Inflectra; Remicade; Renflexis
Inflectra; Remicade; Remsima; Renflexis
- 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 infliximab. 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 people who take this drug or drugs like it. This has been deadly in some cases. Talk with the doctor.
- A rare type of cancer called hepatosplenic T-cell lymphoma (HSTCL) has happened with this drug and other drugs like it. These cases have been deadly. Almost all cases were in people who were using drugs like this one along with certain other drugs (azathioprine or 6-mercaptopurine). Most of the time, this happened during treatment for Crohn’s disease or ulcerative colitis. Also, most cases were in male teenagers or young men. Talk with the doctor.
- It is used to treat Crohn’s disease.
- It is used to treat ulcerative colitis.
- It is used to treat juvenile arthritis.
- It may be given to your child for other reasons. Talk with the doctor.
- If your child has an allergy to this drug or any part of this drug.
- If your child is allergic to any drugs like this one or any other drugs, foods, or other substances. Tell the doctor about the allergy and what signs your child had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
- If your child has heart failure, talk with the doctor.
- If your child is taking any of these drugs: Abatacept or anakinra.
- If your child is taking or will be taking another drug like this one.
If your child is breast-feeding a baby:
- Be sure your child does not breast-feed a baby while taking this drug.
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 for your child to take this drug with all of his/her 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.
- This drug may lower the ability of your child’s bone marrow to make blood cells that your child’s body needs. This can lead to very bad and sometimes deadly bleeding problems or infections. Talk with your child’s doctor.
- Your child may have more chance of getting infections. Have your child wash hands often. Avoid crowds and people with infections, colds, or flu.
- Be sure your child does not get a weakened bacteria like BCG for bladder cancer while using this drug. Talk with the doctor.
- Talk with the doctor before your child gets any vaccines. Use of some vaccines with this drug may raise the chance of an infection.
- Have your child’s blood work checked often. Talk with your child’s 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.
- This drug may affect certain lab tests. Tell all of your child’s health care providers and lab workers that your child takes this drug.
- 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.
- Abnormal heartbeats, heart attacks, high or low blood pressure, and strokes have happened during and within 24 hours after the infusion. Sometimes, heart attacks have been deadly. Loss of eyesight has also happened during and within 2 hours after the infusion. Talk with the doctor.
- Use with care in children. Talk with the doctor.
- Make sure your child is up to date with all vaccines before treatment with this drug.
If your child is pregnant:
- Tell the doctor if your child is pregnant or becomes pregnant. You will need to talk about the benefits and risks of your child using this drug while pregnant.
- 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 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 or low blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
- Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
- Any unexplained bruising or bleeding.
- Feeling very tired or weak.
- Chest pain or pressure.
- Very bad back pain.
- Pale skin.
- Swollen gland.
- Night sweats.
- A big weight loss.
- Black, tarry, or bloody stools.
- A skin lump or growth.
- Fast or slow heartbeat.
- Loss of eyesight.
- Red scaly patches or bumps that are pus filled.
- Fever, chills, itching, hives, chest pain or pressure, or shortness of breath when drug is given. Other drugs may be given to avoid these.
- 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.
- Very bad and sometimes deadly liver problems have happened with this drug. Call your child’s doctor right away if your child has 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.
- 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.
- A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if your child has signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in the mouth, throat, nose, or eyes.
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:
- Belly pain.
- Upset stomach or throwing up.
- Feeling tired or weak.
- Irritation where the shot 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 a list of all your child’s drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your child’s doctor.
- Talk with your child’s doctor before giving your child any new drug, including prescription or OTC, natural products, or vitamins.
- 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.
© 2019 Wolters Kluwer Clinical Drug Information, Inc. and its affiliates and/or licensors. All rights reserved.