Tofaxen 5 MG (Tofacitinib)

Product Name : Tofaxen
Generic Name : Tofacitinib
Formulation : Tablet
Available Pack Size : 60’s
Available Strengths : 5 mg
Registrations : Export Only

Product Information

Tofaxen 5 MG (Tofacitinib) is an oral Janus kinase (JAK) inhibitor supplied as a 5 mg tablet in a 60’s pack under an Export Only registration. Its active ingredient, tofacitinib, blocks the JAK1 and JAK3 enzymes that transmit inflammatory cytokine signals, and it is used to treat moderate to severe rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), and ulcerative colitis (UC) in adults. Tofacitinib works by inhibiting JAK-STAT signaling inside immune cells, which reduces the production of inflammatory mediators that drive joint damage and intestinal inflammation. Because JAK inhibitors suppress immune function, treating physicians monitor patients for infections and malignancy, so Mediaid Pharmacy supplies Tofaxen 5 MG Tofacitinib alongside its wider oncology and specialty medicines portfolio and ships it worldwide to licensed importers, hospitals, and distributors.

Basic Product Information of Tofaxen 5 MG (Tofacitinib)

Brand Name Tofaxen 5 MG (Tofacitinib)
Product Name Tofaxen
Generic Name Tofacitinib
Drug Class Janus Kinase (JAK) Inhibitor, Targeted Synthetic Disease-Modifying Antirheumatic Drug (tsDMARD)
Formulation Tablet
Available Strength 5 mg
Available Pack Size 60’s (60 tablets per pack)
Primary Indication Moderate to severe rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and ulcerative colitis in adults
Registrations Export Only
Originator Reference Brand Xeljanz (tofacitinib) by Pfizer
Global Supplier Mediaid Pharmacy, Worldwide Shipping Available
Storage Conditions Store in a dry place away from light and moisture, at the temperature printed on the pack. Keep out of the reach of children.

How Tofaxen 5 MG (Tofacitinib) Works: JAK-STAT Inhibition Mechanism

Tofacitinib, the active ingredient in Tofaxen 5 MG, is a Janus kinase (JAK) inhibitor that acts mainly on JAK1 and JAK3, with lesser activity on JAK2. JAK enzymes sit inside immune cells and pass signals from cytokine receptors on the cell surface to the nucleus through signal transducers and activators of transcription (STAT) proteins. This chain of events is called the JAK-STAT pathway.

In autoimmune disease, cytokines such as interleukin-6 (IL-6), interleukin-2, interleukin-7, interleukin-15, interleukin-21, and interferons overactivate this pathway, which keeps immune cells inflamed and damages joints or the intestinal lining. Tofacitinib blocks the pathway inside the cell, so it dampens signaling from several cytokines at once instead of neutralizing one cytokine outside the cell as TNF blockers do. Because the drug lowers immune activity, clinicians screen for tuberculosis and other infections before treatment and follow malignancy risk during long-term use. Teams managing patients with both immune disease and cancer history can review the broader oncology medicines catalogue at Mediaid Pharmacy.

In the ORAL Solo trial, 59.8% of patients with rheumatoid arthritis reached an ACR20 response at month 3 on tofacitinib 5 mg twice daily, compared with 26.7% on placebo. In ORAL Standard, ACR20 response at month 6 was 51.5% on tofacitinib 5 mg twice daily versus 28.3% on placebo and 47.2% on adalimumab. An ACR20 response means at least a 20% improvement in tender and swollen joint counts plus other disease measures.

Approved Indications of Tofacitinib (Reference Label for Tofaxen 5 MG (Tofacitinib))

Tofacitinib, the active ingredient in Tofaxen 5 MG, is approved internationally in the following adult conditions. Prescribers should confirm the exact indications on the product label supplied with their import.

Rheumatoid Arthritis (RA)

Approved for adults with moderate to severe active rheumatoid arthritis, used alone or with methotrexate or other non-biologic DMARDs. In ORAL Solo, the ACR20 response at month 3 was 59.8% on 5 mg twice daily versus 26.7% on placebo. Many labels reserve tofacitinib for patients who responded inadequately to or could not tolerate one or more TNF blockers.

Psoriatic Arthritis (PsA)

Approved for adults with active psoriatic arthritis who had an inadequate response to a conventional DMARD, or a TNF blocker depending on the regional label, and it is given with a non-biologic DMARD. Tofacitinib reduces joint pain, swelling, and stiffness in this setting.

Ankylosing Spondylitis (AS)

Approved for adults with active ankylosing spondylitis, an inflammatory arthritis of the spine and sacroiliac joints. The standard dose is 5 mg twice daily, and the label typically requires a prior inadequate response to a TNF blocker.

Ulcerative Colitis (UC)

Approved for adults with moderately to severely active ulcerative colitis. In the OCTAVE Sustain trial, 34.3% of patients on 5 mg twice daily were in remission at week 52 versus 11.1% on placebo. Treatment starts with an induction phase and continues at the lowest effective dose.

Key Clinical Benefits of Tofaxen 5 MG (Tofacitinib)

Rapid Symptom Relief in Rheumatoid Arthritis

In ORAL Solo, 59.8% of patients reached ACR20 at month 3 on tofacitinib 5 mg twice daily versus 26.7% on placebo, and improvement in pain and physical function appeared within the first weeks of treatment.

Efficacy Comparable to Adalimumab

In ORAL Standard, ACR20 response at month 6 was 51.5% on tofacitinib 5 mg twice daily versus 47.2% on adalimumab, which places the oral JAK inhibitor in the same efficacy range as a leading injectable TNF blocker.

Oral Tablet, No Injections or Infusions

Tofaxen 5 MG is a tablet taken by mouth, which suits patients who prefer to avoid self-injection or hospital infusion visits and supports routine home use under specialist follow-up.

Remission Maintenance in Ulcerative Colitis

In OCTAVE Sustain, 34.3% of UC patients on tofacitinib 5 mg twice daily were in remission at week 52 versus 11.1% on placebo, which shows durable benefit in maintenance therapy.

One Drug Across Several Inflammatory Diseases

A single JAK inhibitor addresses rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and ulcerative colitis, which simplifies supply for hospitals and distributors serving rheumatology and gastroenterology departments.

Export Supply From Mediaid Pharmacy

Tofaxen 5 MG is available for export in a 60’s pack, which equals a 30-day supply at 5 mg twice daily, with specialist ordering support and worldwide shipping.

How to Take Tofaxen 5 MG (Tofacitinib): Dosage Guidelines

Route of Administration: Oral. Swallow the tablet with water, twice daily at about the same times each day, with or without food. If a dose is missed, take the next dose at the regular time and do not double the dose.

RA, PsA, and AS: The reference label recommends 5 mg twice daily. Your rheumatologist decides the final dose and whether to combine treatment with methotrexate or another non-biologic DMARD.

Ulcerative Colitis: The reference label recommends 10 mg twice daily for induction for at least 8 weeks (extended up to 16 weeks in some patients), then 5 mg twice daily for maintenance. Physicians use the lowest effective dose and limit long-term 10 mg use to selected patients with refractory disease.

Renal Impairment: For severe renal impairment (creatinine clearance below 30 mL/min), the reference label reduces the dose to 5 mg once daily in RA, PsA, and AS, and halves the daily dose in UC. No adjustment is needed for mild or moderate renal impairment.

Hepatic Impairment: No adjustment is needed for mild impairment. Moderate impairment (Child-Pugh B) calls for 5 mg once daily, and severe hepatic impairment is not recommended.

CYP Interactions: Reduce the dose to 5 mg once daily in patients taking 5 mg twice daily who also use a strong CYP3A4 inhibitor such as ketoconazole, or a moderate CYP3A4 inhibitor combined with a strong CYP2C19 inhibitor such as fluconazole. Avoid strong CYP3A4 inducers such as rifampin.

Pediatric Use: Use in children follows a separate weight-based regimen for polyarticular course juvenile idiopathic arthritis on the reference label, and a 5 mg tablet must be used in patients under 18 years only when the prescriber directs.

Prescription Medication: Boxed Warning for Serious Infections, Mortality, Malignancy, Cardiovascular Events, and Thrombosis. The reference label for tofacitinib carries a boxed warning for these risks, which were higher in an ORAL Surveillance study of patients aged 50 or older with at least one cardiovascular risk factor. Tofaxen 5 MG (Tofacitinib) must be used only under specialist supervision. Always follow your prescribing physician’s instructions.

Clinical Monitoring Requirements During Tofaxen 5 MG (Tofacitinib) Treatment

Screening and monitoring are mandatory. Before starting tofacitinib, clinicians test for latent and active tuberculosis and screen for hepatitis B and hepatitis C. The reference label advises against starting treatment when the absolute lymphocyte count is below 500 cells per cubic millimeter, the absolute neutrophil count is below 1,000, or hemoglobin is below 9 g/dL.

Laboratory monitoring includes lymphocyte counts, neutrophil counts, and hemoglobin at baseline, 4 to 8 weeks after starting, and every 3 months afterward. Lipid panels are checked 4 to 8 weeks after starting because tofacitinib raises total cholesterol, LDL, and HDL. Liver enzymes are monitored routinely. Patients should also receive zoster vaccination before treatment when possible, avoid live vaccines during therapy, and undergo periodic skin examinations, since lymphoma, lung cancer, and non-melanoma skin cancer have been reported.

Drug Interactions and Important Safety Information for Tofaxen 5 MG (Tofacitinib)

Tofacitinib is cleared mainly through CYP3A4 metabolism, with a smaller contribution from CYP2C19. Strong CYP3A4 inhibitors such as ketoconazole raise tofacitinib exposure and require a dose reduction, and strong inducers such as rifampin lower exposure and reduce efficacy. Combination with potent immunosuppressants such as azathioprine, cyclosporine, or tacrolimus, and with biologic DMARDs, is not recommended because it increases the risk of serious infection.

Patients must tell their physician about all prescription medicines, over-the-counter products, and herbal supplements before starting Tofaxen 5 MG. Women of reproductive potential must use effective contraception during treatment and for at least 4 weeks after the final dose. Breastfeeding is not advised during treatment and for 18 hours after the final dose.

Side Effects and Precautions of Tofaxen 5 MG (Tofacitinib)

Common Side Effects

Upper respiratory tract infection and nasopharyngitis

Headache

Diarrhea

Nausea

Hypertension (elevated blood pressure)

Rash

Increased cholesterol levels

Elevated creatine phosphokinase (CPK) and liver enzymes

Herpes zoster (shingles)

Decreased white blood cell counts and anemia

Serious Warnings and Precautions

Serious infections: tuberculosis, bacterial, fungal, viral, and opportunistic infections can be fatal. Interrupt treatment during a serious infection.

Malignancy: lymphoma, lung cancer, and non-melanoma skin cancer have been reported. Perform periodic skin examinations.

Major adverse cardiovascular events and thrombosis: higher risk in older patients with cardiovascular risk factors. Stop treatment and evaluate if a clot is suspected.

Gastrointestinal perforation: report severe abdominal pain promptly, especially with prior diverticulitis.

Embryo-fetal toxicity: not recommended during pregnancy. Use effective contraception during treatment and for at least 4 weeks after the final dose.

Who Should Use Tofaxen 5 MG (Tofacitinib)?

Tofaxen 5 MG (Tofacitinib) is prescribed for adults with moderate to severe rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or ulcerative colitis who have not responded adequately to conventional therapy, and in many labels to one or more TNF blockers. Patients with active serious infection, severe hepatic impairment, or a history of blood clots require careful specialist evaluation, and those aged 50 or older with cardiovascular risk factors or a history of malignancy need an individual risk-benefit review. Tofaxen 5 MG is prescribed by rheumatologists and gastroenterologists experienced with JAK inhibitor therapy. Buyers who supply patients with complex immune and cancer care needs can also source medicines from the Mediaid Pharmacy oncology specialty medicines range.

Global Supplier: Mediaid Pharmacy Worldwide Shipping for Tofaxen 5 MG (Tofacitinib)

Mediaid Pharmacy is a Dhaka-based supplier of specialty and oncology medicines with worldwide shipping. Tofaxen 5 MG (Tofacitinib) is available under an Export Only registration in a 60’s tablet pack, so orders are handled for importers, hospitals, and distributors in destination markets with the necessary import authorization. Our team provides pricing quotations, stock confirmation, documentation, and delivery tracking through WhatsApp, phone, or WeChat for all questions about Tofaxen 5 MG Tofacitinib. Importers who need several products in one consignment can review the complete oncology medicine collection and request a combined quotation.

Why Choose Tofaxen 5 MG (Tofacitinib) from Mediaid Pharmacy?

Tofaxen 5 MG (Tofacitinib) gives importers and healthcare providers an export-supplied tofacitinib tablet for rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and ulcerative colitis, backed by the evidence from the ORAL and OCTAVE clinical programs. Mediaid Pharmacy provides clear product specifications, direct specialist support, and worldwide shipping for every order, and each enquiry is handled as a prescription-based or licensed-buyer request. To source additional specialty therapies, visit the Mediaid Pharmacy oncology medicines section, then contact our team for a personalized quotation.

Frequently Asked Questions About Tofaxen 5 MG (Tofacitinib)

What is Tofaxen 5 MG (Tofacitinib) used for?

Tofaxen 5 MG (Tofacitinib) is a Janus kinase (JAK) inhibitor tablet used in adults with moderate to severe rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and ulcerative colitis. Tofacitinib blocks JAK-STAT signaling inside immune cells and reduces the inflammatory activity that damages joints and the intestinal lining.

What is the generic name of Tofaxen?

The generic name of Tofaxen is tofacitinib. Tofaxen 5 MG is a tablet available in a 60’s pack under an Export Only registration. The originator reference brand for tofacitinib is Xeljanz by Pfizer.

What is the correct dose of Tofaxen 5 MG (Tofacitinib)?

Your physician sets the dose. The reference label recommends 5 mg twice daily for rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. In ulcerative colitis, the label recommends 10 mg twice daily for induction, then 5 mg twice daily for maintenance. Doses are lowered in severe renal impairment, moderate hepatic impairment, and with certain CYP inhibitors, so never change your dose without medical advice.

What strengths and pack sizes is Tofaxen available in?

Tofaxen is available as a 5 mg tablet in a pack of 60 tablets, which is a 30-day supply at 5 mg twice daily. Contact Mediaid Pharmacy for current stock and shipping details.

What are the side effects of Tofaxen 5 MG (Tofacitinib)?

Common side effects include upper respiratory tract infection, headache, diarrhea, nausea, high blood pressure, rash, and raised cholesterol. Serious risks include serious infections such as tuberculosis, malignancy, major adverse cardiovascular events, blood clots, and gastrointestinal perforation. Blood counts, lipids, and liver enzymes are monitored during treatment, so discuss your individual risk with your physician.

Do I need tests before starting tofacitinib?

Yes. Physicians screen for tuberculosis and for hepatitis B and C before treatment, and they check lymphocyte count, neutrophil count, and hemoglobin. Blood counts are repeated 4 to 8 weeks after starting and then every 3 months, and lipids are checked 4 to 8 weeks after starting.

Is Tofaxen 5 MG safe during pregnancy or while breastfeeding?

No. Tofacitinib is not recommended during pregnancy and may cause fetal harm. Women of reproductive potential must use effective contraception during treatment and for at least 4 weeks after the final dose, and breastfeeding is not advised during treatment and for 18 hours after the final dose. Speak with your physician before starting treatment if you are pregnant or planning pregnancy.

What does an Export Only registration mean for Tofaxen?

An Export Only registration means Tofaxen is manufactured and registered for supply to markets outside its country of origin, so it is not sold to patients in the domestic market. Importers must hold the authorization required by their own country’s drug regulator before ordering.

Can I order Tofaxen 5 MG (Tofacitinib) online with worldwide shipping?

Yes, for eligible importers, hospitals, and licensed healthcare providers. Contact Mediaid Pharmacy via WhatsApp, phone, or WeChat at +8801773428128, or email info@mediaidpharmacy.com for pricing, stock availability, and delivery details for your country.

Order Tofaxen 5 MG (Tofacitinib) with Worldwide Shipping

Phone / WhatsApp / WeChat: +8801773428128 | Email: info@mediaidpharmacy.com

Message on WhatsApp