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
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.