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BARICITINIB 4 MG TABLET (OLUMIANT ®) |
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RECOMMENDATION
FOR PRESCRIBER |
PRIOR
to the TREATMENT, EXPLAIN THOROUGHLY the efficacy and risks (including risk
of exposure to fetus) IN WRITING to patients or their family
members and OBTAIN their WRITTEN CONSENT. PATIENT OFF-LABEL CONSENT FORM [BR/1269] is required - prior to starting the therapy. |
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Pregnancy |
If you are pregnant or breast-feeding, think you
may be pregnant or are planning to have a baby, ask your doctor or pharmacist
for advice before taking this medicine. |
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Lactation |
It is unknown whether baricitinib/metabolites are
excreted in human milk. Available pharmacodynamic/toxicological data in animals
have shown excretion of baricitinib in milk. A risk to newborns / infants cannot be excluded and Olumiant should not be used during breast-feeding. A decision must be made whether to discontinue breast-feeding or to discontinue Olumiant therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman. |
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Fertility |
Studies in animals suggest that treatment with
baricitinib has the potential to decrease female fertility while on
treatment, but there was no effect on male spermatogenesis |
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Therapeutic
indications |
Leaflet:
Rheumatoid arthritis and atopic dermatitis |
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Dosage
Recommendation for COVID-19 *Renal
Impairment *Hepatic
Impairment |
CLINICAL MANAGEMENT OF CONFIRMED COVID-19 CASE IN ADULT AND PAEDIATRIC (Annex 2e): For COVID-19 Category 4b & 5b: •
4mg
OD oral x 14 days or until hospital discharge (whichever earlier) •
Avoid in patients with previous history of
thrombosis. •
Renal
adjustment (based on eGFR):
·
Hepatic impairment prior to treatment
initiation: o Mild
to moderate impairment: No dosage adjustment necessary. o Severe
impairment: Use is not recommended (has not been studied). o ALT/AST
increased: If baricitinib-induced liver injury is suspected, interrupt therapy
and further evaluate until DILI is excluded.
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Paediatrics |
Leaflet:
The safety, efficacy and pharmacokinetics of baricitinib have not yet been
established in a paediatric population (less than 18 years old) COVID-19
(hospitalized patients), treatment: Very limited data
available: o Children
2 to <9 years: Oral: 2 mg once daily in combination with remdesivir. o Children
≥9 years and Adolescents: Oral: 4 mg once daily in combination with
remdesivir. o Duration
of baricitinib is 14 days or until hospital discharge, whichever is first
(FDA 2020). o The
role of baricitinib in the treatment of COVID-19 is evolving. The NIH states
that data are insufficient to recommend for or against the use of baricitinib
in pediatric patients (NIH 2021). Pediatric dosing is based on ongoing
clinical trials for other indications (FDA 2020). |
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Geriatrics |
Leaflet;
Age ≥ 65 years or ≥ 75 years has no effect on baricitinib exposure (Cmax and
AUC). |
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Laboratory
measures and monitoring guidance |
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Administration |
Oral: · May be administered with or without food. · For patients unable to swallow tablets whole, the
tablet may be chewed (although the tablet is NOT designed to be
swollen); ensure entire dose is swallowed. · Alternatively, the tablet may be dispersed in a
small amount (5 to 10 mL) of liquid (water, whole milk, green tea, miso
soup); the tablet will disperse in <5 minutes. A small amount of food may
be added to the liquid mixture; the entire mixture should be consumed at
one time (manufacturer data on file). · Place required number of tablets to achieve
desired dose in a container with ~30 mL of room temperature water. · Gently
swirl the tablet(s) to disperse; ensure tablets
are sufficiently dispersed to pass through syringe tip. · Withdraw entire contents of container into an
appropriate syringe and immediately administer through NG tube. · For small tubes (<12 French), hold the
syringe horizontally and shake during administration to avoid clogging of
tube. · Rinse
container with a minimum of 15 mL of room temperature water, withdraw
contents into the syringe, and administer through NG tube (FDA 2021). · Place required number of tablets to achieve
desired dose in a container with ~15 mL (minimum: 10 mL) of room temperature
water. · Gently swirl the tablet(s) to disperse; ensure
tablets are sufficiently dispersed to pass through syringe tip. · Withdraw entire contents of container into an
appropriate syringe and immediately administer through G tube. · Rinse container with an additional ~15 mL
(minimum: 10 mL) of room temperature water, withdraw contents into the
syringe, an |
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Contraindications |
Hypersensitivity(especially
if serious allergic or anaphylactic reaction) |
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Special
Warnings and Precautions for Use |
Infections
§ Baricitinib
is associated with an increased rate of infections such as upper respiratory
tract infections compared to placebo. § The
risks and benefits of treatment with Olumiant should be carefully considered
prior to initiating therapy in patients with active, chronic or recurrent
infections. § If
an infection develops, the patient should be monitored carefully and Olumiant
therapy should be temporarily interrupted if the patient is not responding to
standard therapy. § Olumiant
treatment should not be resumed until the infection resolves § Tuberculosis
: Patients
should be screened for tuberculosis (TB) before starting Olumiant therapy.
Olumiant should not be given to patients with active TB. Anti-TB therapy
should be considered prior to initiation of Olumiant in patients with
previously untreated latent TB. § Absolute
Neutrophil Count (ANC) < 1 x 10^9 cells/L, Absolute Lymphocyte Count (ALC)
< 0.5 x 10^9 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 § The
risk of lymphocytosis is increased in elderly patients with rheumatoid
arthritis. Rare cases of lymphoproliferative disorders have been reported. § Viral
reactivation, including cases of herpes virus reactivation (e.g., herpes
zoster, herpes simplex), were reported in clinical studies. § Herpes
zoster was reported more commonly in patients ≥ 65 years of age who had
previously been treated with both biologic and conventional DMARDs. If a
patient develops herpes zoster, Olumiant treatment should be temporarily
interrupted until the episode resolves. § Screening
for viral hepatitis should be performed in accordance with clinical
guidelines before starting therapy with Olumiant. o Patients,
who were positive for hepatitis C antibody but negative for hepatitis C virus
RNA, were allowed to participate. o Patients
with hepatitis B surface antibody and hepatitis B core antibody, without
hepatitis B surface antigen, were also allowed to participate; such patients
should be monitored for expression of hepatitis B virus (HBV) DNA. If HBV DNA
is detected, a liver specialist should be consulted to determine if treatment
interruption is warranted. § No
data are available on the response to vaccination with live vaccines in
patients receiving baricitinib. § Use
with live, attenuated vaccines during, or immediately prior to, Olumiant
therapy is NOT recommended. § Prior
to initiating Olumiant, it is recommended that all patients be brought up to
date with all immunisations in agreement with current immunisation
guidelines. § 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
Olumiant 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. § 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. § If
increases in ALT or AST are observed during routine patient management and
drug-induced liver injury is suspected, Olumiant should be temporarily
interrupted until this diagnosis is excluded. § The
risk of malignancies including lymphoma is increased in patients with
rheumatoid arthritis. Immunomodulatory medicinal products may increase the
risk of malignancies including lymphoma. § The
clinical data are insufficient to assess the potential incidence of
malignancies following exposure to baricitinib. Long-term safety evaluations
are ongoing. § Events
of deep venous thrombosis (DVT) and pulmonary embolism (PE) have been
reported in patients receiving baricitinib. § Olumiant
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, Olumiant treatment should be discontinued
and patients should be evaluated promptly, followed by appropriate treatment. § Combination
with biologic DMARDs or other Janus kinase (JAK) inhibitors is not
recommended, as a risk of additive immunosuppression cannot be excluded. § Data
concerning use of baricitinib with potent immunosuppressive medicinal
products (e.g., azathioprine, tacrolimus, ciclosporin) are limited and
caution should be exercised when using such combinations. |
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Adverse
reactions |
(b) Combined term (eczema herpeticum,
herpes simplex, ophthalmic herpes simplex, oral herpes). (c) Includes changes detected during
laboratory monitoring (see text below). |
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Potential
Drug interactions |
In
particular, tell your doctor or pharmacist before taking Olumiant if you are
taking: o probenecid
(for gout) - may increase the levels of Olumiant in your blood. With
concomitant probenecid, the recommended dose of Olumiant is half of normal
dose o injectable
anti-rheumatic medicine o injectable
medicines that depress the immune system, including targeted biologic
(antibody) therapies o immunosuppresants,
such as azathioprine, tacrolimus or ciclosporin o Janus
kinase (JAK) inhibitors, such as ruxolitinib o medicines
that may increase risk of diverticulitis such as a non-steroidal
anti-inflammatory medicines and/or corticosteroids |
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Tablet
properties |
Film-coated
tablet, no score
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References |
1.
UptoDate: Baricitinib (Drug Information) –
Accessed online on 19 Aug 2021 2.
Olumiant 2mg Tablet & 4mg Tablet -
PI_EU_SPC (by Lilly del Caribe, Inc.) - Updated on 24 June 2020 3.
Package leaflet: Information for the
patient (by Eli Lilly and Company Limited) - Updated in Oct 2020 4.
CLINICAL
MANAGEMENT OF CONFIRMED COVID-19 CASE IN ADULT AND PAEDIATRIC (Annex 2e),
Ministry of Health, Malaysia [Aug 2021] 5.
Baricitinib: Safety Data Sheet (by Lilly) –
Updated on 19 Dec 2018 6.
FACT SHEET FOR HEALTHCARE PROVIDERS
EMERGENCY USE AUTHORIZATION (EUA) OF BARICITINIB - Eli Lilly and Company, Indianapolis, USA – Revised on July 2021 |
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