Xeljanz XR (Tofacitinib) belongs to the class of medications called immunomodulators or selective immunosuppressants. It is usually used in combination with Methotrexate to decrease the inflammation and joint damage that is experienced with Rheumatoid Arthritis when methotrexate alone has not been effective enough. Xeljanz XR (Tofacitinib) is used to treat active Psoriatic Arthritis in combination with methotrexate or other therapies when other treatments have not been effective. It is also used to treat moderate-to- severe active Ulcerative Colitis (UC) when other treatments for UC have failed or the effectiveness has decreased.

Xeljanz XR (Tofacitinib) works by blocking the activity of an enzyme called Janus kinase. This enzyme is responsible for sending inflammatory signals in the body. Blocking this enzyme helps to decrease the immune reaction which causes rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis.

Xeljanz XR (Tofacitinib) may be available under multiple brand names and/or in several different forms. Any specific brand name of Xeljanz XR (Tofacitinib) may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of Xeljanz XR (Tofacitinib) may not be used for all of the conditions discussed here.

Your doctor may have suggested Xeljanz XR (Tofacitinib) for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking Xeljanz XR (Tofacitinib), speak to your doctor. Do not stop taking Xeljanz XR (Tofacitinib) without consulting your doctor.

Do not give Xeljanz XR (Tofacitinib) to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take Xeljanz XR (Tofacitinib) if their doctor has not prescribed it.

[for Xeljanz XR]

The recommended dose of Xeljanz XR (Tofacitinib) is 5 mg taken 2 times daily in combination with methotrexate.

It may be taken with or without food.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important that Xeljanz XR (Tofacitinib) be taken exactly as prescribed by your doctor.

If you miss a dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store Xeljanz XR (Tofacitinib) at room temperature, protect it from light and moisture, and keep it out of the reach of children.

[for Xeljanz XR]

The recommended dose of the long acting formulation of Xeljanz XR (Tofacitinib) is 11 mg taken once daily in combination with methotrexate.

It may be taken with or without food.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important that Xeljanz XR (Tofacitinib) be taken exactly as prescribed by your doctor.

If you miss a dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store Xeljanz XR (Tofacitinib) at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes Xeljanz XR (Tofacitinib). If you are concerned about side effects, discuss the risks and benefits of Xeljanz XR (Tofacitinib) with your doctor.

The following side effects have been reported by at least 1% of people taking Xeljanz XR (Tofacitinib). Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• back pain
• cough
• Diarrhea
• headache
• heartburn
• joint pain
• loss of appetite
• nausea
• runny or stuffy nose
• skin rash
• vomiting

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• abdominal pain
• dizziness
• flu-like symptoms (sudden lack of energy, Fever, cough, sore throat)
• increased blood pressure
• muscle pain, weakness
• new skin lesions or changes to existing skin lesions
• shortness of breath (new or worsening)
• signs of Anemia (low red blood cells; e.g., dizziness, pale skin, unusual tiredness or weakness, shortness of breath)
• signs of heart problems (e.g., fast or irregular heartbeat or pulse, chest pain, sudden weight gain, difficulty breathing, leg swelling)
• signs of infection (symptoms may include fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness)
• signs of a skin infection (e.g., redness, inflammation, swelling, warmth)
• signs of kidney problems (e.g., decreased urination, nausea, vomiting, swelling of the feet and ankles)
• signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
• signs of pneumonia (e.g., fever, chills, shortness of breath, cough)
• swelling of legs and ankles or hands and arms
• symptoms of shingles/herpes zoster infection (e.g., painful skin rash with blisters)
• symptoms of a urinary tract infection (e.g., pain when urinating, urinating more often than usual, low back or flank pain)

Stop taking the medication and seek immediate medical attention if any of the following occur:

• signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
• signs of bleeding in the stomach (e.g., bloody, black, or tarry stools; spitting up of blood; vomiting blood or material that looks like coffee grounds)
• signs of a blood clot in the arm or leg (tenderness, pain, swelling, warmth, or redness in the arm or leg) or lungs (difficulty breathing, sharp chest pain that is worst when breathing in, coughing, coughing up blood, sweating, or passing out)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking Xeljanz XR (Tofacitinib).

Xeljanz 5 mg
Each white-to-off-white, round, immediate-release, film-coated tablet contains 5 mg of Xeljanz XR (Tofacitinib). Nonmedicinal ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, and microcrystalline cellulose; film coating: HPMC 2910/Hypromellose 6 cP, lactose monohydrate, Macrogol/PEG 3350, titanium dioxide, and triacetin (glycerol triacetate).

Xeljanz XR 11 mg
Each pink, oval, extended-release, coated tablet contains 11 mg of Xeljanz XR (Tofacitinib). Nonmedicinal ingredients: sorbitol, hydroxyethyl cellulose, copovidone, and magnesium stearate; film coating: cellulose acetate, hydroxypropyl cellulose, HPMC 2910/hypromellose, titanium dioxide, triacetin, and red iron oxide; printing ink: shellac glaze, ammonium hydroxide, propylene glycol, and ferrosoferric oxide/black iron oxide.

Do not take Xeljanz XR (Tofacitinib) if you:

• are allergic to Xeljanz XR (Tofacitinib) or any ingredients of the medication
• are pregnant or breast-feeding
• have severely decreased liver function

There may be an interaction between Xeljanz XR (Tofacitinib) and any of the following:

• Abatacept
• Adalimumab
• Amiodarone
• Anakinra
• Apalutamide
• Aprepitant
• Azathioprine
• "azole" antifungals (e.g., itraconazole, ketoconazole, Voriconazole)
• BCG
• Baricitinib
• Belimumab
• beta-blockers (e.g., Carvedilol, Labetalol, Metoprolol, Propranolol)
• Bicalutamide
• Bosentan
• calcium channel blockers (e.g., Diltiazem, Verapamil)
• Carbamazepine
• certolizumab
• Clonidine
• Clozapine
• Cobicistat
• conivaptan
• corticosteroids (e.g., budesonide, Dexamethasone, Hydrocortisone, fluticasone, Prednisone)
• Cyclosporine
• Dabrafenib
• Deferasirox
• Denosumab
• Digoxin
• Donepezil
• Dronedarone
• echinacea
• Enzalutamide
• Etanercept
• Everolimus
• Fingolimod
• Galantamine
• Glatiramer
• Golimumab
• grapefruit juice
• Guanfacine
• Haloperidol
• Hepatitis C antivirals (e.g., ombitasvir, paritaprevir)
• HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., delavirdine, efavirenz, etravirine, nevirapine)
• HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
• Hydroxyurea
• Infliximab
• imatinib
• Lanreotide
• Leflunomide
• Lomitapide
• macrolide antibiotics (e.g., clarithromycin, erythromycin)
• medications to treat cancer (e.g., Carboplatin, Cyclophosphamide, Doxorubicin, Ifosfamide, Vincristine)
• Mesalamine
• methotrexate
• methyldopa
• mifepristone
• Modafinil
• mycophenolate
• Natalizumab
• Octreotide
• Ocrelizumab
• Pasireotide
• Phenobarbital
• Phenytoin
• Pimecrolimus
• primidone
• rifabutin
• rifampin
• Rituximab
• Rivastigmine
• Roflumilast
• Romidepsin
• St. John's wort
• Sarilumab
• Secukinumab
• Sertraline
• Sirolimus
• Stiripentol
• Tacrolimus
• Tetracycline
• Tizanidine
• Tocilizumab
• tretinoin
• vaccines

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Xeljanz XR (Tofacitinib). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Xeljanz XR (Tofacitinib).

Blood Clots: Xeljanz XR (Tofacitinib) may increase the chance of blood clot formation, causing reduction of blood flow to organs or the extremities. If you have a history of clotting you may be at increased risk of experiencing blood clot-related problems such as Heart Attack, Stroke, or clots in the deep veins of your leg. Discuss with your doctor how Xeljanz XR (Tofacitinib) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Xeljanz XR (Tofacitinib), and whether any special monitoring is needed.

If you experience symptoms such as sharp pain and swelling in the leg, difficulty breathing, chest pain, blurred vision or difficulty speaking, get immediate medical attention.

Cancer: Although not common, Xeljanz XR (Tofacitinib) has been associated with several different types of cancer including skin, lung, breast, prostate, and lymphoma. Discuss any concerns that you may have with your doctor.

Gastrointestinal narrowing: The long acting formulation of Xeljanz XR (Tofacitinib) should be used with caution by people who have narrowing of the stomach. Because the shell around the medication does not break down, people with narrowing in the digestive system are at increased risk of experiencing a blockage.

Gastrointestinal perforation: People who take anti-inflammatory medications such as NSAIDs or corticosteroids while they are also taking Xeljanz XR (Tofacitinib) may be more likely to experience a tear in the lining of the stomach, which can cause serious bleeding. This can occur without abdominal pain.

If you notice bloody or black and tarry stools, or vomit blood or material that looks like coffee grounds, seek medical help immediately.

Infection: Xeljanz XR (Tofacitinib) reduces your body's response to infection. People taking Xeljanz XR (Tofacitinib) are at an increased risk of developing serious infections that can be difficult to treat and may cause hospitalization or death. These infections include Tuberculosis and fungal infections as well as infections caused by bacteria and viruses. These infections are more likely to occur if you are taking another medication that reduces the activity of the immune system.

If you have been exposed to tuberculosis, have a history of serious or recurrent infections or have medical conditions that may increase the likelihood of developing infections, discuss with your doctor how Xeljanz XR (Tofacitinib) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Xeljanz XR (Tofacitinib), and whether any special monitoring is needed.

If possible, avoid contact with people with contagious infections. Tell your doctor immediately if you notice signs of an infection, such as fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness.

Heart rate: Xeljanz XR (Tofacitinib) may cause decreases in heart rate. If you have a history of decreased heart rate, irregular heart rhythms, or heart disease, discuss with your doctor how Xeljanz XR (Tofacitinib) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Xeljanz XR (Tofacitinib), and whether any special monitoring is needed.

Kidney function: If you have reduced kidney function or Kidney Disease, discuss with your doctor how Xeljanz XR (Tofacitinib) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Xeljanz XR (Tofacitinib), and whether any special monitoring is needed. A lower dose of Xeljanz XR (Tofacitinib) may be necessary.

Liver function: People taking Xeljanz XR (Tofacitinib) may have changes in liver function that produce abnormal liver test results. Your doctor will recommend regular liver tests while you are taking Xeljanz XR (Tofacitinib). If you have severe changes in liver function, your doctor may recommend that you take a lower dose of Xeljanz XR (Tofacitinib) or stop taking it altogether.

Lung inflammation: Lung inflammation (interstitial lung disease), causing difficulty breathing has occurred rarely for some people taking Xeljanz XR (Tofacitinib). This complication can be serious and sometimes fatal. If you experience new or worsening shortness of breath or cough (with or without fever) at any time while you are taking Xeljanz XR (Tofacitinib), contact your doctor immediately.

Vaccinations: People taking Xeljanz XR (Tofacitinib) should not receive certain vaccines. Talk to your doctor about whether any vaccines you are scheduled to have may be used with Xeljanz XR (Tofacitinib).

Pregnancy: Xeljanz XR (Tofacitinib) should not be used during pregnancy. If you become pregnant while taking Xeljanz XR (Tofacitinib), contact your doctor immediately.

Women who may become pregnant should use effective birth control during treatment with Xeljanz XR (Tofacitinib) and for 4 to 6 weeks after the last dose.

Breast-feeding: It is not known if Xeljanz XR (Tofacitinib) passes into breast milk. If you are a breast-feeding mother and are taking Xeljanz XR (Tofacitinib), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using Xeljanz XR (Tofacitinib) have not been established for children.

Seniors: People over the age of 65 have a higher risk of developing a serious infection when taking Xeljanz XR (Tofacitinib). Talk to your doctor to determine whether the benefits outweigh the risks for your condition.