CIBINQO Film-Coated Tablet 100 mg

PFIZER PRIVATE LIMITED

PFIZER PRIVATE LIMITED

Therapeutic

Prescription Only

TABLET, FILM COATED

**4.2 Posology and method of administration** Treatment should be initiated and supervised by a healthcare professional experienced in the diagnosis and treatment of conditions for which CIBINQO is indicated (see Section 4.1). Posology The recommended starting dose of CIBINQO 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 Section 4.4 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). If the patient does not respond adequately to 100 mg once daily, the dose can be increased to 200 mg once daily (see below). - A dose of 200 mg once daily may be appropriate for patients who are not at higher risk of VTE, MACE and malignancy 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. The lowest effective dose for maintenance should be used (see Section 5.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). 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. _Treatment initiation_ Treatment with CIBINQO 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 × 103/mm3 or who have a haemoglobin value <8 g/dL (see Section 4.4 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _Dose interruption_ If a patient develops a serious infection, sepsis or opportunistic infection, consider interruption of CIBINQO until the infection is controlled (see Section 4.4 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Interruption of dosing may be needed for management of laboratory abnormalities as described in Table 1 (see Section 4.4 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _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, resume dosing at the regular scheduled time. Special dosage instructions In patients receiving strong inhibitors of cytochrome P450 (CYP) 2C19 (e.g., fluvoxamine, fluconazole, fluoxetine and ticlopidine), the recommended dose of CIBINQO should be reduced by half to 100 mg or 50 mg once daily. The use of CIBINQO is not recommended concomitantly with moderate or strong inducers of CYP2C19/CYP2C9 enzymes (e.g., rifampin, apalutamide, efavirenz, enzalutamide, phenytoin) (see Section 4.5 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _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 renal impairment (eGFR 30 to <60 mL/min), the recommended dose of CIBINQO should be reduced by half to 100 mg or 50 mg once daily (see Section 5.2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). In patients with severe renal impairment (eGFR <30 mL/min), the recommended starting dose of CIBINQO should be 50 mg once daily. The maximum daily dose is 100 mg. The dosing of CIBINQO in severe renal impairment patients is based on modelling and simulation which demonstrated comparability of active moiety exposures to patients with normal renal function administered doses of 100 mg and 200 mg once daily. CIBINQO 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 (see Section 5.2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). CIBINQO must not be used in patients with severe (Child Pugh C) hepatic impairment (see Section 4.3). _Elderly population_ The recommended starting dose for patients ≥65 years of age is 100 mg once daily (see Section 4.4 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). The risks and benefits of the recommended dose for patients ≥65 years of age should be considered (see Section 4.4 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). There are no conclusive data in patients 75 years of age and older. _Paediatric population_ Use in paediatric patients under 12 years of age is not recommended. Method of administration CIBINQO is to be taken orally once daily with or without food at approximately the same time each day. In patients who experience nausea, taking CIBINQO with food may improve nausea. CIBINQO tablets should be swallowed whole with water and should not be split, crushed, or chewed.