Advise the patient to read the FDA-approved patient labeling (Patient Information).
Hypertension
Advise patients that hypertension may develop during INLYTA treatment and that blood pressure should be monitored regularly during treatment [see Warnings and Precautions (5.1)].
Arterial/Venous Thromboembolic Events
Advise patients that arterial and venous thromboembolic events have been observed during INLYTA treatment and to inform their doctor if they experience symptoms suggestive of thromboembolic events [see Warnings and Precautions (5.2, 5.3)].
Hemorrhage
Advise patients that INLYTA may increase the risk of bleeding and to promptly inform their doctor of any bleeding episodes [see Warnings and Precautions (5.4)].
Cardiac Failure
Advise patients that cardiac failure may develop during INLYTA treatment and that signs or symptoms of cardiac failure should be regularly monitored for during treatment [see Warnings and Precautions (5.5)].
Gastrointestinal Disorders
Advise patients that gastrointestinal disorders such as diarrhea, nausea, vomiting, and constipation may develop during INLYTA treatment and to seek immediate medical attention if they experience persistent or severe abdominal pain because cases of gastrointestinal perforation and fistula have been reported in patients taking INLYTA [see Warnings and Precautions (5.6) and Adverse Reactions (6.1)].
Abnormal Thyroid Function
Advise patients that abnormal thyroid function may develop during INLYTA treatment and to inform their doctor if symptoms of abnormal thyroid function occur [see Warnings and Precautions (5.7)].
Impaired Wound Healing
Advise patients that INLYTA may impair wound healing. Advise patients to inform their healthcare provider of any planned surgical procedure [see Warnings and Precautions (5.8)].
Reversible Posterior Leukoencephalopathy Syndrome
Advise patients to inform their doctor if they have worsening of neurological function consistent with RPLS (headache, seizure, lethargy, confusion, blindness and other visual and neurologic disturbances) [see Warnings and Precautions (5.9)].
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 Warnings and Precautions (5.11)].
Major Adverse Cardiovascular Events
Advise patients receiving INLYTA in combination with avelumab to contact their healthcare provider immediately for signs or symptoms of cardiovascular events including but not limited to new or worsening chest discomfort, dyspnea, or peripheral edema [see Warnings and Precautions (5.13)].
Embryo-Fetal Toxicity
Advise females to inform their healthcare provider if they are pregnant or become pregnant. Inform female patients of the risk to a fetus and potential loss of the pregnancy [see Use in Specific Populations (8.1)].
Advise females of reproductive potential to use effective contraception during treatment with INLYTA and for 1 week after the last dose.
Advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 1 week following the last dose [see Warnings and Precautions (5.14) and Use in Specific Populations (8.3)].
When INLYTA is used in combination with avelumab or pembrolizumab, refer to the full prescribing information of avelumab or pembrolizumab for pregnancy and contraception information.
Lactation
Advise patients not to breastfeed while taking INLYTA and for 2 weeks after receiving the last dose [see Use in Specific Populations (8.2)].
When INLYTA is used in combination with avelumab or pembrolizumab, refer to the full prescribing information of avelumab or pembrolizumab for lactation information.
Infertility
Advise males and females of reproductive potential that INLYTA may impair fertility [see Use in Specific Populations (8.3)].
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Hypertension
Advise patients that hypertension may develop during INLYTA treatment and that blood pressure should be monitored regularly during treatment [see Warnings and Precautions (5.1)].
Arterial/Venous Thromboembolic Events
Advise patients that arterial and venous thromboembolic events have been observed during INLYTA treatment and to inform their doctor if they experience symptoms suggestive of thromboembolic events [see Warnings and Precautions (5.2, 5.3)].
Hemorrhage
Advise patients that INLYTA may increase the risk of bleeding and to promptly inform their doctor of any bleeding episodes [see Warnings and Precautions (5.4)].
Cardiac Failure
Advise patients that cardiac failure may develop during INLYTA treatment and that signs or symptoms of cardiac failure should be regularly monitored for during treatment [see Warnings and Precautions (5.5)].
Gastrointestinal Disorders
Advise patients that gastrointestinal disorders such as diarrhea, nausea, vomiting, and constipation may develop during INLYTA treatment and to seek immediate medical attention if they experience persistent or severe abdominal pain because cases of gastrointestinal perforation and fistula have been reported in patients taking INLYTA [see Warnings and Precautions (5.6) and Adverse Reactions (6.1)].
Abnormal Thyroid Function
Advise patients that abnormal thyroid function may develop during INLYTA treatment and to inform their doctor if symptoms of abnormal thyroid function occur [see Warnings and Precautions (5.7)].
Impaired Wound Healing
Advise patients that INLYTA may impair wound healing. Advise patients to inform their healthcare provider of any planned surgical procedure [see Warnings and Precautions (5.8)].
Reversible Posterior Leukoencephalopathy Syndrome
Advise patients to inform their doctor if they have worsening of neurological function consistent with RPLS (headache, seizure, lethargy, confusion, blindness and other visual and neurologic disturbances) [see Warnings and Precautions (5.9)].
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 Warnings and Precautions (5.11)].
Major Adverse Cardiovascular Events
Advise patients receiving INLYTA in combination with avelumab to contact their healthcare provider immediately for signs or symptoms of cardiovascular events including but not limited to new or worsening chest discomfort, dyspnea, or peripheral edema [see Warnings and Precautions (5.13)].
Embryo-Fetal Toxicity
Advise females to inform their healthcare provider if they are pregnant or become pregnant. Inform female patients of the risk to a fetus and potential loss of the pregnancy [see Use in Specific Populations (8.1)].
Advise females of reproductive potential to use effective contraception during treatment with INLYTA and for 1 week after the last dose.
Advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 1 week following the last dose [see Warnings and Precautions (5.14) and Use in Specific Populations (8.3)].
When INLYTA is used in combination with avelumab or pembrolizumab, refer to the full prescribing information of avelumab or pembrolizumab for pregnancy and contraception information.
Lactation
Advise patients not to breastfeed while taking INLYTA and for 2 weeks after receiving the last dose [see Use in Specific Populations (8.2)].
When INLYTA is used in combination with avelumab or pembrolizumab, refer to the full prescribing information of avelumab or pembrolizumab for lactation information.
Infertility
Advise males and females of reproductive potential that INLYTA may impair fertility [see Use in Specific Populations (8.3)].
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