Cibinqo

CIBINQO- abrocitinib tablet, film coated
Pfizer Laboratories Div Pfizer Inc

Mortality

In a large, randomized, postmarketing safety study in rheumatoid arthritis (RA) patients 50 years of age and older with at least one cardiovascular risk factor comparing another JAK inhibitor to TNF blocker treatment, a higher rate of all-cause mortality, including sudden cardiovascular death, was observed with the JAK inhibitor. CIBINQO is not approved for use in RA patients [see Warnings and Precautions (5.2)].

Malignancies

Malignancies were reported in patients treated with CIBINQO. Lymphoma and other malignancies have been observed in patients receiving JAK inhibitors used to treat inflammatory conditions. In RA patients treated with another JAK inhibitor, a higher rate of malignancies (excluding non-melanoma skin cancer (NMSC)) was observed when compared with TNF blockers. Patients who are current or past smokers are at additional increased risk [see Warnings and Precautions (5.3)].

Major Adverse Cardiovascular Events

Major adverse cardiovascular events were reported in patients treated with CIBINQO. In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with another JAK inhibitor, a higher rate of major adverse cardiovascular events (MACE) (defined as cardiovascular death, myocardial infarction, and stroke), was observed when compared with TNF blockers. Patients who are current or past smokers are at additional increased risk. Discontinue CIBINQO in patients that have experienced a myocardial infarction or stroke [see Warnings and Precautions (5.4)].

Thrombosis

Deep venous thrombosis (DVT) and pulmonary embolism (PE) have been reported in patients treated with CIBINQO. Thrombosis, including PE, DVT, and arterial thrombosis have been reported in patients receiving JAK inhibitors used to treat inflammatory conditions. Many of these adverse reactions were serious and some resulted in death. In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with another JAK inhibitor, a higher rate of thrombosis was observed when compared with TNF blockers. Avoid CIBINQO in patients at risk. If symptoms of thrombosis occur, discontinue CIBINQO and treat appropriately [see Warnings and Precautions (5.5)].

1 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.

Limitations of Use

CIBINQO is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, or with other immunosuppressants.

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:

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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)].

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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)].

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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

* 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.
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)].