Perform the following tests and evaluations prior to CIBINQO initiation:
Complete any necessary immunizations, including herpes zoster vaccinations, in agreement with current immunization guidelines prior to CIBINQO initiation [see Warnings and Precautions (5.7)].
The recommended dose is 100 mg once daily. If an adequate response is not achieved with CIBINQO 100 mg once daily, consider increasing the dosage to 200 mg once daily.
Discontinue CIBINQO if an adequate response is not achieved with 200 mg once daily.
Use the lowest efficacious dose to maintain response.
CIBINQO can be used with or without topical corticosteroids.
If a dose is missed, administer the dose as soon as possible unless it is less than 12 hours before the next dose, in which case skip the missed dose. Thereafter, resume dosing at the regular scheduled time.
Renal Impairment
CIBINQO dosage recommendations for patients with renal impairment are provided in Table 1 [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)]. In patients with mild and moderate renal impairment, if an adequate response is not achieved with initial dose, the dose of CIBINQO can be doubled [see Dosage and Administration (2.2)].
Renal Impairment Stage | Estimated Glomerular Filtration (eGFR)* | Dosage |
Mild | 60 – 89 mL/minute | CIBINQO 100 mg once daily |
Moderate | 30 – 59 mL/minute | CIBINQO 50 mg once daily |
Severe† | 15 – 29 mL/minute | Not recommended for use |
End-Stage Renal Disease† (ESRD) | <15 mL/minute | |
Hepatic Impairment
CIBINQO is not recommended for use in patients with severe hepatic impairment [see Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)].
In patients who are known or suspected to be CYP2C19 poor metabolizers, the recommended dosage of CIBINQO is 50 mg once daily [see Use in Specific Populations (8.8) and Clinical Pharmacology (12.5)]. If an adequate response is not achieved with CIBINQO 50 mg once daily, consider increasing the dosage to 100 mg once daily. Discontinue therapy if inadequate response is seen after dosage increase to 100 mg once daily.
In patients taking strong inhibitors of cytochrome P450 (CYP) 2C19, reduce the dosage to 50 mg once daily [see Drug Interactions (7.1) and Clinical Pharmacology (12.3)]. If an adequate response is not achieved with CIBINQO 50 mg daily, consider increasing the dosage to 100 mg once daily. Discontinue therapy if inadequate response is seen after dosage increase to 100 mg once daily.
Serious or Opportunistic Infections
If a patient develops a serious or opportunistic infection, discontinue CIBINQO and control the infection. The risks and benefits of treatment with CIBINQO should be carefully considered prior to reinitiating therapy with CIBINQO [see Warnings and Precautions (5.1)].
Hematologic Abnormalities
Recommendations for CIBINQO discontinuation for laboratory abnormalities are summarized in Table 2.
| Abbreviations: ALC=absolute lymphocyte count; ANC=absolute neutrophil count; CBC=complete blood count; Hb=hemoglobin | |
Laboratory Measure | Recommendation |
Platelet Count <50,000/mm3 | Discontinue CIBINQO and follow with CBC until >100,000/mm3 |
ALC <500/mm3 | Treatment should be temporarily discontinued if ALC is less than 500 cells/mm3 and may be restarted once ALC return above this value |
ANC <1,000/mm3 | Treatment should be temporarily discontinued if ANC is less than 1,000 cells/mm3 and may be restarted once ANC return above this value |
Hb value <8 g/dL | Treatment should be temporarily discontinued if Hb is less than 8 g/dL and may be restarted once Hb return above this value |
CBC evaluations are recommended at baseline, 4 weeks after treatment initiation and 4 weeks after dosage increase of CIBINQO. Laboratory evaluations may be extended for patients on chronic CIBINQO therapy who develop hematologic abnormalities [see Warnings and Precautions (5.6)].
Perform the following tests and evaluations prior to CIBINQO initiation:
Complete any necessary immunizations, including herpes zoster vaccinations, in agreement with current immunization guidelines prior to CIBINQO initiation [see Warnings and Precautions (5.7)].
The recommended dose is 100 mg once daily. If an adequate response is not achieved with CIBINQO 100 mg once daily, consider increasing the dosage to 200 mg once daily.
Discontinue CIBINQO if an adequate response is not achieved with 200 mg once daily.
Use the lowest efficacious dose to maintain response.
CIBINQO can be used with or without topical corticosteroids.
If a dose is missed, administer the dose as soon as possible unless it is less than 12 hours before the next dose, in which case skip the missed dose. Thereafter, resume dosing at the regular scheduled time.
Renal Impairment
CIBINQO dosage recommendations for patients with renal impairment are provided in Table 1 [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)]. In patients with mild and moderate renal impairment, if an adequate response is not achieved with initial dose, the dose of CIBINQO can be doubled [see Dosage and Administration (2.2)].
Renal Impairment Stage | Estimated Glomerular Filtration (eGFR)* | Dosage |
Mild | 60 – 89 mL/minute | CIBINQO 100 mg once daily |
Moderate | 30 – 59 mL/minute | CIBINQO 50 mg once daily |
Severe† | 15 – 29 mL/minute | Not recommended for use |
End-Stage Renal Disease† (ESRD) | <15 mL/minute | |
Hepatic Impairment
CIBINQO is not recommended for use in patients with severe hepatic impairment [see Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)].
In patients who are known or suspected to be CYP2C19 poor metabolizers, the recommended dosage of CIBINQO is 50 mg once daily [see Use in Specific Populations (8.8) and Clinical Pharmacology (12.5)]. If an adequate response is not achieved with CIBINQO 50 mg once daily, consider increasing the dosage to 100 mg once daily. Discontinue therapy if inadequate response is seen after dosage increase to 100 mg once daily.
In patients taking strong inhibitors of cytochrome P450 (CYP) 2C19, reduce the dosage to 50 mg once daily [see Drug Interactions (7.1) and Clinical Pharmacology (12.3)]. If an adequate response is not achieved with CIBINQO 50 mg daily, consider increasing the dosage to 100 mg once daily. Discontinue therapy if inadequate response is seen after dosage increase to 100 mg once daily.
Serious or Opportunistic Infections
If a patient develops a serious or opportunistic infection, discontinue CIBINQO and control the infection. The risks and benefits of treatment with CIBINQO should be carefully considered prior to reinitiating therapy with CIBINQO [see Warnings and Precautions (5.1)].
Hematologic Abnormalities
Recommendations for CIBINQO discontinuation for laboratory abnormalities are summarized in Table 2.
| Abbreviations: ALC=absolute lymphocyte count; ANC=absolute neutrophil count; CBC=complete blood count; Hb=hemoglobin | |
Laboratory Measure | Recommendation |
Platelet Count <50,000/mm3 | Discontinue CIBINQO and follow with CBC until >100,000/mm3 |
ALC <500/mm3 | Treatment should be temporarily discontinued if ALC is less than 500 cells/mm3 and may be restarted once ALC return above this value |
ANC <1,000/mm3 | Treatment should be temporarily discontinued if ANC is less than 1,000 cells/mm3 and may be restarted once ANC return above this value |
Hb value <8 g/dL | Treatment should be temporarily discontinued if Hb is less than 8 g/dL and may be restarted once Hb return above this value |
CBC evaluations are recommended at baseline, 4 weeks after treatment initiation and 4 weeks after dosage increase of CIBINQO. Laboratory evaluations may be extended for patients on chronic CIBINQO therapy who develop hematologic abnormalities [see Warnings and Precautions (5.6)].
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