Cibinqo Dosage/Direction for Use




Zuellig Pharma
Full Prescribing Info
Dosage/Direction for Use
Treatment should be initiated and supervised by a healthcare professional experienced in the diagnosis and treatment of conditions for which CIBINQO is indicated (see Indications/Uses).
Posology: The recommended dose of CIBINQO is 100 mg once daily. An initial dose of 200 mg once daily for 12 weeks followed by maintenance with 100 mg once daily may be appropriate for some patients who need rapid relief of symptoms. The lowest effective dose for maintenance should be used (see Pharmacology: Pharmacodynamics under Actions).
CIBINQO can be used with or without medicated topical therapies for atopic dermatitis.
Consider discontinuation of CIBINQO if adequate therapeutic benefit is not achieved after 24 weeks.
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 Precautions).
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.
Dose interruption: If a patient develops a serious infection, sepsis or opportunistic infection, consider interruption of CIBINQO until the infection is controlled (see Precautions).
Interruption of dosing may be needed for management of laboratory abnormalities as described in Table 3 (see Precautions).
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 Interactions).
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 Pharmacology: Pharmacokinetics under Actions).
In patients with severe renal impairment (eGFR <30 mL/min), the recommended dose of CIBINQO should be 50 mg once daily. 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 Pharmacology: Pharmacokinetics under Actions). CIBINQO must not be used in patients with severe (Child Pugh C) hepatic impairment (see Contraindications).
Elderly population: The risks and benefits of the recommended dose for patients ≥65 years of age should be considered (see Precautions). 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 while taking CIBINQO, taking with food may improve nausea.
CIBINQO tablets should be swallowed whole with water and should not be split, crushed, or chewed.
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