Cibinqo
(Abrocitinib)Dosage & Administration
Cibinqo Prescribing Information
Indications and Usage ( CIBINQO is indicated for the treatment of adults and pediatric patients 12 years of age and older with refractory, moderate-to-severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable.CIBINQO is a Janus kinase (JAK) inhibitor indicated for the treatment of adults and pediatric patients 12 years of age and older with refractory, moderate-to-severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable. Limitation of Use : CIBINQO is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, or with other immunosuppressants.Limitations of Use CIBINQO is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, or other immunosuppressants. | 02/2023 | ||||||||||||||
Dosage and Administration ( 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)] . Inpatients with mild and moderate renal impairment, if an adequate responseis not achieved with initial dose, the dose of CIBINQO can be doubled[see Dosage and Administration (2.2)] .
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 mgonce daily, consider increasingthe 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 mgdaily, consider increasingthe dosage to 100 mg once daily. Discontinue therapy if inadequate response is seen after dosage increase to 100 mg once daily. | 12/2023 |
CIBINQO is indicated for the treatment of adults
• For recommended testing, evaluations, and procedures prior to CIBINQO initiation, see Full Prescribing Information. ()2.1 Recommended Testing, Evaluations, and Procedures Prior to Treatment InitiationPerform the following tests and evaluations prior to CIBINQO initiation:
• Tuberculosis (TB) infection evaluation – CIBINQO initiation is not recommended in patients with active TB. For patients with latent TB or those with a negative latent TB test who are at high risk for TB, start preventive therapy for latent TB prior to initiation of CIBINQO[see Warnings and Precautions (5.1)].• Viral hepatitis screening in accordance with clinical guidelines – CIBINQO initiation is not recommended in patients with active hepatitis B or hepatitis C[see Warnings and Precautions (5.1)].• A complete blood count (CBC) – CIBINQO initiation is not recommended in patients with a platelet count <150,000/mm3, an absolute lymphocyte count <500/mm3, an absolute neutrophil count <1,000/mm3, or a hemoglobin value <8 g/dL[see Warnings and Precautions (5.6)].
Complete any necessary immunizations, including herpes zoster vaccinations, in agreement with current immunization guidelines prior to CIBINQO initiation
[see Warnings and Precautions (5.7)].• Recommended dosage is 100 mg orally once daily. ()2.2 Recommended DosageThe 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.
• 200 mg orally once daily is recommended for those patients who are not responding to 100 mg once daily. ()2.2 Recommended DosageThe 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.
• Moderate renal impairment: 50 mg once daily or 100 mg once daily for those patients who are not responding to 50 mg once daily. ()2.3 Recommended Dosage in Patients with Renal Impairment or Hepatic ImpairmentRenal ImpairmentCIBINQO dosage recommendations for patients with renal impairment are provided in Table 1
[see Use in Specific Populations (8.6)and Clinical Pharmacology (12.3)]. Inpatientswith mild and moderate renal impairment, if an adequate responseis not achieved with initial dose, the doseof CIBINQO can be doubled[see Dosage and Administration (2.2)].Table 1. Dosage Recommendations in Patients with Renal Impairment Renal Impairment StageEstimated Glomerular Filtration (eGFR)Glomerular filtration rate was estimated by the Modification of Diet in Renal Disease (MDRD) formula.DosageMild
60 – 89 mL/minute
CIBINQO 100 mg once daily
Moderate
30 – 59 mL/minute
CIBINQO 50 mg once daily
SevereSevere Renal Impairment and End-Stage Renal Disease include patients on renal replacement therapy.
15 – 29 mL/minute
Not recommended for use
End-Stage Renal Disease
(ESRD)<15 mL/minute
Hepatic ImpairmentCIBINQO is not recommended for use in patients with severe hepatic impairment
[see Use in Specific Populations (8.7)and Clinical Pharmacology (12.3)].• CYP2C19 poor metabolizer: 50 mg once daily or 100 mg once daily for those patients who are not responding to 50 mg once daily. ()2.4 Recommended Dosage in CYP2C19 Poor MetabolizersIn 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 mgonce daily, considerincreasingthedosage to 100 mg once daily. Discontinue therapy if inadequate response is seen after dosage increase to 100 mg once daily.• For dosage modifications for certain adverse reactions, see Full Prescribing Information. ()2.6 Treatment Discontinuation due to Serious Infections or Hematologic Adverse ReactionsSerious or Opportunistic InfectionsIf 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 AbnormalitiesRecommendations for CIBINQO discontinuation for laboratory abnormalities are summarized in Table 2.
Table 2. Recommendations for CIBINQO Discontinuation for Hematologic Abnormalities Abbreviations: ALC=absolute lymphocyte count; ANC=absolute neutrophil count; CBC=complete blood count; Hb=hemoglobin Laboratory MeasureRecommendationPlatelet 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/mm3and 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/mm3and 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)].
• 50 mg: Pink, oval, film-coated tablet debossed with "PFE" on one side and "ABR 50" on the other.• 100 mg: Pink, round, film-coated tablet debossed with "PFE" on one side and "ABR 100" on the other.• 200 mg: Pink, oval, film-coated tablet debossed with "PFE" on one side and "ABR 200" on the other.
CIBINQO is contraindicated in patients taking antiplatelet therapies, except for low-dose aspirin (≤81 mg daily), during the first 3 months of treatment
Treatment with CIBINQO was associated with an increased incidence of thrombocytopenia and lymphopenia
Dose-dependent increase in blood lipid parameters were reported in subjects treated with CIBINQO
Table 5 includes clinically significant drug interactions affecting other drugs.
P-gp Substrate Where Small Concentration Changes May Lead to Serious or Life-threatening Toxicities | |
Clinical Impact | Coadministration of CIBINQO with P-gp substrate increases plasma concentrations of P-gp substrates and may result in potential adverse reactions of the P-gp substrate where small concentration changes may lead to serious or life-threatening toxicities (e.g., digoxin) [see Clinical Pharmacology (12.3)] . |
Intervention | Monitor appropriately or dose titrate P-gp substrate where small concentration changes may lead to serious or life-threatening toxicities when coadministered with CIBINQO . |
Antiplatelet Therapy Drugs | |
Clinical Impact | Coadministration of CIBINQO with antiplatelet therapy drugs may increase the risk of bleeding with thrombocytopenia [see Warnings and Precautions (5.5)and Clinical Pharmacology (12.2)]. |
Intervention | Antiplatelet drugs, except for low-dose aspirin (≤81 mg daily), during the first 3 months of treatment are contraindicated with CIBINQO [see Contraindications (4)] . |
Treatment with CIBINQO was associated with dose-dependent reduction in serum markers of inflammation, including high sensitivity C-reactive protein (hsCRP), interleukin-31 (IL-31) and thymus and activation regulated chemokine (TARC). These changes returned to near baseline within 4 weeks of drug discontinuation.
Treatment with CIBINQO was also associated with a transient, dose-dependent decrease in platelet count with the nadir occurring at a median of 24 days after continuous administration of abrocitinib 200 mg once daily. The percent change from baseline of the nadir increases with decreasing baseline platelet counts (-41.2%, -33.4%, and -26.5% for baseline platelet counts of 170, 220, and 270 × 103/mm3, respectively). Partial recovery of platelet count (~40% recovery in platelet count by 12 weeks) occurred without discontinuation of the treatment.
At a dose 3 times the maximum approved recommended dose, abrocitinib does not prolong the QT interval to any clinically relevant extent.