Product Information
Tofaxen (Tofacitinib) 5mg is an oral Janus Kinase (JAK) inhibitor used to treat moderately to severely active Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA), and Ulcerative Colitis (UC) in adult patients who have had an inadequate response or intolerance to methotrexate or other standard therapy. It works by modulating the JAK/STAT signalling pathway, blocking the phosphorylation and activation of signal transducers (STATs) that drive chronic inflammation and abnormal immune activity. Manufactured by Everest Pharmaceuticals Ltd., Bangladesh and globally supplied by Mediaid Pharmacy with worldwide shipping.
Basic Product Information of Tofaxen (Tofacitinib) 5mg
| Brand Name | Tofaxen (Tofacitinib) |
| Generic Name | Tofacitinib (as Tofacitinib Citrate) INN |
| Drug Class | Janus Kinase (JAK) Inhibitor |
| Available Strength | 5mg |
| Formulation | Film-Coated Tablet |
| Pack Size | 60 Tablets per Pack |
| Primary Indication | Rheumatoid Arthritis, Psoriatic Arthritis and Ulcerative Colitis |
| Regulatory Approvals | USFDA Approved (RA, PsA, UC). Carries an FDA Boxed Warning for infection, mortality, malignancy, MACE, and thrombosis risk. |
| Originator Brand | Xeljanz / Xeljanz XR by Pfizer |
| Manufacturer | Everest Pharmaceuticals Ltd., Dhaka, Bangladesh |
| Global Supplier | Mediaid Pharmacy, Worldwide Shipping Available |
| Registration Status | Export Only – Manufactured for International Markets |
| Storage Conditions | Store below 30 degrees Celsius. Protect from light and moisture. Keep out of the reach of children. |
How Tofaxen (Tofacitinib) Works
Tofaxen contains Tofacitinib, a potent, selective inhibitor of the Janus kinase (JAK) family of enzymes, preferentially inhibiting JAK1 and JAK3 with functional selectivity over JAK2. JAKs are intracellular enzymes that transmit signals from cytokine and growth factor receptors on the cell membrane, and play a key role in haematopoiesis and immune cell function.
In conditions such as rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis, these signalling pathways become chronically overactive, driving persistent inflammation and tissue damage. Tofacitinib modulates signalling at the point of the JAKs, preventing the phosphorylation and activation of signal transducers and activators of transcription (STATs). By interrupting this cascade, Tofaxen reduces the inflammatory signals responsible for joint pain, swelling, and bowel inflammation in these autoimmune conditions.
Unlike biologic therapies that require injection or infusion, Tofaxen is a convenient oral tablet, offering patients an effective alternative for managing chronic inflammatory disease once other standard therapies have proven inadequate.
Indications for Tofaxen (Tofacitinib)
Tofaxen (Tofacitinib) is indicated for the following conditions:
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Rheumatoid Arthritis (RA) For adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. May be used as monotherapy or in combination with methotrexate or other non-biologic DMARDs. |
Psoriatic Arthritis (PsA) For adult patients with active psoriatic arthritis who have had an inadequate response or intolerance to methotrexate or other non-biologic DMARDs. |
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Ulcerative Colitis (UC) For adult patients with moderately to severely active ulcerative colitis who have had an inadequate response or intolerance to conventional or biologic therapy, using an initial higher-dose induction course followed by a lower maintenance dose. |
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Benefits of Tofaxen (Tofacitinib) 5mg
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Oral Alternative to Biologics Tofaxen offers a convenient tablet-based option for patients who might otherwise require injectable or infused biologic therapy for their inflammatory condition. |
Multi-Condition Coverage Approved for rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis, Tofaxen offers a versatile treatment option across several chronic inflammatory conditions. |
Combination Therapy Compatible Tofaxen can be used as monotherapy or in combination with methotrexate or other non-biologic DMARDs, giving physicians flexibility in treatment planning. |
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Affordable Alternative to Xeljanz Tofaxen contains the same active ingredient as Xeljanz by Pfizer, at a significantly lower cost, making long-term treatment more financially accessible for patients worldwide. |
Flexible Induction and Maintenance Dosing For ulcerative colitis, Tofaxen supports a higher-dose induction phase followed by a lower maintenance dose, allowing treatment to be tailored to disease response. |
cGMP Certified Manufacturing Produced by Everest Pharmaceuticals Ltd. under cGMP-compliant manufacturing standards, helping ensure consistent quality, purity, and potency in every batch of Tofaxen tablets. |
How to Take Tofaxen (Tofacitinib)
Route: Oral, taken by mouth, with or without food.
Standard dose for RA and PsA: 5mg (one tablet) taken twice daily, exactly as directed by the prescribing physician.
Standard dose for UC: 10mg (two 5mg tablets) taken twice daily for induction, for 8 weeks (extendable to 16 weeks in patients who have not achieved adequate benefit), followed by a maintenance dose of 5mg (one tablet) taken twice daily, as directed by the prescribing physician.
Renal impairment: The recommended dose is 5mg once daily in patients with moderate or severe renal impairment.
Hepatic impairment: No dose adjustment is required in mild hepatic impairment. In moderate hepatic impairment, the recommended dose is 5mg once daily. Tofaxen is not recommended in severe hepatic impairment.
CYP interactions: The recommended dose is 5mg once daily when co-administered with strong CYP3A4 inhibitors, or with medicines that are both moderate CYP3A4 inhibitors and strong CYP2C19 inhibitors.
Missed dose: If a dose is missed, take the next dose at its normal scheduled time; do not double up doses.
Paediatric use: The safety and efficacy of Tofaxen in children and adolescents have not been established for most indications. No data are currently available.
Monitoring and Dosage Adjustments
Regular monitoring is essential during Tofaxen treatment. All patients should be screened for tuberculosis before starting, with treatment for latent TB completed first if the test is positive, and should be monitored for active TB throughout treatment regardless of initial results. Your healthcare provider will also monitor blood counts for lymphopenia, neutropenia, and anaemia, liver function tests, lipid levels, and signs of infection, blood clots, or cardiovascular symptoms. Report any fever, unusual fatigue, chest pain, sudden breathlessness, leg swelling or pain, or signs of infection to your doctor immediately.
Drug Interactions and Important Information
Avoid concomitant use of Tofaxen with biologic DMARDs, other JAK inhibitors, or potent immunosuppressants such as azathioprine and cyclosporine, as these combinations may increase the risk of serious infection and immunosuppression.
Reduce the Tofaxen dose to 5mg once daily when co-administered with strong CYP3A4 inhibitors (such as ketoconazole), or with medicines that are both moderate CYP3A4 inhibitors and strong CYP2C19 inhibitors (such as fluconazole). Avoid the use of live vaccines during treatment. Always inform your physician of all medications, supplements, and herbal products you are currently taking before starting Tofaxen.
Side Effects and Precautions
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Common Side Effects Upper respiratory tract infections Headache Diarrhoea Nasopharyngitis Elevated blood cholesterol (LDL and HDL) Elevated liver enzymes Hypertension Rash |
Serious Warnings and Precautions Serious infections including tuberculosis and bacterial, invasive fungal, viral, and opportunistic infections, which can lead to hospitalisation or death. Major adverse cardiovascular events (MACE), including heart attack and stroke. Thrombosis, including deep vein thrombosis, pulmonary embolism, and arterial thrombosis, some fatal. Malignancy, including lymphoma and other cancers. Increased risk of all-cause mortality, including sudden cardiovascular death. Gastrointestinal perforation. Not recommended during pregnancy or breastfeeding. |
Who Should Use Tofaxen (Tofacitinib)?
Tofaxen is suitable for adult patients diagnosed with moderately to severely active rheumatoid arthritis, psoriatic arthritis, or moderately to severely active ulcerative colitis who have had an inadequate response to, or are intolerant of, methotrexate or other standard therapies. Given its boxed warning, current clinical guidance generally reserves JAK inhibitors such as Tofaxen for patients who have already tried a TNF-blocker therapy where appropriate. It is prescribed by rheumatologists, gastroenterologists, and specialist physicians experienced in managing autoimmune and inflammatory conditions. A thorough medical assessment including tuberculosis screening, blood counts, and cardiovascular risk evaluation is required before initiating treatment.
Manufacturer: Everest Pharmaceuticals Ltd.
Everest Pharmaceuticals Ltd. is a vertically integrated pharmaceutical company based in Dhaka, Bangladesh, focused on complex, technology-driven specialty medicines across oncology, immunology, hematology, and virology. Operating under Bangladesh’s TRIPS/Doha Declaration exemption for least-developed countries, Everest manufactures advanced generics such as Tofaxen under cGMP-compliant standards, with the stated mission of making high-cost, life-saving medicines accessible and affordable to patients around the world. Tofaxen is one of Everest’s specialty immunology products, offering a bioequivalent alternative to Xeljanz by Pfizer at a fraction of the cost.
Global Supplier: Mediaid Pharmacy with Worldwide Shipping
Mediaid Pharmacy is a trusted global supplier of specialty and autoimmune medications. We ensure Tofaxen (Tofacitinib) is accessible to patients and healthcare providers worldwide through reliable worldwide shipping. Whether you are located in South Asia, the Middle East, Africa, Europe, or beyond, Mediaid Pharmacy provides fast and reliable delivery with full order support. Contact us directly via WhatsApp, phone, or WeChat for pricing, availability, and delivery enquiries.
Why Choose Tofaxen (Tofacitinib) from Mediaid Pharmacy?
Tofaxen represents a well-established, versatile option for patients managing rheumatoid arthritis, psoriatic arthritis, or ulcerative colitis. As the generic equivalent of Xeljanz by Pfizer, it delivers the same active ingredient, Tofacitinib, with the same proven JAK-inhibition mechanism at a dramatically more affordable price. Manufactured by Everest Pharmaceuticals Ltd. under cGMP-compliant standards and distributed globally by Mediaid Pharmacy, Tofaxen gives patients worldwide access to effective autoimmune therapy without the financial burden of brand-name alternatives. For patients and physicians seeking a proven, affordable, and accessible Tofacitinib option with worldwide delivery, Tofaxen from Mediaid Pharmacy is the trusted choice.
Frequently Asked Questions About Tofaxen (Tofacitinib)
What is Tofaxen (Tofacitinib) used for?
Tofaxen (Tofacitinib) is a JAK inhibitor used to treat adult patients with moderately to severely active rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis who have had an inadequate response or intolerance to methotrexate or other standard therapy. It works by blocking the abnormal immune signals that cause inflammation in these conditions.
How should I take Tofaxen (Tofacitinib)?
Tofaxen is taken orally, with or without food. The standard dose for RA and PsA is 5mg twice daily. For ulcerative colitis, treatment typically starts at 10mg twice daily for induction, then reduces to 5mg twice daily for maintenance. Reduced doses are used for renal or hepatic impairment and certain drug interactions. Always follow your physician’s exact instructions.
What strength is Tofaxen (Tofacitinib) available in?
Tofaxen is available in a 5mg film-coated tablet, supplied in a pack of 60 tablets. Higher doses, such as the 10mg ulcerative colitis induction dose, are achieved by taking two 5mg tablets together, exactly as prescribed by your physician.
Is Tofaxen the same as Xeljanz (Tofacitinib by Pfizer)?
Yes. Tofaxen is the generic equivalent of Xeljanz. Both contain the same active ingredient, Tofacitinib, and work through the same JAK-inhibition mechanism. Tofaxen is manufactured by Everest Pharmaceuticals Ltd. in Bangladesh and delivers the same clinical mechanism as Xeljanz at a significantly lower cost.
What are the side effects of Tofaxen (Tofacitinib)?
Common side effects include upper respiratory infections, headache, diarrhoea, and elevated cholesterol or liver enzymes. Tofaxen carries a boxed warning for serious infection, increased mortality, cancer, major cardiovascular events, and blood clots. Always consult your physician for a complete assessment of your individual risks and benefits before starting treatment.
Can Tofaxen be used with other medications?
Tofaxen should not be combined with biologic DMARDs, other JAK inhibitors, or potent immunosuppressants such as azathioprine or cyclosporine, as these combinations increase the risk of serious infection. Reduce the dose to 5mg once daily when co-administering with strong CYP3A4 inhibitors, and avoid live vaccines during treatment.
Is Tofaxen (Tofacitinib) safe during pregnancy or breastfeeding?
No. Tofaxen is not recommended during pregnancy or breastfeeding. Women of childbearing potential should discuss effective contraception with their physician before and during treatment. Please consult your physician before starting treatment if you are pregnant, planning to become pregnant, or breastfeeding.
Can I order Tofaxen (Tofacitinib) online with worldwide shipping?
Yes. Mediaid Pharmacy supplies Tofaxen (Tofacitinib) 5mg globally with worldwide shipping. Contact us via WhatsApp, phone, or WeChat at +8801773428128 or email us at info@mediaidpharmacy.com to enquire about pricing, availability, and delivery to your country.
Order Tofaxen (Tofacitinib) 5mg with Worldwide Shipping
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