Advise the patient or caregiver to read the FDA-approved patient labeling (Medication Guide; Instructions for Use).
Hepatotoxicity
Inform patients to immediately report symptoms of hepatotoxicity [see Warnings and Precautions (5.1)].
Interstitial Lung Disease (Pneumonitis)
Advise patients to immediately report any new or worsening pulmonary symptoms [see Warnings and Precautions (5.2)].
Bradycardia
Advise patients to report any symptoms of bradycardia and to inform their healthcare provider about the use of any heart or blood pressure medications [see Warnings and Precautions (5.4)].
Severe Visual Loss
Inform patients of the potential risk of severe visual loss and to immediately contact their healthcare provider if they develop severe visual loss. Inform patients that visual changes such as perceived flashes of light, blurry vision, light sensitivity, and floaters are commonly reported adverse reactions and may occur while driving or operating machinery. The onset of visual disorders most commonly occurs during the first week of treatment [see Warnings and Precautions (5.5), Adverse Reactions (6)].
Gastrointestinal Toxicity in Pediatric and Young Adult Patients with ALCL or Pediatric Patients with IMT
Inform patients with ALCL or pediatric patients with IMT of the risk of severe nausea, vomiting, diarrhea, and stomatitis. Advise patients to immediately inform their healthcare provider of problems with swallowing, vomiting, or diarrhea [see Warnings and Precautions (5.6)].
Drug Interactions
Inform patients to avoid grapefruit or grapefruit juice while taking XALKORI. Advise patients to inform their healthcare providers of all concomitant medications, including prescription medicines, over-the-counter drugs, vitamins, and herbal products [see Drug Interactions (7)].
Photosensitivity
Inform patients of the signs and symptoms of photosensitivity. Advise patients to avoid prolonged sun exposure and to use sunscreen or protective clothing during treatment with XALKORI [see Adverse Reactions (6.1)].
Dosage and Administration
Advise patients to take XALKORI with or without food. If a patient misses a dose, advise the patient to take it as soon as remembered unless it is less than 6 hours until the next dose, in which case, advise the patient not to take the missed dose. If a patient vomits after taking a dose of XALKORI, advise the patient not to take an extra dose, but to take the next dose at the regular time [see Dosage and Administration (2.4)].
Capsules:
Advise patients to swallow XALKORI capsules whole [see Dosage and Administration (2.4)].
Oral Pellets:
Inform patient or caregiver to open the encapsulated XALKORI oral pellets and administer the oral pellets directly in the patient’s mouth or with a consumer-supplied oral dosing aid, for example a spoon or medicine cup. Advise patient or caregiver that the oral pellets are not to be chewed and to give a sufficient amount of water after pellets are administered to ensure all oral pellets are swallowed [see Dosage and Administration (2.4)].
Embryo-Fetal Toxicity
Advise females of reproductive potential of the potential risk to a fetus and to inform their healthcare provider of a known or suspected pregnancy [see Warnings and Precautions (5.7), Use in Specific Populations (8.1)].
Females and Males of Reproductive Potential
Advise females of reproductive potential to use effective contraception during treatment with XALKORI and for 45 days after the last dose [see Use in Specific Populations (8.3)].
Advise male patients with female partners of reproductive potential to use condoms during treatment with XALKORI and for 90 days after the last dose [see Use in Specific Populations (8.3), Nonclinical Toxicology (13.1)].
Lactation
Advise females not to breastfeed during treatment with XALKORI and for 45 days after the last dose [see Use in Specific Populations (8.2)].
Infertility
Advise females and males of reproductive potential of the potential for reduced fertility from XALKORI [see Use in Specific Populations (8.3), Nonclinical Toxicology (13.1)].
Advise the patient or caregiver to read the FDA-approved patient labeling (Medication Guide; Instructions for Use).
Hepatotoxicity
Inform patients to immediately report symptoms of hepatotoxicity [see Warnings and Precautions (5.1)].
Interstitial Lung Disease (Pneumonitis)
Advise patients to immediately report any new or worsening pulmonary symptoms [see Warnings and Precautions (5.2)].
Bradycardia
Advise patients to report any symptoms of bradycardia and to inform their healthcare provider about the use of any heart or blood pressure medications [see Warnings and Precautions (5.4)].
Severe Visual Loss
Inform patients of the potential risk of severe visual loss and to immediately contact their healthcare provider if they develop severe visual loss. Inform patients that visual changes such as perceived flashes of light, blurry vision, light sensitivity, and floaters are commonly reported adverse reactions and may occur while driving or operating machinery. The onset of visual disorders most commonly occurs during the first week of treatment [see Warnings and Precautions (5.5), Adverse Reactions (6)].
Gastrointestinal Toxicity in Pediatric and Young Adult Patients with ALCL or Pediatric Patients with IMT
Inform patients with ALCL or pediatric patients with IMT of the risk of severe nausea, vomiting, diarrhea, and stomatitis. Advise patients to immediately inform their healthcare provider of problems with swallowing, vomiting, or diarrhea [see Warnings and Precautions (5.6)].
Drug Interactions
Inform patients to avoid grapefruit or grapefruit juice while taking XALKORI. Advise patients to inform their healthcare providers of all concomitant medications, including prescription medicines, over-the-counter drugs, vitamins, and herbal products [see Drug Interactions (7)].
Photosensitivity
Inform patients of the signs and symptoms of photosensitivity. Advise patients to avoid prolonged sun exposure and to use sunscreen or protective clothing during treatment with XALKORI [see Adverse Reactions (6.1)].
Dosage and Administration
Advise patients to take XALKORI with or without food. If a patient misses a dose, advise the patient to take it as soon as remembered unless it is less than 6 hours until the next dose, in which case, advise the patient not to take the missed dose. If a patient vomits after taking a dose of XALKORI, advise the patient not to take an extra dose, but to take the next dose at the regular time [see Dosage and Administration (2.4)].
Capsules:
Advise patients to swallow XALKORI capsules whole [see Dosage and Administration (2.4)].
Oral Pellets:
Inform patient or caregiver to open the encapsulated XALKORI oral pellets and administer the oral pellets directly in the patient’s mouth or with a consumer-supplied oral dosing aid, for example a spoon or medicine cup. Advise patient or caregiver that the oral pellets are not to be chewed and to give a sufficient amount of water after pellets are administered to ensure all oral pellets are swallowed [see Dosage and Administration (2.4)].
Embryo-Fetal Toxicity
Advise females of reproductive potential of the potential risk to a fetus and to inform their healthcare provider of a known or suspected pregnancy [see Warnings and Precautions (5.7), Use in Specific Populations (8.1)].
Females and Males of Reproductive Potential
Advise females of reproductive potential to use effective contraception during treatment with XALKORI and for 45 days after the last dose [see Use in Specific Populations (8.3)].
Advise male patients with female partners of reproductive potential to use condoms during treatment with XALKORI and for 90 days after the last dose [see Use in Specific Populations (8.3), Nonclinical Toxicology (13.1)].
Lactation
Advise females not to breastfeed during treatment with XALKORI and for 45 days after the last dose [see Use in Specific Populations (8.2)].
Infertility
Advise females and males of reproductive potential of the potential for reduced fertility from XALKORI [see Use in Specific Populations (8.3), Nonclinical Toxicology (13.1)].
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