t they will need to undergo laboratory tests to monitor for liver function and to report any new symptoms indicating hepatic toxicity or failure [see WARNINGS AND PRECAUTIONS (5.4)].
Diarrhea:
Advise patients when to start standard anti-diarrheal therapy and to maintain adequate hydration. Advise patients to contact their healthcare provider if they are unable to maintain adequate hydration [see WARNINGS AND PRECAUTIONS (5.6)].
Proteinuria and Renal Failure/Impairment:
Advise patients that they will need to undergo regular laboratory tests to monitor for kidney function and protein in the urine [see Warnings and Precautions (5.5, 5.7)].
Gastrointestinal perforation or fistula formation:
Advise patients that LENVIMA can increase the risk of gastrointestinal perforation or fistula and to seek immediate medical attention for severe abdominal pain [see WARNINGS AND PRECAUTIONS (5.8)].
QTc Interval Prolongation
Advise patients who are at risk for QTc prolongation that they will need to undergo regular ECGs. Advise all patients that they will need to undergo laboratory tests to monitor electrolytes [see WARNINGS AND PRECAUTIONS (5.9)].
Hemorrhagic Events:
Advise patients that LENVIMA can increase the risk for bleeding and to contact their healthcare provider for bleeding or symptoms of severe bleeding [see WARNINGS AND PRECAUTIONS (5.12)].
Embryofetal 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 (5.14), USE IN SPECIFIC POPULATIONS (8.1)].
Advise females of reproductive potential to use effective contraception during treatment with LENVIMA and for at least 2 weeks following completion of therapy [see USE IN SPECIFIC POPULATIONS (8.3)].
Lactation:
Advise nursing women to discontinue breastfeeding during treatment with LENVIMA [see USE IN SPECIFIC POPULATIONS (8.2)].
Distributed by:
Eisai Inc.
Woodcliff Lake, NJ 07677
LENVIMA® is a registered trademark of Eisai R&D Management Co., Ltd. and is licensed to Eisai Inc.
© 2017 Eisai Inc.
PATIENT PACKAGE INSERT
PATIENT INFORMATION
LENVIMA® (lehn-veema)
(lenvatinib)
capsules
What is LENVIMA?
LENVIMA is a prescription medicine that is used to treat certain kinds of cancer.
LENVIMA is used by itself to treat differentiated thyroid cancer (DTC), a type of thyroid cancer that can no longer be treated with radioactive iodine and is progressing.
LENVIMA is used along with another medicine everolimus to treat advanced renal cell carcinoma (RCC), a type of kidney cancer, after one course of treatment with another anti-cancer medicine.
It is not known if LENVIMA is safe and effective in children.
What should I tell my healthcare provider before taking LENVIMA?
Before you take LENVIMA, tell your healthcare provider if you:
have high blood pressure
have heart problems
have a history of blood clots in your arteries (type of blood vessel), including stroke, heart attack, or change in vision
have or have had kidney or liver problems
have a history of a tear (perforation) in your stomach or intestine, or an abnormal connection between two parts of your gastrointestinal tract (fistula)
have headaches, seizures, or vision problems
have any bleeding problems
are pregnant or plan to become pregnant. LENVIMA can harm your unborn baby.
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