Tofajak In Xr 11mg Tab

TOFAJAK IN XR 11MG TABLET

Name

Common Name: Tofacitinib extended-release. Brand Name: TOFAJAK IN XR 11MG Tablet (by CIPLA-SUPRACARE 1), also known by other brands like Xeljanz XR.

Composition

Active Ingredient: Each extended-release tablet contains Tofacitinib citrate, equivalent to 11 mg of Tofacitinib. Tofacitinib is a Janus kinase (JAK) inhibitor.

Uses

TOFAJAK IN XR 11MG Tablet is prescribed for the management of several autoimmune conditions when other treatments have been ineffective or poorly tolerated. It works by decreasing the activity of the immune system to reduce inflammation.

• Moderate to severely active Rheumatoid Arthritis (RA): Used alone or in combination with other disease-modifying anti-rheumatic drugs (DMARDs) to reduce pain, swelling, and stiffness in joints.
• Active Psoriatic Arthritis (PsA): Helps to control symptoms like joint pain, swelling, and stiffness.
• Moderately to severely active Ulcerative Colitis (UC): Used to induce and maintain remission.
• Ankylosing Spondylitis (AS): For adult patients with active AS who have responded inadequately to conventional therapy.
• Polyarticular course Juvenile Idiopathic Arthritis (pcJIA): In patients 2 years of age and older.

Dosage and Administration

For adults with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis, the typical dosage is 11 mg once a day. For ulcerative colitis, the initial dosage may be 22 mg once daily for at least 8 weeks, which may then be reduced to 11 mg once daily based on response. The tablet should be swallowed whole and intact; it should not be crushed, split, or chewed. It can be taken with or without food. Dosage adjustments may be necessary for patients with moderate or severe renal impairment or moderate hepatic impairment, or those taking certain interacting medications.

Side Effects

Common side effects may include:

• Headache, diarrhea, nausea.
• Upper respiratory tract infections, nasopharyngitis, sore throat, and urinary tract infections.
• Elevated cholesterol levels (LDL and HDL).
• Increased blood creatine phosphokinase.

Serious side effects can include:

• Increased risk of serious infections (e.g., tuberculosis, shingles, pneumonia, skin infections), some of which can be fatal.
• Increased risk of major adverse cardiovascular events (e.g., heart attack, stroke).
• Increased risk of blood clots (e.g., deep vein thrombosis, pulmonary embolism).
• Increased risk of certain cancers (e.g., lymphoma, lung cancer, non-melanoma skin cancer).
• Serious allergic reactions (angioedema, urticaria).
• Liver problems.
• Changes in blood cell counts (lymphopenia, neutropenia, anemia).

Precautions

• Patients should be screened for tuberculosis and other infections before starting treatment and monitored throughout therapy.
• Avoid live vaccines during treatment and shortly after stopping.
• Caution is advised in patients with a history of cardiovascular disease, blood clots, cancer, kidney disease, liver disease, or those who are smokers.
• Report any signs of infection, chest pain, swelling in legs, or unusual bleeding/bruising immediately.
• Tofacitinib may increase the risk of serious infections, cardiovascular events, blood clots, and certain cancers compared to TNF inhibitors, especially in patients aged 50 and older with cardiovascular risk factors.
• Interactions with strong CYP3A4 inhibitors (e.g., ketoconazole) or a combination of moderate CYP3A4 and strong CYP2C19 inhibitors (e.g., fluconazole) require dosage adjustment.
• Pregnancy and breastfeeding: Not recommended; may affect female fertility.

Storage

Store the medicine in a closed container at room temperature, ideally below 30°C (86°F). Protect it from direct sunlight, heat, and moisture. Keep it out of reach of children.

What is TOFAJAK IN XR 11MG used for?

TOFAJAK IN XR 11MG (tofacitinib extended-release) is used to treat several inflammatory and autoimmune conditions. These include moderate to severely active rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis in adults. It is also prescribed for moderately to severely active ulcerative colitis and active polyarticular juvenile idiopathic arthritis. It is typically used when other treatments have not been effective or tolerated.

How does TOFAJAK IN XR 11MG work?

TOFAJAK IN XR 11MG contains the active ingredient tofacitinib, which is a Janus kinase (JAK) inhibitor. It works by blocking the action of specific Janus kinase enzymes involved in the inflammatory response. This action helps to decrease the activity of the immune system and reduce the inflammation associated with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and ulcerative colitis, thereby reducing pain, stiffness, and swelling.

What is the usual dosage of TOFAJAK IN XR 11MG?

For rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis, the usual recommended dose for adults is one 11 mg extended-release tablet once daily. For ulcerative colitis, the induction dose can be 22 mg once daily for at least 8 weeks, followed by a maintenance dose of 11 mg once daily. The exact dosage and duration of treatment should always be determined by your doctor. The tablets should be swallowed whole and not cut, crushed, broken, or chewed.

What are the possible side effects of TOFAJAK IN XR 11MG?

Common side effects may include upper respiratory tract infections, headache, diarrhea, nasopharyngitis (common cold symptoms), nausea, and elevated cholesterol levels.

Serious potential side effects include an increased risk of severe infections (such as tuberculosis, shingles, and other bacterial, viral, or fungal infections), an increased risk of certain cancers (including lymphoma, lung cancer, and non-melanoma skin cancer), serious cardiovascular events (like heart attack or stroke), and blood clots (deep vein thrombosis, pulmonary embolism, arterial thrombosis), especially in individuals aged 50 and older with existing cardiovascular risk factors.

Is TOFAJAK IN XR 11MG safe during pregnancy or breastfeeding?

TOFAJAK IN XR 11MG is generally not recommended during pregnancy due to limited safety data in humans and potential risks identified in animal studies. It is important to use effective birth control to prevent pregnancy while taking this medication. If you become pregnant, contact your doctor immediately.

For breastfeeding, it is recommended to stop breastfeeding while taking TOFAJAK IN XR 11MG and for at least 36 hours after the last dose, as the active ingredient (tofacitinib) passes into breast milk and could cause serious side effects in a breastfed infant.

Can TOFAJAK IN XR 11MG be taken with other medications?

You should inform your doctor about all medications you are taking, including over-the-counter drugs and herbal supplements. TOFAJAK IN XR 11MG should generally not be taken with other biologic disease-modifying anti-rheumatic drugs (DMARDs) or potent immunosuppressants (such as azathioprine or cyclosporine) due to an increased risk of infections and other adverse effects.

Certain medications, like strong CYP3A4 inhibitors (e.g., ketoconazole) or a combination of moderate CYP3A4 inhibitors and strong CYP2C19 inhibitors (e.g., fluconazole), can increase the levels of tofacitinib in your body, requiring a dose adjustment. Conversely, some seizure medications (e.g., phenytoin, carbamazepine) can make TOFAJAK IN XR 11MG less effective. Avoid live vaccines while on this medication.

What precautions should be taken while using TOFAJAK IN XR 11MG?

Several precautions are necessary:

• Infections: You will be screened for tuberculosis (TB) before starting treatment, and your doctor will monitor you for any signs of infection throughout your treatment, including serious bacterial, viral, fungal, or opportunistic infections.
• Cardiovascular and Blood Clot Risk: There's an increased risk of serious heart problems (heart attack, stroke) and blood clots (in legs, lungs, or arteries), particularly for patients aged 50 or older with cardiovascular risk factors or a history of smoking.
• Cancer Risk: An increased risk of certain cancers, including lymphoma, lung cancer, and skin cancer, has been observed.
• Blood Counts & Liver/Cholesterol Monitoring: Regular blood tests will be conducted to monitor your white blood cell counts (lymphocytes, neutrophils), hemoglobin, liver function, and cholesterol levels, as this medication can affect them.
• Vaccinations: Avoid live vaccines while taking this medication.

What happens if a dose of TOFAJAK IN XR 11MG is missed?

If you miss a dose of TOFAJAK IN XR 11MG, 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. If you miss multiple doses or are unsure, consult your healthcare provider for guidance.

How should TOFAJAK IN XR 11MG be stored?

TOFAJAK IN XR 11MG tablets should be stored in a closed container at room temperature, typically between 20°C to 25°C (68°F to 77°F), with excursions permitted between 15°C and 30°C (59°F and 86°F). Keep the medication away from heat, moisture, and direct light, and prevent it from freezing. It should always be kept out of the reach of children.