Olumiant® ▼ (baricitinib)

This information is intended for UK registered healthcare professionals only as a scientific exchange in response to your search for information. Please refer to the link for full prescribing information: Olumiant Summary of Product Characteristics (SmPC)

Olumiant® ▼ (baricitinib): Laboratory Monitoring

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

Laboratory Monitoring with Baricitinib Treatment

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

Table 1.  Laboratory measures and monitoring guidance2

Laboratory Measure

Action

Monitoring Guidance

 

Lipid parameters

Patients should be managed according to international clinical guidelines for hyperlipidaemia

12 weeks after initiation of treatment and thereafter according to international clinical guidelines for hyperlipidaemia

Absolute Neutrophil Count (ANC)

Treatment should be interrupted if ANC

< 1 x 109 cells/L and may be restarted once ANC return above this value

 

 

 

 

Before treatment initiation and thereafter according to routine patient management

Absolute Lymphocyte Count (ALC)

Treatment should be interrupted if ALC

< 0.5 x 109 cells/L and may be restarted once ALC return above this value

 

Haemoglobin (Hb)

Treatment should be interrupted if Hb

< 8 g/dL and may be restarted once Hb return above this value

Hepatic transaminases

Treatment should be temporarily interrupted if drug-induced liver injury is suspected

Neutropenia, Lymphopenia and Hemoglobin

Absolute Neutrophil Count (ANC) < 1 x 109 cells/L, Absolute Lymphocyte Count (ALC) < 0.5 x 109 cells/L and haemoglobin < 8 g/dL were reported in less than 1 % of patients in clinical trials.2

Treatment should not be initiated, or should be temporarily interrupted, in patients with an

  • ANC < 1 x 109 cells/L,

  • ALC < 0.5 x 109 cells/L or

  • haemoglobin < 8 g/dL

observed during routine patient management.2

Liver Enzymes

Increases in alanine transaminase (ALT) and aspartate transaminase (AST) to ≥ 5 and ≥ 10 x upper limit of normal (ULN) were reported in less than 1 % of patients in clinical trials. In treatment-naïve patients, combination with methotrexate resulted in increased frequency of hepatic transaminase elevations compared with baricitinib monotherapy.2

If increases in ALT or AST are observed during routine patient management and drug-induced liver injury is suspected, baricitinib should be temporarily interrupted until this diagnosis is excluded.2

Lipids

Dose dependent increases in blood lipid parameters were reported in patients treated with baricitinib compared to placebo.2

  • Elevations in LDL cholesterol decreased to pre- treatment levels in response to statin therapy.2

  • Lipid parameters should be assessed approximately 12 weeks following initiation of baricitinib therapy and thereafter patients should be managed according to international clinical guidelines for hyperlipidaemia.2

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

Venous Thromboembolism

Events of deep venous thrombosis (DVT) and pulmonary embolism (PE) have been reported in patients receiving baricitinib.2

Baricitinib should be used with caution in patients with risk factors for DVT/PE, such as

  • older age,

  • obesity,

  • a medical history of DVT/PE, or

  • patients undergoing surgery and immobilisation.2

If clinical features of DVT/PE occur, baricitinib treatment should be discontinued and patients should be evaluated promptly, followed by appropriate treatment.2

References

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

2. Olumiant [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

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

Date of Last Review: July 20, 2020

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