Xeljanz 10 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

XELJANZ 5 mg film-coated tablets

XELJANZ 10 mg film-coated tablets

tofacitinib

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult 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 reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

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

Leaflet contents

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
5. How to store XELJANZ
6. 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
• ulcerative colitis
• ankylosing spondylitis
• polyarticular juvenile idiopathic arthritis and juvenile psoriatic arthritis

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 previous 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 improve the ability to perform daily activities, whether administered 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 treated with another medicine. If you do not respond adequately or cannot tolerate that treatment, XELJANZ may be prescribed to reduce the signs and symptoms of active psoriatic arthritis and improve your ability to carry out 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 treated with other medicines. 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.

Ulcerative colitis

Ulcerative colitis is an inflammatory disease of the large intestine. XELJANZ is used in adult patients to reduce the signs and symptoms of ulcerative colitis when previous treatments have not provided an adequate response or were not tolerated.

Polyarticular juvenile idiopathic arthritis and juvenile psoriatic arthritis

XELJANZ is used for the treatment of active polyarticular juvenile idiopathic arthritis, a long-term disease that primarily causes joint pain and inflammation in patients 2 years of age and older.

XELJANZ is also used for the treatment of juvenile psoriatic arthritis, a condition that is an inflammatory joint disease, often accompanied by psoriasis, in patients 2 years of age and older.

XELJANZ may be used in combination with methotrexate when previous treatment for polyarticular juvenile idiopathic arthritis or juvenile psoriatic arthritis has not been effective or was not well tolerated. XELJANZ may also be used as monotherapy in cases where methotrexate treatment is not tolerated or is not recommended.

2. What you need to know before taking XELJANZ

Do not take XELJANZ

• if you are allergic to tofacitinib or 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 above points.

Warnings and precautions

Consult your doctor or pharmacist before starting 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, skin that is hot, red or painful, sores on the body, difficulty or pain when swallowing, diarrhoea or stomach pain, burning when urinating or urinating more often than normal, or feel very tired
• if you have any disease that increases your likelihood of infection (e.g., 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 recurring. 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 likelihood of developing a new infection
• if you have tuberculosis 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 hepatitis B or hepatitis C (viruses that affect the liver) or have a history of these conditions. The virus may become active while you are taking XELJANZ. Your doctor may perform blood tests for hepatitis before starting and during treatment with 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 administered 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.

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 appropriate for you. If you have previously had problems with blood clots in the lungs or veins or have a higher risk of developing them [e.g., if you are significantly overweight, have cancer, heart problems, diabetes, have had a heart attack (within the previous 3 months), have recently undergone major surgery, use hormonal contraceptives/hormone replacement therapy, or if you or your close family members have been identified as having a clotting disorder], 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 arms or legs, pain or tenderness upon touch in the legs, or redness or colour change in the arms or legs 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 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 status, seizures or loss of consciousness, as these may be signs of blood clots in the veins around the brain.
• if you experience signs and symptoms of myocardial infarction, such as severe chest pain or pressure (which may radiate 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 appropriate for you.
• if you, your partner or caregiver notice new-onset or worsening neurological symptoms, including general 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 but 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 red blood cell count is too low. If necessary, your doctor may suspend your treatment with XELJANZ 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 treatment with XELJANZ. 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 incidence of herpes zoster has 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 safety and efficacy of XELJANZ have not yet been established in patients under 2 years of age.

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 a lower dose of your diabetes 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 to be adjusted. 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 is not recommended, including 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. 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 must 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 must 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 treatment with XELJANZ.

Driving and using machines

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

XELJANZ contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

XELJANZ contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; that is, essentially “sodium-free”.

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 use of this medicine given by your doctor. Do not exceed the recommended dose. If in doubt, consult your doctor or pharmacist again.

Rheumatoid arthritis

• The recommended dose is 5 mg twice daily.

Psoriatic arthritis

• The recommended dose is 5 mg twice daily.

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

Ankylosing spondylitis

• The recommended dose is 5 mg twice daily.
• Your doctor may decide to discontinue XELJANZ if it has not worked for you within 16 weeks.

Ulcerative colitis

• The recommended dose is 10 mg twice daily for 8 weeks, followed by 5 mg twice daily.
• Your doctor may decide to extend the initial treatment of 10 mg twice daily for another 8 weeks (16 weeks in total), followed by 5 mg twice daily.
• Your doctor may decide to discontinue XELJANZ if it has not worked for you within 16 weeks.
• For patients who have previously taken biological medicines to treat ulcerative colitis (such as those that block tumour necrosis factor activity in the body) and these medicines were ineffective, your doctor may decide to increase your XELJANZ dose to 10 mg twice daily if you do not respond adequately to 5 mg twice daily. Your doctor will consider the potential risks, including the development of blood clots in the lungs or veins, and the possible benefits for you. Your doctor will inform you if this applies to you.
• If your treatment is interrupted, your doctor may decide to restart it.

Use in children and adolescents

Polyarticular juvenile idiopathic arthritis and juvenile psoriatic arthritis

• The recommended dose is 5 mg twice daily for patients ≥ 40 kg.

Try to take the tablets at the same time every day (one tablet in the morning and one tablet in the evening).

Tofacitinib tablets may be crushed and taken with water.

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 counts of white or red blood cells.

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

If you take more XELJANZ than you should

If you take more 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 forgotten doses. Take the next 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 adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

Some may be serious and require medical attention.

Adverse effects observed in patients with polyarticular juvenile idiopathic arthritis and juvenile psoriatic arthritis were consistent with those observed in adult patients with rheumatoid arthritis, except for certain infections (influenza, pharyngitis, sinusitis, viral infection) and gastrointestinal or general disorders (abdominal pain, nausea, vomiting, fever, headache, cough), which were more frequent in the paediatric population with juvenile idiopathic arthritis.

Possible serious adverse effects

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

If you notice any of the following serious adverse effects, inform your doctor immediately.

Signs of serious infection (frequent) include

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

Signs of stomach ulcers or holes (perforations) in the stomach (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

• tightness in the chest
• 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 upon touch in legs
• redness or change in skin colour of arms or legs
• severe changes in vision
• sudden onset of severe headaches
• fainting, dizziness, or feeling lightheaded
• weakness on one side of the body, progressive deterioration in 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, and back)
• difficulty breathing
• cold sweat
• lightheadedness or sudden dizziness

Other adverse effects observed with XELJANZ are listed below.

Frequent (may affect up to 1 in 10 patients): lung infections (pneumonia and bronchitis), shingles (herpes zoster), infections of the nose, throat, or trachea (nasopharyngitis), influenza, sinusitis, urinary 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, discomfort (nausea), indigestion, low white blood cell count, low red blood cell count (anaemia), swelling of hands and feet, headache, high blood pressure (hypertension), cough, skin rash, acne.

Uncommon (may affect up to 1 in 100 patients): lung cancer, tuberculosis, kidney infection, skin infection, cold sores (herpes simplex), 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, certain types of non-melanoma skin cancer.

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 adverse effects were observed in rheumatoid arthritis when XELJANZ was administered alone compared to when used in combination with methotrexate.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system detailed in Appendix V. By reporting adverse 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 visible signs of deterioration in the tablets (for example, if they are cracked or discolored).

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of any unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of XELJANZ

XELJANZ 5 mg film-coated tablets

• The active substance is tofacitinib.
• Each 5 mg film-coated tablet contains 5 mg of tofacitinib (as tofacitinib citrate).
• The other components are microcrystalline cellulose, lactose monohydrate (see section 2 “XELJANZ contains lactose”), sodium croscarmellose (see section 2 “XELJANZ contains sodium”), magnesium stearate, hypromellose (E464), titanium dioxide (E171), macrogol and triacetin.

XELJANZ 10 mg film-coated tablets

• The active substance is tofacitinib.
• Each 10 mg film-coated tablet contains 10 mg of tofacitinib (as tofacitinib citrate).
• The other components are microcrystalline cellulose, lactose monohydrate (see section 2 “XELJANZ contains lactose”), sodium croscarmellose (see section 2 “XELJANZ contains sodium”), magnesium stearate, hypromellose (E464), titanium dioxide (E171), macrogol, triacetin, FD&C Blue #2/Aluminum lake with indigo carmine (E132) and FD&C Blue #1/Aluminum lake with brilliant blue FCF (E133).

Nature and contents of the container

XELJANZ 5 mg film-coated tablets

XELJANZ 5 mg film-coated tablets are white and round.

The tablets are supplied in blisters containing 14 tablets. Each pack contains 56, 112 or 182 tablets and each bottle contains 60 or 180 tablets.

XELJANZ 10 mg film-coated tablets

XELJANZ 10 mg film-coated tablets are blue and round.

The tablets are supplied in blisters containing 14 tablets. Each pack contains 56, 112 or 182 tablets and each bottle contains 60 or 180 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder

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

Manufacturer

Pfizer Manufacturing Deutschland GmbH
Mooswaldallee 1
79108 Freiburg im Breisgau
Germany

For more information about this medicine, patients should contact the local representative of the Marketing Authorization Holder:

Belgium/Belgium/Belgium Luxembourg/Luxembourg Pfizer S.A./N.V. Tel/Tel: + 32 (0)2 554 62 11	Lithuania Pfizer Luxembourg SARL filialas Lietuvoje Tel: +370 52 51 4000
	Hungary Pfizer Kft Tel: +36 1 488 3700
Czech Republic Pfizer, spol. s r.o. Tel: + 420 283 004 111	Malta Vivian Corporation Ltd. Tel: + 35621 344610
Denmark Pfizer ApS Tlf: + 45 44 201 100	Netherlands Pfizer BV Tel: +31 (0)800 63 34 636
Germany Pfizer Pharma GmbH Tel: + 49 (0)30 550055-51000	Norway Pfizer AS Tlf: +47 67 52 61 00
Estonia Pfizer Luxembourg SARL Eesti filiaal Tel.: +372 666 7500	Austria Pfizer Corporation Austria Ges.m.b.H Tel: + 43 (0)1 521 15-0
Greece Pfizer Ελλάς A.E. Tel.: +30 210 6785 800	Poland Pfizer Polska Sp. z o.o. Tel.: +48 22 335 61 00
Spain Pfizer, S.L. Tel: +34 914909900	Portugal Laboratórios Pfizer, Lda. Tel: (+351) 21 423 55 00
France Pfizer Tél: +33 1 58 07 34 40	Romania Pfizer Romania S.R.L Tel: +40 (0) 21 207 28 00
Croatia Pfizer Croatia d.o.o. Tel: + 385 1 3908 777	Slovenia Pfizer Luxembourg SARL Pfizer, podružnica za svetovanje s podrocja farmacevtske dejavnosti, Ljubljana Tel.: + 386 (0)1 52 11 400
Ireland Pfizer Healthcare Ireland Unlimited Company Tel: 1800 633 363 (toll free) +44 (0)1304 616161	Slovakia Pfizer Luxembourg SARL, organizačná zložka Tel: + 421 2 3355 5500
Iceland Icepharma hf Simi: + 354 540 8000	Finland Pfizer Oy Puh/Tel: +358 (0)9 430 040
Italy Pfizer s.r.l Tel: +39 06 33 18 21	Sweden Pfizer AB Tel: +46 (0)8 550 520 00
Cyprus PFIZER ΕΛΛΆΣ Α.Ε. (CYPRUS BRANCH) Tel: +357 22 817690
Latvia Pfizer Luxembourg SARL filiale Latvija Tel.: + 371 670 35 775

Date of the most recent review of this summary:

Other sources of information

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