Tofacinix (Tofacitinib) 5mg

Tofacinix (Tofacitinib) is a generic inhibitor of Janus kinases (JAKs) indicated for the treatment of:

1. Adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. It may be used as monotherapy or in combination with methotrexate or other nonbiologic disease-modifying antirheumatic drugs (DMARDs).

• Limitations of Use: Use of Tofacinix (Tofacitinib) in combination with biologic DMARDs or potent immunosuppressants such as azathioprine and cyclosporine is not recommended.

2. Adult patients with active psoriatic arthritis who have had an inadequate response or intolerance to methotrexate or other disease-modifying antirheumatic drugs (DMARDs). 

• Limitations of Use: Use of Tofacinix (Tofacitinib) in combination with biologic DMARDs or potent immunosuppressants such as azathioprine and cyclosporine is not recommended.

3. Ulcerative Colitis: Tofacinix (Tofacitinib) is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC), who have had an inadequate response or who are intolerant to TNF blockers.

• Limitations of Use: Use of Tofacinix (Tofacitinib) in combination with biological therapies for UC or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended.

4. Polyarticular Course Juvenile Idiopathic Arthritis: Tofacinix (Tofacitinib)  Oral Solution is indicated for the treatment of active polyarticular course juvenile idiopathic arthritis (pcJIA) in patients 2 years of age and older.

• Limitations of Use: Use of Tofacinix (Tofacitinib) Oral Solution in combination with biologic DMARDs or potent immunosuppressants such as azathioprine and cyclosporine is not recommended.

Tofacitinib DOSAGE

1.Rheumatoid Arthritis

• Recommended dose of Tofacinix (Tofacitinib) is 5 mg twice daily.
• Recommended dose of Tofacitinib 11 mg once daily.
• Recommended dose in patients with moderate and severe renal impairment and moderate hepatic impairment is Tofacinix (Tofacitinib) 5 mg once daily.
• Use of Tofacinix (Tofacitinib) (Tofacitinib 11mg) in patients with severe hepatic impairment is not recommended.

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2.Psoriatic Arthritis

• Recommended dose of Tofacinix (Tofacitinib) is 5 mg twice daily, used in combination with nonbiologic DMARDs.
• Recommended dose of (Tofacitinib) 11 mg once daily, used in combination with nonbiologic DMARDs.
• Recommended dose in patients with moderate and severe renal impairment and moderate hepatic impairment is Tofacinix (Tofacitinib) 5 mg once daily.
• Use of Tofacinix Tofacitinib/ (Tofacitinib 11mg) in patients with severe hepatic impairment is not recommended. 

3.Ulcerative Colitis

• Induction: Tofacinix (Tofacitinib) 10 mg twice daily or Tofacinix (Tofacitinib) 22 mg once daily for 8 weeks; evaluate patients and transition to maintenance therapy depending on therapeutic response. If needed, continue Tofacinix (Tofacitinib) 10 mg twice daily or Tofacinix (Tofacitinib) 22 mg once daily for a maximum of 16 weeks. Discontinue Tofacinix (Tofacitinib) 10 mg twice daily or Tofacinix (Tofacitinib) 22 mg once daily after 16 weeks if adequate therapeutic response is not achieved. 
• Maintenance: Tofacinix (Tofacitinib) 5 mg twice daily or Tofacinix (Tofacitinib) 11 mg once daily. For patients with loss of response during maintenance treatment, Tofacinix (Tofacitinib)10 mg twice daily or Tofacinix (Tofacitinib) 22 mg once daily may be considered and limited to the shortest duration, with careful consideration of the benefits and risks for the individual patient. Use the lowest effective dose needed to maintain response. 
• Dosage adjustment is needed in patients with moderate and severe renal impairment or moderate hepatic impairment: see full prescribing information. 

4.Polyarticular Course Juvenile Idiopathic Arthritis

• Tofacinix (Tofacitinib) Oral Solution 5 mg twice daily or weight-based equivalent twice daily. 
• Dosage adjustment is needed in patients with moderate and severe renal impairment or moderate hepatic impairment: see full prescribing information.

Tofacitinib Side Effects：
1.Serious infections.
TOFACITINIB 5MG/11MG is a medicine that affects your immune system. TOFACITINIB 5MG/11MG can lower the ability of your immune system to fight infections. Some people can have serious infections while taking TOFACITINIB 5MG/11MG, 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 5MG/11MG and during treatment.
• Your healthcare provider should monitor you closely for signs and symptoms of TB infection during treatment with TOFACITINIB 5MG/11MG.

You should not start taking TOFACITINIB 5MG/11MG 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).

Before starting TOFACITINIB 5MG/11MG, tell your healthcare provider if you:

• think you have an infection or have symptoms of an infection such as:
• 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.
• live or have lived, or have traveled to certain parts of the country (such as the Ohio and Mississippi River valleys and the Southwest) where there is an increased chance for getting certain kinds of fungal infections (histoplasmosis, coccidioidomycosis, or blastomycosis). These infections may happen or become more severe if you use TOFACITINIB 5MG/11MG. Ask your healthcare provider if you do not know if you have lived in an area where these infections are common.

1. have or have had hepatitis B or C.
2. ever, sweating, or chills
3. cough
4. blood in phlegm
5. warm, red, or painful skin or sores on your body
6. burning when you urinate or urinating more often than normal
7. muscle aches
8. shortness of breath
9. weight loss
10. diarrhea or stomach pain
11. feeling very tired

Cancer and immune system problems. After starting TOFACITINIB 5MG/11MG, call your healthcare provider right away if you have any symptoms of an infection. TOFACITINIB 5MG/11MG can make you more likely to get infections or make worse any infection that you have.

TOFACITINIB 5MG/11MG 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 5MG/11MG. 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 (Epstein Barr Virus-associated post-transplant lymphoproliferative disorder).
• 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 5MG/11MG 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.
• Changes in certain laboratory test results. Your healthcare provider should do blood tests before you start receiving TOFACITINIB 5MG/11MG and while you take TOFACITINIB 5MG/11MG 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 TOFACITINIB 5MG/11MG 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 TOFACITINIB 5MG/11MG 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 TOFACITINIB 5MG/11MG, and as needed after that. Normal cholesterol levels are important to good heart health

Generic Tofacitinib Cost& Price：

Generic Tofacitinib’s price is 5-10% of the brand Tofacitinib

Tofacitinib PI

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