Tofator 5 5 mg Tablet

Tofator 5 5 mg tablet by Square Pharmaceuticals PLC, Gazipur is a medicine containing Tofacitinib. In Bangladesh, it is mainly used on a doctor’s prescription for inflammatory autoimmune conditions such as rheumatoid arthritis, and sometimes for other approved conditions where reducing immune-related inflammation is needed.

Tofacitinib works by blocking Janus kinase enzymes, which are involved in inflammatory signalling in the body. A key caution is that it can increase the risk of serious infections and other serious adverse events, so medical screening and monitoring are important.

• Moderate to severe rheumatoid arthritis in adults when suitable disease-modifying treatment is needed.
• Active psoriatic arthritis in adults, usually when previous treatment has not worked well enough or was not tolerated.
• Active ankylosing spondylitis in adults, where approved and considered appropriate by a specialist.
• Moderate to severe ulcerative colitis in adults, where approved and prescribed by a specialist.
• Polyarticular course juvenile idiopathic arthritis in eligible children/adolescents where approved; dosing and formulation must be decided by a specialist.

The dose and schedule of Tofacitinib depend on the condition being treated, the dosage form, kidney and liver function, blood test results, other medicines, and infection risk. Immediate-release tablets are commonly taken on a regular daily schedule, while extended-release tablets are designed for once-daily use and should be swallowed whole. Do not crush, split, or chew XR tablets. Always follow the prescribing doctor’s exact instructions and do not start, stop, or change the dose without medical advice.

• Common effects may include upper respiratory tract infection, headache, diarrhoea, nausea, indigestion, high blood pressure, and increased cholesterol levels.
• It may lower white blood cells, red blood cells, or other blood counts, and may affect liver enzymes; blood tests are usually needed.
• Serious risks include severe infections such as tuberculosis, pneumonia, fungal infections, and shingles.
• Seek urgent medical help for fever, persistent cough, shortness of breath, painful rash/blisters, chest pain, weakness on one side, severe abdominal pain, black stools, or signs of blood clots such as leg swelling or sudden breathlessness.
• Long-term or high-risk use has been associated with increased risks of malignancy, major cardiovascular events, and thrombosis in some patients.

Tofacitinib should be used carefully in people with current or recurrent infections, a history of tuberculosis or hepatitis B/C, diabetes, chronic lung disease, kidney or liver problems, low blood counts, high cholesterol, cancer history, smoking history, heart disease, stroke risk, or previous blood clots. Screening for tuberculosis and viral hepatitis, vaccination review, and regular blood tests may be required. Avoid live vaccines during treatment. Use this medicine only under the guidance of a registered doctor or pharmacist.

• Strong CYP3A4 inhibitors such as ketoconazole, and medicines such as fluconazole that affect CYP3A4/CYP2C19, can increase tofacitinib levels and may require dose adjustment or avoidance.
• Strong CYP3A4 inducers such as rifampicin may reduce effectiveness and are generally avoided.
• Combining with biologic DMARDs or potent immunosuppressants such as azathioprine, cyclosporine, or tacrolimus can increase infection risk and is generally not recommended.
• Live vaccines should be avoided during treatment; needed vaccines should preferably be given before starting therapy.
• Grapefruit or grapefruit juice may increase exposure to some CYP3A4-metabolised medicines; ask a healthcare professional for individual advice.

• Do not use in anyone with known hypersensitivity to tofacitinib or any component of the product.
• It should not be started in patients with active serious infection, including active tuberculosis.
• Use is generally not recommended in severe liver impairment.
• It should not be used together with biologic DMARDs or strong immunosuppressants unless specifically directed by a specialist.

Tofacitinib is generally avoided during pregnancy unless a specialist decides that the potential benefit clearly outweighs the risk. Women who may become pregnant should discuss contraception and treatment planning with their doctor. Breastfeeding is not recommended during treatment and for a period after the last dose; follow the prescribing doctor’s advice on timing.

Store at room temperature, protected from excess heat and moisture, and keep in the original packaging until use. Keep out of the reach of children. Do not use after the expiry date or if the tablet packaging is damaged.