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.
Xeljanz; Xeljanz XR
AURO-Tofacitinib; PMS-Tofacitinib; TARO-Tofacitinib; Xeljanz; Xeljanz XR
- Severe infections like tuberculosis, shingles, fungal infections and other bacterial or viral infections have happened in patients who take this drug. Sometimes, these have been deadly. The risk is greater if your child also takes drugs that suppress the immune system like methotrexate or corticosteroids. If your child gets a bad infection, the doctor may stop this drug until the infection is under control. Call the doctor right away if your child has a fever, chills, or sweating; cough; muscle aches; shortness of breath; more sputum or change in color of sputum; red, warm, swollen, painful, or blistered skin; weight loss; stomach pain; diarrhea; pain with passing urine or passing urine more often; or feeling tired or weak.
- 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. The doctor may test to see if your child has been exposed to TB before starting this drug.
- This drug may raise the risk of heart attack, stroke, blood clots, and death. These effects were seen in a study of people taking this drug to treat rheumatoid arthritis. These people were at least 50 years of age and also had at least 1 heart disease risk factor. Call the doctor right away if your child has signs of a heart attack, stroke, or blood clot like chest, throat, neck, or jaw tightness, pain, pressure, or heaviness; abnormal arm, back, neck, jaw, or stomach pain; coughing up blood; shortness of breath; cold sweats; severe upset stomach or throwing up; swelling, warmth, numbness, coldness, color change, or pain in a leg or arm; trouble speaking, swallowing, or thinking; weakness on 1 side of the body; change in balance; drooping on one side of the face; feeling lightheaded; or change in eyesight.
- Tell the doctor if your child smokes, has smoked in the past, or has ever had a heart attack, other heart problems, stroke, or blood clot.
- Lymphoma, skin cancer, and other types of cancer have happened in people treated with this drug.
- If your child has had a kidney transplant and takes drugs that work on the immune system, your child is at a greater risk for a problem with certain white blood cells growing out of control. This is called post-transplant lymphoproliferative disorder and is caused by the Epstein Barr virus. If you have questions, talk with the doctor.
- It is used to treat juvenile arthritis.
- If your child has been given this drug for some other reason, talk with the doctor 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 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 any of these health problems: Anemia, infection, low white blood cell count, kidney disease, or liver disease.
- If your child is taking any of these drugs: Abatacept, adalimumab, anakinra, certolizumab, etanercept, golimumab, infliximab, rifampin, rituximab, secukinumab, tocilizumab, ustekinumab, or vedolizumab.
- If your child is taking any drugs used to suppress the immune system like azathioprine or cyclosporine. There are many drugs that can do this. Ask the doctor or pharmacist if you are not sure.
If your child is breast-feeding a baby:
- If your child is breast-feeding a baby. Be sure your child does not breast-feed while taking this drug. Your child may also need to avoid breast-feeding for some time after the last dose. Talk with your child’s doctor to see if your child needs to avoid breast-feeding after the last dose.
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.
- Some viral infections like herpes zoster have become active again with this drug. Tell your child’s doctor if your child has ever had a viral infection like herpes zoster.
- Hepatitis B or C testing may be done. A hepatitis B or C infection may get worse while taking this drug.
- Have blood work checked as you have been told by the doctor. Talk with the doctor.
- High cholesterol has happened with this drug. If you have questions, talk with the doctor.
- Your child’s skin may need to be checked while taking this drug. If you have questions, talk with the doctor.
- If your child drinks grapefruit juice or eats grapefruit often, talk with your child’s doctor.
- 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.
- Make sure your child is up to date with all vaccines before treatment with this drug.
- 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.
- Your child may have more chance of getting infections. Have your child wash hands often. Avoid crowds and people with infections, colds, or flu.
- If your child has high blood sugar (diabetes), talk with the doctor. Your child may be more likely to get infections.
- This drug may be used with other drugs to treat your child’s health condition. If your child is also taking other drugs, talk with your child’s doctor about the risks and side effects that may happen.
- This drug may cause fertility problems. This may affect being able to have children. It is not known if this will go back to normal. If you have questions, talk with the doctor.
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.
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, tiredness, decreased appetite, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
- 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.
- Warm, red, or painful skin or sores on the body.
- Change in color or size of a mole.
- A skin lump or growth.
- Feeling very tired or weak.
- Change in bowel habits.
- Muscle pain or weakness.
- Slow heartbeat.
- A heartbeat that does not feel normal.
- Call your child’s doctor right away if your child has a swollen gland, night sweats, shortness of breath, or weight loss without trying.
- Tears in the stomach or bowel wall have happened in certain people taking this drug. Call your child’s doctor right away if your child has swelling or pain in the stomach that is very bad, gets worse, or does not go away. Call your child’s doctor right away if your child throws up blood or has throw up that looks like coffee grounds; upset stomach or throwing up that does not go away; or black, tarry, or bloody stools.
- 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:
- Diarrhea, upset stomach, or throwing up.
- Signs of a common cold.
- Nose or throat irritation.
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.
- Do not give more than the doctor told you to give. Giving more than you are told may raise the chance of very bad side effects.
- If your child is on dialysis and is taking this drug on the day of dialysis, give it to your child after dialysis. If you have questions, talk with your child’s doctor.
- If the adapter has not been put in the bottle when you get it, follow how to prepare the bottle as you have been told or read the package insert.
- Measure liquid doses carefully. Use the measuring device that comes with this drug. If there is none, ask the pharmacist for a device to measure this drug.
- 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 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.
- Store in original container.
- Store in the original container to protect from light.
- After opening, throw away any part not used after 60 days.
- 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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