Trijan is a medicine that contains the active substance tofacitinib.

Trijan is used for the treatment of the following inflammatory diseases:

·    Rheumatoid arthritis

·    Psoriatic arthritis

·    Ulcerative colitis

Rheumatoid arthritis

Trijan is used to treat adult patients with moderate to severe active rheumatoid arthritis, a long-term disease that mainly causes pain and swelling of your joints.

Trijan is used together with methotrexate when previous rheumatoid arthritis treatment was not sufficient or was not well tolerated. Trijan can also be taken on its own in those cases where methotrexate treatment is not tolerated or treatment with methotrexate is not advised.

Tofacitinib has been shown to reduce pain and swelling of the joints and improve the ability to perform daily activities, when given on its own or together with methotrexate.

Psoriatic arthritis

Trijan is used to treat a condition called psoriatic arthritis. This condition is an inflammatory disease of the joints, often accompanied by psoriasis. If you have active psoriatic arthritis you will be first given another medicine to treat your psoriatic arthritis. If you do not respond well enough or the medicine is not tolerated, you may be given Trijan to reduce the sign and symptoms of active psoriatic arthritis and improve the ability to perform daily activities.

Trijan is used together with methotrexate to treat adult patients with active psoriatic arthritis.

Ulcerative colitis

Ulcerative colitis is an inflammatory disease of the large bowel. Trijan is used to reduce the signs and symptoms of ulcerative colitis when you did not respond well enough or were intolerant to previous ulcerative colitis treatment.

Do not take Trijan:

·    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 such as bloodstream infection or active tuberculosis

·    If you have been informed that you have severe liver problems, including cirrhosis (scarring of the liver)

·    If you are pregnant or breast-feeding

Don’t take Trijan 10 mg twice daily if you have any of the following conditions:

·    Are taking combined hormonal contraceptives or hormone replacement therapy

·    Have heart failure (when the heart does not work as well as it should)

·    Have had blood clots in the veins

·    Have cancer

·    Will have or have recently had major surgery

If you are not sure regarding any of the information provided above, please contact your doctor.

Warnings and Precautions

Talk to your doctor or pharmacist before taking Trijan:

·    If you think you have an infection or have symptoms of an infection such as fever, sweating, chills, muscle aches, cough, shortness of breath, new phlegm or change in phlegm, weight loss, warm or red or painful skin or sores on your body, difficulty or pain when swallowing, diarrhoea or stomach pain, burning when you urinate or urinating more often than normal, feeling very tired

·    If you have any condition that increases your chance of infection (e.g., diabetes, HIV/AIDS, or a weak immune system)

·    If you have any kind of infection, are being treated for any infection, or if you have infections that keep coming back. Tell your doctor immediately if you feel unwell. Trijan can reduce your body’s ability to respond to infections and may make an existing infection worse or increase the chance of getting a new infection

·    If you have or have a history of tuberculosis or have been in close contact with someone with tuberculosis. Your doctor will test you for tuberculosis before starting Trijan and may retest during treatment

·    If you have any chronic lung disease

·    If you have liver problems

·    If you have or had hepatitis B or hepatitis C (viruses that affect the liver). The virus may become active while you are taking Trijan. Your doctor may do blood tests for hepatitis before you start treatment with Trijan and while you are taking Trijan

·    If you have ever had any type of cancer. Trijan may increase your risk of certain cancers. Lymphoma and other cancers (such as lung, breast, melanoma, prostate and pancreatic) have been reported in patients treated with tofacitinib. If you develop cancer while taking Trijan your doctor will review whether to stop Trijan treatment

·    If you are at high risk of developing skin cancer, your doctor may recommend that you have regular skin examinations while taking Trijan.

·    If you have had diverticulitis (a type of inflammation of the large intestine) or ulcers in stomach or intestines (see section 4)

·    If you have kidney problems

·    If you are planning to get vaccinated, tell your doctor. Certain types of vaccines should not be given when taking Trijan. Before you start Trijan, you should be up to date with all recommended vaccinations. Your doctor will decide whether you need to have herpes zoster vaccination

·    If you have heart problems, high blood pressure, or high cholesterol

There have been reports of patients treated with tofacitinib who have developed blood clots. Talk to your doctor if you smoke. He / she will also evaluate whether your body weight, age, or problems being mobile will affect your risk to develop blood clots.

Additional monitoring tests

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

You should not receive Trijan if your white blood cell (neutrophil or lymphocyte) count or red blood cell count is too low. If needed, your doctor may interrupt your Trijan treatment to reduce the risk of infection (white blood cell counts) or anaemia (red blood cell counts).

Your doctor may also perform other tests, for example to check your blood cholesterol levels or monitor the health of your liver. Your doctor should test your cholesterol levels 8 weeks after you start receiving Trijan. Your doctor should perform liver tests periodically.

Elderly

There is a higher rate of infections in patients aged 65 years and older. Tell your doctor as soon as you notice any signs or symptoms of infections.

Asian patients

There is a higher rate of shingles in Japanese and Korean patients. Tell your doctor if you notice any painful blisters on your skin.

You may also be at higher risk of certain lung problems. Tell your doctor if you notice any breathing difficulties.

Children and adolescents

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

Other medicines and Trijan

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

Trijan may be used in combination with methotrexate or sometimes alone when used to treat rheumatoid arthritis. In general, fewer side effects were seen when tofacitinib was used alone in rheumatoid arthritis.

Some medicines should not be taken with Trijan. If taken with Trijan, they could alter the level of Trijan in your body, and the dose of Trijan may require adjustment. You should tell your doctor if you are using medicines (taken by mouth) that contain any of the following active substances:

·    Antibiotics such as clarithromycin and rifampicin, used to treat bacterial infections

·    Fluconazole, ketoconazole, clotrimazole, itraconazole, and voriconazole, used to treat fungal infections

Trijan is not recommended for use with medicines that depress the immune system, including so-called targeted biologic (antibody) therapies, such as those that inhibit tumour necrosis factor, interleukin-17, interleukin-12/interleukin-23, anti-integrins, and strong chemical immunosuppressants including azathioprine, mercaptopurine, ciclosporine, and tacrolimus. Taking Trijan with these medicines may increase your risk of side effects including infection.

Serious infections may happen more often in people who also take corticosteroids (e.g., prednisone).

Pregnancy, breast-feeding and fertility

If you are a woman of childbearing age, you should use effective birth control during treatment with Trijan and for at least 4 weeks after the last dose.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Trijan must not be used during pregnancy. Tell your doctor right away if you become pregnant while taking Trijan.

If you are taking Trijan and breast-feeding, you must stop breast-feeding until you talk to your doctor about stopping treatment with Trijan.

Driving and using machines

Tofacitinib has no or limited effect on your ability to drive or use machines.

Trijan contains lactose

Trijan contains lactose. Each 5 mg and 10 mg film-coated tablet contain 59 mg or 118 mg lactose; respectively.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

This medicine is provided to you and supervised by a specialised doctor who knows how to treat your condition.

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Rheumatoid arthritis

·    The recommended dose is 5 mg twice a day.

Psoriatic arthritis

·    The recommended dose is 5 mg twice a day.

Ulcerative colitis

·   The recommended dose is 10 mg twice a day for 8 weeks, followed by 5 mg twice a day.

·   Your doctor may decide to extend the initial 10 mg twice a day treatment by an additional 8 weeks (16 weeks in total), followed by 5 mg twice a day.

·   Your doctor may decide to stop Trijan if Trijan does not work for you within 16 weeks.

·   For patients, who have previously taken biologic medicines to treat ulcerative colitis (such as those that block the activity of tumour necrosis factor in the body) and these medicines did not work, the doctor may decide to continue giving 10 mg twice a day. Your doctor will tell you if this applies to you.

·   If maintaining Trijan 5 mg twice a day did not work for you, your doctor may decide to increase the dose to 10 mg twice a day.

·  If your treatment is interrupted, your doctor may decide to restart your treatment.

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

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

Trijan is for oral use. You can take Trijan with or without food.

If you take more Trijan than you should

If you take more tablets than you should, immediately tell your doctor or pharmacist.

If you forget to take Trijan

Do not take a double dose to make up for a forgotten tablet. Take your next tablet at the usual time and continue as before.

If you stop taking Trijan

You should not stop taking Trijan without discussing this with your doctor.

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

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

Some may be serious and need medical attention.

Possible serious side effects

In rare cases, infection may be life-threatening.

If you notice any of the following serious side effects you need to tell a doctor straight away.

Signs of serious infections (common) include

·    Fever and chills

·    Cough

·    Skin blisters

·    Stomach ache

·    Persistent headaches

Signs of allergic reactions (rare) include

·    Chest tightness

·    Wheezing

·    Severe dizziness or light-headedness

·    Swelling of the lips, tongue or throat

·    Hives (itching or skin rash)

Signs of stomach problems (uncommon: ulcers or holes in your stomach or intestines) include

·    Fever

·    Stomach or abdominal pain

·    Blood in the stool

·    Unexplained changes in bowel habits

Holes in stomach or intestines happen most often in people who also take nonsteroidal anti-inflammatory drugs or corticosteroids (e.g., prednisone).

Other side effects which have been observed with tofacitinib are listed below.

Common (may affect up to 1 in 10 people): lung infection (pneumonia and bronchitis), shingles (herpes zoster), infections of nose, throat or the windpipe (nasopharyngitis), influenza, sinusitis, urinary bladder infection (cystitis), sore throat (pharyngitis), increased muscle enzymes in the blood (sign of muscle problems), stomach (belly) pain (which may be from inflammation of the stomach lining), vomiting, diarrhoea, feeling sick (nausea), indigestion, joint sprain, low red blood cell count (anaemia), fever, fatigue (tiredness), swelling of the feet and hands, headache, high blood pressure (hypertension), cough, rash.

Uncommon (may affect up to 1 in 100 people): tuberculosis, kidney infection, skin infection, herpes simplex or cold sores (oral herpes), low white blood cell counts, increased liver enzymes in the blood (sign of liver problems), blood creatinine increased (a possible sign of kidney problems), increased cholesterol, weight gain, dehydration, muscle strain, pain in the muscles and joints, tendonitis, joint swelling, abnormal sensations, poor sleep, sinus congestion, shortness of breath or difficulty breathing, skin redness, itching, fatty liver, painful inflammation of small pockets in the lining of your intestine (diverticulitis), viral infections, viral infections affecting the gut, some types of skin cancers (non-melanoma-types).

Rare (may affect up to 1 in 1,000 people): blood infection (sepsis), disseminated tuberculosis involving bones and other organs, other unusual infections, joint infections.

Very rare (may affect up to 1 in 10,000 people): tuberculosis involving the brain and spinal cord, meningitis.

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

Do not store above 30°C.

Store in the original package in order to protect from moisture.

Do not use this medicine after the expiry date which is stated on the carton after “EXP”. The expiry date refers to the last day of that month.

Do not use this medicine if you notice the tablets show visible signs of deterioration (for example, are broken or discoloured).

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.