Tofacitinib (Xeljanz) is an oral Janus kinase inhibitor used for the treatment of various autoimmune diseases. It alleviates inflammatory responses and improves disease conditions by regulating the signaling pathways of the immune system.

Indications for Tofacitinib (Xeljanz)

Adult Indications

Rheumatoid Arthritis: Indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to or intolerance of one or more tumor necrosis factor (TNF) inhibitors.

Psoriatic Arthritis: Indicated for adult patients with active psoriatic arthritis who have had an inadequate response to or intolerance of one or more TNF inhibitors.

Ankylosing Spondylitis: Indicated for adult patients with active ankylosing spondylitis who have had an inadequate response to or intolerance of one or more TNF inhibitors.

Ulcerative Colitis: Indicated for adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to or intolerance of one or more TNF inhibitors.

Pediatric Indications

Psoriatic Arthritis: Indicated for pediatric patients aged 2 years and older with active psoriatic arthritis who have had an inadequate response to or intolerance of one or more TNF inhibitors.

Polyarticular Juvenile Idiopathic Arthritis: Indicated for pediatric patients aged 2 years and older with active polyarticular juvenile idiopathic arthritis who have had an inadequate response to or intolerance of one or more TNF inhibitors.

Usage Restrictions

Tofacitinib is not recommended for combined use with biologic disease-modifying antirheumatic drugs (bDMARDs) or other potent immunosuppressants (such as azathioprine, cyclosporine), to avoid an increased risk of infections and other adverse outcomes.

Specifications and Properties of Tofacitinib (Xeljanz)

Immediate-Release Tablets

5 mg Tablets: White, round, film-coated tablets, engraved with "Pfizer" on one side and "JKI5" on the other side.

10 mg Tablets: Blue, round, film-coated tablets, engraved with "Pfizer" on one side and "JKI10" on the other side.

Extended-Release Tablets

11 mg Extended-Release Tablets: Pink, oval, film-coated tablets with a 钻孔 (drilled hole) at one end, and imprinted with "JKI11" on the tablet body.

22 mg Extended-Release Tablets: Beige, oval, film-coated tablets with a drilled hole at one end, and imprinted with "JKI22" on the tablet body.

Oral Solution

1 mg/mL Oral Solution: A clear, colorless liquid dosage form, equipped with a dedicated press-fit bottle cap adapter and an oral syringe for accurate dose measurement.

These dosage forms are designed to allow patients to choose the most suitable administration method as prescribed by the doctor. In particular, the oral solution can be used for children and patients with swallowing difficulties.

Storage Methods for Tofacitinib (Xeljanz)

Tablets and Extended-Release Tablets

Should be stored at room temperature between 20°C and 25°C, away from high temperatures, moisture, and direct sunlight.

Tablets should be kept in their original packaging and must not be transferred to arbitrary containers.

Extended-release tablets must be swallowed whole; they must not be crushed, chewed, or split.

Oral Solution

The storage temperature is also between 20°C and 25°C, with short-term storage allowed between 15°C and 30°C.

Must be stored in the original bottle and carton, protected from light.

Once opened, the oral solution must be used within 60 days; any remaining solution should be discarded.

It is recommended to mark the opening date on the bottle or outer carton for tracking the usage period.

Other Precautions

All dosage forms should be stored out of the reach of children.

The syringe provided with the oral solution should be cleaned and dried promptly after use, stored properly, and must not be discarded.

If the medication has expired or is no longer needed, it should be disposed of properly in accordance with local regulations.