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CIBINQO Dosage and Administration (abrocitinib)

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Testing, Evaluations, and Procedures Prior to Treatment Initiation

Perform 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)].

2.2 Recommended Dosage

The recommended dosage of CIBINQO is 100 mg orally once daily.

If an adequate response is not achieved with CIBINQO 100 mg orally daily after 12 weeks, consider increasing dosage to 200 mg orally once daily. Discontinue therapy if inadequate response is seen after dosage increase to 200 mg once daily.

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.

2.3 Recommended Dosage in Patients with Renal Impairment or Hepatic Impairment

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 subjects with mild and moderate renal impairment, if an adequate response is not achieved after 12 weeks, dose of 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)*Dosage
*
Glomerular filtration rate was estimated by the Modification of Diet in Renal Disease (MDRD) formula.
Severe Renal Impairment and End-Stage Renal Disease include patients on renal replacement therapy.
Mild60 – 89 mL/minuteCIBINQO 100 mg once daily
Moderate30 – 59 mL/minuteCIBINQO 50 mg once daily
Severe15 – 29 mL/minuteNot 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)].

2.4 Recommended Dosage in CYP2C19 Poor Metabolizers

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 orally daily after 12 weeks, consider increasing dosage to 100 mg orally once daily. Discontinue therapy if inadequate response is seen after dosage increase to 100 mg once daily.

2.5 Dosage Modifications due to Strong Inhibitors

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 orally daily after 12 weeks, consider increasing dosage to 100 mg orally once daily. Discontinue therapy if inadequate response is seen after dosage increase to 100 mg once daily.

2.6 Treatment Discontinuation due to Serious Infections or Hematologic Adverse Reactions

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.

Table 2. Recommendations for CIBINQO Discontinuation for Hematologic Abnormalities
Laboratory MeasureRecommendation
Abbreviations: ALC=absolute lymphocyte count; ANC=absolute neutrophil count; CBC=complete blood count; Hb=hemoglobin
Platelet Count <50,000/mm3Discontinue CIBINQO and follow with CBC until >100,000/mm3
ALC <500/mm3Treatment 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/mm3Treatment 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/dLTreatment 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 dosing increase of CIBINQO. Laboratory evaluations may be extended for patients on chronic CIBINQO therapy who develop hematologic abnormalities [see Warnings and Precautions (5.6)].

2.7 Administration Instructions

Administer CIBINQO with or without food at approximately the same time each day.

Swallow CIBINQO tablets whole with water. Do not crush, split, or chew CIBINQO tablets.

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