Warnings & Recalls for Xeljanz
Black Box Warning
Xeljanz | Tofacitinib Citrate has an associated “black box” warning attached to it that denotes that serious infections that often lead to hospitalization or death which can include TB, bacteria, invasive fungal, viral and other opportunistic infections, have occurred in patients receiving this drug. If a serious infection develops, interrupt Xeljanz until the infection is controlled. Prior to starting Xeljanz, a test should be performed for latent TB. If the test is positive for TB, a treatment for treating the TB first should be initiated before going on a Xeljanz regimen. The patient should be monitored for active TB during treatment, even if the initial TB test had resulted negatively.
Lymphoma and other malignancies has been reported in patients who are treated with Xeljanz. Epstein-Barr virus-associated post-transplant lymphoproliferative disorder has been reported at an increased rate in patients who undergo kidney transplants who are treated with this drug concurrently with other immunosuppressive medications.
Contraindications
Specific contraindications for Xeljanz have not yet been determined.
Precautions
Patients with the following preexisting conditions or warnings should take these precautionary measures or not consider taking
Xeljanz | Tofacitinib Citrate at all:
- Patients with active infections
- Patients with TB exposure or history of TB
- Patients with known malignancies
- Patients with hepatic impairments
- Patients with renal impairments
- Patients undertaking vaccines currently
Pregnancy Warning
Xeljanz | Tofacitinib Citrate has been given a pregnancy category rating of “C” by the FDA, implying that it should be discontinued while pregnant due to posing a risk to both the expecting mother and her developing child.
Xeljanz Treatment and Use
Xeljanz | Tofacitinib Citrate is a drug that’s manufactured and marketed by Pfizer prescribed specifically for the treatment of rheumatoid arthritis. It was approved by the FDA on November of 2012. A pitfall of this drug is that many rheumatologists have complained that the price-tag of $2,500 for a month of Xeljanz | Tofacitinib Citrate is just much too expensive.
Non-FDA labeled indications for this drug are for treating:
Please refer to the “Warnings and Recalls” tab to get more information on Xeljanz | Tofacitinib Citrate’s “black box” warning.
How This Drug Works
Xeljanz | Tofacitinib Citrate inhibits Janus kinases (JAK), or intracellular enzymes, and modulates a signaling pathway which influences the cellular processes of hematopoiesis and immune cellular function. Signals from this pathway arise from cytokine or growth factor-receptor interactions on cellular membranes. Inhibition of JAK prevents many of the complications that arise from rheumatoid arthritis and other immunological diseases.
Dosage Information
The safety and the efficacy of using Xeljanz | Tofacitinib Citrate on pediatric patients has not been established as of yet. The following is the adult dosing of Xeljanz | Tofacitinib Citrate for patients with rheumatoid arthritis:
- For adult patients with rheumatoid arthritis (moderate to severe): 5mg ORALLY twice daily