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TOFAXEL® (Tofacitinib)

TOFAXEL® (Tofacitinib)

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5,10  mg tablets
11 mg ER tablets




INDICATIONS

Tofaxel®/ Tofaxel® ER are indicated for:

• Rheumatoid Arthritis: the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more TNF blockers⃰.

• Psoriatic Arthritis: the treatment of adult patients with active psoriatic arthritis who have had an inadequate response or intolerance to one or more TNF blockers⃰.

• Ankylosing Spondylitis: the treatment of adult patients with active ankylosing spondylitis who have had an inadequate response or intolerance to one or more TNF blockers⃰.

• Ulcerative Colitis: the treatment of adult patients with moderately to severely active ulcerative colitis (UC), who have had an inadequate response or intolerance to one or more TNF blockers⃰⃰⃰⃰⃰ ⃰.

  • Polyarticular Course Juvenile Idiopathic Arthritis: Tofaxel® is indicated for the treatment of active polyarticular course juvenile idiopathic arthritis (pcJIA) in patients 2 years of age and older who have had an inadequate response or intolerance to one or more TNF blockers⃰.

 

⃰  Limitations of Use: Use of Tofaxel®/ Tofaxel® ER in combination with biologic DMARDs or potent immunosuppressants such as azathioprine and cyclosporine is not recommended.

⃰⃰ ⃰ Limitations of Use: Use of Tofaxel®/ Tofaxel® ER in combination with biological therapies for UC or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended.

 

It is not known if Tofaxel® ER is safe and effective in children

DOSAGE AND ADMINISTRATION

Administration Instructions

  • Changes between Tofaxel® and Tofaxel® ER should be made by the healthcare provider.
  • Do not initiate Tofaxel®/ Tofaxel® ER if absolute lymphocyte count <500 cells/mm3, an absolute neutrophil count (ANC) <1000 cells/mm3 or hemoglobin <9 g/dL.

 

Recommended Dosage

Rheumatoid Arthritis

• Tofaxel® 5 mg twice daily or Tofaxel® ER 11 mg once daily with or without food.

• Recommended dosage in patients with moderate and severe renal impairment or moderate hepatic impairment is Tofaxel® 5 mg once daily.

Psoriatic Arthritis (in combination with nonbiologic DMARDs)

• Tofaxel® 5 mg twice daily or Tofaxel® ER 11 mg once daily with or without food.

• Recommended dosage in patients with moderate and severe renal impairment or moderate hepatic impairment is Tofaxel® 5 mg once daily.

Ankylosing Spondylitis

• Tofaxel® 5 mg twice daily or Tofaxel® ER 11 mg once daily with or without food.

• Recommended dosage in patients with moderate and severe renal impairment or moderate hepatic impairment is Tofaxel® 5 mg once daily.

Ulcerative Colitis

• Induction: Tofaxel® 10 mg twice daily for 8 weeks; evaluate patients and transition to maintenance therapy depending on therapeutic response. If needed, continue Tofaxel® 10 mg twice daily for a maximum of 16 weeks. Discontinue Tofaxel® 10 mg twice daily after 16 weeks if adequate therapeutic response is not achieved.

• Maintenance: Tofaxel® 5 mg twice daily or Tofaxel® ER 11 mg once daily. For patients with loss of response during maintenance treatment, Tofaxel® 10 mg twice 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.

Polyarticular Course Juvenile Idiopathic Arthritis

• Tofaxel® 5 mg twice daily or weight-based equivalent twice daily with or without food.

• Dosage adjustment is needed in patients with moderate and severe renal impairment or moderate hepatic impairment.

Dosage Adjustment

  • Use of Tofaxel®/ Tofaxel® ER in patients with severe hepatic impairment is not recommended in any patient population.

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WARNINGS AND PRECAUTIONS

Tofaxel® and Tofaxel® ER may cause serious side effects including:

  • Serious infections. Some people can have serious infections while taking Tofaxel® and Tofaxel® ER, including tuberculosis (TB). These infections can be life threatening.
    • Your healthcare provider should test you for TB before starting Tofaxel® and Tofaxel® ER and during treatment. You should not start taking Tofaxel® and Tofaxel® ER 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 with ulcerative colitis taking the higher dose of Tofaxel® (10 mg twice daily) have a higher risk of serious infections and shingles.

 

Before starting Tofaxel® and Tofaxel® ER, tell your healthcare provider if you:

  • think you have an infection or have symptoms of an infection such as: fever, sweating, or chills, muscle aches, cough, shortness of breath, blood in phlegm, weight loss, warm, red, or painful skin or sores on your body, diarrhea or stomach pain, burning when you urinate or urinating more often than normal, and 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.

     

  • Increased risk of death in people 50 years of age and older who have at least 1 heart disease (cardiovascular) risk factor and are taking Tofaxel® 5 mg twice daily or Tofaxel® 10 mg twice daily.
  • Cancer and immune system problems.
  • Lymphoma and other cancers including lung and skin cancers can happen in patients taking Tofaxel® and Tofaxel® ER. Tell your healthcare provider if you have ever had any type of cancer.
  • Some people who have taken Tofaxel® with certain other medicines to prevent kidney transplant rejection have had Epstein Barr Virus-associated post-transplant lymphoproliferative disorder.
  • Increased risk of major cardiovascular events such as heart attack, stroke or death in people 50 years of age and older who have at least 1 heart disease (cardiovascular) risk factor and are taking Tofaxel® 5 mg twice daily or Tofaxel® 10 mg twice daily, especially if you are a current or past smoker.

    Get emergency help right away if you have any symptoms of a heart attack or stroke while taking Tofaxel®, including:

    • discomfort in the center of your chest that lasts for more than a few minutes, or that goes away and comes back

    • severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw

    • pain or discomfort in your arms, back, neck, jaw, or stomach

    • shortness of breath with or without chest discomfort

    • breaking out in a cold sweat

    • nausea or vomiting

    • feeling lightheaded

    • weakness in one part or on one side of your body

    • slurred speech

     

  • Blood clots in the lungs, veins of the legs or arms, and arteries. Stop taking Tofaxel® and Tofaxel® ER 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. These blood clots can be life threatening.

 

  • Tears (perforation) in the 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.

  • Allergic reactions.
  • Symptoms including swelling of your lips, tongue, or throat, or hives (raised, red patches of skin that are often very itchy). If any of these symptoms occur, stop Tofaxel® and Tofaxel® ER and call your healthcare provider right away.
  • Changes in certain laboratory test results. Your healthcare provider should do blood and liver tests before and while you take Tofaxel® and Tofaxel® ER to check for the following side effects:
  • changes in lymphocyte counts.
  • low neutrophil counts.
  • low red blood cell count.

 

Your healthcare provider should do blood tests to check your cholesterol levels 4 to 8 weeks after you start taking Tofaxel® and Tofaxel® ER, and as needed after that.

 

 

  • Hepatitis B or C activation infection. If you are a carrier of the hepatitis B or C virus, the virus may become active while you use Tofaxel® and Tofaxel® ER. Tell your healthcare provider if you have any of the following symptoms of a possible hepatitis B or C infection:
  • Feel very tired
  • skin or eyes look yellow
  • little or no appetite
  • ·vomiting
  • clay-colored bowel movements
  • fevers
  • chills
  • stomach discomfort
  • muscle aches
  • dark urine
  • skin rash

 

Call your healthcare provider right away if you have aforementioned symptoms.

 

Common side effects

Common side effects of Tofaxel® and Tofaxel® ER in people with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis include:

  • Upper respiratory tract infections (common cold, sinus infections)
  • Headache
  • Diarrhea
  • Nasal congestion, sore throat and runny nose (nasopharyngitis)
  • High blood pressure (hypertension)

Common side effects of Tofaxel® and Tofaxel® ER in patients with ulcerative colitis include:

  • Nasal congestion, sore throat and runny nose (nasopharyngitis)
  • Increased cholesterol levels
  • Headache
  • Upper respiratory tract infections (common cold, sinus infections)
  • Increased muscle enzyme levels
  • Rash
  • Diarrhea
  • Shingles (herpes zoster)

     Common side effects of Tofaxel® in people with polyarticular course juvenile arthritis include:

  • Upper respiratory tract infections (common cold, sinus infections)
  • Nasal congestion, sore throat, and runny nose (nasopharyngitis)
  • Headache
  • Fever
  • Nausea
  • Vomiting

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

DRUG INTERACTIONS
  • Strong CYP3A4 Inhibitors (e.g., ketoconazole)
    • Increased exposure to tofacitinib.
    • Dosage adjustment of Tofaxel® and Tofaxel® ER is recommended.

       

  • Moderate CYP3A4 Inhibitors Coadministered with Strong CYP2C19 Inhibitors (e.g., fluconazole)
  • Increased exposure to tofacitinib.
  • Dosage adjustment of Tofaxel® and Tofaxel® ER is recommended.

 

  • Strong CYP3A4 Inducers (e.g., rifampin)
  • Decreased exposure to tofacitinib and may result in loss of or reduced clinical response.
  • Coadministration with Tofaxel® and Tofaxel® ER is not recommended.

 

  • Immunosuppressive Drugs (e.g., azathioprine, tacrolimus, cyclosporine)
  • Risk of added immunosuppression; coadministration with biologic DMARDs or potent immunosuppressants has not been studied in patients with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, UC, or pcJIA.
  • Coadministration with Tofaxel® and Tofaxel® ER is not recommended.

 

Brouchure

Brouchure




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