Peripheral Neuropathy
Advise patients that ADCETRIS can cause a peripheral neuropathy. They should be advised to report to their health care provider any numbness or tingling of the hands or feet or any muscle weakness [see Warnings and Precautions (5.1)].
Fever/Neutropenia
Advise patients to contact their health care provider if a fever of 100.5°F or greater or other evidence of potential infection such as chills, cough, or pain on urination develops [see Warnings and Precautions (5.3)].
Infusion Reactions
Advise patients to contact their health care provider if they experience signs and symptoms of infusion reactions including fever, chills, rash, or breathing problems within 24 hours of infusion [see Warnings and Precautions (5.2)].
Hepatotoxicity
Advise patients to report symptoms that may indicate liver injury, including fatigue, anorexia, right upper abdominal discomfort, dark urine, or jaundice [see Warnings and Precautions (5.8)].
Progressive Multifocal Leukoencephalopathy
Instruct patients receiving ADCETRIS to immediately report if they have any of the following neurological, cognitive, or behavioral signs and symptoms or if anyone close to them notices these signs and symptoms [see Boxed Warning, Warnings and Precautions (5.9)]:
• changes in mood or usual behavior
• confusion, thinking problems, loss of memory
• changes in vision, speech, or walking
• decreased strength or weakness on one side of the body
Pulmonary Toxicity
Instruct patients to report symptoms that may indicate pulmonary toxicity, including cough or shortness of breath [see Warnings and Precautions (5.10)].
Acute Pancreatitis
Advise patients to contact their health care provider if they develop severe abdominal pain [see Warnings and Precautions (5.12)].
Gastrointestinal Complications
Advise patients to contact their health care provider if they develop severe abdominal pain, chills, fever, nausea, vomiting, or diarrhea [see Warnings and Precautions (5.12)].
Hyperglycemia
Educate patients about the risk of hyperglycemia and how to recognize associated symptoms [see Warnings and Precautions (5.13)].
Females and Males of Reproductive Potential
ADCETRIS can cause fetal harm. Advise women receiving ADCETRIS to use effective contraception during ADCETRIS treatment and for 2 months after the last dose of ADCETRIS.
Advise males with female sexual partners of reproductive potential to use effective contraception during ADCETRIS treatment and for 4 months after the last dose of ADCETRIS [see Use in Specific Populations (8.3)].
Advise patients to report pregnancy immediately [see Warnings and Precautions (5.14)].
Lactation
Advise patients to avoid breastfeeding while receiving ADCETRIS [see Use in Specific Populations (8.2)].
Manufactured by:
Seagen Inc.
Bothell, WA 98021
1-855-473-2436
U.S. License 2257
ADCETRIS, Seagen and are US registered trademarks of Seagen Inc.
© 2023 Seagen Inc., Bothell, WA 98021. All rights reserved.
uspi-125388-v19
Peripheral Neuropathy
Advise patients that ADCETRIS can cause a peripheral neuropathy. They should be advised to report to their health care provider any numbness or tingling of the hands or feet or any muscle weakness [see Warnings and Precautions (5.1)].
Fever/Neutropenia
Advise patients to contact their health care provider if a fever of 100.5°F or greater or other evidence of potential infection such as chills, cough, or pain on urination develops [see Warnings and Precautions (5.3)].
Infusion Reactions
Advise patients to contact their health care provider if they experience signs and symptoms of infusion reactions including fever, chills, rash, or breathing problems within 24 hours of infusion [see Warnings and Precautions (5.2)].
Hepatotoxicity
Advise patients to report symptoms that may indicate liver injury, including fatigue, anorexia, right upper abdominal discomfort, dark urine, or jaundice [see Warnings and Precautions (5.8)].
Progressive Multifocal Leukoencephalopathy
Instruct patients receiving ADCETRIS to immediately report if they have any of the following neurological, cognitive, or behavioral signs and symptoms or if anyone close to them notices these signs and symptoms [see Boxed Warning, Warnings and Precautions (5.9)]:
• changes in mood or usual behavior
• confusion, thinking problems, loss of memory
• changes in vision, speech, or walking
• decreased strength or weakness on one side of the body
Pulmonary Toxicity
Instruct patients to report symptoms that may indicate pulmonary toxicity, including cough or shortness of breath [see Warnings and Precautions (5.10)].
Acute Pancreatitis
Advise patients to contact their health care provider if they develop severe abdominal pain [see Warnings and Precautions (5.12)].
Gastrointestinal Complications
Advise patients to contact their health care provider if they develop severe abdominal pain, chills, fever, nausea, vomiting, or diarrhea [see Warnings and Precautions (5.12)].
Hyperglycemia
Educate patients about the risk of hyperglycemia and how to recognize associated symptoms [see Warnings and Precautions (5.13)].
Females and Males of Reproductive Potential
ADCETRIS can cause fetal harm. Advise women receiving ADCETRIS to use effective contraception during ADCETRIS treatment and for 2 months after the last dose of ADCETRIS.
Advise males with female sexual partners of reproductive potential to use effective contraception during ADCETRIS treatment and for 4 months after the last dose of ADCETRIS [see Use in Specific Populations (8.3)].
Advise patients to report pregnancy immediately [see Warnings and Precautions (5.14)].
Lactation
Advise patients to avoid breastfeeding while receiving ADCETRIS [see Use in Specific Populations (8.2)].
Manufactured by:
Seagen Inc.
Bothell, WA 98021
1-855-473-2436
U.S. License 2257
ADCETRIS, Seagen and are US registered trademarks of Seagen Inc.
© 2023 Seagen Inc., Bothell, WA 98021. All rights reserved.
uspi-125388-v19
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