Xeljanz
Xeljanz (tofacitinib) is an oral medication that can treat different inflammatory problems. It can help adults with psoriatic arthritis, rheumatoid arthritis (RA), and ulcerative colitis, among other conditions. It's also helpful for children with a certain kind of arthritis. Xeljanz (tofacitinib) is a JAK inhibitor that lowers inflammation in the body. It comes as a tablet or liquid that's taken twice a day. There's also a longer-lasting once-daily tablet for adults. Xeljanz (tofacitinib) is a good option for people who've tried other medications first. But it can have side effects like headache, diarrhea, and a higher risk of infection. This medication is brand name only; there isn't a generic yet.
What is Xeljanz (tofacitinib)?
What is Xeljanz (tofacitinib) used for?
- Moderate-to-severe rheumatoid arthritis (RA) in adults
- Psoriatic arthritis (PsA) in adults
- Ankylosing spondylitis (AS) in adults
- Moderate-to-severe ulcerative colitis (UC) in adults
- Moderate-to-severe polyarticular course juvenile idiopathic arthritis (pcJIA) in children 2 years and older - immediate-release tablets and liquid only
How Xeljanz (tofacitinib) works
Xeljanz (tofacitinib) is a Janus kinase (JAK) inhibitor. It blocks proteins in the body called JAK. When JAK proteins get blocked, it stops immune cells from talking to each other. Xeljanz (tofacitinib) helps calm an overactive immune system that causes certain autoimmune conditions. This helps lower inflammation in your body.
Drug facts
Side effects of Xeljanz (tofacitinib)
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
Arthritis:
- Upper respiratory tract infection (4%)
- Nose and throat infection (3-4%)
- Diarrhea (3-4%)
- Headache (3-4%)
Ulcerative colitis:
- Nose and throat infection (10-14%)
- High cholesterol (5-9%)
- Headache (3-9%)
- Upper respiratory tract infection (6-7%)
- Lab results suggesting muscle damage (3-7%)
- Rash (3-6%)
- Diarrhea (2-5%)
- Stomach infection (3-4%)
- Anemia (2-4%)
Less Common Side Effects
- Fever
- Nausea
- High blood pressure
- Other infection
Note: The side effects you have might differ based on your dose and the reason why you're taking Xeljanz or Xeljanz XR (tofacitinib).
Xeljanz (tofacitinib) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Serious infection: fever, weakness, chills, night sweats, trouble breathing, cough, diarrhea, stomach pain, burning when you urinate, urinating more or less often
- Stroke: sudden weakness on one side of your body, severe headache, trouble speaking or walking, confusion
- Heart attack: chest pain; short of breath; pain in the jaw, neck, or back; feeling weak or lightheaded
- Blood clot in the lung (pulmonary embolism): cough, chest pain, trouble breathing, racing heart
- Blood clot in the leg (deep vein thrombosis): leg cramp, swelling or pain in the leg, muscle tightness
- Stomach tear: stomach pain, bloating, change in bowel movements, bleeding
- Liver damage: nausea, stomach pain, yellowing of the skin or whites of the eyes
- Severe allergic reaction: rash, trouble breathing, swelling of the face or throat
- Cancer
More on Xeljanz (tofacitinib) side effects
The following Xeljanz (tofacitinib) side effects have also been reported
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
difficult, burning, or painful urination
difficulty breathing
dizziness
ear congestion
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
stuffy or runny nose
swollen glands
trouble breathing
unusual tiredness or weakness
yellow eyes and skin
Incidence not known
Bloating or swelling of the face, arms, hands, lower legs, or feet
confusion
dark urine
decreased urination
fainting
hives or welts, rash
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
pain, redness, swelling, or tenderness in the arms or legs
pale skin
persistent non-healing sore
rapid breathing
rapid weight gain
reddish patch or irritated area of the skin
sunken eyes
thirst
tingling of the hands or feet
unusual bleeding or bruising
unusual weight gain
upper right abdominal or stomach pain
vomiting
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
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
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.
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Pros and cons of Xeljanz (tofacitinib)
Pros
- Liquid form available for the immediate-release version if you have trouble swallowing pills whole
- Extended-release, once-daily tablets available for adults
- Good option for people when other treatments haven't worked well
Cons
- Has potentially serious risks (e.g., serious infections, blood clots)
- Can raise cholesterol levels
- Not clear if it's safe to take during pregnancy
- Breastfeeding not recommended during treatment
Pharmacist tips for Xeljanz (tofacitinib)
- Take Xeljanz or Xeljanz XR (tofacitinib) with or without food.
- Get blood tests done on time while taking Xeljanz (tofacitinib) when your prescriber tells you to. This helps them check that the medication is safe for you. There are some serious side effects that you might not feel but can be found from your blood tests. They include high cholesterol, low blood cell counts, and liver problems.
- Xeljanz (tofacitinib) can raise your risk of getting sick more easily. This can sometimes be serious and dangerous. Call your care team right away if you have signs that you might be sick. Look out for signs like a fever, cough, trouble breathing, weakness, sweating, or chills. You might have to stop taking the medication so your body can fight the infection.
- Before getting any vaccines, tell the healthcare professional that you're taking Xeljanz (tofacitinib). Most vaccines, like the usual flu shot or COVID-19 vaccine, are fine to get. But you should avoid getting live vaccines. These include Varivax (chickenpox vaccine) and MMR (measles, mumps, and rubella vaccine).
- Tell your care team about all the medications you take or plan to take. Xeljanz (tofacitinib) can have harmful drug interactions with other medications. Examples include fluconazole (Diflucan) and other medications that weaken your immune system. Your care team can make sure all your medications are safe to take.
Tips for Xeljanz XR (tofacitinib extended-release):
- Swallow Xeljanz XR whole. Don't crush, split, or chew these extended-release tablets. This can damage the tablet, which can affect how well the medication works or raise your risk of side effects.
- Don't be alarmed if you notice parts of the Xeljanz XR tablet in your stool. This is the leftover tablet shell after the medication has gotten absorbed in your body.
Tips for the Xeljanz (tofacitinib) liquid:
- The carton with the Xeljanz (tofacitinib) liquid also comes with an oral dosing syringe and a press-in bottle adapter. When you use a new bottle for the first time, press the adapter into the opening of the bottle and leave it in.
- Once you open a new bottle of the Xeljanz (tofacitinib) liquid, it's good for 60 days. Write the date 60 days from opening on the bottle. This will help you remember when the medication expires and when you need to throw it away, even if there's still some left.
- Be sure you know how to measure your dose properly. Always use the dosing syringe that came in the carton. Don't use household spoons because they aren't accurate. Ask your pharmacist if you have questions about how to measure out the dose.
- How to measure the liquid with the oral syringe: Push the plunger all the way down to get rid of any air in the syringe. Then, put the syringe tip into the adapter and turn the bottle upside down. Pull the plunger to draw the liquid up to the marking on the syringe for the prescribed dose. Double check you have the correct dose.
- How to take the liquid with the oral syringe: Once you've drawn up the prescribed dose into the syringe, place the tip of the syringe against the inside of the cheek. Slowly push the plunger all the way down. Make sure there's enough time to swallow the liquid as it goes into the mouth. Rinse the plunger and barrel of the syringe with water and air dry after each use.
- Store the Xeljanz (tofacitinib) liquid at room temperature (up to 77ºF). Keep it in the original bottle and carton to protect it from light.
Common questions about Xeljanz (tofacitinib)
No, Xeljanz (tofacitinib) isn't a biologic. Biologics are medications that are made from living sources, like cells. But Xeljanz (tofacitinib) is a medication that's made from chemicals.
You can think of Xeljanz (tofacitinib) as an immunosuppressant, or a medication that can weaken your immune system. Xeljanz (tofacitinib) helps lower inflammation from autoimmune conditions by blocking how your immune cells talk to each other. It can also lower your white blood cell count, which helps your body fight infections. Because of this, Xeljanz (tofacitinib) can put you at risk of getting sick more easily.
Xeljanz (tofacitinib) doesn't appear to cause weight gain. Talk to your primary care provider if you notice any weight changes while taking this medication.
In studies, hair loss wasn't a side effect that people who took Xeljanz (tofacitinib) had. Speak to your primary care provider if you notice hair loss while taking this medication. They can help you figure out if there's something causing your hair loss.
Yes, it's usually okay to take ibuprofen (Advil) or acetaminophen (Tylenol) for pain with Xeljanz (tofacitinib). But remember, these pain relievers also have their own risks. For example, ibuprofen (Advil) has a risk of heart problems, kidney problems, and stomach damage. And acetaminophen (Tylenol) can be hard on your liver. Before taking any pain relievers with Xeljanz (tofacitinib), ask a healthcare professional to check it's safe for you.
It depends on the antibiotic. Some antibiotics, like clarithromycin, can make the levels of Xeljanz (tofacitinib) in your body go up. This can raise your risk of side effects. Another antibiotic called rifampin does the opposite. It makes the amount of Xeljanz (tofacitinib) in your body go down. This means that Xeljanz (tofacitinib) might not work as well. There are lots of medications that interact with Xeljanz (tofacitinib). So it's important to tell your healthcare team that you're taking Xeljanz (tofacitinib) before you start any new medications.
Xeljanz (tofacitinib) can raise the risk of getting a blood clot. This can include a clot in the arm or leg or in the lungs. A blood clot can also lead to a heart attack if it travels to the heart or a stroke if it reaches the brain. Because of this, people who are at risk of blood clots should avoid taking Xeljanz (tofacitinib). Tell your prescriber about your full medical history and talk to them about your risk for clots.
No. Rinvoq (upadacitinib) and Xeljanz (tofacitinib) are not the same medication. They're both JAK inhibitors that can treat some of the same autoimmune conditions. This includes psoriatic arthritis, ulcerative colitis, and juvenile arthritis. But Rinvoq can also help with eczema, Crohn's disease, and non-radiographic axial spondyloarthritis. Also, they have some different side effects. Talk to your prescriber to compare the medications to see which is right for you.
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Risks and warnings for Xeljanz (tofacitinib)
Xeljanz (tofacitinib) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Risk of serious infections
- Risk factors: Current infection | Past infections that keep coming back | Other health conditions that raise your risk of infection | Living in or traveling to places with high rates of TB infections | Lung problems | Taking medications that weaken your immune system
Xeljanz (tofacitinib) can make it harder for your body to fight off germs. This can raise your risk of getting serious bacterial, viral, or fungal infections. Some examples include pneumonia, shingles, and urinary tract infection. Xeljanz (tofacitinib) can also make old tuberculosis (TB), shingles, or hepatitis infections come back.
Before you start Xeljanz (tofacitinib), tell your prescriber about all your past medical problems and all the medications you take. This helps them check if you're at risk of getting infected easily during treatment. You'll also get tested for TB and hepatitis. You shouldn't take Xeljanz (tofacitinib) if you already have a serious infection.
It's important to know the signs of an infection. And let your care team know right away if you feel sick. Signs of an infection can include a fever, chills, body aches, cough, night sweats, or pain when urinating.
Possible higher risk of death for some older people with rheumatoid arthritis
- Risk factors: Age 50 years and older | High blood pressure | High cholesterol | High blood sugar | Other risk factor for heart disease
In a study, there was a higher risk of death in people 50 years and older with RA and at least one risk factor for heart disease who took Xeljanz (tofacitinib). This was compared to those who took a different RA medication called a TNF blocker. Talk to your prescriber about the risks and benefits of taking Xeljanz (tofacitinib).
Possible risk of cancer
- Risk factors: History of cancer | People who smoke
Some people who took Xeljanz (tofacitinib) got cancer while taking this medication. These cancers included lymphoma, lung cancer, and skin cancer, among others. Your prescriber will check if you're at risk of cancer as you take the medication. If you're worried about this risk with Xeljanz (tofacitinib), talk to your prescriber.
To help lower your risk of getting skin cancer, be sure to wear clothes that cover your skin and use sunscreen when you go outside. Also, get your skin checked by a dermatologist every so often and tell them if you see any strange changes to your skin. Ask your prescriber about recommendations to screen for other cancers.
Risk of blood clots, heart attack, or stroke
- Risk factors: People who smoke or have smoked in the past
Xeljanz (tofacitinib) can raise your risk of having a serious and sometimes life-threatening blood clot. Blood clots can happen anywhere in the body. This includes in the leg (also called a deep vein thrombosis or DVT). They can also happen in the lung (also called a pulmonary embolism or PE).
Sometimes, blood clots can cause other very serious problems, like a heart attack or stroke. In studies, heart attack or stroke happened more often in people 50 years and up with RA and at least one risk factor for heart disease who took Xeljanz (tofacitinib). This was compared to those who took TNF blocker, a different kind of RA medication.
It's important to tell your prescriber everything about your health and the medications you take. They can check your risk for clots. Be sure you can recognize signs of a blood clot.
- DVT: cramp or any swelling or pain in one leg
- PE: cough, chest pain, trouble breathing, and a racing heart
- Heart attack: chest pain; shortness of breath; sweating; and pain in the jaw, neck, or back
- Stroke: sudden weakness in one side of the body, severe headache, trouble speaking or walking, and confusion
Call 911 right away if you think you have a blood clot, heart attack, or stroke.
Stomach problems
- Risk factors: Taking nonsteroidal anti-inflammatory drugs (NSAIDs) | History of stomach problems (e.g., diverticulitis, narrow intestines)
During studies, some people taking Xeljanz (tofacitinib) have gotten a tear in their stomach or intestines. We don't know if the medication caused this.
Tell your prescriber about all the medications you take and the health problems you have. Taking NSAIDs or having diverticulitis before might raise your risk of this gut damage.
Also be careful taking Xeljanz XR if you have stomach problems that make your gut narrower. Although rare, other similar extended-release medications have caused blockages in the intestines. Talk to your prescriber if you're worried about this.
Get medical help right away if you notice stomach pain or blood in your stool. These could be signs of problems in the digestive tract.
Allergic reactions
It's possible to have an allergic reaction to Xeljanz (tofacitinib). Sometimes, these reactions can be serious. It could make your face, mouth, tongue, or throat swell up and cause a rash. An allergic reaction can also make you have trouble breathing. Stop taking Xeljanz (tofacitinib) and get medical help right away if this happens.
Low blood cell counts
Xeljanz (tofacitinib) can lower your red blood cell count and put you at risk of anemia. The medication can also lower your white blood cell count, which can make you more likely to get sick easily.
Before you start Xeljanz (tofacitinib), Your prescriber will check your blood counts to make sure it's safe for you. Then, they'll check every few months during treatment. If your blood counts get low, your prescriber will have you stop taking it until your numbers go back up. If it gets too low, you might need to stop the medication altogether.
Tell your care team if you have symptoms of anemia like tiredness, pale skin, and fast heart rate. Also let them know if you feel sick with a fever, chills, body aches, or cough.
Liver damage
Xeljanz (tofacitinib) can raise the level of liver enzymes in your blood. This can be a sign of liver damage. While you're taking Xeljanz (tofacitinib), you'll need blood tests done from time to time to check that your liver is okay.
If the tests show liver damage or if you have signs of liver problems, your prescriber will stop treatment for a bit to figure out what's happening. Let your care team know if you have nausea, stomach pain, or yellow skin or eyes. These could be signs of liver problems.
Xeljanz (tofacitinib) dosage
Typical dosage for Xeljanz (tofacitinib)
Your dose depends on what you're taking Xeljanz (tofacitinib) for.
-
Xeljanz (tofacitinib) immediate-release tablets or liquid
- Rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis: The typical dose is 5 mg by mouth twice daily.
- Ulcerative colitis: The typical starting dose is 10 mg by mouth twice daily for 2 months. Then, the typical maintenance dose is 5 mg by mouth twice daily.
- Polyarticular course juvenile idiopathic arthritis: The dose is based on your child's body weight.
- Weigh 22 lbs to less than 44 lbs (10 kg to less than 20 kg): The typical dose is 3.2 mg by mouth twice daily.
- Weigh 44 lbs to less than 88 lbs (20 kg to less than 40 kg): The typical dose is 4 mg by mouth twice daily.
- Weigh 88 lbs (40 kg) or more: The typical dose is 5 mg by mouth twice daily.
-
Xeljanz XR (tofacitinib) extended-release tablets
- Rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis: The typical dose is 11 mg by mouth once daily.
- Ulcerative colitis: The typical starting dose is 22 mg by mouth once daily for at least 2 months. Then, the typical maintenance dose is 11 mg by mouth once daily.
The dose might be lower if you have kidney or liver problems or if you take certain interacting medications.
Your prescriber will adjust the dose based on how well Xeljanz (tofacitinib) is working for you and if you have side effects.
More on Xeljanz (tofacitinib) dosage
Interactions between Xeljanz (tofacitinib) and other drugs
More on Xeljanz (tofacitinib) 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
- Abciximab
- Adalimumab
- Adenovirus Vaccine
- Alefacept
- Alemtuzumab
- Anakinra
- Antithymocyte Globulin Equine
- Antithymocyte Globulin Rabbit
- Apremilast
- Azathioprine
- Bacillus of Calmette and Guerin Vaccine, Live
- Baricitinib
- Basiliximab
- Belatacept
- Belimumab
- Bevacizumab
- Brentuximab Vedotin
- Brodalumab
- Canakinumab
- Carbamazepine
- Catumaxomab
- Certolizumab Pegol
- Cetuximab
- Cholera Vaccine, Live
- Cyclosporine
- Daclizumab
- Dengue Tetravalent Vaccine, Live
- Denosumab
- Eculizumab
- Efalizumab
- Elotuzumab
- Enzalutamide
- Etanercept
- Everolimus
- Evolocumab
- Fingolimod
- Fosphenytoin
- Gemtuzumab Ozogamicin
- Glatiramer
- Golimumab
- Guselkumab
- Ibritumomab Tiuxetan
- Infliximab
- Influenza Virus Vaccine, Live
- Ipilimumab
- Ixekizumab
- Lumacaftor
- Measles Virus Vaccine, Live
- Mitotane
- Mumps Virus Vaccine, Live
- Muromonab-CD3
- Mycophenolate Mofetil
- Mycophenolate Sodium
- Mycophenolic Acid
- Natalizumab
- Nivolumab
- Ofatumumab
- Omalizumab
- Panitumumab
- Pembrolizumab
- Pertuzumab
- Phenytoin
- Pimecrolimus
- Poliovirus Vaccine, Live
- Ramucirumab
- Ranibizumab
- Rifampin
- Rilonacept
- Rituximab
- Rotavirus Vaccine, Live
- Rubella Virus Vaccine, Live
- Secukinumab
- Siltuximab
- Sirolimus
- Smallpox Vaccine
- St John's Wort
- Tacrolimus
- Temsirolimus
- Tocilizumab
- Trastuzumab
- Typhoid Vaccine, Live
- Ustekinumab
- Varicella Virus Vaccine, Live
- Vedolizumab
- 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.
How much does Xeljanz (tofacitinib) cost?
$2,192.58
What are alternatives to Xeljanz (tofacitinib)?
Moderate-to-severe inflammatory conditions in which other treatments haven't worked:
News about Xeljanz (tofacitinib)
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