Description
Tofacitinib is used alone or together with other medicines (eg, DMARDs) to treat moderate to severely active rheumatoid arthritis, active psoriatic arthritis, ulcerative colitis, ankylosing spondylitis, and polyarticular course juvenile idiopathic arthritis (pcJIA) 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.
This product is available in the following dosage forms:
- Tablet
- Tablet, Extended Release
- Solution
Before Using
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.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of tofacitinib extended-release tablet in the pediatric population. Safety and efficacy have not been established.
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of tofacitinib tablet and oral liquid in children 2 to 17 years of age with pcJIA. Safety and efficacy have been established.
Geriatric
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.
Breastfeeding
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.
Drug Interactions
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.
- Abatacept
- Adenovirus Vaccine Type 4, Live
- Adenovirus Vaccine Type 7, Live
- Anifrolumab-fnia
- Apalutamide
- Avacopan
- Azathioprine
- Bacillus of Calmette and Guerin Vaccine, Live
- Carbamazepine
- Cholera Vaccine, Live
- Cyclosporine
- Dengue Tetravalent Vaccine, Live
- Enzalutamide
- Fluconazole
- Fosphenytoin
- Infliximab
- Influenza Virus Vaccine, Live
- Letermovir
- Lumacaftor
- Measles Virus Vaccine, Live
- Mitotane
- Mumps Virus Vaccine, Live
- Nirmatrelvir
- Phenytoin
- Poliovirus Vaccine, Live
- Rifampin
- Rotavirus Vaccine, Live
- Rubella Virus Vaccine, Live
- Ruxolitinib
- Smallpox Monkeypox Vaccine
- St John's Wort
- Tacrolimus
- Tazemetostat
- Typhoid Vaccine, Live
- Varicella Virus Vaccine, Live
- Yellow Fever Vaccine
- Zoster Vaccine, Live
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.
- Mavacamten
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:
- Anemia (blood disease) or
- Hyperlipidemia (high cholesterol in the blood) or
- Infection, history of or
- Neutropenia (blood disease) or
- Stomach or bowel problems (eg, blockage, diverticulitis, perforation, ulcers), history of—Use with caution. May make these conditions worse.
- Diabetes or
- Lung disease (eg, interstitial lung disease), or history of or
- Lymphopenia (blood disease)—Use with caution. May increase risk of developing infections.
- Heart or blood vessel disease or
- Hepatitis B, history of or
- Hepatitis C, history of or
- Herpes zoster infection 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 (eg, patients on dialysis), moderate or severe or
- Liver disease, moderate—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
- Smoker, current or past—May increase risk for serious side effects.
Proper Use
Use this medicine exactly as directed by your doctor. Do not take more or less of it, do not take it more often, and do not take it for a longer time than your doctor ordered.
This medicine should come with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.
You may take this medicine with or without food.
Swallow the extended-release tablet whole with water. Do not cut, crush, break, or chew it.
A part of the extended-release tablet may pass into your stools. This is normal and is nothing to worry about.
If you are taking the tablet form of this medicine, your doctor may switch you to the extended-release tablet form after your last dose. Ask your doctor if you have questions.
Measure the oral liquid medicine with an oral dosing syringe.
Use only the brand of medicine your doctor prescribed. Other brands may not work the same way.
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 psoriatic arthritis, rheumatoid arthritis, and ankylosing spondylitis:
- For oral dosage form (extended-release tablets):
- Adults—11 milligrams (mg) once a day together with another medicine. Your doctor may adjust your dose as needed.
- Children—Use and dose must be determined by your doctor.
- For oral dosage form (tablets):
- Adults—5 milligrams (mg) 2 times a day together with another medicine. Your doctor may adjust your dose as needed.
- Children—Use and dose must be determined by your doctor.
- For oral dosage form (extended-release tablets):
- For ulcerative colitis:
- For oral dosage form (extended-release tablets):
- Adults—22 milligrams (mg) once a day for at least 8 weeks, then 11 mg once a day. Your doctor may adjust your dose as needed.
- Children—Use and dose must be determined by your doctor.
- For oral dosage form (tablets):
- Adults—10 milligrams (mg) 2 times a day for at least 8 weeks, then 5 or 10 mg 2 times a day. Your doctor may adjust your dose as needed.
- Children—Use and dose must be determined by your doctor.
- For oral dosage form (extended-release tablets):
- For pcJIA:
- For oral dosage form (tablets):
- Children 2 to 17 years of age—Dose is based on body weight and must be determined by your doctor.
- Weighing 40 kilograms (kg) or more—5 milligrams (mg) 2 times a day. Your doctor may adjust your dose as needed.
- Weighing 20 to less than 40 kg—4 mg 2 times a day. Your doctor may adjust your dose as needed.
- Weighing 10 to less than 20 kg—3.2 mg 2 times a day. Your doctor may adjust your dose as needed.
- Children younger than 2 years of age—Use and dose must be determined by your doctor.
- Children 2 to 17 years of age—Dose is based on body weight and must be determined by your doctor.
- For oral dosage form (solution):
- Children 2 to 17 years of age—Dose is based on body weight and must be determined by your doctor.
- Weighing 40 kilograms (kg) or more—5 milliliters (mL) 2 times a day. Your doctor may adjust your dose as needed.
- Weighing 20 to less than 40 kg—4 mL 2 times a day. Your doctor may adjust your dose as needed.
- Weighing 10 to less than 20 kg—3.2 mL 2 times a day. Your doctor may adjust your dose as needed.
- Children younger than 2 years of age—Use and dose must be determined by your doctor.
- Children 2 to 17 years of age—Dose is based on body weight and must be determined by your doctor.
- For oral dosage form (tablets):
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.
Use the oral liquid within 60 days of opening the bottle. Throw away any remaining oral liquid after 60 days.
Precautions
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 are needed to check for unwanted effects.
Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using this medicine, tell your doctor right away.
If you plan to have children, talk with your doctor before using this medicine. Some women using this medicine have become infertile (unable to have children).
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.
This medicine may increase your risk of serious heart or blood vessel problems (eg, heart attack, stroke), especially in patients with rheumatoid arthritis who are 50 years of age and older and with a heart or blood vessel disease. Call your doctor right away if you have chest pain or discomfort, confusion, difficulty in speaking, double vision, headache, inability to move arms, legs, or facial muscles, nausea, pain or discomfort in the arms, jaw, back, or neck, sweating, trouble breathing, or vomiting.
Your body's ability to fight infections 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.
This medicine may increase your risk of cancer (eg, lymphoma, lung cancer, non-melanoma skin cancer). Tell your doctor right away if you have black, tarry stools, general feeling of illness, swollen glands, weight loss, yellow skin and eyes, persistent non-healing sore, reddish patch or irritated area, shiny bump, pink growth, or white, yellow or waxy scar-like area on the skin.
This medicine can cause serious allergic reactions, including angioedema or urticaria. Tell your doctor right away if you start to have swelling of your face, lips, tongue, throat, arms, or legs, or if you are having trouble swallowing or breathing.
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 right away 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 right away 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.
This medicine may increase your risk of developing blood clots (eg, arterial thrombosis, deep vein thrombosis, pulmonary embolism), especially in patients with rheumatoid arthritis who are 50 years of age and older and with a heart or blood vessel disease. Check with your doctor right away if you have anxiety, chest pain, cough, dizziness, lightheadedness, or fainting, fast heartbeat, pain, redness, or swelling in the arm or leg, pains in the chest, groin, or legs, especially calves of the legs, severe headaches, sudden loss of coordination, sudden onset of slurred speech, sudden vision changes, or trouble breathing.
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 there is a chance 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
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
- Black, tarry stools
- bladder pain
- bloody or cloudy urine
- blurred vision
- body aches or pain
- chest pain or tightness
- chills
- cough
- difficult, burning, or painful urination
- difficulty breathing
- dizziness
- ear congestion
- fever
- frequent urge to urinate
- headache
- itching, pain, redness, swelling, tenderness, warmth on the skin
- 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
- swollen glands
- trouble breathing
- unusual tiredness or weakness
- weight loss
- yellow eyes and skin
Incidence not known
- Bloating or swelling of the face, arms, hands, lower legs, or feet
- confusion
- dark urine
- decreased urination
- double vision
- dry mouth
- fainting
- hives or welts, rash
- inability to move the arms, legs, or facial muscles
- increase in heart rate
- labored breathing
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
- light-colored stools
- lightheadedness
- nausea
- no blood pressure or pulse
- pain or discomfort in the arms, jaw, back, or neck
- pain, redness, swelling, or tenderness in the arms or legs
- pale skin
- pink growth
- persistent non-healing sore
- rapid breathing
- rapid weight gain
- reddish patch or irritated area of the skin
- shiny bump
- slow speech
- stopping of heart
- sunken eyes
- sweating
- thirst
- tingling of the hands or feet
- unconsciousness
- unusual bleeding or bruising
- unusual weight gain
- upper right abdominal or stomach pain
- vomiting
- white, yellow or waxy scar-like area
- wrinkled 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
Incidence not known
- Belching
- burning feeling in the chest or stomach
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- difficulty with moving
- heartburn
- indigestion
- muscle pain or stiffness
- pain in the joints
- 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.
CON-XXXXXXXX
