Xeljanz Xr

[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.

In addition to its desired action, this medication may cause some adverse effects, notably: it may cause headaches; it may cause diarrhea; it could make you more prone to respiratory infections. Each person may react differently to a treatment. If you think this medication may be causing adverse effects (including those described here, or others), talk to your health care professional. He or she can help you to determine whether or not the medication is the source of the problem.

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).

HEALTH CANADA ADVISORY

April 6, 2021

Health Canada has issued information concerning the use of Xeljanz XR (Tofacitinib). To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.

Previous advisories on Xeljanz XR (Tofacitinib) were issued on December 2, 2019 and March 15, 2019.

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.

This medication is typically used only once a day. However, your pharmacist may have suggested a different schedule that is more appropriate for you. Important: Follow the instructions on the label. Do not use more of this product, or more often, than prescribed. This medication should be swallowed whole. It should not be split, crushed or chewed. It must be used regularly and continuously to maintain its beneficial effects. Be sure to keep an adequate supply on hand. If you forget a dose, simply skip it and then take the next dose at the regularly scheduled time. This medication may be taken with or without food. Avoid grapefruit and grapefruit juice during your treatment. Grapefruit can seriously affect how this medication works.