Tofacitinib (Oral route)
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 .
Tyrosine Kinase Inhibitor
Uses of This Medicine:
Tofacitinib is used alone or together with other medicines to treat rheumatoid arthritis. This medicine is used in patients who have taken other medicines (eg, methotrexate) that did not work well. Tofacitinib is a Janus kinase (JAK) inhibitor that works on the immune system.
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:
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.
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.
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.
|All Trimesters||C||Animal 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.|
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.
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.
- 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.
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:
- Anemia or
- Hyperlipidemia (high cholesterol in the blood) or
- Infection, history of or
- Stomach or bowel problems (eg, diverticulitis, perforation, ulcers)—Use with caution. May make these conditions worse.
- Hepatitis B, history of or
- Hepatitis C, history of or
- Tuberculosis, active or history of or
- Weakened immune system—May cause side effects to become worse.
- Infection, active or
- Liver disease, severe—Use is not recommended in patients with these conditions.
- Kidney disease or
- Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
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. Read the information carefully. Ask your doctor about anything you do not understand.
You may take this medicine with or without food.
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) 2 times a day.
- Children—Use and dose must be determined by your doctor.
- For rheumatoid arthritis:
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.
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 an infection. Check with your doctor right away if you have a fever, chills, cough, flu-like symptoms, or unusual tiredness or weakness.
Using this medicine may increase your risk of getting skin cancer (eg, non-melanoma 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, and after you stop treatment with it, do not have any immunizations (vaccines) without your doctor's approval. Tofacitinib may lower your body's resistance and the vaccine may not work as well or you might get the infection the vaccine is meant to prevent. In addition, you should not be around other persons living in your household who receive live virus vaccines because there is a chance they could pass the virus on to you. Some examples of live vaccines include measles, mumps, influenza (nasal flu vaccine), poliovirus (oral form), rotavirus, and rubella. Do not get close to them and do not stay in the same room with them for very long. If you have questions about this, talk to your doctor.
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:
- Less common
- Bladder pain
- bloody or cloudy urine
- blurred vision
- body aches or pain
- difficult, burning, or painful urination
- difficulty breathing
- ear congestion
- frequent urge to urinate
- loss of voice
- lower back or side pain
- muscle aches
- pounding in the ears
- slow or fast heartbeat
- 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
- dark urine
- decreased urination
- difficult or labored breathing
- dry mouth
- increase in heart rate
- light-colored stools
- nausea and vomiting
- pale skin
- persistent non-healing sore
- rapid breathing
- rapid weight gain
- reddish patch or irritated area
- sunken eyes
- 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
- Less common
- Incidence not known
- Acid or sour stomach
- 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
- itching skin or rash
- muscle pain or stiffness
- pain in the joints
- stomach discomfort, upset, or pain
- tenderness in the stomach area
- trouble sleeping
- unusually warm skin
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:
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:
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: 11/4/2014