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Tofacitinib (Oral route)

Pronunciation:

toe-fa-SYE-ti-nib

Brand Names:

  • Xeljanz

Dosage Forms:

  • Tablet

Warnings:

Oral route(Tablet)

Serious infections leading to hospitalization or death, including tuberculosis and bacterial, invasive fungal, viral, and other opportunistic infections, have occurred in patients receiving tofacitinib. If a serious infection develops, interrupt tofacitinib until the infection is controlled. Prior to starting tofacitinib, perform a test for latent tuberculosis; if it is positive, start treatment for tuberculosis prior to starting tofacitinib. Monitor all patients for active tuberculosis during treatment, even if the initial latent tuberculosis test is negative. Lymphoma and other malignancies have been observed in patients treated with tofacitinib. Epstein Barr Virus-associated posttransplant lymphoproliferative disorder has been observed at an increased rate in renal transplant patients treated with tofacitinib and concomitant immunosuppressive medications .

Classifications:

Therapeutic—

Musculoskeletal Agent

Pharmacologic—

Tyrosine Kinase Inhibitor

Uses of This Medicine:

Tofacitinib is used alone or together with other medicines to treat moderate to severely active rheumatoid arthritis. This medicine is used in adult patients who have taken other medicines (e.g., methotrexate) that did not work well. Tofacitinib is a Janus kinase (JAK) inhibitor.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of tofacitinib in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of tofacitinib in the elderly. However, elderly patients are more likely to have serious infections, which may require caution in patients receiving tofacitinib.

Pregnancy—

Pregnancy CategoryExplanation
All TrimestersCAnimal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Carbamazepine
  • Enzalutamide
  • Fosphenytoin
  • Mitotane
  • Phenobarbital
  • Phenytoin
  • Primidone
  • Rifabutin
  • Rifampin
  • Rifapentine
  • St John's Wort

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Fluconazole

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Hyperlipidemia (high cholesterol or fats in the blood) or
  • Infection (e.g., bacteria, virus, fungus), history of or
  • Stomach or bowel problems (e.g., diverticulitis, perforation, ulcers)—Use with caution. May make these conditions worse.
  • Cancer, active or history of—Use with caution. May increase the chance of getting new cancers.
  • Diabetes or
  • Hepatitis B, history of or
  • Hepatitis C, history of or
  • Weakened immune system—May increase chance for infection.
  • Infection, active—Should not be used in patients with this condition.
  • Kidney disease, moderate to severe or
  • Liver disease, moderate—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
  • Liver disease, severe—Use is not recommended in patients with this condition.
  • Tuberculosis, active or history of—Should be treated first before taking this medicine.

Proper Use of This Medicine:

Use this medicine exactly as directed by your doctor. Do not take more or less of it, or do not take it more often than your doctor ordered.

This medicine should come with a Medication Guide. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

You may take this medicine with or without food.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (tablets):
    • For rheumatoid arthritis:
      • Adults—5 milligrams (mg) two times a day.
      • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

If you will be using this medicine for a long time, it is very important that your doctor check your progress at regular visits. This will allow your doctor to see if this medicine is working properly and to decide whether you should continue to use it. Blood tests may be needed to check for unwanted effects.

You will need to have a skin test for tuberculosis before you start using this medicine. Tell your doctor if you or anyone in your home has ever had a positive reaction to a tuberculosis skin test.

Your body's ability to fight infection may be reduced while you are using tofacitinib. It is very important that you call your doctor at the first sign of any infection. Check with your doctor right away if you have any of the following symptoms while using this medicine: fever, chills, cough, flu-like symptoms, or unusual tiredness or weakness.

Using this medicine may increase your risk of getting skin cancer or cancer of the lymph system (lymphoma). Talk to your doctor if you have concerns about this risk.

Tofacitinib can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection:

  • If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
  • Check with your doctor immediately if you notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin.
  • Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
  • Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
  • Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
  • Avoid contact sports or other situations where bruising or injury could occur.

While you are being treated with tofacitinib, do not have any immunizations (vaccines) without your doctor's approval. Live virus vaccines should not be given to patients who are using tofacitinib. Your vaccinations need to be current before you begin using this medicine. Be sure to ask your doctor if you have any questions about this.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common
Bladder pain
bloody or cloudy urine
blurred vision
body aches or pain
chills
cough
difficult, burning, or painful urination
difficulty breathing
dizziness
ear congestion
fever
frequent urge to urinate
headache
loss of voice
lower back or side pain
muscle aches
nervousness
pounding in the ears
slow or fast heartbeat
sneezing
sore throat
stuffy or runny nose
unusual tiredness or weakness
Incidence not known
Bloating or swelling of the face, arms, hands, lower legs, or feet
confusion
dark urine
decreased urination
difficult or labored breathing
dry mouth
fainting
increase in heart rate
light-colored stools
lightheadedness
nausea and vomiting
pale skin
rapid breathing
rapid weight gain
shortness of breath
sunken eyes
thirst
tightness in the chest
tingling of the hands or feet
troubled breathing with exertion
unusual bleeding or bruising
unusual weight gain or loss
upper right abdominal or stomach pain
wrinkled skin
yellow eyes and skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common
Diarrhea
headache
Incidence not known
Acid or sour stomach
belching
burning feeling in the chest or stomach
burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
difficulty with moving
flushing or redness of the skin
heartburn
indigestion
itching skin
muscle pain or stiffness
pain in the joints
rash
stomach discomfort, upset, or pain
tenderness in the stomach area
trouble sleeping
unusually warm skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.


Last Updated: 4/4/2014

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