What is JAKURA-5

• JAKURA-5 is a prescription medicine called a Janus kinase (JAK) inhibitor. JAKURA 5 is used to treat adults with moderately to severely active rheumatoid arthritis in whom methotrexate did not work well or cannot be tolerated.

It is not known if ‘Tofacitinib’ is safe and effective in people with Hepatitis B or C. ‘Tofacitinib’ is not recommended for people with severe liver problems.

It is not known if ‘Tofacitinib’ is safe and effective in children.

What are the ingredients in JAKURA 5?

Active ingredient: Tofacitinib citrate

JAKURA-5 is an oral tablet that contains “Tofacitinib 5 mg”. Below mentioned is useful information of Tofacitnib use in patients with Rheumatoid Arthritis.

Tofacitinib may cause serious side effects including:

1. Serious infections. ‘Tofacitinib’ is a medicine that affects your immune system. ‘Tofacitinib’ can lower the ability of your immune system to fight infections. Some people can have serious infections while taking ‘Tofacitinib’, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have died from these infections.

• Your healthcare provider should test you for TB before starting ‘Tofacitinib’ and during treatment.
• Your healthcare provider should monitor you closely for signs and symptoms of TB infection during treatment with ‘Tofacitinib’.

You should not start taking ‘Tofacitinib’ if you have any kind of infection unless your healthcare provider tells you it is okay. You may be at a higher risk of developing shingles (herpes zoster).

People taking the higher dose of 10 mg ‘Tofacitinib’ twice daily have a higher risk of serious infections and shingles.

Before starting JAKURA-5, tell your healthcare provider if you:

• think you have an infection or have symptoms of an infection such as:
• fever, sweating, or chills
• cough
• blood in phlegm
• warm, red, or painful skin or sores on your body
• burning when you urinate or urinating more often than normal
• muscle aches
• shortness of breath
• weight loss
• diarrhea or stomach pain
• feeling very tired
• are being treated for an infection.
• get a lot of infections or have infections that keep coming back.
• have diabetes, chronic lung disease, HIV, or a weak immune system. People with these conditions have a higher chance for infections.
• have TB, or have been in close contact with someone with TB.
• have or have had hepatitis B or C.

After starting JAKURA-5, call your healthcare provider (consult) right away if you have any symptoms of an infection. ‘Tofacitinib’ can make you more likely to get infections or make worse any infection that you have.

2. Increased risk of death in people 50 years of age and older with rheumatoid arthritis who have at least 1 heart disease (cardiovascular) risk factor and who are taking a higher than recommended dose of ‘Tofacitinib’. The recommended dose in patients with rheumatoid arthritis is JAKURA 5 mg twice daily.

3. Cancer and immune system problems. ‘Tofacitinib’ may increase your risk of certain cancers by changing the way your immune system works.

• Lymphoma and other cancers including skin cancers can happen in patients taking ‘Tofacitinib’. People taking the higher dose of ‘Tofacitinib’ 10 mg have a higher risk of skin cancers. Tell your healthcare provider if you have ever had any type of cancer.
• Some people who have taken ‘Tofacitinib’ with certain other medicines to prevent kidney transplant rejection have had a problem with certain white blood cells growing out of control

4. Blood clots in the lungs, veins of the legs or arms, and arteries. Blood clots in the lungs (pulmonary embolism, PE), veins of the legs (deep vein thrombosis, DVT) and arteries (arterial thrombosis) have happened more often in patients with rheumatoid arthritis who are 50 years of age and older and with at least 1 heart disease (cardiovascular) risk factor taking a higher than recommended dose of ‘Tofacitinib’. The recommended dose in patients with rheumatoid arthritis is JAKURA 5 mg twice daily. Blood clots in the lungs have also happened in patients with ulcerative colitis. Some people have died from these blood clots.

• Stop taking JAKURA-5 and tell your healthcare provider right away if you develop signs and symptoms of a blood clot, such as sudden shortness of breath or difficulty breathing, chest pain, swelling of the leg or arm, leg pain or tenderness, or redness or discoloration in the leg or arm.

5. Tears (perforation) in the stomach or intestines.

• Tell your healthcare provider if you have had diverticulitis (inflammation in parts of the large intestine) or ulcers in your stomach or intestines. Some people taking ‘Tofacitinib’ can get tears in their stomach or intestines. This happens most often in people who also take nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or methotrexate. Tell your healthcare provider right away if you have fever and stomach-area pain that does not go away, and a change in your bowel habits.

6. Allergic reactions.

• Symptoms such as swelling of your lips, tongue, or throat, or hives (raised, red patches of skin that are often very itchy) that may mean you are having an allergic reaction have been seen in patients taking ‘Tofacitinib’. Some of these reactions were serious. If any of these symptoms occur while you are taking JAKURA-5, stop JAKURA-5 and consult your healthcare provider right away.

7. Changes in certain laboratory test results. Your healthcare provider should do blood tests before you start receiving JAKURA-5 and while you take JAKURA-5 to check for the following side effects:

• changes in lymphocyte counts. Lymphocytes are white blood cells that help the body fight off infections.
• low neutrophil counts. Neutrophils are white blood cells that help the body fight off infections.
• low red blood cell count. This may mean that you have anemia, which may make you feel weak and tired.

Your healthcare provider should routinely check certain liver tests.

You should not receive JAKURA-5 if your lymphocyte count, neutrophil count, or red blood cell count is too low or your liver tests are too high.

Your healthcare provider may stop your JAKURA-5 treatment for a period of time if needed because of changes in these blood test results.

You may also have changes in other laboratory tests, such as your blood cholesterol levels. Your healthcare provider should do blood tests to check your cholesterol levels 4 to 8 weeks after you start receiving JAKURA-5, and as needed after that. Normal cholesterol levels are important to good heart health.

See "What are the possible side effects of ‘Tofacitinib’" for more information about side effects.

‘Tofacitinib’ may cause serious side effects, including:

• See "What is the most important information I should know about JAKURA-5"
• Hepatitis B or C activation infection in people who carry the virus in their blood. If you are a carrier of the hepatitis B or C virus (viruses that affect the liver), the virus may become active while you use ‘Tofacitinib’. Your healthcare provider may do blood tests before you start treatment with ‘Tofacitinib’ and while you are using ‘Tofacitinib’. Tell your healthcare provider if you have any of the following symptoms of a possible hepatitis B or C infection:
• feel very tired
• little or no appetite
• clay-colored bowel movements
• chills
• muscle aches
• skin rash
• skin or eyes look yellow
• vomiting
• fevers
• stomach discomfort
• dark urine

Common side effects of JAKURA 5 in rheumatoid arthritis patients

• upper respiratory tract infections (common cold, sinus infections)
• headache
• diarrhea
• nasal congestion, sore throat, and runny nose (nasopharyngitis)
• high blood pressure (hypertension)

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of JAKURA-5. For more information, ask your healthcare provider.

If such reactions are encountered, please report to the Hetero either by filling of Suspect Adverse Drug Reactions Reporting Form (form.heteroworld.com) or by Hetero Helpline No.1800-120-8689 and for all India safety cases and complaints, please write to drugsafetyindia@heterodrugs.com

Before taking JAKURA-5 , tell your healthcare provider about all of your medical conditions, including if you:

• have an infection. See "What is the most important information I should know about JAKURA-5"
• have had blood clots in the veins of your legs, arms, or lungs, or clots in the arteries in the past.
• have liver problems.
• have kidney problems.
• have any stomach area (abdominal) pain or been diagnosed with diverticulitis or ulcers in your stomach or intestines.
• have had a reaction to tofacitinib or any of the ingredients in JAKURA-5.
• have recently received or are scheduled to receive a vaccine. People who take ‘Tofacitinib’ should not receive live vaccines. People taking ‘Tofacitinib’ can receive non-live vaccines.
• plan to become pregnant or are pregnant. ‘Tofacitinib’ may affect the ability of females to get pregnant. It is not known if this will change after stopping JAKURA-5. It is not known if JAKURA-5 will harm an unborn baby.
• plan to breastfeed or are breastfeeding. You and your healthcare provider should decide if you will take JAKURA-5 or breastfeed. You should not do both. After you stop your treatment with JAKURA-5 do not start breastfeeding again until:
• 18 hours after your last dose of JAKURA 5 or

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. ‘Tofacitinib’ and other medicines may affect each other causing side effects.

Especially tell your healthcare provider if you take:

• any other medicines to treat your rheumatoid arthritis. You should not take tocilizumab, etanercept, adalimumab, infliximab, rituximab, abatacept, anakinra, certolizumab, golimumab, ustekinumab, secukinumab, vedolizumab, azathioprine, cyclosporine, or other immunosuppressive drugs while you are taking JAKURA-5. Taking JAKURA-5 with these medicines may increase your risk of infection.
• medicines that affect the way certain liver enzymes work. Ask your healthcare provider if you are not sure if your medicine is one of these.

Know the medicines you take. Keep a list of them to show your healthcare provider and when you get a new medicine.

Take JAKURA-5 exactly as your healthcare provider tells you to take it.

• Take JAKURA 5, 1 tablet 2 times a day with or without food.
• If you take too much JAKURA-5, consult your healthcare provider or go to the nearest hospital emergency room right away.

• Store JAKURA 5 at a temperature not exceeding 30°C, protect from moisture.
• Safely throw away JAKURA-5 that is out of date or no longer needed.

Keep JAKURA-5 and all medicines out of the reach of children.

General information about the safe and effective use of JAKURA-5.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use JAKURA-5 for a condition for which it was not prescribed. Do not give JAKURA-5 to other people, even if they have the same symptoms you have. It may harm them.

This Medication Guide summarizes the most important information about JAKURA-5. If you would like more information, talk to your healthcare provider. You can ask your or healthcare provider for information about JAKURA-5 that is written for health professionals.