Tofacitinib (tofacitinib)

Tofacitinib is a small-molecule drug, so conventional generics are possible and have been approved via the ANDA route (demonstrating pharmaceutical equivalence and bioequivalence to Xeljanz, not biosimilarity to a biologic). Generic tofacitinib tablets are now available in the US, with reported prices as low as USD 25-150 per month in some discount programs. Cipla (Tofajak) and Natco (Jaknat) market generic tofacitinib in India, and multiple local manufacturers sell it in Bangladesh. Generic products are bioequivalent to the reference product but are not identical in excipients and are not interchangeable between the immediate-release tablet and the extended-release tablet or oral solution. The same JAK-inhibitor boxed warning and monitoring apply to every tofacitinib product, branded or generic. Manufacturers supplying tofacitinib generic versions include Aristopharma, Breckenridge Pharmaceutical, Cipla, Hikma Pharmaceuticals, Incepta Pharmaceuticals, Natco Pharma, Popular Pharmaceuticals, Square Pharmaceuticals. Brands registered in Bangladesh include Arthanib, Arthanib XR, Jakloc, Jakloc XR, Jaknib, Jakrif.

Tofacitinib (Janus kinase (JAK) inhibitor — oral small molecule targeting JAK1/JAK3, non-biologic DMARD; carries an FDA boxed warning, originally Xeljanz / Xeljanz XR (尚杰) by Pfizer (initial U.S. approval 2012)) Tofacitinib is an oral tablet that blocks Janus kinase (JAK) enzymes inside immune cells, interrupting the signals that keep inflammation switched on. This reduces inflammation and joint damage, but it also dampens the immune system's ability to fight infection. Rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis: 5 mg twice daily (immediate release) or Xeljanz XR 11 mg once daily. Ulcerative colitis induction: 10 mg twice daily or XR 22 mg once daily for 8 weeks; may continue for a maximum of 16 weeks, then discontinue if an adequate response is not achieved. UC maintenance: 5 mg twice daily or XR 11 mg once daily. Xeljanz XR is not inte

Standard dosing for tofacitinib: Rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis: 5 mg twice daily (immediate release) or Xeljanz XR 11 mg once daily. Ulcerative colitis induction: 10 mg twice daily or XR 22 mg once daily for 8 weeks; may continue for a maximum of 16 weeks, then discontinue if an adequate response is not achieved. UC maintenance: 5 mg twice daily or XR 11 mg once daily. Xeljanz XR is not interchangeable or substitutable with Xeljanz Oral Solution, and changes between formulations should be made by the healthcare provider. Dose adjustments: Recommended dosage in patients with moderate to severe renal impairment or moderate hepatic impairment is 5 mg once daily (instead of twice daily). Do not initiate treatment if absolute lymphocyte count <500 cells/mm3, absolute neutrophil count <1000 cells/mm3, or hemoglobin <9 g/dL. Dose is interrupted or reduced for cytopenias and laboratory abnormalities per label.

Tofacitinib (Janus kinase (JAK) inhibitor — oral small molecule targeting JAK1/JAK3, non-biologic DMARD; carries an FDA boxed warning, originally Xeljanz / Xeljanz XR (尚杰) by Pfizer (initial U.S. approval 2012)) Tofacitinib is an oral tablet that blocks Janus kinase (JAK) enzymes inside immune cells, interrupting the signals that keep inflammation switched on. This reduces inflammation and joint damage, but it also dampens the immune system's ability to fight infection. Rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis: 5 mg twice daily (immediate release) or Xeljanz XR 11 mg once daily. Ulcerative colitis induction: 10 mg twice daily or XR 22 mg once daily for 8 weeks; may continue for a maximum of 16 weeks, then discontinue if an adequate response is not achieved. UC maintenance: 5 mg twice daily or XR 11 mg once daily. Xeljanz XR is not inte

Elimination half-life: Approximately 3 hours (elimination half-life). Peak plasma concentrations are reached within 0.5 to 1 hour after oral administration of the immediate-release tablet; the extended-release tablet reaches peak concentrations at about 4 hours. Breastfeeding is not recommended during treatment and for at least 18 hours after the last immediate-release dose or 36 hours after the last XR dose (approximately 6 elimination half-lives).. Dosing intervals are designed around this, which is why most regimens are once or twice daily.

Recommended monitoring for tofacitinib: Test for latent tuberculosis before and during therapy; treat latent TB prior to use; monitor all patients for active TB; Monitor for serious infections during and after treatment; Baseline and periodic blood counts — lymphocyte count, neutrophil count, hemoglobin (do not initiate outside label thresholds); Baseline and periodic liver enzymes (hepatotoxicity); Lipid panel after initiation (elevated lipids); Monitor for thrombosis and for symptoms of MACE; Monitor for malignancy including skin cancer; Renal and hepatic function to guide dose reduction; Avoid live vaccines during treatment

Tofacitinib is approved for: Rheumatoid arthritis: moderately to severely active RA in adults who have had an inadequate response or intolerance to one or more TNF blockers; Psoriatic arthritis: active PsA in adults who have had an inadequate response or intolerance to one or more TNF blockers; Ankylosing spondylitis: active AS in adults who have had an inadequate response or intolerance to one or more TNF blockers; Ulcerative colitis: moderately to severely active UC in adults who have had an inadequate response or intolerance to one or more TNF blockers; Polyarticular course juvenile idiopathic arthritis: active pcJIA in patients 2 years of age and older who have had an inadequate response or intolerance to one or more TNF blockers (Xeljanz Oral Solution). It is a tofacitinib (Janus kinase), originally marketed as Xeljanz / Xeljanz XR (尚杰) by Pfizer (initial U.S. approval 2012).

Publicly listed pricing for tofacitinib in India: Jaknat Tablet (Natco Pharma) tofacitinib 5 mg, strip of 10 — INR 319 to INR 346.88 per strip of 10 tablets (approximately INR 27.10-27.75 per tablet). Tofajak 5 mg tablet (Cipla) — Listed on the 1mg product page (see source for the current price). The practical benchmark is therefore the Bangladesh price below, plus freight, customs duty and importer margin. Bangladesh benchmark: 15 manufacturers sell generic tofacitinib 5 mg; unit prices range from BDT 30 (US$0.24) to BDT 48 (US$0.39), i.e. about US$7.32–US$11.72 per 30 units. Cheapest listed brand: Tofacit (Delta Pharma Ltd.) at BDT 30 per unit. Prices move with pack size, pharmacy and the exchange rate — confirm current stock and price with a licensed importer before ordering.

Tofacitinib (Janus kinase (JAK) inhibitor — oral small molecule targeting JAK1/JAK3, non-biologic DMARD; carries an FDA boxed warning, originally Xeljanz / Xeljanz XR (尚杰) by Pfizer (initial U.S. approval 2012)) Tofacitinib is an oral tablet that blocks Janus kinase (JAK) enzymes inside immune cells, interrupting the signals that keep inflammation switched on. This reduces inflammation and joint damage, but it also dampens the immune system's ability to fight infection. Rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis: 5 mg twice daily (immediate release) or Xeljanz XR 11 mg once daily. Ulcerative colitis induction: 10 mg twice daily or XR 22 mg once daily for 8 weeks; may continue for a maximum of 16 weeks, then discontinue if an adequate response is not achieved. UC maintenance: 5 mg twice daily or XR 11 mg once daily. Xeljanz XR is not inte

Storage: Store Xeljanz / Xeljanz XR at room temperature between 68°F to 77°F (20°C to 25°C). Store Xeljanz Oral Solution at room temperature 20°C to 25°C in the original bottle and carton to protect from light. Safely throw away oral solution that is out of date or no longer needed. Keep the product in its original packaging and check the expiry date printed on the pack.