pregnant or plan to become pregnant. BRAFTOVI can harm your unborn baby.
o Females who are able to become pregnant should use effective non-hormonal birth control (contraception) duringtreatment with BRAFTOVI and for 2 weeks after the final dose of BRAFTOVI. Birth control methods that contain
hormones (such as birth control pills, injections or transdermal systems) may not work as well during treatmentwith BRAFTOVI.
o Talk to your healthcare provider about birth control methods that may be right for you during this time.
o Your healthcare provider will do a pregnancy test before you start taking BRAFTOVI. Tell your healthcare providerright away if you become pregnant or think you might be pregnant during treatment with BRAFTOVI.
● are breastfeeding or plan to breastfeed. It is not known if BRAFTOVI passes into your breast milk. Do not breastfeedduring treatment with BRAFTOVI and for 2 weeks after the final dose of BRAFTOVI. Talk to your healthcare provider
about the best way to feed your baby during this time.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines,vitamins, and herbal supplements.
BRAFTOVI and certain other medicines can affect each other, causing side effects or affecting how BRAFTOVI or theother medicines work.
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a newmedicine.
How should I take BRAFTOVI?
Take BRAFTOVI exactly as your healthcare provider tells you. Do not change your dose or stop taking BRAFTOVIunless your healthcare provider tells you to.
Your healthcare provider may change your dose of BRAFTOVI, temporarily stop, or completely stop your treatmentwith BRAFTOVI if you develop certain side effects.
Take BRAFTOVI in combination with binimetinib by mouth one time each day.
BRAFTOVI may be taken with or without food.
Avoid grapefruit during treatment with BRAFTOVI. Grapefruit products may increase the amount of BRAFTOVI inyour body.
If you miss a dose of BRAFTOVI, take it as soon as you remember. If it is within 12 hours of your next scheduleddose, take your next dose at your regular time. Do not make up for the missed dose.
Do not take an extra dose if you vomit after taking your scheduled dose. Take your next dose at your regular time.
If you stop treatment with binimetinib, talk to your healthcare provider about your BRAFTOVI treatment.
YourBRAFTOVI dose may need to be changed.
What are the possible side effects of BRAFTOVI?
BRAFTOVI may cause serious side effects, including:
See “What is the most important information I should know about BRAFTOVI?”
● Bleeding problems. BRAFTOVI, when taken with binimetinib, can cause serious bleeding problems, including in yourstomach or brain, that can lead to death. Call your healthcare provider and get medical help right away if you have
any signs of bleeding, including:
o headaches, dizziness, or feeling weak
o cough up blood or blood clots
o vomit blood or your vomit looks like “coffee grounds”
o red or black stools that look like tar
Eye problems. Tell your healthcare provider right away if you develop any of these symptoms of eye problems:
o blurred vision, loss of vision, or other vision changes
o see colored dots
o see halos (blurred outline around objects)