Xeljanz - Consumer Medicine Information
|Ingredients:||tofacitinib citrate, croscarmellose sodium, HPMC 2910/Hypromellose 6cP, lactose monohydrate, macrogol/PEG3350, magnesium stearate, microcrystalline cellulose, titanium dioxide, triacet|
About This Medication
What the Medication is Used For
XELJANZ (tofacitinib) in combination with methotrexate (MTX), is indicated for reducing the signs and symptoms of rheumatoid arthritis (RA), in adult patients with moderately to severely active RA who have had an inadequate response to MTX.
What It Does
XELJANZ is believed to interfere with the activity of an enzyme called Janus kinase (JAK), which activates other cellular components which normally start the immune response in your body. By reducing the immune response XELJANZ reduces the signs and symptoms of rheumatoid arthritis.
When It Should not be Used
If you are allergic to tofacitinib or any other non-medicinal ingredients in XELJANZ, you should not take XELJANZ (See What the nonmedicinal ingredients are).
What the Medicinal Ingredient Is
The active ingredient of XELJANZ is called tofacitinib citrate
What the Nonmedicinal Ingredients Are
Croscarmellose sodium, HPMC 2910/Hypromellose 6cP, lactose monohydrate, macrogol/PEG3350, magnesium stearate, microcrystalline cellulose, titanium dioxide, triacetin
What Dosage Forms It Comes In
XELJANZ is supplied as 5 mg tablets and is available in bottles or foil blisters.
Warnings and Precautions
Serious Warning and Precautions
- XELJANZ is a medicine that affects your immune system and can lower the ability of your immune system to fight infections such as tuberculosis, and infections caused by bacteria, fungi, or viruses that can spread throughout the body. These infections may lead to hospitalization or death. Most patients who developed these infections were taking other immunosuppressants at the same time such as methotrexate or corticosteroids.
You should not be using XELJANZ if you have any kind of infection.
- If a serious infection develops, stop XELJANZ and contact your doctor.
- Your doctor will closely monitor you for the signs and symptoms of infection during and after the treatment with XELJANZ.
- Lymphoma and other serious conditions have been reported in patients treated with XELJANZ
Before taking XELJANZ, tell your healthcare provider if you:
- think you have an infection or have symptoms of an infection such as:
- fever, sweating, or chills
- muscle aches
- shortness of breath
- blood in spit
- weight loss
- warm, red, or painful skin or sores on your body
- diarrhea or stomach pain
- burning when you urinate or urinating more often than normal
- feeling very tired
- are being treated for an infection, get a lot of infections or have infections that keep coming back
- have diabetes, HIV/AIDS, or a weak immune system. People with these conditions have a higher chance for infections.
- have tuberculosis, or a history of tuberculosis or have been in close contact with someone with tuberculosis
- have or have had hepatitis B or C
- have gastrointestinal perforations (tear in the stomach or intestines).
- have diverticulitis (inflammation in parts of the large intestine)
- have ulcers in your stomach or intestines
- have low blood counts : treatment with XELJANZ can be associated with low red blood cell counts (anemia), with low white blood cell counts (neutrophils or lymphocytes). Your health care provider will monitor your blood counts frequently after you start XELJANZ, and may adjust your dose of XELJANZ or withhold the drug temporarily in the event your blood counts drops too low, or administer additional supportive medicines to help your body regain normal blood level cells .
- have high cholesterol. Your health care provider should monitor your liver tests routinely and blood cholesterol level 4-8 weeks after your start receiving XELJANZ.
- are pregnant or planning to become pregnant
- are breastfeeding or planning to breastfeed. Women should not breastfeed while being treated with XELJANZ.
- have or had any type of cancer
- have liver or kidney problems
- have a history of interstitial lung disease
- have muscle pain or muscle weakness
- develop new skin lesions during or after therapy or if existing lesions change appearance.
- if you are planning to get vaccinated, tell your doctor. Certain types of vaccines should not be given when taking XELJANZ. Before you start XELJANZ, you should be up to date with all recommended vaccinations
- have chest pain or any heart problems.
Interactions With This Medication
It is important that your healthcare provider be aware of all medications you are taking prior to starting XELJANZ including the Disease Modifying Anti-Rheumatic Drugs (DMARDs) such as CimziaTM. Enbrel,Humira, Kineret, Orencia, Remicade, Rituxan and SimponiTM.
- Tell your doctor if you are taking immunosuppressants ( e.g. tacrolimus, sirolimus, cyclosporine), antiarrythmics, beta-blockers, calcium channel blockers, cholinesterase inhibitors, HIV protease inhibitors, rifampin, ketoconazole, fluconazole.
- Avoid grapefruit juice
- St. John’s Wort (Hypericum perforatum) may reduce the response to XELJANZ.
Proper Use of This Medication
Usual Adult Dose
The recommended dose is 5 mg taken by mouth twice daily. Patients taking XELJANZ are usually also prescribed methotrexate.
XELJANZ can be taken with or without food.
Your doctor may reduce the dose if you have liver or kidney problems. You should not increase the dose.
XELJANZ treatment should not be used if you have or develop a serious infection until the infection is controlled.
|In case of a drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.|
If you have missed your dose of XELJANZ, take the next dose as planned at the next scheduled time. Do not take a double dose to make up for a forgotten dose
Side Effects and What to Do About Them
Like all medicines, XELJANZ can have side effects. The following information describes the most important side effects which you should know of. If you experience any symptom that bothers you or does not go away, contact your healthcare provider or get medical attention as soon as possible.
The most common side effects of XELJANZ include:
- Upper respiratory tract infection
- Nasopharyngitis (runny or stuffy nose)
- Urinary tract infections
- High blood pressure
- Nausea(upset stomach)
The uncommon side effects of XELJANZ include:
- Bronchitis, cough
- Shingles/ Herpes Zoster (painful skin rash with blisters)
- Anemia (low count of red blood cells)
- Gastritis, abdominal pain, loss of appetite
- Back pain
- Swelling of legs and ankles or the arms and hands (Peripheral edema)
- Influenza (Flu)
- Congestive heart failure. Your heart isn’t able to pump enough blood to meet your body needs.
Serious Side Effects, how Often They Happen and What to Do About Them
|Symptom / effect||Talk with your|
|Common||Urinary tract infections||✓|
|High blood pressure||✓|
|Uncommon||Shingles/ Herpes Zoster (painful skin rash with blisters)||✓|
|Skin lesions during or after therapy or if existing lesions change appearance.||✓|
|Anemia (low red blood cells count)||✓|
|Swelling of legs and ankles or the arms and hands (Peripheral edema)||✓|
|Congestive heart failure||✓|
This is not a complete list of side effects. For any unexpected effects while taking XELJANZ, contact your doctor or pharmacist.
How to Store It
Store between 15°C and 30°C.
Keep out of reach of children
Reporting Suspected Side Effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to: Canada Vigilance Program
Postal Locator 0701E
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect Canada Web site at
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
This document plus the full product monograph, prepared for health professionals can be found at:
or by contacting the sponsor, Pfizer Canada Inc., at: