Olumiant ® (baricitinib) tabletter

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Olumiant® ▼ (baricitinib): Laboratorieövervakning

Neutrofil, lymfocyt, och hemoglobinnivåer bör bedömas före initiering av baricitinib, och lipider bör bedömas 12 veckor efter initiering.

Summary

Neutropaenia, lymphopenia, anaemia, liver enzyme abnormalities, lipid parameter changes, and deep venous thrombosis (DVT) and pulmonary embolism (PE) observed before or during baricitinib (BARI) treatment should be managed as described below Table 1.1

Table 1.  Laboratory measures and monitoring guidance1

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. 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.1

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. 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.1

Lipids

Dose dependent increases in blood lipid parameters were reported in patients treated with baricitinib compared to placebo. Elevations in LDL cholesterol decreased to pre- treatment levels in response to statin therapy. 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. The effect of these lipid parameter elevations on cardiovascular morbidity and mortality has not been determined.1

Venous Thromboembolism

Events of deep venous thrombosis (DVT) and pulmonary embolism (PE) have been reported in patients receiving baricitinib. 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. If clinical features of DVT/PE occur, baricitinib treatment should be discontinued and patients should be evaluated promptly, followed by appropriate treatment.1

References

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

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.

Datum fӧr senaste ӧversyn 2017 M10 13

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