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Xeljanz

Generic Name: Tofacitinib Tablets (toe fa SYE ti nib)
Brand Name: Xeljanz

Warning

  • Very bad and sometimes deadly infections like tuberculosis, shingles, fungal infections and other bacterial or viral infections have happened in patients who take Xeljanz (tofacitinib tablets). The risk is greater if you also take drugs that suppress the immune system like methotrexate or corticosteroids. If you get a bad infection, your doctor may stop this medicine until the infection is under control. Call your doctor right away if you have fever, chills, cough, muscle aches, shortness of breath, more sputum or change in color of sputum, red, warm, swollen, painful, or blistered skin, weight loss, belly pain, loose stools (diarrhea), pain with passing urine, or feeling tired or weak.
  • TB (tuberculosis) has been seen in patients started on Xeljanz. These patients were exposed to TB in the past, but never got the infection. You will be tested to see if you have been exposed to TB before starting this medicine.
  • Lymphoma, skin cancer, and other types of cancer have happened in people treated with Xeljanz. Talk with your doctor.
  • If you have had a kidney transplant and take drugs that work on the immune system, you are at a greater risk for a problem with certain white blood cells growing out of control called post-transplant lymphoproliferative disorder caused by the Epstein Barr virus. Talk with your doctor.

Uses of Xeljanz:

  • It is used to treat rheumatoid arthritis.

What do I need to tell my doctor BEFORE I take Xeljanz?

  • If you have an allergy to tofacitinib or any other part of this medicine.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you have liver disease.
  • If you have an infection.
  • If you have anemia.
  • If you have a low white blood cell count.
  • If you are taking rifampin.
  • If you are taking any of these drugs: Abatacept, adalimumab, anakinra, certolizumab, etanercept, golimumab, infliximab, natalizumab, rituximab, or tocilizumab.
  • If you are taking any drugs used to suppress your immune system like azathioprine or cyclosporine. There are many drugs that can do this. Ask your doctor or pharmacist if you are not sure.
  • If you are breast-feeding. Do not breast-feed while you take Xeljanz.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Xeljanz with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Xeljanz?

  • Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
  • Some viral infections like herpes zoster have become active again with Xeljanz. Tell your doctor if you have ever had a viral infection like herpes zoster. Talk with your doctor.
  • Hepatitis B or C testing may be done. A hepatitis B or C infection may get worse during care. Talk with the doctor.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • Have your cholesterol checked before starting this medicine.
  • If you have high cholesterol, talk with your doctor.
  • You may need to have your skin checked while you take Xeljanz. Talk with your doctor.
  • If you drink grapefruit juice or eat grapefruit often, talk with your doctor.
  • This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take this medicine.
  • Make sure you are up to date with all your vaccines before treatment with Xeljanz (tofacitinib tablets).
  • Talk with your doctor before getting any vaccines. Use with this medicine may either raise the chance of an infection or make the vaccine not work as well.
  • You may have more chance of getting an infection. Wash hands often. Stay away from people with infections, colds, or flu.
  • If you have high blood sugar (diabetes), talk with your doctor. You may be more likely to get infections.
  • If you are 65 or older, use Xeljanz with care. You could have more side effects.
  • This medicine may cause fertility problems. This may affect being able to have children. Talk with the doctor.
  • Use birth control that you can trust to prevent pregnancy while taking this medicine and for 1 month after stopping Xeljanz.
  • If you get pregnant while taking this medicine or within 1 month after your last dose, call your doctor right away.

How is this medicine (Xeljanz) best taken?

Use Xeljanz as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • Take with or without food.
  • Take as you have been told by your doctor.

What do I do if I miss a dose?

  • Skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.

Dosage Information (comprehensive)

What are some side effects that I need to call my doctor about right away?

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 doctor or get medical help right away if you have 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 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.
  • Change in color or size of a mole.
  • A skin lump or growth.
  • Feeling very tired or weak.
  • Change in bowel habits.
  • Night sweats.
  • Shortness of breath.
  • Muscle pain or weakness.
  • Slow heartbeat.
  • A heartbeat that does not feel normal.
  • Tears in the stomach or bowel wall have happened in certain people taking this medicine. Call your doctor right away if you have swelling or pain in your stomach that is very bad, gets worse, or does not go away. Call your doctor right away if you throw up blood or have throw up that looks like coffee grounds; upset stomach or throwing up that does not go away; or black, tarry, or bloody stools.
  • Very bad and sometimes deadly lung problems have happened with Xeljanz. Call your doctor right away if you have lung or breathing problems like trouble breathing, shortness of breath, or a cough that is new or worse.

What are some other side effects of Xeljanz?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Headache.
  • Loose stools (diarrhea).
  • Signs of a common cold.
  • Runny nose.
  • Sore throat.
  • Stuffy nose.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Side Effects (complete list)

If OVERDOSE is suspected:

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.

How do I store and/or throw out Xeljanz?

  • Store in the original container at room temperature.
  • 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.
  • Check with your pharmacist about how to throw out unused drugs.

Consumer Information Use and Disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time this medicine is refilled. If you have any questions about Xeljanz, please talk with the doctor, 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 Xeljanz. 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 Xeljanz (tofacitinib tablets).

Review Date: December 6, 2017

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