Rybrevant Patient Counseling Information

Advise the patient to read the approved patient labeling (Patient Information).
Infusion-Related Reactions: Advise patients that RYBREVANT can cause infusion-related reactions, the majority of which may occur with the first infusion. Advise patients to alert their healthcare provider immediately for any signs or symptoms of infusion-related reactions [see Infusion-Related Reactions under Precautions].
Interstitial Lung Disease/Pneumonitis: Advise patients of the risks of interstitial lung disease (ILD)/pneumonitis. Advise patients to immediately contact their healthcare provider for new or worsening respiratory symptoms [see Interstitial Lung Disease/Pneumonitis under Precautions].
Dermatologic Adverse Reactions: Advise patients of the risk of dermatologic adverse reactions. Advise patients to apply alcohol-free (e.g., isopropanol-free, ethanol-free) emollient cream to reduce the risk of skin reactions. Consider prophylactic measures (e.g., use of oral antibiotics) to reduce the risk of dermatologic adverse reactions. Advise patients to limit direct sun exposure during and for 2 months after treatment, to use broad-spectrum UVA/UVB sunscreen, and to wear protective clothing during treatment with RYBREVANT [see Dermatologic Adverse Reactions under Precautions].
Ocular Toxicity: Advise patients of the risk of ocular toxicity. Advise patients to contact their ophthalmologist if they develop eye symptoms and advise discontinuation of contact lenses until symptoms are evaluated [see Ocular Toxicity under Precautions].
Paronychia/Nail Toxicity: Advise patients of the risk of paronychia. Advise patients to contact their healthcare provider for signs or symptoms of paronychia [see Clinical Trials Experience under Adverse Reactions].
Embryo-Fetal Toxicity: Advise females of reproductive potential of the potential risk to a fetus, to use effective contraception during treatment with RYBREVANT and for 3 months after the last dose, and to inform their healthcare provider of a known or suspected pregnancy. [See Embryo-Fetal Toxicity under Precautions; Pregnancy and Females and Males of Reproductive Potential under Use in Pregnancy & Lactation.]
Lactation: Advise women not to breastfeed during treatment with RYBREVANT and for 3 months after the last dose [see Lactation under Use in Pregnancy & Lactation].