17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
Advise patients not to crush, split or chew LITFULO capsules [see Dosage and Administration (2.2)].
Inform patients that they may develop infections when taking LITFULO which in some cases can be serious. 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 LITFULO [see Warnings and Precautions (5.1)].
Inform patients that LITFULO may increase their risk of certain cancers, including skin cancers. Periodic skin examinations are recommended while using LITFULO [see Warnings and Precautions (5.3)].
Advise patients that events of PE and retinal artery occlusion have been reported in clinical trials with LITFULO. Instruct patients to seek immediate medical attention if they develop any signs or symptoms of a thrombosis [see Warnings and Precautions (5.5)].
Advise patients to discontinue LITFULO and seek immediate medical attention if they develop any signs and symptoms of serious allergic reaction [see Warnings and Precautions (5.6)].
Inform patients that LITFULO may affect certain lab tests, and that blood tests are required before and during LITFULO treatment [see Dosage and Administration (2.1) and Warnings and Precautions (5.7)].
Advise patients that vaccination with live vaccines is not recommended during LITFULO treatment and shortly prior to LITFULO treatment. Instruct patients to inform the healthcare practitioner that they are taking LITFULO prior to a potential vaccination [see Warnings and Precautions (5.8)].
Advise pregnant females and females of reproductive potential to inform their healthcare providers if they are pregnant or intend to becomes pregnant during treatment with LITFULO. Instruct patients to report their pregnancy to Pfizer Inc. at 1-877-390-2940 [see Use in Specific Populations (8.1)].
Advise women not to breastfeed during treatment with LITFULO and for 14 hours after the last dose [see Use in Specific Populations (8.2)].