Olumiant® (Baricitinib)

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Baricitinib: Laboratory Monitoring

Los niveles de neutrófilos, linfocitos y hemoglobina deben evaluarse antes del inicio de baricitinib, y los lípidos deben evaluarse 12 semanas después del inicio.

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Laboratory Monitoring With Baricitinib Treatment

Neutrophil, lymphocyte, and hemoglobin levels should be assessed prior to initiation of BARI, and lipids should be assessed 12 weeks after initiation.1

Neutropenia, lymphopenia, anemia, liver enzyme abnormalities, lipid parameter changes, and DVT and PE observed before or during BARI treatment should be managed as described below.1

Neutropenia

Absolute neutrophil counts less than 1x109 cells/L (<1000 cells/mm3) were uncommonly reported in the BARI clinical trials.1

Avoid initiation or interrupt BARI treatment in patients with an ANC less than 1x109 cells/L (<1000 cells/mm3).1

Lymphopenia

Absolute lymphocyte counts less than 0.5x109 cells/L (<500 cells/mm3) were uncommonly reported in BARI clinical trials.1

Avoid initiation or interrupt BARI treatment in patients with an ALC <0.5x109 cells/L (<500 cells/ mm3).1

Hemoglobin

Decreases in hemoglobin levels to less than 4.9 mmol (Fe)/L (<8 g/dL) were uncommonly reported with BARI treatment. Small decreases in hemoglobin followed by a return to and subsequent exceeding of baseline values were observed with BARI treatment.1

Avoid use of BARI treatment in patients with hemoglobin less than 4.9 mmol (Fe)/L (<8 g/dL).1

Liver Enzymes

In patients treated with BARI in clinical trials, increases to ≥5 and ≥10 times the upper limit of normal were uncommonly observed for both ALT and AST.1

If increases in ALT or AST are observed and drug-induced liver injury is suspected, BARI should be interrupted until this diagnosis is excluded.1

Lipids

Increases in lipid parameters were reported in patients treated with BARI. Elevations in LDL cholesterol decreased to pretreatment levels in response to statin therapy for patients receiving BARI.1

Assess lipid parameters approximately 12 weeks following BARI initiation. Manage patients according to applicable clinical guidelines for the management of hyperlipidemia.1

The effect of these lipid parameter elevations on cardiovascular morbidity and mortality has not been determined.2

Venous Thromboembolism

Events of DVT and PE have been reported in patients treated with BARI.1

Baricitinib should be used with caution in patients with risk factors for DVT or PE. If clinical features of DVT or PE occur,

  • interrupt BARI
  • evaluate the patient promptly, and
  • institute appropriate treatment.1

References

1Data on file, Eli Lilly and Company and/or one of its subsidiaries.

2Olumiant [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.

Glossary

ALC = absolute lymphocyte count

ALT = alanine aminotransferase

ANC = absolute neutrophil count

AST = aspartate aminotransferase

BARI = baricitinib

DVT = deep vein thrombosis

LDL = low-density lipoprotein

PE = pulmonary embolism

Fecha de la última revisión: 2020 M11 13


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