Moderate-to-severe atopic dermatitis

Active Ingredient: Abrocitinib

Indication for Abrocitinib

Population group: only adults (18 - 65 years old)

Abrocitinib is indicated for the treatment of moderate-to-severe atopic dermatitis in adults who are candidates for systemic therapy.

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

200 mg once daily

Route of admnistration

Oral

Defined daily dose

200 - 200 mg

Dosage regimen

From 200 To 200 mg once every day

Detailed description

The recommended starting dose is 200 mg once daily.

  • During treatment, the dose may be decreased or increased based on tolerability and efficacy. The lowest effective dose for maintenance should be considered. The maximum daily dose is 200 mg.

Abrocitinib can be used with or without medicated topical therapies for atopic dermatitis.

Discontinuation of treatment should be considered in patients who show no evidence of therapeutic benefit after 24 weeks.

Laboratory monitoring

Table 1. Laboratory measures and monitoring guidance:

Laboratory measures Monitoring guidance Action
Complete blood count
including Platelet
Count, Absolute
Lymphocyte Count
(ALC), Absolute
Neutrophil Count
(ANC) and
Haemoglobin (Hb)
Before treatment initiation, 4 weeks
after initiation and thereafter
according to routine patient
management.
Platelets: Treatment should be
discontinued if platelet counts are
<50 × 103/mm³.
ALC: Treatment should be
interrupted if ALC is
<0.5 × 103/mm³ and may be restarted
once ALC returns above this value.
Treatment should be discontinued if
confirmed.
ANC: Treatment should be
interrupted if ANC is <1 × 103/mm³
and may be restarted once ANC
returns above this value.
Hb: Treatment should be interrupted
if Hb is <8 g/dL and may be
restarted once Hb returns above this
value.
Lipid parametersBefore treatment initiation, 4 weeks
after initiation and thereafter
according to the patient’s risk for
cardiovascular disease and clinical
guidelines for hyperlipidaemia.
Patients should be monitored
according to clinical guidelines for
hyperlipidaemia.

Treatment initiation Treatment should not be initiated in patients with a platelet count <150 × 103/mm³, an absolute lymphocyte count (ALC) <0.5 × 103/mm³, an absolute neutrophil count (ANC) <1.2 × 103/mm³ or who have a haemoglobin value <10 g/dL.

Dose interruption

If a patient develops a serious infection, sepsis or opportunistic infection, dose interruption should be considered until the infection is controlled.

Interruption of dosing may be needed for management of laboratory abnormalities as described in Table 1.

Missed doses

If a dose is missed, patients should be advised to take the dose as soon as possible unless it is less than 12 hours before the next dose, in which case the patient should not take the missed dose. Thereafter, dosing should be resumed at the regular scheduled time.

Dosage considerations

Abrocitinib is to be taken orally once daily with or without food at approximately the same time each day.

In patients who experience nausea, taking tablets with food may improve nausea.

Active ingredient

Abrocitinib

Abrocitinib is a Janus kinase (JAK)1 inhibitor. JAKs are intracellular enzymes which transmit signals arising from cytokine or growth factor-receptor interactions on the cellular membrane to influence cellular processes of haematopoiesis and immune cell function. It is used for the treatment of moderate-to-severe atopic dermatitis in adults.

Read more about Abrocitinib

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