Tofajak In Tablet 5 Mg

Name

• Brand Name: TOFAJAK IN TABLET 5 MG, Tofajak, Tofajak-IN
• Common Name: Tofacitinib

Composition Each tablet contains Tofacitinib 5 mg as the active ingredient.

Uses TOFAJAK IN TABLET 5 MG is a Janus kinase (JAK) inhibitor used for the treatment of:

• Moderately to severely active rheumatoid arthritis in adults who have had an inadequate response or intolerance to methotrexate.
• Active psoriatic arthritis in adults who have had an inadequate response or intolerance to methotrexate or other disease-modifying antirheumatic drugs (DMARDs).
• Moderately to severely active ulcerative colitis.
• Ankylosing spondylitis
• Active polyarticular course juvenile idiopathic arthritis (pcJIA) in patients 2 years of age and older.

Dosage and Administration TOFAJAK tablets can be taken with or without food and should be swallowed whole; do not crush, chew, or break them.

• Rheumatoid Arthritis and Psoriatic Arthritis: The recommended dosage is 5 mg twice daily.
• Ulcerative Colitis (Induction): 10 mg (two 5 mg tablets) twice daily for 8 weeks, potentially extending up to 16 weeks if needed.
• Ulcerative Colitis (Maintenance): 5 mg twice daily.
• Dosage Adjustment: For patients with moderate to severe renal impairment or moderate hepatic impairment, the recommended dosage is 5 mg once daily.

Side Effects Common side effects include upper respiratory tract infections, nasopharyngitis, diarrhea, headache, elevated cholesterol levels, increased blood creatine phosphokinase, rash, herpes zoster, nausea, and vomiting. Serious side effects may include severe infections (such as tuberculosis, fungal, bacterial, and viral infections), thrombosis (including pulmonary embolism, deep venous thrombosis, and arterial thrombosis), and an increased risk of certain malignancies.

Precautions Patients treated with TOFAJAK are at an increased risk of developing serious infections, which can be life-threatening. Patients should be tested for latent tuberculosis before and during therapy. The use of TOFAJAK in combination with biologic DMARDs or potent immunosuppressants is not recommended. Caution is advised in patients with a history of chronic or recurrent infections, diabetes, low hemoglobin, low white blood cell count, or hepatitis B or C. Dosage adjustments are required for patients with moderate to severe renal impairment or moderate hepatic impairment; it is not recommended for severe hepatic impairment. TOFAJAK is not recommended during pregnancy or breastfeeding. Regular blood tests are necessary to monitor liver function, kidney function, blood counts, and cholesterol levels.

Storage Store TOFAJAK IN TABLET 5 MG below 30°C in a dry place, protected from light. Keep out of the reach of children.

TOFAJAK IN TABLET 5 MG contains the active ingredient Tofacitinib, which is a Janus kinase (JAK) inhibitor. It is used to treat various inflammatory and autoimmune conditions.

Here are some frequently asked questions about TOFAJAK IN TABLET 5 MG:

What is TOFAJAK IN TABLET 5 MG used for?

TOFAJAK IN TABLET 5 MG is used to manage moderate to severely active rheumatoid arthritis, active psoriatic arthritis, ulcerative colitis, ankylosing spondylitis, and polyarticular course juvenile idiopathic arthritis (pcJIA) in patients who have not responded well to or tolerated other treatments like methotrexate or TNF blockers. It helps reduce pain, tenderness, and swelling in the joints by lowering inflammation, and can also slow the progression of bone and joint damage.

How does TOFAJAK IN TABLET 5 MG work?

Tofacitinib, the active ingredient in TOFAJAK IN TABLET 5 MG, is a Janus kinase (JAK) inhibitor. It works by blocking the action of Janus kinase enzymes (primarily JAK1 and JAK3) inside cells. These enzymes play a crucial role in the signaling pathways of various cytokines and growth factors that influence immune cell function and promote inflammatory responses. By inhibiting JAKs, Tofacitinib disrupts these pathways, reducing the inflammatory response and helping to control the symptoms of autoimmune and inflammatory diseases.

What is the usual dosage of TOFAJAK IN TABLET 5 MG?

For rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis, the typical adult dosage of TOFAJAK 5 mg tablets is 5 mg twice a day. For ulcerative colitis, the initial dosage is often 10 mg twice daily for at least 8 weeks, which may then be reduced to 5 mg twice daily as a maintenance dose. For polyarticular course juvenile idiopathic arthritis, the dose for children aged 2 to 17 years is based on body weight. Your doctor may adjust your dose based on your condition and other factors. TOFAJAK IN TABLET 5 MG can be taken with or without food.

What are the possible side effects of TOFAJAK IN TABLET 5 MG?

Common side effects can include upper respiratory tract infections (such as the common cold, sinus infections), headache, diarrhea, and nasopharyngitis (sore throat, runny nose). More serious side effects are possible due to its effect on the immune system, including:

• Increased risk of infections: This medicine can lower your ability to fight infections, including serious bacterial, fungal, viral, and opportunistic infections like tuberculosis and shingles.
• Changes in blood cell counts: Tofacitinib can temporarily lower white blood cell counts, increasing the risk of infection. It can also affect red blood cell counts and platelets. Regular blood tests are needed to monitor this.
• Elevated cholesterol levels: Increases in total, LDL, and HDL cholesterol can occur, and blood lipid levels should be monitored.
• Liver enzyme abnormalities: Tofacitinib can cause changes in liver enzyme levels, requiring routine monitoring.
• Serious cardiovascular events: There is an increased risk of heart attack and stroke, especially in rheumatoid arthritis patients aged 50 and older with existing cardiovascular risk factors.
• Blood clots: An increased risk of blood clots (e.g., deep vein thrombosis, pulmonary embolism) has been observed, particularly in certain patient populations.
• Malignancies: An increased risk of certain cancers, including lymphoma, lung cancer, and non-melanoma skin cancer, has been reported.

You should contact your doctor immediately if you experience severe symptoms or signs of infection, chest pain, swelling in legs, or unusual bleeding or bruising.

Is TOFAJAK IN TABLET 5 MG safe during pregnancy or breastfeeding?

Using Tofacitinib during pregnancy is not recommended as it can harm an unborn baby. Women who can become pregnant should use effective birth control while taking this medicine. If pregnancy occurs, contact your doctor immediately.

It is also generally recommended not to breastfeed while taking TOFAJAK IN TABLET 5 MG due to limited information on its safety and reports that tofacitinib passes into human breast milk. If you are taking immediate-release tablets, you should not breastfeed for at least 18 hours after the last dose.

Can TOFAJAK IN TABLET 5 MG be taken with other medications?

TOFAJAK IN TABLET 5 MG can interact with other medications. It is often used with other nonbiologic disease-modifying anti-rheumatic drugs (DMARDs) like methotrexate. However, it is not recommended to be used in combination with biologic DMARDs or potent immunosuppressants like azathioprine or cyclosporine due to an increased risk of severe immunosuppression and infection.

Interactions can also occur with:

• Strong CYP3A4 inhibitors: Medications like oral antifungals (e.g., ketoconazole, fluconazole) and macrolide antibiotics can increase Tofacitinib levels, raising the risk of side effects. A lower dose of Tofacitinib may be needed.
• CYP3A4 inducers: Certain seizure medications (e.g., phenytoin, carbamazepine) can decrease Tofacitinib levels, making it less effective. Always inform your doctor about all medications, supplements, and herbal products you are taking.

What precautions should be taken with TOFAJAK IN TABLET 5 MG?

Several precautions are important when taking TOFAJAK IN TABLET 5 MG:

• Infections: Do not start treatment if you have an active infection. Your doctor will screen you for infections, including tuberculosis (TB) and hepatitis B/C, before and during treatment.
• Vaccinations: Avoid live vaccines while taking Tofacitinib and after stopping treatment, as your immune system is suppressed.
• Cardiovascular and cancer risk: Patients aged 50 and older with at least one cardiovascular risk factor, or those with cancer risk factors, may have an increased risk of serious adverse events. Discuss your medical history with your doctor.
• Blood monitoring: Regular blood tests are necessary to monitor blood cell counts, liver function, kidney function, and cholesterol levels.
• Surgery: If you need surgery, your doctor may advise stopping Tofacitinib one week beforehand.
• Digestive system: Rarely, there is an increased risk of gastrointestinal perforations, particularly with other risk factors.

What happens if a dose is missed?

If you miss a dose of TOFAJAK IN TABLET 5 MG, take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. Inform your healthcare provider about any missed doses.

How should TOFAJAK IN TABLET 5 MG be stored?

Store TOFAJAK IN TABLET 5 MG in a closed container at room temperature, away from heat, moisture, and direct light. Keep it from freezing. For oral solutions, store in the original bottle and carton to protect from light and use within 60 days of opening.