11 mg prolonged-release tablet er
tofacitinib
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 diseases:
- rheumatoid arthritis
- psoriatic arthritis
- ankylosing spondylitis
Rheumatoid arthritis
XELJANZ is used to treat adult patients with moderately to severely active rheumatoid arthritis, a chronic disease that mainly causes aching and swollen joints.
XELJANZ is used with methotrexate when other rheumatoid arthritis treatments have not worked well enough or were not tolerated. XELJANZ can also be used as the only medicine in cases where you cannot tolerate methotrexate or if treatment with methotrexate is unsuitable for you.
XELJANZ has been shown to reduce joint pain and swelling and increase the patient’s ability to perform daily activities, both when given alone and in combination with methotrexate.
Psoriatic arthritis
XELJANZ is used to treat adult patients with a disease called psoriatic arthritis. This is an inflammatory joint disease that often occurs in connection with psoriasis. If you have active psoriatic arthritis, you will first be given another medicine to treat your psoriatic arthritis. If your treatment doesn’t work well enough or if you can’t tolerate the medicine, you can get XELJANZ to reduce the signs and symptoms of active psoriatic arthritis and improve your ability to carry out everyday activities.
XELJANZ is used together with methotrexate to treat adult patients with active psoriatic arthritis.
Ankylosing spondylitis
XELJANZ is used to treat a disease called ankylosing spondylitis. It is an inflammatory disease of the spine.
If you have ankylosing spondylitis, you may initially be treated with other medicines. If the treatment does not work well enough, you will be treated with XELJANZ. XELJANZ can reduce back pain and improve physical ability, which can make everyday activities easier and increase the quality of life.
What you need to know before using XELJANZ
Do not use XELJANZ
- if you are allergic to tofacitinib or any of the other ingredients of this medicine (listed in section 6).
- if you have a severe infection, e.g. infection in the blood or active tuberculosis.
- if you have a serious liver disease, e.g. cirrhosis (liver cirrhosis).
- if you are pregnant or breastfeeding.
Contact your doctor if you are unsure about any of the 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, shortness of breath, mucus production or change in existing mucus production, weight loss, warm, red or painful skin or sores on the body, difficulty swallowing or pain when swallowing, diarrhea or stomach pain, burning when urinating or urinating more often than normal, extreme tiredness
- if you have any disease that increases the risk of infection (e.g. diabetes, HIV/AIDS or weak immune system)
- if you have any type of infection, are currently being treated for an infection, or if you have an infection that keeps coming back. Tell your doctor immediately if you feel unwell. XELJANZ can reduce the body’s defenses against infection and can make an existing infection worse or increase the risk of getting a new infection
- if you have or have previously had tuberculosis or have been in close contact with someone with tuberculosis. Your doctor will test you for tuberculosis before you start taking XELJANZ and may repeat the test during treatment
- if you have any chronic lung disease
- if you have liver problems
- if you or have had hepatitis B or hepatitis C ( viruses that affect the liver). A virus may become active while taking XELJANZ. Your doctor may do blood tests to check for hepatitis before you start treatment with XELJANZ and while you are taking XELJANZ.
- if you are older than 65 years, if you have ever had any type of cancer, and if you are or have been a smoker. XELJANZ may increase the risk of certain types of cancer. Cancers of the white blood cells, lung cancer, and other types of cancer (eg breast cancer, skin cancer, prostate cancer, and pancreatic cancer) have occurred in patients treated with XELJANZ. If you develop cancer while being treated with XELJANZ, your doctor will consider possibly stopping XELJANZ treatment
- if you have a known risk of fracture, e.g. if you are over 65, female, or taking corticosteroids (eg prednisone)
- if you are at high risk of developing skin cancer, your doctor may recommend that you have regular skin examinations while taking XELJANZ
- if you have had diverticulitis (a type of inflammation of the large intestine) or ulcers in the stomach or intestines (see section 4)
- if you have problems with your kidneys
- if you plan to get vaccinated, talk to your doctor. Certain types of vaccines should not be given while taking XELJANZ. Before you start taking XELJANZ, you must have adequate protection according to all vaccination recommendations. Your doctor will decide if you need to be vaccinated against shingles ( herpes zoster).
- if you have heart problems, high blood pressure, or high cholesterol, and if you are or have been a smoker
- if you have a narrowing of the gastrointestinal tract, you must tell the doctor because there have been rare cases of blockage of the gastrointestinal tract in patients taking other medicines with similar prolonged-release tablets er
- when you take XELJANZ 11 mg prolonged-release tablet you may see something in your stool that looks like a tablet. This is the empty shell of a prolonged-release tablet once the medicine has been absorbed by the body. This is to be expected and nothing to worry about.
There have been reports of patients treated with XELJANZ developing blood clots in the lungs or veins. Your doctor will assess your risk of developing blood clots in the lungs and veins and decide whether XELJANZ is suitable for you. If you have already had problems with the development of blood clots in the lungs and veins or have an increased risk of developing this (for example, if you are severely overweight, if you have cancer or heart problems, diabetes, have had a heart attack (within the last 3 months) have recently undergone major surgery, if you are using hormonal contraceptives/receiving hormone replacement therapy, if you or a close relative have a clotting disorder), if you are elderly or if you smoke or have smoked in the past, your doctor may decide that XELJANZ is not suitable for you.
Talk to your doctor immediately if you develop sudden shortness of breath or difficulty breathing, chest pain or upper back pain, swelling of a leg or arm, pain or tenderness in a leg, or redness or abnormal color of a leg or arm when you take XELJANZ because it may be a sign of a blockage in the lungs or veins.
Talk to your doctor immediately if you experience acute vision changes (blurred vision, partial or complete vision loss), as this may be a sign of blood clots in the eyes.
There have been reports of heart problems, including heart attacks, in patients treated with XELJANZ. Your doctor will assess your risk of developing a heart problem and decide whether XELJANZ is suitable for you. Talk to your doctor right away if you develop signs and symptoms of a heart attack, severe chest pain or pressure in the chest (which may spread to the arms, jaw, neck, and back), shortness of breath, cold sweats, lightheadedness, or sudden dizziness.
Additional samples for monitoring
Your doctor will do blood tests before you start taking XELJANZ, after 4 to 8 weeks of treatment, and every 3 months thereafter, to determine whether you have low white blood cell counts ( neutrophils or lymphocytes ) or low red blood cell counts ( anemia ).
You should not take XELJANZ if you have too few white ( neutrophils or lymphocytes ) or red blood cells. The doctor may interrupt XELJANZ treatment for a time if necessary to reduce the risk of infection ( white blood cells ) or anemia ( red blood cells ).
The doctor may also take more samples, e.g. to check the cholesterol level or the liver. The doctor should test the cholesterol level 8 weeks after you start XELJANZ. The doctor must take liver samples at regular intervals.
Older
The rate of infection is higher in patients who are 65 years of age or older. Talk to the doctor as soon as you notice any signs or symptoms of infection.
Patients who are 65 years of age or older may be at increased risk of infection, heart attack, and certain types of cancer. Your doctor may decide that XELJANZ is not suitable for you.
Patients of Asian origin
Shingles occur more often in patients of Japanese or Korean descent. Tell your doctor if you get painful blisters on your skin.
The risk of certain lung problems may also be higher. Tell the doctor if you experience breathing difficulties.
Children and young people
XELJANZ is not recommended for children and adolescents under 18 years of age. The safety and benefit of XELJANZ in children and adolescents have not yet been established.
Other medicines and XELJANZ
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Tell the doctor if you have diabetes or are taking medicines to treat diabetes. Your doctor can determine if you need less diabetes medicine while taking tofacitinib.
Certain medicines should not be taken with XELJANZ. If taken together with XELJANZ, they may change the amount of XELJANZ in the body and the dose of XELJANZ may need to be changed. Tell the doctor if you are taking medicines containing any of the following active substances:
- antibiotics such as rifampicin, which are used against bacterial infections
- fluconazole and ketoconazole, which are used against fungal infections.
XELJANZ is not recommended together with medicines that suppress the immune system, including so-called targeted biological (antibody) therapies, for example, those that inhibit tumor necrosis factor, interleukin ‑17, interleukin ‑12/interleukin ‑23, anti-integrins or strong chemical agents that suppress the immune system such as azathioprine, mercaptopurine, cyclosporine, and tacrolimus. Taking XELJANZ together with these medicines may increase the risk of side effects, including the risk of infection.
Serious infections and fractures may also occur more often in people who also take corticosteroids (eg prednisolone ).
Pregnancy, breastfeeding, and fertility
If you are a woman of childbearing potential, you must use effective contraception while you are being treated with XELJANZ and for at least 4 weeks after the last dose.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor before taking this medicine. XELJANZ must not be used during pregnancy. If you become pregnant while taking XELJANZ, tell your doctor immediately.
If you are taking XELJANZ and breastfeeding, you must stop breastfeeding until you have spoken to your doctor about stopping XELJANZ treatment.
Driving ability and use of machinery
XELJANZ has no or limited effect on your ability to drive and use machines.
XELJANZ 11 mg prolonged-release tablet contains sorbitol
This medicine contains approximately 152 mg of sorbitol per prolonged-release tablet.
How to take XELJANZ
This medicine is prescribed and monitored by a specialist doctor who knows how to treat your disease.
Always take this medicine as directed by your doctor. The recommended dose must not be exceeded. Ask your doctor or pharmacist if you are unsure.
Rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis
The recommended dose is one 11 mg prolonged-release tablet once daily.
Try to take the tablet (an 11 mg prolonged-release tablet ) at the same time every day, e.g. in the morning or evening.
XELJANZ 11 mg prolonged-release tablet must be swallowed whole for the entire dose to be delivered correctly. They must not be crushed, split, or chewed.
The doctor may lower the dose if you have liver or kidney problems or if you are taking certain other medicines at the same time. The doctor can also stop treatment temporarily or permanently if blood tests show a low number of white or red blood cells.
If you have rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis, you can, in consultation with your doctor, switch treatment between XELJANZ 5 mg film-coated tablets twice daily and XELJANZ 11 mg prolonged-release tablets once daily. You can start XELJANZ prolonged-release tablets once daily, or XELJANZ film-coated tablets twice daily, the day after your last dose of either tablet. You should not switch between XELJANZ film-coated tablets and XELJANZ prolonged-release tablets unless your doctor tells you to do so.
XELJANZ is intended for oral use (by mouth). You can take XELJANZ with or without food.
Ankylosing spondylitis
- The doctor may decide to stop treatment with XELJANZ if XELJANZ has not worked within 16 weeks.
If you use too much XELJANZ
If you have taken too much of a prolonged-release tablet, you must tell your doctor or pharmacist immediately.
If you forget to use XELJANZ
Do not take a double dose to compensate for a forgotten extended-release tablet. Take the next 11 mg prolonged-release tablet at the usual time and continue as before.
If you stop using XELJANZ
You should not stop taking XELJANZ without first talking to your doctor.
If you have any further questions about this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some side effects can be serious and require care.
Side effects that can be serious
In rare cases, the infection can be life-threatening. Lung cancer, cancer of white blood cells, and heart attack have also been reported.
If you notice any of the following serious side effects, contact your doctor immediately.
Signs of serious infection are (common) and include
- fever and chills
- cough
- blisters on the skin
- stomach ache
- persistent headache.
Signs of ulcers or holes ( perforations ) in the stomach (less common) include:
- fever
- stomach or abdominal pain
- blood in the stool
- unexplained changes in bowel habits.
Holes in the stomach or intestines most often occur in people who also take non-steroidal anti-inflammatory drugs or corticosteroids (eg prednisolone ).
Signs of allergic reactions (frequency not known) include
- pressure over the chest
- wheezing
- severe dizziness or vertigo
- swelling of the lips, tongue, or throat
- hives (itchy raised skin rash).
Signs of blood clots in the lungs or veins or eyes (less common: venous thromboembolism ) include
- sudden shortness of breath or difficulty breathing
- chest pain or upper back pain
- swelling in a leg or arm
- pain or tenderness in a leg
- redness or abnormal color of a leg or arm
- acute vision changes.
Signs of a heart attack (uncommon) include:
- severe chest pain or pressure across the chest (which may spread to the arms, jaw, neck, and back)
- respiratory distress
- cold sweat
- lightheadedness or sudden dizziness.
Other side effects that have occurred with XELJANZ are listed below.
Common (may affect up to 1 in 10 people): pneumonia ( pneumonia and bronchitis ), shingles ( herpes zoster), infection of the nose, throat, or windpipe ( nasopharyngitis ), influenza, sinusitis, inflammation of the bladder ( cystitis ), pain in the throat ( pharyngitis ), increased muscle enzymes in the blood (signs of muscle problems), stomach pain (which may be due to inflammation of the stomach lining), vomiting, diarrhea, nausea, indigestion, low white blood cell count, low red blood cell count blood cells (anemia), swollen hands and feet, headache, high blood pressure ( hypertension ), cough, skin rash.
Uncommon (may affect up to 1 in 100 people): lung cancer, tuberculosis, kidney infection, skin infection, herpes simplex or mouth sores ( oral herpes ), increased blood creatinine (may be a sign of kidney problems), increased cholesterol (including increased LDL ), fever, exhaustion (tiredness), weight gain, dehydration, muscle strain, tendonitis, joint swelling, joint sprain, abnormal sensations, difficulty sleeping, swollen sinuses, shortness of breath or difficulty breathing, skin flushing, itching, fatty liver, painful inflammation of small pockets of the intestinal lining (diverticulitis ), viral infections, viral infections of the gut, certain types of skin cancer (not melanoma ).
Rare (may affect up to 1 in 1,000 people): infection in the blood ( sepsis ), lymphoma (cancer of the white blood cells ), disseminated tuberculosis of the skeleton and other organs, other unusual infections, joint infections, elevated liver enzymes in the blood (signs of liver problems), pain in muscles and joints.
Very rare (may affect up to 1 in 10,000 users):
tuberculosis of the brain and spinal cord, meningitis, and infection of soft tissues, and connective tissue membranes.
In general, fewer side effects were seen when XELJANZ was used alone than in combination with methotrexate in rheumatoid arthritis.
How to store XELJANZ
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the blister, can, or carton. The expiration date is the last day of the specified month.
No special temperature instructions.
Store in the original packaging. Moisture sensitive.
Do not use this medicine if the tablets show visible signs of deterioration (eg, are broken or discolored).
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is tofacitinib.
- Each 11 mg prolonged-release tablet contains 11 mg tofacitinib (as tofacitinib citrate).
- Other ingredients are sorbitol (E420) (see section 2 “XELJANZ 11 mg prolonged-release tablet contains sorbitol”), hydroxyethyl cellulose, copovidone, magnesium stearate, cellulose acetate, hydroxypropyl cellulose (E463), hypromellose (E464), titanium dioxide (E171), triacetin, red iron oxide (E172 ), shellac (E904), ammonium hydroxide (E527), propylene glycol (E1520) and black iron oxide (E172).
Appearance and package sizes of the medicine
XELJANZ 11 mg prolonged-release tablet is a pink and oval tablet.
The tablets are available in blister cards containing 7 tablets. Each pack contains 28 or 91 tablets. The tablets are also available in cans with silica gel as a desiccant and contain 30 or 90 tablets.
Not all pack sizes may be marketed.
Pfizer Europe MA EEIG
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T iron manufacturer
Pfizer Manufacturing Deutschland GmbH
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79090 Freiburg
Germany
Contact the representative of the Marketing Authorization Holder if you would like to know more about this medicine:
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