Diarrhea: YULAREB may cause diarrhea, which may be severe in some cases [see Diarrhea under Precautions].
Early identification and intervention is critical for the optimal management of diarrhea. Instruct patients that at the first sign of loose stools, they should start antidiarrheal therapy (for example, loperamide) and notify their healthcare provider for further instructions and appropriate follow up.
Encourage patients to increase oral fluids.
If diarrhea does not resolve with antidiarrheal therapy within 24 hours to ≤Grade 1, suspend YULAREB dosing [see Dose Modification under Dosage & Administration].
Neutropenia: Advise patients of the possibility of developing neutropenia and to immediately contact their healthcare provider should they develop a fever, particularly in association with any signs of infection [see Neutropenia under Precautions].
Interstitial Lung Disease/Pneumonitis: Advise patients to immediately report new or worsening respiratory symptoms [see Interstitial Lung Disease (ILD)/Pneumonitis under Precautions].
Hepatotoxicity: Inform patients of the signs and symptoms of hepatotoxicity. Advise patients to contact their healthcare provider immediately for signs or symptoms of hepatotoxicity [see Hepatotoxicity under Precautions].
Venous Thromboembolism: Advise patients to immediately report any signs or symptoms of thromboembolism such as pain or swelling in an extremity, shortness of breath, chest pain, tachypnea, and tachycardia [see Venous Thromboembolism under Precautions].
Embryo-Fetal Toxicity: Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception during YULAREB therapy and for at least 3 weeks after the last dose. Advise patients to inform their healthcare provider of a known or suspected pregnancy [see Embryo-Fetal Toxicity under Precautions and Pregnancy and Females and Males of Reproductive Potential under Use in Pregnancy & Lactation].
Lactation: Advise lactating women not to breastfeed during YULAREB treatment and for at least 3 weeks after the last dose [see Lactation under Use in Pregnancy & Lactation].
Drug Interactions: Inform patients to avoid concomitant use of ketoconazole. Dose reduction may be required for other strong CYP3A inhibitors or for moderate CYP3A inhibitors [see Dose Modification under Dosage & Administration and Interactions].
Grapefruit may interact with YULAREB. Advise patients not to consume grapefruit products while on treatment with YULAREB.
Advise patients to avoid concomitant use of strong and moderate CYP3A inducers and to consider alternative agents [see Dose Modification under Dosage & Administration and Interactions].
Advise patients to inform their healthcare providers of all concomitant medications, including prescription medicines, over-the-counter drugs, vitamins, and herbal products [see Dose Modification under Dosage & Administration and Interactions].
Dosing: Instruct patients to take the doses of YULAREB at approximately the same time every day and to swallow whole (do not chew, crush, or split them prior to swallowing) [see Dosage & Administration].
If patient vomits or misses a dose, advise the patient to take the next prescribed dose at the usual time [see Dosage & Administration].
Advise the patient that YULAREB may be taken with or without food [see Dosage & Administration].