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.
ACCEL-Leflunomide; APO-Leflunomide; Arava; SANDOZ Leflunomide; TEVA-Leflunomide
- This drug may cause harm to the unborn baby or loss of the unborn baby if your child takes it during pregnancy.
- Do not let your child take this drug while pregnant, or if your child may get pregnant and is not using birth control. A pregnancy test will be done to show that your child is NOT pregnant before starting this drug. Have your child use birth control while taking this drug. After stopping this drug, your child must keep using birth control until a special process is done to remove extra leflunomide from the body. Blood tests will be done to show that the body is free of this drug. If your child gets pregnant while taking this drug, call the doctor right away.
- Severe and sometimes deadly liver problems have happened with this drug. Tell the doctor if your child has liver disease. This drug must not be used in people with certain liver problems. Have your child’s liver function checked as you were told by the doctor.
- Tell the doctor if your child is taking any drugs that can raise the chance of liver problems. There are many drugs that can do this. Ask the doctor or pharmacist if you are not sure.
- It is used to treat juvenile arthritis.
- This drug is not approved for use in children. However, the doctor may decide the benefits of taking this drug outweigh the risks. If your child has been given this drug, ask the doctor for information about the benefits and risks. Talk with the doctor if you have questions 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 any of these health problems: Bone marrow disease or low blood cell counts.
- If your child has an infection.
- If your child has a weak immune system.
- If your child is taking teriflunomide.
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 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.
- Have blood work checked as you have been told by the doctor. Talk with the doctor.
- High blood pressure has happened with this drug. Have your child’s blood pressure checked as you have been told by the doctor.
- Talk with the doctor before your child gets any vaccines while taking this drug and after your child stops taking it. Vaccine use with this drug may either raise the chance of an infection or make the vaccine not work as well. Talk with the doctor.
- This drug may lower the ability of the bone marrow to make blood cells that the body needs. If blood cell counts get very low, this can lead to bleeding problems, infections, or anemia. If you have questions, talk with the doctor.
- Your child may have more chance of getting an infection. Some infections have been deadly. Have your child wash hands often. Have your child stay away from people with infections, colds, or flu.
- Your child may bleed more easily. Make sure your child is careful and avoids injury. Be sure your child has a soft toothbrush.
- Your child will need a TB (tuberculosis) test before starting this drug.
- This drug will stay in your child’s body for some time after your child stops taking it. Sometimes, the doctor may give your child other drugs to get rid of this drug faster. If you have questions, talk with the doctor.
- Drugs that may suppress the immune system like this drug may raise the risk of cancer. If you have questions, talk with the doctor.
- Nerve problems have happened with this drug. Most of the time, these nerve problems went away after this drug was stopped. Sometimes, people had nerve problems that did not go away even after this drug was stopped. Talk with the doctor.
- A severe and sometimes deadly reaction has happened. Most of the time, this reaction has signs like fever, rash, or swollen glands with problems in body organs like the liver, kidney, blood, heart, muscles and joints, or lungs. If you have questions, talk with the doctor.
If your child is or may be sexually active:
- If your child misses a period, has unprotected sex, or thinks that their birth control has not worked, call the doctor right away.
- If your child’s sex partner may get pregnant or your child wishes to father a child, talk with the doctor.
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 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 high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
- 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 bleeding like throwing up or coughing up blood; vomit that looks like coffee grounds; blood in the urine; black, red, or tarry stools; bleeding from the gums; abnormal vaginal bleeding; bruises without a cause or that get bigger; or bleeding you cannot stop.
- A burning, numbness, or tingling feeling that is not normal.
- Pale skin.
- A severe skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause severe 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.
- Some people have had lung problems with this drug. Sometimes, this has been deadly. Call your child’s doctor right away if your child has signs of lung problems like shortness of breath or other trouble breathing, cough that is new or worse, or fever.
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:
- Upset stomach or throwing up.
- Stomach pain or diarrhea.
- Hair loss.
- Feeling dizzy, tired, or weak.
- Back pain.
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.
- Give this drug with or without food.
- Keep giving this drug to your child as you have been told by your child’s doctor or other health care provider, even if your child feels well.
- Give a missed dose as soon as you think about it.
- If it is close to the time for your child’s next dose, skip the missed dose and go back to your child’s normal time.
- Do not give 2 doses at the same time or extra doses.
- Store at room temperature protected from light. Store in a dry place. Do not store in a bathroom.
- 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.
- 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.
- 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.
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