How does this medication work? What will it do for me?

Tofacitinib belongs to the class of medications called immunomodulators. 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.

Rheumatoid arthritis (RA) is caused by the body's immune system attacking the tissues found in joints and internal organs. This medication works by reducing the actions of chemicals in the body that start the immune response. This in turn reduces the immune response and inflammation that occurs with RA.

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

Your doctor may have suggested this medication 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 this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

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

What form(s) does this medication come in?

Each white-to-off-white, round, immediate-release, film-coated tablet contains 5 mg of 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).

How should I use this medication?

The recommended dose of 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 this medication 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 this medication 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.

Who should NOT take this medication?

Do not take this medication if you are allergic to tofacitinib or any ingredients of the medication.

What side effects are possible with this medication?

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 this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. 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.

  • diarrhea
  • headache
  • heartburn
  • loss of appetite
  • nausea
  • runny or stuffy nose
  • 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:

  • change in appearance or development of skin lesions
  • flu-like symptoms (sudden lack of energy, fever, cough, sore throat)
  • increased blood pressure
  • 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)
  • 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 bleeding in the stomach (e.g., bloody, black, or tarry stools; spitting up of blood; vomiting blood or material that looks like coffee grounds)

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 this medication.

Are there any other precautions or warnings for this medication?

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 this medication.

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

Gastrointestinal perforation: People who take anti-inflammatory medications such as NSAIDs or corticosteroids while they are also taking 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: This medication reduces your body's response to infection. People taking 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 this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, 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: This medication 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 this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

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

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

Lung inflammation: Lung inflammation (interstitial lung disease), causing difficulty breathing has occurred rarely in some people taking this medication. 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 tofacitinib, contact your doctor immediately.

Vaccinations: People taking this medication should not receive certain vaccines. Talk to your doctor about whether any vaccines you are scheduled to take may be used with this medication.

Pregnancy: This medication should not be used during pregnancy. If you become pregnant while taking this medication, contact your doctor immediately.

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

Children: The safety and effectiveness of using this medication have not been established for children.

Seniors: People over the age of 65 have a higher risk of developing a serious infection when taking tofacitinib. Talk to your doctor to determine if the benefits outweigh the risks for your condition.

What other drugs could interact with this medication?

There may be an interaction between tofacitinib and any of the following:

  • abatacept
  • abiraterone
  • amiodarone
  • anakinra
  • aprepitant
  • anti-tumour necrosis factor agents (e.g., adalimumab, etanercept, infliximab, thalidomide)
  • azathioprine
  • "azole" antifungals (e.g., itraconazole, ketoconazole, voriconazole)
  • beta-blockers (e.g., carvedilol, labetalol, metoprolol, propranolol)
  • boceprevir
  • bosentan
  • carbamazepine
  • clonidine
  • clozapine
  • conivaptan
  • corticosteroids (e.g., budesonide, dexamethasone, hydrocortisone, fluticasone, prednisone)
  • cyclosporine
  • deferasirox
  • denosumab
  • digoxin
  • diltiazem
  • dipyrone
  • donepezil
  • echinacea
  • everolimus
  • fingolimod
  • galantamine
  • grapefruit juice
  • guanfacine
  • HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., delavirdine, efavirenz, etravirine, nevirapine)
  • HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
  • hydroxyurea
  • imatinib
  • leflunomide
  • macrolide antibiotics (e.g., clarithromycin, erythromycin)
  • medications to treat cancer (e.g., carboplatin, cyclophosphamide, doxorubicin, ifosfamide, vincristine)
  • methotrexate
  • methyldopa
  • mifepristone
  • mycophenolate
  • nefazodone
  • norfloxacin
  • octreotide
  • phenobarbital
  • phenytoin
  • primidone
  • rifabutin
  • rifampin
  • rituximab
  • rivastigmine
  • roflumilast
  • romidepsin
  • St. John's Wort
  • simeprevir
  • sirolimus
  • stiripentol
  • tacrolimus
  • telaprevir
  • tretinoin
  • vaccines
  • verapamil

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 this medication. 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.

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