Xeljanz 11 mg XR 30 Tablets

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Tofacitinib 11 mg Extended-release (XR) tablets

What Tofacitinib is used for:

Tofacitinib a medicine that is used to for the treatment of the following indications:
Adults with moderately to severely active rheumatoid arthritis (RA; long-term autoimmune disease in which your immune system attacks primarily your joints), after taking another medicine known as methotrexate that did not give good results.
Adults with active psoriatic arthritis (type of joint inflammation) in which methotrexate or other similar medicines known as nonbiologic disease-modifying antirheumatic drugs (DMARDs) did not give good result.
Adults with moderately to severely active ulcerative colitis (a type of inflammatory bowel disease).
It is not known if this medicine is safe and effective for the treatment of patients with Hepatitis B or C (a type of liver viral infection). Tofacitinib is not recommended for patients who have severe liver problems.
It is not known if Tofacitinib is safe and effective in children.

Do not take Tofacitinib:

If you are allergic to Tofacitinib, or any of the ingredients in this medicine.
Tell your doctor about the allergy and what signs you had.

Warnings and Precautions:

Stop the medication right away and talk to your doctor or pharmacist if you develop allergic reactions such as shortness of breath, skin rash, swelling of the face or neck, decreased blood pressure and dizziness.
Make sure that you tell your doctor about all your medical problems before you receive this medicine including if you have an infection, liver problems, kidney problems, any abdominal pain, previously experienced a reaction to Tofacitinib or any of the ingredients in this product.
Make sure that you tell your doctor about all your medical problems before you receive this medicine including if you have recently received or are scheduled to receive a vaccine.
You and your doctor should make sure that all your vaccines are up-to-date before you start this medicine.
You should not receive any live vaccines when taking this medicine. However, you can still receive non-live vaccines.
This medicine may increase the risk of developing shingles (herpes zoster).
Patients taking the higher dose (10 mg twice daily) of tofacitinib are at higher risk of developing serious infections and shingles.
Make sure that you tell your doctor before you receive this medicine if you are pregnant, breastfeeding, plan to get pregnant.
This medicine may affect the ability of females to get pregnant. It is unknown if this effect lasts after stopping the medicine. Talk to your doctor for advice.
This medicine may affect your immune system which may lead to serious Infections including tuberculosis, and bacterial, viral or fungal infections that can spread throughout the body.
These infections may be deadly if not treated. Your doctor should test you for tuberculosis before you start taking this medicine and should make sure that he/she monitors you for tuberculosis development throughout the treatment.
You should not use this medicine if you have an infection unless prescribed by your doctor.
Make sure that you tell your doctor if you have an infection (including localized infections) or signs of infection (developed during or before start of therapy) with or without fever like weight loss, sweating, chills, difficulty breathing, muscle aches, tiredness, cough, abdominal pain, diarrhea, increased urination or burning when urinating, blood in phlegm, sores on your body or warm red or painful skin. In case of a serious infection, this medicine should be stopped until the infection is controlled.
Make sure that you tell your doctor before starting this medicine if you have or have previously had Hepatitis B or Hepatitis C infection (type of viral liver infections), if you are receiving a treatment for an infection, or if you experience a lot of infections or have recurrent infections.
You should also tell your doctor if you have diabetes (high blood glucose levels), HIV, or a weak immune system as these conditions may put you at higher risk for infections.
Additionally, you should tell your doctor before starting this medicine if you have tuberculosis, or if you have been in close contact with someone who has tuberculosis.
You should tell your doctor before starting this medicine if you currently live or have previously lived or traveled to certain parts of the world (such as the Ohio and Mississippi River valleys and the Southwest) where the chance of developing some types of fungal infections (histoplasmosis, coccidioidomycosis, or blastomycosis) is higher.
These infections may occur or be more severe if you are also taking this medicine. Ask your healthcare provider, if you are not sure if you have lived in an area where these infections are common.
This medicine may cause gastrointestinal (stomach or bowel) perforation (tears), especially if you have predisposing risk factors like if you have been previously diagnosed with diverticulitis (infection or inflammation of pouches that can form in your intestines), if you have ulcers in your stomach or intestines or if you are taking nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or methotrexate. Make sure that you tell your doctor before starting this medicine if you have any of these risk factors.
Talk to your doctor if you experience gastrointestinal signs like abdominal pain (stomach pain) that does not go away, change in bowel habits or fever.
Your healthcare provider should recommend laboratory monitoring of some blood tests before you start using this medicine due to its potential in causing changes in neutrophils, lymphocytes, lipids, red blood cells and liver function tests.
Blood tests that your healthcare provider should be doing include neutrophils count which are white blood cells that help your body in fighting bacterial infections (due to the risk of low neutrophil count), lymphocytes count which are white blood cells that help your body in fighting viral infections (due to the risk of low lymphocytes count), red blood cells (due to the risk of low levels of red blood cells which may cause anemia and weakness), certain liver function tests and blood cholesterol levels (due to the risk of increase or change in blood cholesterol levels). Your healthcare provider should test your blood cholesterol levels every 4 to 8 weeks after you start receiving this medicine, and as needed after that.
You should not use this medicine if you have too low neutrophil, red blood cell, lymphocyte counts or too high liver function tests. Your healthcare provider may stop your treatment with this medicine for a period of time.
This medicine may increase the risk of certain cancers due to its ability to change how your immune system functions. Make sure that you tell your healthcare provider if you have ever had any type of cancer.
Lymphoma and other types of cancers including skin cancers may occur in patients taking tofacitinib XR. Patients taking the higher dose (10 mg twice daily) of tofacitinib are at a higher risk of developing skin cancers.
Some patients who have taken tofacitinib with some other medications to prevent kidney transplant rejection have experienced a problem with some white blood cells growing out of control (Epstein Barr Virus-associated post-transplant lymphoproliferative disorder).

Possible side effects:

Possible side effects include allergic reactions, signs of hepatitis B or C infections if you carry the virus (a type of virus that affects the liver), like tiredness, yellow skin or eyes, decreased appetite, vomiting, fevers, clay-colored bowel movements, chills, muscle aches, stomach discomfort, skin rash or dark urine.
Common side effects of Tofacitinib in rheumatoid arthritis patients and psoriatic arthritis patients include upper respiratory tract infections (common cold, sinus infections), headache, sore throat and runny nose (nasopharyngitis), high blood pressure, nasal congestion and diarrhea.
Common side effects of Tofacitinib tablets (immediate release) in ulcerative colitis patients include increased cholesterol levels, diarrhea, shingles (herpes zoster), sore throat, nasal congestion, and runny nose (nasopharyngitis), headache, increased muscle enzyme levels, rash and upper respiratory tract infections (common cold, sinus infections).

Other medicines and Tofacitinib:

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medications including prescription medicines, over the counter medicines, herbals, vitamins and supplements.
If you are taking other medicines to treat your rheumatoid arthritis, ulcerative colitis or psoriatic arthritis. You should not take any of the following medicines; azathioprine, cyclosporine or other immunosuppressants, tocilizumab, ustekinumab, secukinumab, vedolizumab, adalimumab, etanercept, rituximab, anakinra, certolizumab, abatacept, infliximab, or golimumab with this medicine due to the increased risk of infection when used concomitantly.
If you are taking medications that may affect how some liver enzymes function. Consult your healthcare provider if you are not sure if the medicine you are taking is one of them.

How to take Tofacitinib:

Take your medication exactly as prescribed by your doctor. Your doctor will determine the dose that you need to take.
Take Tofacitinib tablets twice a day with or without food.
Take Tofacitinib XR tablets once a day with or without food for rheumatoid or psoriatic arthritis.
Tofacitinib XR tablets should not be taken for ulcerative colitis.
Swallow Tofacitinib XR tablets whole and intact. Make sure that you do not crush, split, or chew the XR tablets.
When you take tofacitinib XR tablets, you may notice the empty shell from the tablet after the medicine has been absorbed by your body as something in your stool that is similar to a tablet.
If you are being treated for psoriatic arthritis, you will have to take tofacitinib in combination with methotrexate, sulfasalazine or leflunomide as directed by your healthcare provider.

How to store Tofacitinib:

Keep out of the reach of children and pets
Store medication at room temperature at 20 to 25 °C
Do not use beyond the expiry date mentioned on the box
Keep medication in its original pack to protect it from moisture and light
Do not dispose medication in the wastewater or household waste

Product Details:

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Xeljanz 11 mg XR 30 Tablets

Genuine brands

Temperature Controlled

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About Product

Tofacitinib 11 mg Extended-release (XR) tablets

What Tofacitinib is used for:

Tofacitinib a medicine that is used to for the treatment of the following indications:
Adults with moderately to severely active rheumatoid arthritis (RA; long-term autoimmune disease in which your immune system attacks primarily your joints), after taking another medicine known as methotrexate that did not give good results.
Adults with active psoriatic arthritis (type of joint inflammation) in which methotrexate or other similar medicines known as nonbiologic disease-modifying antirheumatic drugs (DMARDs) did not give good result.
Adults with moderately to severely active ulcerative colitis (a type of inflammatory bowel disease).
It is not known if this medicine is safe and effective for the treatment of patients with Hepatitis B or C (a type of liver viral infection). Tofacitinib is not recommended for patients who have severe liver problems.
It is not known if Tofacitinib is safe and effective in children.

Do not take Tofacitinib:

If you are allergic to Tofacitinib, or any of the ingredients in this medicine.
Tell your doctor about the allergy and what signs you had.

Warnings and Precautions:

Stop the medication right away and talk to your doctor or pharmacist if you develop allergic reactions such as shortness of breath, skin rash, swelling of the face or neck, decreased blood pressure and dizziness.
Make sure that you tell your doctor about all your medical problems before you receive this medicine including if you have an infection, liver problems, kidney problems, any abdominal pain, previously experienced a reaction to Tofacitinib or any of the ingredients in this product.
Make sure that you tell your doctor about all your medical problems before you receive this medicine including if you have recently received or are scheduled to receive a vaccine.
You and your doctor should make sure that all your vaccines are up-to-date before you start this medicine.
You should not receive any live vaccines when taking this medicine. However, you can still receive non-live vaccines.
This medicine may increase the risk of developing shingles (herpes zoster).
Patients taking the higher dose (10 mg twice daily) of tofacitinib are at higher risk of developing serious infections and shingles.
Make sure that you tell your doctor before you receive this medicine if you are pregnant, breastfeeding, plan to get pregnant.
This medicine may affect the ability of females to get pregnant. It is unknown if this effect lasts after stopping the medicine. Talk to your doctor for advice.
This medicine may affect your immune system which may lead to serious Infections including tuberculosis, and bacterial, viral or fungal infections that can spread throughout the body.
These infections may be deadly if not treated. Your doctor should test you for tuberculosis before you start taking this medicine and should make sure that he/she monitors you for tuberculosis development throughout the treatment.
You should not use this medicine if you have an infection unless prescribed by your doctor.
Make sure that you tell your doctor if you have an infection (including localized infections) or signs of infection (developed during or before start of therapy) with or without fever like weight loss, sweating, chills, difficulty breathing, muscle aches, tiredness, cough, abdominal pain, diarrhea, increased urination or burning when urinating, blood in phlegm, sores on your body or warm red or painful skin. In case of a serious infection, this medicine should be stopped until the infection is controlled.
Make sure that you tell your doctor before starting this medicine if you have or have previously had Hepatitis B or Hepatitis C infection (type of viral liver infections), if you are receiving a treatment for an infection, or if you experience a lot of infections or have recurrent infections.
You should also tell your doctor if you have diabetes (high blood glucose levels), HIV, or a weak immune system as these conditions may put you at higher risk for infections.
Additionally, you should tell your doctor before starting this medicine if you have tuberculosis, or if you have been in close contact with someone who has tuberculosis.
You should tell your doctor before starting this medicine if you currently live or have previously lived or traveled to certain parts of the world (such as the Ohio and Mississippi River valleys and the Southwest) where the chance of developing some types of fungal infections (histoplasmosis, coccidioidomycosis, or blastomycosis) is higher.
These infections may occur or be more severe if you are also taking this medicine. Ask your healthcare provider, if you are not sure if you have lived in an area where these infections are common.
This medicine may cause gastrointestinal (stomach or bowel) perforation (tears), especially if you have predisposing risk factors like if you have been previously diagnosed with diverticulitis (infection or inflammation of pouches that can form in your intestines), if you have ulcers in your stomach or intestines or if you are taking nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or methotrexate. Make sure that you tell your doctor before starting this medicine if you have any of these risk factors.
Talk to your doctor if you experience gastrointestinal signs like abdominal pain (stomach pain) that does not go away, change in bowel habits or fever.
Your healthcare provider should recommend laboratory monitoring of some blood tests before you start using this medicine due to its potential in causing changes in neutrophils, lymphocytes, lipids, red blood cells and liver function tests.
Blood tests that your healthcare provider should be doing include neutrophils count which are white blood cells that help your body in fighting bacterial infections (due to the risk of low neutrophil count), lymphocytes count which are white blood cells that help your body in fighting viral infections (due to the risk of low lymphocytes count), red blood cells (due to the risk of low levels of red blood cells which may cause anemia and weakness), certain liver function tests and blood cholesterol levels (due to the risk of increase or change in blood cholesterol levels). Your healthcare provider should test your blood cholesterol levels every 4 to 8 weeks after you start receiving this medicine, and as needed after that.
You should not use this medicine if you have too low neutrophil, red blood cell, lymphocyte counts or too high liver function tests. Your healthcare provider may stop your treatment with this medicine for a period of time.
This medicine may increase the risk of certain cancers due to its ability to change how your immune system functions. Make sure that you tell your healthcare provider if you have ever had any type of cancer.
Lymphoma and other types of cancers including skin cancers may occur in patients taking tofacitinib XR. Patients taking the higher dose (10 mg twice daily) of tofacitinib are at a higher risk of developing skin cancers.
Some patients who have taken tofacitinib with some other medications to prevent kidney transplant rejection have experienced a problem with some white blood cells growing out of control (Epstein Barr Virus-associated post-transplant lymphoproliferative disorder).

Possible side effects:

Possible side effects include allergic reactions, signs of hepatitis B or C infections if you carry the virus (a type of virus that affects the liver), like tiredness, yellow skin or eyes, decreased appetite, vomiting, fevers, clay-colored bowel movements, chills, muscle aches, stomach discomfort, skin rash or dark urine.
Common side effects of Tofacitinib in rheumatoid arthritis patients and psoriatic arthritis patients include upper respiratory tract infections (common cold, sinus infections), headache, sore throat and runny nose (nasopharyngitis), high blood pressure, nasal congestion and diarrhea.
Common side effects of Tofacitinib tablets (immediate release) in ulcerative colitis patients include increased cholesterol levels, diarrhea, shingles (herpes zoster), sore throat, nasal congestion, and runny nose (nasopharyngitis), headache, increased muscle enzyme levels, rash and upper respiratory tract infections (common cold, sinus infections).

Other medicines and Tofacitinib:

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medications including prescription medicines, over the counter medicines, herbals, vitamins and supplements.
If you are taking other medicines to treat your rheumatoid arthritis, ulcerative colitis or psoriatic arthritis. You should not take any of the following medicines; azathioprine, cyclosporine or other immunosuppressants, tocilizumab, ustekinumab, secukinumab, vedolizumab, adalimumab, etanercept, rituximab, anakinra, certolizumab, abatacept, infliximab, or golimumab with this medicine due to the increased risk of infection when used concomitantly.
If you are taking medications that may affect how some liver enzymes function. Consult your healthcare provider if you are not sure if the medicine you are taking is one of them.

How to take Tofacitinib:

Take your medication exactly as prescribed by your doctor. Your doctor will determine the dose that you need to take.
Take Tofacitinib tablets twice a day with or without food.
Take Tofacitinib XR tablets once a day with or without food for rheumatoid or psoriatic arthritis.
Tofacitinib XR tablets should not be taken for ulcerative colitis.
Swallow Tofacitinib XR tablets whole and intact. Make sure that you do not crush, split, or chew the XR tablets.
When you take tofacitinib XR tablets, you may notice the empty shell from the tablet after the medicine has been absorbed by your body as something in your stool that is similar to a tablet.
If you are being treated for psoriatic arthritis, you will have to take tofacitinib in combination with methotrexate, sulfasalazine or leflunomide as directed by your healthcare provider.

How to store Tofacitinib: