Xeljanz to be used with caution in thrombosis patients

Recently changed permission to the MFDS, add warning to a package insert

Send a safety letter to clinics & hospitals,

The FDA, Last Year's Measures to Convert Primary and Secondary Therapies for Ulcerative Colitis

Among the indications for Pfizer's JAK inhibitor Xeljanz (Tofacitinib citrate), the standard for 10 mg high dose prescription of ulcerative colitis has changed.

 

Pfizer recently changed the permission, and added that patients with risk factors for thrombosis should avoid using this drug and patients with signs·symptoms of thrombosis should be evaluated urgently and discontinued if thrombosis is suspected, regardless of efficacy and dosage.

 

In this regard, Pfizer immediately posts the relevant contents on the product homepage, as well as black box warning processing on the package insert, sending hospitals safety letter, and regularly reporting the results of the PMS risk assessment to the MFDS in order to prevent prescription confusion and side effects.

 

Pfizer's actions are attributable to the impact of the results of a post-marketing interim analysis of Xeljanz and TNF blockers such as Humira and Remicade .

 

According to the analysis data, there were significant differences between 3,884 patients in the Xeljanz group (patient-years), 19 cases of pulmonary embolism, and 45 cases of death, whereas 3 cases of pulmonary embolism, and 25 cases of death per 3,982 patients in the TNF-administered group.

 

In July of last year, the US FDA changed the license for ulcerative colitis, one of the indications for Xeljanz, from primary treatment to secondary treatment (only for patients with ulcerative colitis who have failed the existing TNF blocker).

 

In November of the same year, the EMA also announced that it should not use 10 mg maintenance therapy twice a day with Xeljanz for patients with ulcerative colitis at high risk of thrombosis, unless there is no alternative.

 

If high doses must be used in ulcerative colitis, it is recommended that patients at risk for embolism should not start, and that patients in risk groups should be switched to other drugs.

 

Xeljanz is administered 5mg twice a day for rheumatoid arthritis, whereas 10mg twice a day for 8 weeks for ulcerative colitis, followed by 5mg or 10mg twice a day depending on the treatment response.

 

Xeljanz is the first oral drug to appear in the market for rheumatoid arthritis and ulcerative colitis, which has been dominated by biologic injections for the past several decades.