Xeljanz

Xeljanz Manufacturers

• U.s. Pharmaceuticals
  

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  Xeljanz | U.s. Pharmaceuticals

  

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  XELJANZ is given orally with or without food.

  2.1 Rheumatoid Arthritis

  XELJANZ may be used as monotherapy or in combination with methotrexate or other nonbiologic disease modifying antirheumatic drugs (DMARDs). The recommended dose of XELJANZ is 5 mg twice daily.

  Dose interruption is recommended for management of lymphopenia, neutropenia and anemia [see Dosage and Administration (2.3), Warnings and Precautions (5.4), and Adverse Reactions (6.1)]. XELJANZ dosage should be reduced to 5 mg once daily in patients: with moderate or severe renal insufficiency with moderate hepatic impairment receiving potent inhibitors of Cytochrome P450 3A4 (CYP3A4) (e.g., ketoconazole) receiving one or more concomitant medications that result in both moderate inhibition of CYP3A4 and potent inhibition of CYP2C19 (e.g., fluconazole). 2.2 General Considerations for Administration XELJANZ should not be used in patients with severe hepatic impairment. It is recommended that XELJANZ not be initiated in patients with a lymphocyte count less than 500 cells/mm3, an absolute neutrophil count (ANC) less than 1000 cells/mm3, or who have hemoglobin levels less than 9 g/dL. Coadministration of XELJANZ with potent inducers of CYP3A4 (e.g., rifampin) may result in loss of or reduced clinical response to XELJANZ. 2.3 Dosage Modifications

  XELJANZ treatment should be interrupted if a patient develops a serious infection until the infection is controlled.

  Table 1: Dose Adjustments for Lymphopenia Low Lymphocyte Count [see Warnings and Precautions (5.4)] Lab Value
  (cells/mm3) Recommendation Lymphocyte count greater than or equal to 500 Maintain dose Lymphocyte count less than 500 Discontinue XELJANZ (Confirmed by repeat testing) Table 2: Dose Adjustments for Neutropenia Low ANC [see Warnings and Precautions (5.4)] Lab Value
  (cells/mm3) Recommendation ANC greater than 1000 Maintain dose ANC 500–1000 For persistent decreases in this range, interrupt dosing until ANC is greater than 1000 When ANC is greater than 1000, resume XELJANZ 5 mg twice daily ANC less than 500 Discontinue XELJANZ (Confirmed by repeat testing) Table 3: Dose Adjustments for Anemia Low Hemoglobin Value [see Warnings and Precautions (5.4)] Lab Value
  (g/dL) Recommendation Less than or equal to 2 g/dL decrease and greater than or equal to 9.0 g/dL Maintain dose Greater than 2 g/dL decrease or less than 8.0 g/dL Interrupt the administration of XELJANZ until hemoglobin values have normalized (Confirmed by repeat testing)

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• Pfizer Laboratories Div Pfizer Inc
  

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  Xeljanz | Pfizer Laboratories Div Pfizer Inc

  

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  2.1 Dosage in Rheumatoid Arthritis XELJANZ may be used as monotherapy or in combination with methotrexate or other nonbiologic disease-modifying antirheumatic drugs (DMARDs). The recommended dose of XELJANZ is 5 mg twice daily. XELJANZ is given orally with or without food. 2.2 Dosage Modifications due to Serious Infections and Cytopenias

  (see Tables 1, 2, and 3 below.)

  It is recommended that XELJANZ not be initiated in patients with an absolute lymphocyte count less than 500 cells/mm3, an absolute neutrophil count (ANC) less than 1000 cells/mm3 or who have hemoglobin levels less than 9 g/dL. Dose interruption is recommended for management of lymphopenia, neutropenia and anemia [see Warnings and Precautions (5.4) and Adverse Reactions (6.1)]. Avoid use of XELJANZ if a patient develops a serious infection until the infection is controlled. 2.3 Dosage Modifications due to Drug Interactions XELJANZ dosage should be reduced to 5 mg once daily in patients: receiving potent inhibitors of Cytochrome P450 3A4 (CYP3A4) (e.g., ketoconazole). receiving one or more concomitant medications that result in both moderate inhibition of CYP3A4 and potent inhibition of CYP2C19 (e.g., fluconazole). Coadministration of potent inducers of CYP3A4 (e.g., rifampin) with XELJANZ may result in loss of or reduced clinical response to XELJANZ. Coadministration of potent inducers of CYP3A4 with XELJANZ is not recommended. 2.4 Dosage Modifications in Patients with Renal or Hepatic Impairment XELJANZ dosage should be reduced to 5 mg once daily in patients: with moderate or severe renal insufficiency. with moderate hepatic impairment. Use of XELJANZ in patients with severe hepatic impairment is not recommended. Table 1: Dose Adjustments for Lymphopenia Low Lymphocyte Count [see Warnings and Precautions (5.4)] Lab Value
  (cells/mm3) Recommendation Lymphocyte count greater than or equal to 500 Maintain dose Lymphocyte count less than 500 Discontinue XELJANZ (Confirmed by repeat testing) Table 2: Dose Adjustments for Neutropenia Low ANC [see Warnings and Precautions (5.4)] Lab Value
  (cells/mm3) Recommendation ANC greater than 1000 Maintain dose ANC 500–1000 For persistent decreases in this range, interrupt dosing until ANC is greater than 1000 When ANC is greater than 1000, resume XELJANZ 5 mg twice daily ANC less than 500 Discontinue XELJANZ (Confirmed by repeat testing) Table 3: Dose Adjustments for Anemia Low Hemoglobin Value [see Warnings and Precautions (5.4)] Lab Value
  (g/dL) Recommendation Less than or equal to 2 g/dL decrease and greater than or equal to 9.0 g/dL Maintain dose Greater than 2 g/dL decrease or less than 8.0 g/dL Interrupt the administration of XELJANZ until hemoglobin values have normalized (Confirmed by repeat testing)

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