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XELJANZ
Arthritis/rheumatic disorders
Colorectal disorders
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Drug Name:

XELJANZ Rx

Generic Name and Formulations:
Tofacitinib 5mg, 10mg; tabs.

Company:
Pfizer Inc.

Therapeutic Use:

Indications for XELJANZ:

Moderately-to-severely active rheumatoid arthritis (RA) in adults who have had an inadequate response or intolerance to methotrexate (MTX), as monotherapy or in combination with MTX or other nonbiologic disease-modifying anti-rheumatic drugs (DMARDs). Active psoriatic arthritis in adults who have had an inadequate response or intolerance to MTX or other DMARDs, in combination with nonbiologic DMARDs.

Adult:

5mg twice daily. Switching from immediate-rel to XR tabs: start XR tabs the day following the last immediate-rel 5mg dose. Moderate-to-severe renal impairment or moderate hepatic impairment; concomitant strong CYP3A4 inhibitors, or drugs that result in both moderate CYP3A4 and strong CYP2C19 inhibition: 5mg once daily. Concomitant strong CYP3A4 inducers: not recommended. Other dose adjustments: see full labeling.

Children:

Not established.

Boxed Warning:

Serious infections. Malignancy.

Warnings/Precautions:

Increased risk of serious or fatal infections (eg, TB, bacterial, viral, invasive fungal, or other opportunistic pathogens) esp. with 10mg twice daily dose (in UC treatment). Avoid in active, serious, or localized infections. Chronic, recurrent, or history of serious or opportunistic infections. Travel to, or residence in, areas with endemic TB or mycoses. Conditions that predispose to 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. Hepatitis B or C. Known malignancy. GI perforation risk (eg, history of diverticulitis). 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 consider prevention. Nursing mothers: not recommended [during and for ≥18hrs (tabs) or ≥36hrs (XR tabs) after last dose].

See Also:

XELJANZ XR

Pharmacological Class:

Janus kinase (JAK) inhibitor.

Interactions:

Concomitant live vaccines, biologic DMARDs, biologics for UC, or potent immunosuppressants (eg, azathioprine, cyclosporine): not recommended. Potentiated by strong CYP3A4 inhibitors (eg, ketoconazole), or drugs that result in both moderate CYP3A4 and strong CYP2C19 (eg, fluconazole) inhibition; see Adults. Antagonized by strong CYP3A4 inducers (eg, rifampin); see Adults.

Adverse Reactions:

Upper respiratory tract infections, headache, diarrhea, nasopharyngitis, increased blood CPK, rash, herpes zoster; 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


Data provided by MPR.

Indications for XELJANZ:

Moderately-to-severely active ulcerative colitis (UC).

Adult:

10mg twice daily for ≥8 weeks, then 5mg or 10mg twice daily based on response. Discontinue after 16 weeks if inadequate response with 10mg twice daily. Moderate-to-severe renal impairment or moderate hepatic impairment; concomitant strong CYP3A4 inhibitors, or drugs that result in both moderate CYP3A4 and strong CYP2C19 inhibition: reduce 10mg twice daily to 5mg twice daily, or 5mg twice daily to 5mg once daily. Concomitant strong CYP3A4 inducers: not recommended. Other dose adjustments: see full labeling.

Children:

Not established.

Boxed Warning:

Serious infections. Malignancy.

Warnings/Precautions:

Increased risk of serious or fatal infections (eg, TB, bacterial, viral, invasive fungal, or other opportunistic pathogens) esp. with 10mg twice daily dose (in UC treatment). Avoid in active, serious, or localized infections. Chronic, recurrent, or history of serious or opportunistic infections. Travel to, or residence in, areas with endemic TB or mycoses. Conditions that predispose to 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. Hepatitis B or C. Known malignancy. GI perforation risk (eg, history of diverticulitis). 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 consider prevention. Nursing mothers: not recommended [during and for ≥18hrs (tabs) or ≥36hrs (XR tabs) after last dose].

Pharmacological Class:

Janus kinase (JAK) inhibitor.

Interactions:

Concomitant live vaccines, biologic DMARDs, biologics for UC, or potent immunosuppressants (eg, azathioprine, cyclosporine): not recommended. Potentiated by strong CYP3A4 inhibitors (eg, ketoconazole), or drugs that result in both moderate CYP3A4 and strong CYP2C19 (eg, fluconazole) inhibition; see Adults. Antagonized by strong CYP3A4 inducers (eg, rifampin); see Adults.

Adverse Reactions:

Upper respiratory tract infections, headache, diarrhea, nasopharyngitis, increased blood CPK, rash, herpes zoster; 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


Data provided by MPR.

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