Advise the patient to read the FDA-approved patient labeling (Medication Guide).
Pregnancy Registry
Advise patients to report their pregnancy to 1-877-311-3770 [see Use in Specific Populations (8.1)].
Serious Infections
Inform patients that they may develop infections when taking CIBINQO. Instruct patients to tell their healthcare provider if they develop any signs or symptoms of an infection [see Warnings and Precautions (5.1)].
Advise patients that the risk of herpes zoster is increased in patients treated with CIBINQO and some cases can be serious [see Warnings and Precautions (5.1)].
Malignancies
Inform patients that CIBINQO may increase their risk of certain cancers, including skin cancers. Periodic skin examinations are recommended while using CIBINQO. Advise patients that exposure to sunlight and UV light should be limited by wearing protective clothing and using a broad-spectrum sunscreen [see Warnings and Precautions (5.3)].
Major Adverse Cardiovascular Events
Inform patients that CIBINQO may increase their risk of major adverse cardiovascular events (MACE) including myocardial infarction, stroke, and cardiovascular death. Instruct all patients, especially current or past smokers or patients with other cardiovascular risk factors, to be alert for the development of signs and symptoms of cardiovascular events [see Warnings and Precautions (5.4)].
Thrombosis
Advise patients that events of DVT and PE have been reported in clinical trials with CIBINQO. Instruct patients to seek immediate medical attention if they develop any signs or symptoms of a DVT or PE [see Warnings and Precautions (5.5)].
Laboratory Abnormalities
Inform patients that CIBINQO may affect certain lab tests, and that blood tests are required before and during CIBINQO treatment [see Dosage and Administration (2.1) and Warnings and Precautions (5.6)].
Immunizations
Advise patients that vaccination with live vaccines is not recommended during CIBINQO treatment and immediately prior to or after CIBINQO treatment. Instruct patients to inform the healthcare practitioner that they are taking CIBINQO prior to a potential vaccination [see Warnings and Precautions (5.7)].
Retinal Detachment
Inform patients that retinal detachment has been reported in clinical trials for atopic dermatitis in patients who received CIBINQO. Advise patients to immediately inform their healthcare provider if they develop any sudden changes in vision while receiving CIBINQO [see Adverse Reactions (6.1)].
Infertility
Advise patients who can become pregnant that CIBINQO may impair fertility [see Use in Specific Populations (8.3)].
Lactation
Advise patients not to breastfeed during treatment with CIBINQO [see Use in Specific Populations (8.2)].
Administration
Advise patients not to chew, crush, or split CIBINQO tablets [see Dosage and Administration (2.7)].
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
Pregnancy Registry
Advise patients to report their pregnancy to 1-877-311-3770 [see Use in Specific Populations (8.1)].
Serious Infections
Inform patients that they may develop infections when taking CIBINQO. Instruct patients to tell their healthcare provider if they develop any signs or symptoms of an infection [see Warnings and Precautions (5.1)].
Advise patients that the risk of herpes zoster is increased in patients treated with CIBINQO and some cases can be serious [see Warnings and Precautions (5.1)].
Malignancies
Inform patients that CIBINQO may increase their risk of certain cancers, including skin cancers. Periodic skin examinations are recommended while using CIBINQO. Advise patients that exposure to sunlight and UV light should be limited by wearing protective clothing and using a broad-spectrum sunscreen [see Warnings and Precautions (5.3)].
Major Adverse Cardiovascular Events
Inform patients that CIBINQO may increase their risk of major adverse cardiovascular events (MACE) including myocardial infarction, stroke, and cardiovascular death. Instruct all patients, especially current or past smokers or patients with other cardiovascular risk factors, to be alert for the development of signs and symptoms of cardiovascular events [see Warnings and Precautions (5.4)].
Thrombosis
Advise patients that events of DVT and PE have been reported in clinical trials with CIBINQO. Instruct patients to seek immediate medical attention if they develop any signs or symptoms of a DVT or PE [see Warnings and Precautions (5.5)].
Laboratory Abnormalities
Inform patients that CIBINQO may affect certain lab tests, and that blood tests are required before and during CIBINQO treatment [see Dosage and Administration (2.1) and Warnings and Precautions (5.6)].
Immunizations
Advise patients that vaccination with live vaccines is not recommended during CIBINQO treatment and immediately prior to or after CIBINQO treatment. Instruct patients to inform the healthcare practitioner that they are taking CIBINQO prior to a potential vaccination [see Warnings and Precautions (5.7)].
Retinal Detachment
Inform patients that retinal detachment has been reported in clinical trials for atopic dermatitis in patients who received CIBINQO. Advise patients to immediately inform their healthcare provider if they develop any sudden changes in vision while receiving CIBINQO [see Adverse Reactions (6.1)].
Infertility
Advise patients who can become pregnant that CIBINQO may impair fertility [see Use in Specific Populations (8.3)].
Lactation
Advise patients not to breastfeed during treatment with CIBINQO [see Use in Specific Populations (8.2)].
Administration
Advise patients not to chew, crush, or split CIBINQO tablets [see Dosage and Administration (2.7)].
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