o infection. Test/treat latent TB infection prior to and per applicable guidelines during therapy. Monitor closely if new infection, active TB (even if initial latent test is negative), reactivation of herpes virus or hepatitis occurs; interrupt treatment if serious or opportunistic infection, or sepsis develops. History of chronic lung disease or in those who develop interstitial lung disease. Known malignancy. History of GI perforations. Specifically XR tabs: pre-existing severe GI narrowing. Lymphopenia. Monitor lymphocytes at baseline, then every 3 months; neutrophils and hemoglobin at baseline, after 4–8 weeks, then every 3 months thereafter. Do not initiate therapy if lymphocytes <500cells/mm3, ANC <1000cells/mm3, or hemoglobin <9g/dL. Severe hepatic impairment: not recommended. Routinely monitor liver enzymes; interrupt therapy if drug-induced liver injury suspected. Monitor lipids 4–8 weeks following initiation. Perform periodic skin exam in those with skin cancer risk. Update immunization based on current guidelines prior to initiating therapy. Diabetes. Elderly. Pregnancy. Females of reproductive potential should use effective contraception during and for ≥4wks after last dose. Nursing mothers: not recommended.
Interactions:
Concomitant live vaccines, biologic DMARDs or potent immunosuppressants (eg, azathioprine, cyclosporine): not recommended. Potentiated by potent CYP3A4 inhibitors (eg, ketoconazole), or drugs that result in both moderate CYP3A4 and potent CYP2C19 (eg, fluconazole) inhibition. Antagonized by potent CYP3A4 inducers (eg, rifampin); see Adults.
See Also:
XELJANZ
Pharmacological Class:
Janus kinase (JAK) inhibitor.
Adverse Reactions:
Upper respiratory tract infections, headache, diarrhea, nasopharyngitis; serious or opportunistic infections, TB, malignancies (eg, lymphoma), cytopenias, liver enzyme or lipid elevations, non-melanoma skin cancer.
Metabolism:
Hepatic (CYP3A4, 2C19).
Elimination:
Renal.
Generic Availability:
NO
How Supplied:
Tabs—28, 60, 180; XR tabs—14, 30
1):https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cf74ba2f-afc5-4baa-8594-979c889a5831
2):https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=68e3d6b2-7838-4d2d-a417-09d919b43e13 |
