CIBINQO should 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.
Treatment with CIBINQO should not be initiated in patients with a platelet count less than 150 × 103/mm3, an absolute lymphocyte count (ALC) less than 0.5 × 103/mm3, an absolute neutrophil count (ANC) less than 1 × 103/mm3 or who have a hemoglobin value less than 8 g/dL.
The recommended dose of CIBINQO is 100 mg or 200 mg orally once daily for adolescents and adults under 65 years of age, based on individual goal of therapy and potential risk for adverse reactions. For patients using the 200 mg once daily dosage, after symptom control is achieved by week 12, consider dose reduction to 100 mg once daily. Relative to patients who maintained the 200 mg dose, the risk of occurrence of serious adverse reactions decreased in patients who reduced their dose to 100 mg beyond 12 weeks in clinical studies. If symptom control is lost after dose reduction, the dose can be increased to 200 mg. Exceeding a daily dosage of 200 mg is not recommended.
CIBINQO can be used with or without medicated topical therapies for atopic dermatitis.
Elderly population
The recommended starting dose for patients ≥65 years of age is 100 mg. Some side effects that were more common in elderly patients in clinical trials, including herpes zoster, lymphopenia, and thrombocytopenia, occurred more frequently at the 200 mg daily dosage (see 8.2 Clinical Trial Adverse Reactions).
Pediatric population
For pediatric patients 12 to < 18 years of age, the starting recommended dose of CIBINQO is 100 mg or 200 mg once daily. Dosage adjustment should be considered based on individual goal of therapy and potential risk for adverse reactions.
The safety and efficacy of CIBINQO in pediatric patients under 12 years of age have not yet been established. No data are available.
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) or severe (eGFR <30 mL/min) renal impairment, the recommended dose of CIBINQO is to be reduced by 50% as shown in Table 1.
The use of CIBINQO has not been studied in patients with end-stage renal disease (ESRD) on renal replacement therapy.
| Renal Impairment Stage | Estimated Glomerular Filtration rate (eGFR) | Dose Adjustment | |
|---|---|---|---|
Indicated Dose 100 mg Once Daily | Indicated Dose 200 mg Once Daily | ||
Mild | 60 to <90 mL/min | None | None |
Moderate | 30 to <60 mL/min | CIBINQO 50 mg once daily | CIBINQO 100 mg once daily |
Severe | <30 mL/min | CIBINQO 50 mg once daily | CIBINQO 100 mg once daily |
Hepatic Impairment
No dose adjustment is required in patients with mild (Child Pugh A) or moderate (Child Pugh B) hepatic impairment. The safety of CIBINQO following daily dosing has not been studied in patients with hepatic impairment.
CIBINQO has not been studied in patients with severe hepatic impairment (Child Pugh C).
Concomitant use of CYP2C19 and CYP2C9 inhibitors
The dosage of CIBINQO should be reduced in half when co-administered with strong CYP2C19 and moderate CYP2C9 inhibitors (see 9.4 Drug-Drug Interactions).
Concomitant use of CYP2C19 and CYP2C9 inducers
Co-administration of CIBINQO with CYP2C19/2C9 inducers is not recommended (see 9.4 Drug-Drug Interactions).
Not applicable
CIBINQO should be taken orally once daily with or without food at approximately the same time each day.
Swallow CIBINQO tablets whole and intact with water. Do not crush, split, or chew CIBINQO tablets.
In patients who experience nausea while taking CIBINQO, taking with food may improve nausea.
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, interruption of treatment with CIBINQO until the infection is controlled should be considered (see Section 7 WARNINGS AND PRECAUTIONS).
Interruption of dosing may be needed for management of laboratory abnormalities as described in Table 3.
)CIBINQO should 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.
Treatment with CIBINQO should not be initiated in patients with a platelet count less than 150 × 103/mm3, an absolute lymphocyte count (ALC) less than 0.5 × 103/mm3, an absolute neutrophil count (ANC) less than 1 × 103/mm3 or who have a hemoglobin value less than 8 g/dL.
The recommended dose of CIBINQO is 100 mg or 200 mg orally once daily for adolescents and adults under 65 years of age, based on individual goal of therapy and potential risk for adverse reactions. For patients using the 200 mg once daily dosage, after symptom control is achieved by week 12, consider dose reduction to 100 mg once daily. Relative to patients who maintained the 200 mg dose, the risk of occurrence of serious adverse reactions decreased in patients who reduced their dose to 100 mg beyond 12 weeks in clinical studies. If symptom control is lost after dose reduction, the dose can be increased to 200 mg. Exceeding a daily dosage of 200 mg is not recommended.
CIBINQO can be used with or without medicated topical therapies for atopic dermatitis.
Elderly population
The recommended starting dose for patients ≥65 years of age is 100 mg. Some side effects that were more common in elderly patients in clinical trials, including herpes zoster, lymphopenia, and thrombocytopenia, occurred more frequently at the 200 mg daily dosage (see 8.2 Clinical Trial Adverse Reactions).
Pediatric population
For pediatric patients 12 to < 18 years of age, the starting recommended dose of CIBINQO is 100 mg or 200 mg once daily. Dosage adjustment should be considered based on individual goal of therapy and potential risk for adverse reactions.
The safety and efficacy of CIBINQO in pediatric patients under 12 years of age have not yet been established. No data are available.
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) or severe (eGFR <30 mL/min) renal impairment, the recommended dose of CIBINQO is to be reduced by 50% as shown in Table 1.
The use of CIBINQO has not been studied in patients with end-stage renal disease (ESRD) on renal replacement therapy.
| Renal Impairment Stage | Estimated Glomerular Filtration rate (eGFR) | Dose Adjustment | |
|---|---|---|---|
Indicated Dose 100 mg Once Daily | Indicated Dose 200 mg Once Daily | ||
Mild | 60 to <90 mL/min | None | None |
Moderate | 30 to <60 mL/min | CIBINQO 50 mg once daily | CIBINQO 100 mg once daily |
Severe | <30 mL/min | CIBINQO 50 mg once daily | CIBINQO 100 mg once daily |
Hepatic Impairment
No dose adjustment is required in patients with mild (Child Pugh A) or moderate (Child Pugh B) hepatic impairment. The safety of CIBINQO following daily dosing has not been studied in patients with hepatic impairment.
CIBINQO has not been studied in patients with severe hepatic impairment (Child Pugh C).
Concomitant use of CYP2C19 and CYP2C9 inhibitors
The dosage of CIBINQO should be reduced in half when co-administered with strong CYP2C19 and moderate CYP2C9 inhibitors (see 9.4 Drug-Drug Interactions).
Concomitant use of CYP2C19 and CYP2C9 inducers
Co-administration of CIBINQO with CYP2C19/2C9 inducers is not recommended (see 9.4 Drug-Drug Interactions).
Not applicable
CIBINQO should be taken orally once daily with or without food at approximately the same time each day.
Swallow CIBINQO tablets whole and intact with water. Do not crush, split, or chew CIBINQO tablets.
In patients who experience nausea while taking CIBINQO, taking with food may improve nausea.
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, interruption of treatment with CIBINQO until the infection is controlled should be considered (see Section 7 WARNINGS AND PRECAUTIONS).
Interruption of dosing may be needed for management of laboratory abnormalities as described in Table 3.
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