Braftovi

Braftovi is a prescription medication used to treat patients with skin cancer, containing specific gene mutations, that cannot be surgically removed or has spread throughout the body. Braftovi is taken in combination with another medication called binimetinib (brand name Mektovi).

Braftovi belongs to a group of drugs called kinase inhibitors, which are used in targeting many cancers. Kinases are enzymes that change how proteins work. By targeting BRAF and MEK kinases, Braftovi taken in combination with Mektovi helps to inhibit overactive signals that cause melanoma cells to grow out of control.

This medication comes in capsule form and is taken once a day, with or without food.

Common side effects include tiredness, nausea and vomiting. Braftovi can also cause dizziness. Do not drive or operate heavy machinery until you know how Braftovi affects you.

Braftovi is a prescription medicine used in combination with a medicine called binimetinib to treat people with a type of skin cancer called melanoma:

•  that has spread to other parts of the body or cannot be removed by surgery, and
•  that has a certain type of abnormal "BRAF" gene

Braftovi should not be used to treat people with wild-type BRAF melanoma. Your healthcare provider will perform a test to make sure that Braftovi is right for you. It is not known if Braftovi is safe and effective in children.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Braftovi. See the “Braftovi Precautions” section.

Common side effects of Braftovi include the following:

• fatigue
•  nausea
•  vomiting
•  abdominal pain
•  pain or swelling of your joints

Braftovi may cause fertility problems in males. Talk to your healthcare provider if this is a concern for you.

This is not a complete list of Braftovi side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effects that bother you or that do not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• medications that block a protein in the body (CYP3A4) such as some macrolide antibiotics (clarithromycin, telithromycin), some HIV protease inhibitors (indinavir, nelfinavir, ritonavir, saquinavir), some HCV protease inhibitors (boceprevir, telaprevir), some azole antifungals (ketoconazole, itraconazole, posaconazole, voriconazole), delavirdine (Rescriptor), and nefazodone
• medications that increase the activity of the enzyme CYP3A4 such as carbamazepine (Tegretol, Equetro, Carbatrol), phenobarbital, phenytoin (Dilantin), rifampin (Rifadin), and St John's wort
• medications that use the enzyme CYP3A4 such as budesonide (Entocort), cyclosporine (Neoral, Gengraf, Sandimmune), darifenacin (Enablex), dihydroergotamine (Migranal), fentanyl (Abstral, Fentora, Onsolis, Actiq), pimozide (Orap), quinidine (Cardioquin, Duraquin, Quinact), sirolimus (Rapamune), tacrolimus (Prograf), terfenadine (Seldane), fluticasone (Flovent HFA, Flonase), eletriptan (Relpax), lovastatin (Mevacor), quetiapine (Seroquel), sildenafil (Viagra, Revatio), and simvastatin (Zocor).
• hormonal contraceptives. Braftovi can decrease the effectiveness of hormonal contraceptives.

This is not a complete list of Braftovi drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Braftovi including:

• Risk of new skin cancers. Braftovi when used alone, or with binimetinib, may cause skin cancers called cutaneous squamous cell carcinoma or basal cell carcinoma.

Talk to your healthcare provider about your risk for these cancers.
Check your skin and tell your healthcare provider right away about any skin changes, including a:

• new wart
• skin sore or reddish bump that bleeds or does not heal
• change in size or color of a mole

Your healthcare provider should check your skin before treatment with Braftovi, every 2 months during treatment, and for up to 6 months after you stop treatment with Braftovi to look for any new skin cancers.

Your healthcare provider should also check for cancers that may not occur on the skin. Tell your healthcare provider about any new symptoms that develop during treatment with Braftovi.

• Bleeding problems. Braftovi, when taken with binimetinib, can cause serious bleeding problems, including in your stomach 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:
  • headaches, dizziness, or feeling weak
  • cough up blood or blood clots
  • 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:
  • blurred vision, loss of vision, or other vision changeso see colored dots
  • see halos (blurred outline around objects)
  • eye pain, swelling, or redness
• Changes in the electrical activity of your heart called QT prolongation. QT prolongation can cause irregular heartbeats that can be life-threatening. Your healthcare provider should do tests before you start and during your treatment to check your body salts (electrolytes). Tell your healthcare provider right away if you feel faint, light-headed, dizzy, or if you feel your heart beating irregularly or fast.

Avoid high-fat, high-calorie meals because they can decrease the concentration of Braftovi.

Grapefruit and grapefruit juice may interact with Braftovi and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Before taking Braftovi, tell your healthcare provider about all of your medical conditions, including if you:

• have had bleeding problems
•  have eye problems
•  have heart problems, including a condition called long QT syndrome
•  have been told that you have low blood levels of potassium, calcium, or magnesium
•  have liver or kidney problems
•  are pregnant or plan to become pregnant. Braftovi can harm your unborn baby.
  • Females who are able to become pregnant should use effective non-hormonal birth control (contraception) during treatment 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 treatment with Braftovi.
  • Talk to your healthcare provider about birth control methods that may be right for you during this time.
  • 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 breastfeed during 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 the other medicines work.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

Tell your doctor if you are pregnant or plan to become pregnant.

Based on how it works, Braftovi can cause harm to your unborn baby if you are pregnant. In animal studies, pregnant animals were given this medication and had some babies born with problems. Your doctor will determine if the benefits of this medication outweigh the risks.

Females who are able to become pregnant should use effective non-hormonal birth control (contraception) during treatment 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 treatment with Braftovi.

Talk to your healthcare provider about birth control methods that may be right for you during this time. Your healthcare provider will do a pregnancy test before you start taking Braftovi. Tell your healthcare provider right away if you become pregnant or think you might be pregnant during treatment with Braftovi.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Braftovi passes into your breast milk. Do not breastfeed during 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.

• Take Braftovi exactly as your healthcare provider tells you. Do not change your dose or stop taking Braftovi unless your healthcare provider tells you to.
•  Your healthcare provider may change your dose of Braftovi, temporarily stop, or completely stop your treatment with 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 in your body.
•  If you miss a dose of Braftovi, take it as soon as you remember. If it is within 12 hours of your next scheduled dose, 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. Your Braftovi dose may need to be changed.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• other medications you are taking
• how you respond to this medication

The recommended dose Braftovi for the treatment of melanomas containing mutated genes that cannot be surgically removed or has spread throughout the body is 450 mg once daily, in combination with another drug called binimetinib.

If you take too much Braftovi, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store Braftovi at room temperature 20°C to 25°C (68°F to 77°F).
• Store Braftovi in original bottle.
• Do not remove desiccant packs from bottle in order to protect Braftovi from moisture.
• Keep this and all medicines out of the reach of children.