Rheumatoid arthritis

Active Ingredient: Upadacitinib

Indication for Upadacitinib

Population group: only adults (18 years old or older)
Therapeutic intent: Curative procedure

Upadacitinib is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). Upadacitinib may be used as monotherapy or in combination with methotrexate.

For this indication, competent medicine agencies globally authorize below treatments:

15 mg once daily

For:

Dosage regimens

Oral, 15 milligrams upadacitinib, once daily.

Detailed description

The recommended dose of upadacitinib is 15 mg once daily.

Dose initiation

Treatment should not be initiated in patients with an absolute lymphocyte count (ALC) that is <0.5 × 109 cells/L, an absolute neutrophil count (ANC) that is <1 × 109 cells/L or who have haemoglobin (Hb) levels that are <8 g/dL.

Dose interruption

Treatment should be interrupted if a patient develops a serious infection until the infection is controlled.

Interruption of dosing may be needed for management of laboratory abnormalities as described in the following table.

Laboratory measures and monitoring guidance:

Laboratory
measure
Action Monitoring guidance
Absolute
Neutrophil Count
(ANC)
Treatment should be
interrupted if ANC is
<1 × 109 cells/L and
may be restarted once
ANC returns above
this value
Evaluate at baseline and then no later than 12 weeks
after initiation of treatment. Thereafter evaluate
according to individual patient management.
Absolute
Lymphocyte
Count (ALC)
Treatment should be
interrupted if ALC is
<0.5 × 109 cells/L
and may be restarted
once ALC returns
above this value
Haemoglobin (Hb) Treatment should be
interrupted if Hb is
<8 g/dL and may be
restarted once Hb
returns above this
value
Hepatic
transaminases
Treatment should be
temporarily
interrupted if drug-
induced liver injury
is suspected
Evaluate at baseline and thereafter according to
routine patient management.
LipidsPatients should be
managed according
to international
clinical guidelines for
hyperlipidaemia
Evaluate 12 weeks after initiation of treatment and
thereafter according to international clinical
guidelines for hyperlipidaemia

Elderly

There are limited data in patients 75 years of age and older.

Dosage considerations

Upadacitinib is to be taken orally once daily with or without food and may be taken at any time of the day.

Active ingredient

Upadacitinib

Upadacitinib is a selective and reversible Janus kinase (JAK) inhibitor. In human cellular assays, upadacitinib preferentially inhibits signalling by JAK1 or JAK1/3 with functional selectivity over cytokine receptors that signal via pairs of JAK2. JAK1 is important in inflammatory cytokine signals while JAK2 is important for red blood cell maturation and JAK3 signals play a role in immune surveillance and lymphocyte function.

Read more about Upadacitinib

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