this drug. Some reactions may be severe or life-threatening. When allergic reactions happened, most of the time they happened during the infusion or within 1 hour after the infusion. Call the doctor right away if your child has any signs that are not normal.
- If giving this drug to your child and your child’s weight changes, talk with the doctor. The dose of this drug may need to be changed.
If your child is pregnant or breast-feeding a baby:
- Talk with the doctor if your child is pregnant, becomes pregnant, or is breast-feeding a baby. You will need to talk about the benefits and risks to your child and the baby.
- If your child used this drug when she was pregnant, tell the baby’s doctor. The baby may have a higher chance of getting an infection for at least 6 months after birth. The baby’s doctor will also need to decide when the baby is to get any vaccines. Certain vaccines may cause infections that can lead to very bad health problems or death if given within 6 months after birth.
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your child’s doctor or get medical help right away if your child has any of the following signs or symptoms that may be related to a very bad side effect:
- Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
- Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
- Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
- Signs of lupus like a rash on the cheeks or other body parts, sunburn easy, muscle or joint pain, chest pain or shortness of breath, or swelling in the arms or legs.
- Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
- Chest pain or pressure.
- Feeling very tired or weak.
- Any unexplained bruising or bleeding.
- Pale skin.
- Red scaly patches or bumps that are pus filled.
- A skin lump or growth.
- Flu-like signs.
- Warm, red, or painful skin or sores on the body.
- Call your child’s doctor right away if your child has a swollen gland, night sweats, shortness of breath, or weight loss without trying.
- Heart failure has happened with this drug, as well as heart failure that has gotten worse in people who already have it. Tell the doctor if your child has heart disease. Call the doctor right away if your child has shortness of breath, a big weight gain, a heartbeat that is not normal, or swelling in the arms or legs that is new or worse.
- Rarely, people using drugs like this one have had nervous system problems. Sometimes, these problems have not gone away. Call the doctor right away if your child has a burning, numbness, or tingling feeling that is not normal; change in eyesight; dizziness; seizures; or weakness in the arms or legs.
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your child’s doctor or get medical help if any of these side effects or any other side effects bother your child or do not go away:
- Irritation where this drug is given.
- Signs of a common cold.
These are not all of the side effects that may occur. If you have questions about side effects, call your child’s doctor. Call your child’s doctor for medical advice about side effects.
You may report side effects to your national health agency.
Give this drug as ordered by your child’s doctor. Read all information given to you. Follow all instructions closely.
- It is given as an infusion into a vein over a period of time.
- Call your child’s doctor to find out what to do.
- If you need to store this drug at home, talk with your child’s doctor, nurse, or pharmacist about how to store it.
- If your child’s symptoms or health problems do not get better or if they become worse, call your child’s doctor.
- Do not share your child’s drug with others and do not give anyone else’s drug to your child.
- Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
- Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
- Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your child’s doctor, nurse, pharmacist, or other health care provider.
- If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine. The use of this information is governed by the Lexicomp End User License Agreement, available at https://www.wolterskluwer.com/en/solutions/lexicomp/about/eula.
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