Abrocitinib

Therapeutic indications

Abrocitinib is indicated for:

Moderate-to-severe atopic dermatitis

Irrespective of gender 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, the medical literature mentions below treatments (click for details):

Treatment 1: Oral - 200 mg once daily

Contraindications

Active ingredient Abrocitinib is contraindicated in the following cases:

Severe hepatic impairment

Lactation

There are no data on the presence of abrocitinib in human milk, the effects on the breast-fed infant, or the effects on milk production. Abrocitinib was secreted in milk of lactating rats. A risk to newborns/infants cannot be excluded and abrocitinib is contraindicated during breast-feeding.

Pregnancy

There are no or limited amount of data on the use of abrocitinib in pregnant women. Studies in animals have shown reproductive toxicity. Abrocitinib has been shown to cause embryo-foetal lethality in pregnant rats and rabbits, skeletal variations in the foetuses of pregnant rats and rabbits, and to affect parturition and peri/postnatal development in rats. Abrocitinib is contraindicated during pregnancy.

Active serious systemic infections, including tuberculosis (TB)

Serious infections

Serious infections have been reported in patients receiving abrocitinib. The most frequent serious infections in clinical studies were herpes simplex, herpes zoster and pneumonia.

Treatment must not be initiated in patients with an active, serious systemic infection.

Risks and benefits of treatment prior to initiating abrocitinib should be considered for patients:

  • with chronic or recurrent infection
  • who have been exposed to TB
  • with a history of a serious or an opportunistic infection
  • who have resided or travelled in areas of endemic TB or endemic mycoses; or
  • with underlying conditions that may predispose them to infection.

Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with abrocitinib. A patient who develops a new infection during treatment should undergo prompt and complete diagnostic testing and appropriate antimicrobial therapy should be initiated. The patient should be closely monitored and therapy should be temporarily interrupted if the patient is not responding to standard therapy.

Tuberculosis

Patients should be screened for TB before starting treatment and yearly screening for patients in highly endemic areas for TB should be considered. Abrocitinib must not be given to patients with active TB. For patients with a new diagnosis of latent TB or prior untreated latent TB, preventive therapy for latent TB should be started prior to initiation of treatment.

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