Active Ingredient: Abrocitinib
Abrocitinib is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Regimen A: Oral, 100 milligrams abrocitinib, once daily.
Regimen B: Oral, 200 milligrams abrocitinib, once daily.
The recommended starting dose is 100 mg or 200 mg once daily based on individual patient characteristics:
The lowest effective dose for maintenance should be considered.
Discontinuation of treatment should be considered in patients who show no evidence of therapeutic benefit after 24 weeks.
Abrocitinib can be used with or without medicated topical therapies for atopic dermatitis.
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 parameters | Before 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 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.
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.
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.
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.
For:
Oral, 100 milligrams abrocitinib, once daily.
For patients 65 years of age and older, the recommended dose is 100 mg once daily.
Discontinuation of treatment should be considered in patients who show no evidence of therapeutic benefit after 24 weeks.
Abrocitinib can be used with or without medicated topical therapies for atopic dermatitis.
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 parameters | Before 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 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.
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.
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.
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.
Liability Disclaimer : RxReasoner has utilized reasonable care in providing content and services that are accurate, complete and up to date. However, RxReasoner does not accept any responsibility or liability about it. The content and services of RxReasoner are for informational purposes only and they are not intended to be a substitute for the knowledge, expertise, skill, and judgment of physicians, pharmacists, nurses, or other healthcare professionals involved in patient care. RxReasoner offers no medical advice. Users are responsible for the use of the provided content. A shown indication or treatment should not be construed to indicate that the medication is safe, appropriate, or effective in any given patient or under any particular circumstances. The absence of an indication or treatment should not roule out the existence of other appropriate medications. Always seek the advice of a physician or other qualified health provider with any questions you may have regarding a medical condition or medicament. RxReasoner is not liable for any damages allegedly sustained arising out of the use of its content and services.
