Cibinqo Dosage/Direction for Use

Treatment should be initiated and supervised by a healthcare professional experienced in the diagnosis and treatment of atopic dermatitis.
Posology: The recommended starting dose is 100 mg or 200 mg once daily based on individual patient characteristics: A starting dose of 100 mg once daily is recommended for patients at higher risk of venous thromboembolism (VTE), major adverse cardiovascular event (MACE) and malignancy (see Precautions). If the patient does not respond adequately to 100 mg once daily, the dose can be increased to 200 mg once daily.
A dose of 200 mg once daily may be appropriate for patients who are not at higher risk of VTE, MACE and malignancy with high disease burden or for patients with an inadequate response to 100 mg once daily. Upon disease control, dose should be decreased to 100 mg once daily. If disease control is not maintained after dose reduction, re-treatment with 200 mg once daily can be considered. In adolescents (12 years to 17 years of age), weighing 25 kg to <59 kg, a starting dose of 100 mg once a day is recommended. If the patient does not respond adequately to 100 mg once daily, the dose can be increased to 200 mg once daily. In adolescents weighing at least 59 kg, a starting dose of 100 mg or 200 mg once daily may be appropriate.
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.
CIBINQO can be used with or without medicated topical therapies for atopic dermatitis.
Laboratory monitoring: See Table 5.

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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 (see Precautions).
Dose interruption: If a patient develops a serious infection, sepsis or opportunistic infection, dose interruption should be considered until the infection is controlled (see Precautions).
Interruption of dosing may be needed for management of laboratory abnormalities as described in Table 5.
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.
Interactions: In patients receiving dual strong inhibitors of CYP2C19 and moderate inhibitors of CYP2C9, or strong inhibitors of CYP2C19 alone (e.g., fluvoxamine, fluconazole, fluoxetine and ticlopidine), the recommended dose should be reduced by half to 100 mg or 50 mg once daily (see Interactions).
Treatment is not recommended concomitantly with moderate or strong inducers of CYP2C19/CYP2C9 enzymes (e.g., rifampicin, apalutamide, efavirenz, enzalutamide, phenytoin) (see Interactions).
In patients receiving acid reducing agents (e.g. antacids, proton pump inhibitors and H2 receptor antagonists), 200 mg once daily dose of abrocitinib should be considered (see Interactions).
Special populations: Renal impairment: No dose adjustment is required in patients with mild renal impairment, i.e., estimated glomerular filtration rate (eGFR) of 60 to <90 mL/min.
In patients with moderate (eGFR 30 to <60 mL/min) renal impairment, the recommended dose of abrocitinib should be reduced by half to 100 mg or 50 mg once daily (see Pharmacology: Pharmacokinetics under Actions).
In patients with severe (eGFR <30 mL/min) renal impairment, 50 mg once daily is the recommended starting dose. The maximum daily dose is 100 mg (see Pharmacology: Pharmacokinetics under Actions).
Abrocitinib has not been studied in patients with end-stage renal disease (ESRD) on renal replacement therapy.
Hepatic impairment: No dose adjustment is required in patients with mild (Child Pugh A) or moderate (Child Pugh B) hepatic impairment. Abrocitinib is contraindicated to patients with severe (Child Pugh C) hepatic impairment (see Contraindications).
Elderly: For patients 65 years of age and older, the recommended dose is 100 mg once daily (see Precautions).
Paediatric population: The safety and efficacy of CIBINQO in children under 12 years of age have not yet been established. No clinical data are available.
Method of administration: This medicinal product 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.
Tablets should be swallowed whole with water and should not be split, crushed or chewed because these methods have not been studied in clinical trials.