Xeljanz 11 mg prolonged-release tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

XELJANZ 11 mg prolonged-release tablets

tofacitinib

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

In addition to this leaflet, your doctor will also give you a patient information card containing important safety information you need to know before starting and during treatment with XELJANZ. Keep this patient information card with you.

Contents of the leaflet

1. What XELJANZ is and what it is used for
2. What you need to know before taking XELJANZ
3. How to take XELJANZ
4. Possible side effects
   1. How to store XELJANZ
   2. Contents of the pack and other information

1. What XELJANZ is and what it is used for

XELJANZ is a medicine that contains the active substance tofacitinib.

XELJANZ is used to treat the following inflammatory conditions:

• rheumatoid arthritis
• psoriatic arthritis
• ankylosing spondylitis

Rheumatoid arthritis

XELJANZ is used for the treatment of adult patients with moderate to severe active rheumatoid arthritis, a long-term disease that primarily causes joint pain and inflammation.

XELJANZ is used in combination with methotrexate when prior treatment for rheumatoid arthritis has not been effective or was not well tolerated. XELJANZ may also be taken as monotherapy in cases where treatment with methotrexate is not tolerated or is not recommended.

XELJANZ has been shown to reduce joint pain and swelling and to improve the ability to perform daily activities, whether used alone or in combination with methotrexate.

Psoriatic arthritis

XELJANZ is used to treat adult patients with a condition called psoriatic arthritis. This condition is an inflammatory joint disease, often accompanied by psoriasis. If you have active psoriatic arthritis, you will first be given another medicine to treat your condition. If you do not respond adequately or do not tolerate that medicine, XELJANZ may be prescribed to reduce the signs and symptoms of active psoriatic arthritis and to improve your ability to perform daily activities.

XELJANZ is used in combination with methotrexate to treat adult patients with active psoriatic arthritis.

Ankylosing spondylitis

XELJANZ is used to treat a condition called ankylosing spondylitis. This condition is an inflammatory disease of the spine.

If you have ankylosing spondylitis, you may first be given other medications. If you do not respond adequately to these treatments, XELJANZ may be prescribed. XELJANZ can help reduce back pain and improve physical function. These effects may make your normal daily activities easier and thereby improve your quality of life.

2. What you need to know before taking XELJANZ

Do not take XELJANZ

• if you are allergic to tofacitinib or to any of the other ingredients of this medicine (listed in section 6)
• if you have a serious infection such as blood infection or active tuberculosis
• if you have been told you have severe liver problems, such as cirrhosis (scarring of the liver)
• if you are pregnant or breastfeeding

Please contact your doctor if you have any doubts about any of the points above.

Warnings and precautions

Talk to your doctor or pharmacist before taking XELJANZ:

• if you think you have an infection or have symptoms of an infection such as fever, sweating, chills, muscle aches, cough, difficulty breathing, production of phlegm or changes in phlegm, weight loss, warm, red or painful skin, sores on the body, difficulty or pain when swallowing, diarrhoea or stomach pain, burning when urinating or urinating more frequently than usual, or feel very tired
• if you have any disease that increases your likelihood of infection (for example, diabetes, HIV/AIDS or a weakened immune system)
• if you have any type of infection, are receiving treatment for an infection, or have infections that keep coming back. Inform your doctor immediately if you do not feel well. XELJANZ may reduce your body's ability to respond to infections and may worsen an existing infection or increase the risk of getting a new infection
• if you have or have a history of tuberculosis or have been in close contact with someone who has tuberculosis. Your doctor will perform a tuberculosis test before starting treatment with XELJANZ and may repeat the test during treatment
• if you have any chronic lung disease
• if you have liver problems
• if you have or have had hepatitis B or hepatitis C (viruses that affect the liver). The virus may become active while you are taking XELJANZ. Your doctor may perform blood tests for hepatitis before starting and while you are taking XELJANZ
• if you are 65 years of age or older, if you have ever had any type of cancer, and also if you currently smoke or have smoked in the past. XELJANZ may increase the risk of certain types of cancer. Cases of leukaemia, lung cancer, and other cancers (such as breast, skin, prostate, and pancreatic cancer) have been reported in patients treated with XELJANZ. If you develop cancer while being treated with XELJANZ, your doctor will assess whether treatment with XELJANZ should be stopped
• if you have a known risk of fractures, for example, if you are 65 years or older, are female, or take corticosteroids (e.g., prednisone)
• cases of non-melanoma skin cancer have been observed in patients taking XELJANZ. Your doctor may recommend regular skin examinations while you are taking XELJANZ. If new skin lesions appear during or after treatment, or if existing lesions change in appearance, inform your doctor
• if you have had diverticulitis (a type of inflammation of the large intestine) or stomach or intestinal ulcers (see section 4)
• if you have kidney problems
• if you intend to be vaccinated, inform your doctor. Certain types of vaccines should not be given while taking XELJANZ. Before starting XELJANZ, you should be up to date with all recommended vaccinations. Your doctor will decide whether you need vaccination against herpes zoster
• if you have heart problems, high blood pressure, high cholesterol, and also if you currently smoke or have smoked in the past
• if you have narrowing of the digestive tract, inform your doctor, as rare cases of obstruction in the digestive tract have been reported in patients taking other medicines that use similar prolonged-release tablets
• when taking XELJANZ 11 mg prolonged-release tablets, you may notice something in your stools that looks like a tablet. This is the empty shell of the prolonged-release tablet after the body has absorbed the medicine. This is expected and should not be a cause for concern

Cases of blood clots in the lungs or veins have been reported in patients treated with XELJANZ. Your doctor will review your risk of developing blood clots in the lungs or veins and determine whether XELJANZ is suitable for you. If you have previously had problems with blood clots in the lungs or veins or have a higher risk of developing them [for example, if you are significantly overweight, have cancer, heart problems, diabetes, have had a heart attack (within the last 3 months), have recently undergone major surgery, use hormonal contraceptives/hormone replacement therapy, have a known clotting disorder in yourself or close family members], if you are of advanced age, or if you currently smoke or have smoked in the past, your doctor may decide that XELJANZ is not suitable for you.

Contact your doctor immediately:

• if you experience sudden shortness of breath or difficulty breathing, chest pain or upper back pain, swelling in the legs or arms, pain or tenderness to touch in the legs, or redness or colour change in the legs or arms while taking XELJANZ, as these may be signs of a blood clot in the lungs or veins.
• if you experience serious changes in vision (blurred vision, partial or complete loss of vision), as this may be a sign of blood clots in the eyes.
• if you, your partner, or your caregiver notice the sudden onset of severe headaches, which may be accompanied by nausea and vomiting, fainting, dizziness or lightheadedness, temporary vision problems, weakness on one side of the body, progressive deterioration in mental state, seizures, or loss of consciousness, as these may be signs of blood clots in the veins around the brain.
• if you have signs and symptoms of myocardial infarction, such as severe chest pain or tightness (which may spread to the arms, jaw, neck, back), difficulty breathing, cold sweat, dizziness or sudden lightheadedness. Cases of heart problems, including myocardial infarction, have been reported in patients treated with XELJANZ. Your doctor will evaluate your risk of developing heart problems and determine whether XELJANZ is suitable for you.
• if you, your partner, or your caregiver notice new or worsening neurological symptoms, including generalised muscle weakness, vision problems, changes in thinking, memory, and orientation leading to confusion and personality changes, contact your doctor immediately, as these could be symptoms of a very rare and serious brain infection called progressive multifocal leukoencephalopathy (PML).

Additional monitoring tests

Your doctor should perform blood tests before you start taking XELJANZ, after 4 to 8 weeks of treatment, and then every 3 months, to determine whether you have a low white blood cell count (neutrophils or lymphocytes) or a low red blood cell count (anaemia).

You should not take XELJANZ if your white blood cell count (neutrophils or lymphocytes) or your red blood cell count is too low. If necessary, your doctor may suspend your XELJANZ treatment to reduce the risk of infection (low white blood cell count) or anaemia (low red blood cell count).

Your doctor may also perform other tests, for example, to monitor cholesterol levels in the blood or to monitor your liver function. Your doctor should assess your cholesterol levels within 8 weeks after starting XELJANZ treatment. Your doctor should perform liver function tests periodically.

Elderly patients

A higher number of infections, some of which may be serious, have been observed in patients aged 65 years and older. Inform your doctor as soon as you notice any signs or symptoms of infection.

Patients aged 65 years and older may have an increased risk of infections, myocardial infarction, and certain types of cancer. Your doctor may decide that XELJANZ is not suitable for you.

Asian patients

A higher number of herpes zoster cases have been observed in Japanese and Korean patients. Inform your doctor if you notice painful blisters on the skin.

You may also have an increased risk of certain lung problems. Inform your doctor if you experience any difficulty breathing.

Children and adolescents

The use of XELJANZ is not recommended in children or adolescents under 18 years of age. The safety and benefits of XELJANZ in children have not yet been established.

Other medicines and XELJANZ

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Inform your doctor if you have diabetes or are taking medicines to treat diabetes. Your doctor may decide that you need less anti-diabetic medication while taking tofacitinib.

Some medicines should not be taken with XELJANZ. If taken with XELJANZ, they may alter the level of XELJANZ in your body, and the dose of XELJANZ may need adjustment. Inform your doctor if you are using medicines containing any of the following active substances:

• antibiotics such as rifampicin, used to treat bacterial infections
• fluconazole, ketoconazole, used to treat fungal infections

The use of XELJANZ with medicines that suppress the immune system, including so-called targeted biologic therapies (antibodies), such as those that inhibit tumour necrosis factor, interleukin-17, interleukin-12/interleukin-23, integrin antagonists, and strong chemical immunosuppressants, including azathioprine, mercaptopurine, cyclosporine, and tacrolimus, is not recommended. Using XELJANZ with these medicines may increase the risk of adverse effects, including infection.

Serious infections and fractures may occur more frequently in people who are also taking corticosteroids (e.g., prednisone).

Pregnancy and breastfeeding

If you are a woman of childbearing potential, you should use effective contraception during treatment with XELJANZ and for at least 4 weeks after the last dose.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine. XELJANZ should not be used during pregnancy. Inform your doctor immediately if you become pregnant while taking XELJANZ.

If you are taking XELJANZ and breastfeeding, stop breastfeeding until you have spoken with your doctor about stopping XELJANZ treatment.

Driving and using machines

XELJANZ has no or a negligible effect on your ability to drive or use machines.

XELJANZ 11 mg prolonged-release tablets contain sorbitol

This medicine contains approximately 152 mg of sorbitol in each prolonged-release tablet.

3. How to take XELJANZ

This medicine has been provided and supervised by a specialist doctor who knows how to treat your condition.

Follow exactly the instructions for using this medicine given by your doctor; do not exceed the recommended dose. If in doubt, consult your doctor or pharmacist again.

Rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis

The recommended dose is one 11 mg extended-release tablet taken once daily.

Try to take the tablet (one 11 mg extended-release tablet) at the same time each day, for example, in the morning or at night.

Swallow the XELJANZ 11 mg extended-release tablets whole to ensure the full dose is properly released. Do not crush, split, or chew them.

Your doctor may reduce the dose if you have liver or kidney problems, or if you are prescribed certain medications. Your doctor may also temporarily or permanently stop treatment if blood tests show low white or red blood cell counts.

If you have rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis, your doctor may switch between your XELJANZ 5 mg coated tablets taken twice daily and XELJANZ 11 mg extended-release tablets taken once daily. You may start taking XELJANZ extended-release tablets once daily or XELJANZ coated tablets twice daily the day after your last dose of either tablet. Do not switch between XELJANZ coated tablets and XELJANZ extended-release tablets unless instructed by your doctor.

XELJANZ is for oral use. You may take XELJANZ with or without food.

Ankylosing spondylitis

• Your doctor may decide to discontinue XELJANZ if it has not worked for you within 16 weeks.

If you take more XELJANZ than you should

If you take more extended-release tablets than you should, inform your doctor or pharmacist immediately.

If you forget to take XELJANZ

Do not take a double dose to make up for a missed 11 mg extended-release tablet. Take the next extended-release tablet at your usual time and continue as before.

If you stop taking XELJANZ

Do not stop taking XELJANZ without consulting your doctor.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some may be serious and require medical attention.

Possible serious side effects

In rare cases, infections may be fatal. Cases of lung cancer, cancer of white blood cells (lymphoma), and myocardial infarction have also been reported.

If you notice any of the following serious side effects, tell your doctor immediately.

Signs of serious infection (frequent) include

• fever and chills
• cough
• blisters on the skin
• stomach pain
• persistent headache

Signs of ulcers or holes (perforations) in the stomach or intestine (uncommon) include

• fever
• stomach or abdominal pain
• blood in stools
• unexplained changes in bowel habits

Stomach or intestinal ulcers occur more frequently in patients who are also taking non-steroidal anti-inflammatory drugs or corticosteroids (e.g. prednisone).

Signs of allergic reactions (frequency not known) include

• chest tightness
• wheezing
• severe dizziness or vertigo
• swelling of the lips, tongue or throat
• hives (itching and rash)

Signs of blood clots in the lungs, veins, or eyes (uncommon: venous thromboembolism) include

• sudden shortness of breath or difficulty breathing
• chest pain or upper back pain
• swelling of arms or legs
• pain or tenderness when touching the legs
• redness or color change in arms or legs
• severe changes in vision
• sudden onset of severe headaches
• fainting, dizziness, or feeling lightheaded
• weakness on one side of the body, worsening mental state, seizures, or loss of consciousness

Signs of myocardial infarction (uncommon) include

• chest pain or tightness (which may spread to the arms, jaw, neck, or back)
• difficulty breathing
• cold sweat
• sudden lightheadedness or dizziness

Other side effects observed with XELJANZ are listed below.

Common (may affect up to 1 in 10 patients): lung infections (pneumonia and bronchitis), shingles (herpes zoster), infections of the nose, throat or trachea (nasopharyngitis), flu, sinusitis, bladder infection (cystitis), sore throat (pharyngitis), increased muscle enzymes in blood (signs of muscle problems), stomach pain (which may be due to inflammation of the stomach lining), vomiting, diarrhoea, feeling unwell (nausea), indigestion, low white blood cell count, low red blood cell count (anaemia), swelling of hands and feet, headache, high blood pressure (hypertension), cough, rash, acne.

Uncommon (may affect up to 1 in 100 patients): lung cancer, tuberculosis, kidney infection, skin infection, cold sores (herpes simplex) or mouth ulcers (herpes labialis), increased creatinine in blood (a possible sign of kidney problems), increased cholesterol (including increased LDL), fever, fatigue (tiredness), weight gain, dehydration, muscle strain, tendinitis, joint swelling, joint sprain, abnormal sensations, insufficient sleep, sinus congestion, shortness of breath or difficulty breathing, skin redness, itching, fatty liver, painful inflammation of small pouches protruding from the inner lining of the intestine (diverticulitis), viral infections, viral infections affecting the intestine, some types of skin cancer (non-melanoma type).

Rare (may affect up to 1 in 1,000 patients): blood infection (sepsis), lymphoma (cancer of white blood cells), disseminated tuberculosis affecting bones and other organs, other unusual infections, joint infection, increased liver enzymes in blood (sign of liver problems), muscle and joint pain.

Very rare (may affect up to 1 in 10,000 patients): tuberculosis affecting the brain and spinal cord, meningitis, infection of soft tissues and fascia.

In general, fewer side effects were observed in rheumatoid arthritis when XELJANZ was given alone compared to when used in combination with methotrexate.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly via the national reporting system detailed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of XELJANZ

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the blister, bottle, or carton. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage temperature conditions.

Store in the original packaging to protect it from moisture.

Do not use this medicine if you notice that the tablets show visible signs of deterioration (for example, if they are cracked or discolored).

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Package contents and other information

Composition of XELJANZ

• The active substance is tofacitinib.
• Each 11 mg prolonged-release tablet contains 11 mg of tofacitinib (as tofacitinib citrate).
• The other components are sorbitol (E420) (see section 2 “XELJANZ 11 mg prolonged-release tablets contain sorbitol”), hydroxyethylcellulose, copovidone, magnesium stearate, cellulose acetate, hydroxypropylcellulose (E463), hypromellose (E464), titanium dioxide (E171), triacetin, iron oxide red (E172), shellac (E904), ammonium hydroxide (E527), propylene glycol (E1520), and iron oxide red (E172).

Nature of the product and pack contents

XELJANZ 11 mg prolonged-release tablets are pink and oval-shaped.

The tablets are supplied in blisters containing 7 tablets. Each pack contains either 28 or 91 tablets. The tablets are also available in bottles with a silica gel desiccant containing 30 or 90 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Brussels
Belgium

Manufacturer

Pfizer Service Company BV
Hermeslaan 11
1932 Zaventem
Belgium

For more information about this medicinal product, you may contact the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet:

Other sources of information

Detailed information on this medicine is available on the website of the European Medicines Agency: https://www.ema.europa.eu.