Cobimetinib, Oral

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KEY POINTS

• This medicine is taken by mouth to treat advanced melanoma. Take it exactly as directed.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause serious heart, skin, or eye problems, or other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: antineoplastic (anticancer); kinase inhibitor

Generic and brand names: cobimetinib, oral; Cotellic

What is this medicine used for?

This medicine is taken by mouth to treat a certain kind of melanoma that has spread to other parts of the body or cannot be removed by surgery, and that is linked to an abnormal BRAF gene. It is taken along with another medicine.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• A bleeding disorder, or if you currently take medicine that reduces the chance of blood clots forming such as clopidogrel or warfarin (Coumadin)
• Any skin problems other than melanoma
• Eye problems
• Heart disease or a heart attack
• Unexplained muscle aches or weakness, or other muscle problems

Females of childbearing age: This medicine is not usually given to pregnant women because it can harm the baby. If you are pregnant, tell your healthcare provider. Do not become pregnant during treatment with this medicine. If you become pregnant, contact your healthcare provider right away. Use effective birth control while you are taking this medicine and for 2 weeks after you finish treatment. Talk with your healthcare provider if you need birth control. Do not breast-feed while you are receiving this medicine and for 2 weeks after you finish treatment.

This medicine may make you sterile (unable to have children) whether you are a man or a woman. If you plan to have children someday, talk with your healthcare provider before you start treatment.

How do I take it?

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. Do not stop taking this medicine without your healthcare provider's approval. Treatment will be continued for as long as you continue to benefit and can tolerate the side effects.

Check with your healthcare provider before using this medicine in children under age 18.

This medicine is usually taken once a day for 21 days, then 7 days with no medicine. You may take this medicine with or without food. Taking it with meals may lessen the chance the drug will upset your stomach. Do not break, crush, or chew the tablets. Swallow them whole with a glass of water.

What if I miss a dose?

If you miss a dose, or vomit after taking a dose, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose have not been reported.

What should I watch out for?

You may have blood tests or other tests before you start treatment and regularly during treatment to see how this medicine affects you. Keep all appointments.

While taking this medicine, you may bleed more easily and it may take longer for you to stop bleeding. Avoid activities where you could be bruised, cut, or injured. Report any unusual bruising or bleeding to your healthcare provider right away.

Your healthcare provider may check your heart before your start treatment and regularly during treatment to see how this medicine affects you. This medicine may cause a serious heart problem. Tell your healthcare provider right away if you have constant coughing or wheezing, shortness of breath, unexplained swelling of your ankles and feet, unusual tiredness, or a fast heartbeat while taking this medicine. Talk with your healthcare provider about this.

While you are taking this medicine, report any unusual or ongoing muscle pain, tenderness, or weakness to your healthcare provider right away, especially if you also have a fever or unusual tiredness. After you stop taking this medicine, contact your provider if these symptoms do not go away.

While taking this medicine there is an increased risk of other kinds of skin cancer. Check your skin regularly and tell your healthcare provider if you have any skin changes. Your healthcare provider may continue to check your skin for 6 months after you stop taking this medicine.

This medicine may cause serious eye problems. You should have eye exams regularly during treatment. Tell your healthcare provider right away if you have any vision changes.

Your skin may become more sensitive to sunlight while taking this medicine. You may burn more easily and get severe sunburns. While you are taking this medicine, avoid long exposure to the sun. Wear protective clothing, a hat, and sunscreen lotion when you need to be outdoors. Do not use a sunlamp. Ask your pharmacist for the most protective sunscreen lotion.

This medicine may make you dizzy. Do not drive or operate machinery unless you are fully alert.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat); sudden weakness, numbness, or tingling, especially on one side of your body; sudden or severe headache; sudden trouble with vision, speech, balance, or walking.

Serious (Report these to your healthcare provider right away.): Severe stomach pain or swelling; dark urine; light-colored bowel movements; yellowing of the skin and eyes; unexplained loss of appetite; unusual tiredness or weakness; unusual bruising or bleeding; black or tarry bowel movements; red or brown urine; unusual or ongoing muscle pain, spasms, tenderness, or weakness; vomiting blood; severe nausea or vomiting; unusual dizziness or fainting; chest pain; constant coughing or wheezing; shortness of breath; swelling in your ankles and feet; irregular or fast heartbeat; new warts, changes in moles, or other skin changes; hives, an itchy rash, or peeling skin; vision changes; unexplained mood changes or confusion.

Other: Nausea, vomiting, diarrhea, sun sensitivity, mild fever.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Antibiotics such as azithromycin (Zithromax, Zmax), ciprofloxacin (Cipro), clarithromycin (Biaxin), erythromycin (E.E.S., Ery-Tab, Erythrocin), nafcillin, rifabutin (Mycobutin), rifampin (Rifadin), rifapentine (Priftin), and telithromycin (Ketek)
• Antifungal medicines such as fluconazole (Diflucan), isavuconazonium (Cresemba), itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), and voriconazole (Vfend)
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), eslicarbazepine (Aptiom), phenobarbital, phenytoin (Dilantin, Phenytek), and primidone (Mysoline)
• Antiviral medicines such as daclatasvir (Daklinza), ombitasvir/paritaprevir/ritonavir/dasabuvir (Viekira), ombitasvir/paritaprevir/ritonavir (Technivie), and simeprevir (Olysio)
• Bosentan (Tracleer)
• Cancer medicines such as abiraterone (Zytiga), ceritinib (Zykadia), crizotinib (Xalkori), dabrafenib (Tafinlar), enzalutamide (Xtandi), idelalisib (Zydelig), imatinib (Gleevec), lapatinib (Tykerb), mitotane (Lysodren), nilotinib (Tasigna), sunitinib (Sutent), tamoxifen, vandetanib (Caprelsa), and vemurafenib (Zelboraf)
• Cholesterol-lowering medicines such as atorvastatin (Lipitor) and lomitapide (Juxtapid)
• Conivaptan (Vaprisol)
• Eliglustat (Cerdelga)
• Flibanserin (Addyi)
• Heart medicines such as amiodarone (Cordarone, Pacerone), carvedilol (Coreg), diltiazem (Cardizem, Cartia, Tiazac), dronedarone (Multaq), nicardipine (Cardene), quinidine, ranolazine (Ranexa), and verapamil (Calan, Covera, Verelan)
• HIV medicines such as atazanavir (Reyataz), cobicistat (Tybost), darunavir (Prezista), delavirdine (Rescriptor), efavirenz (Sustiva), elvitegravir/cobicistat/emtricitabine/tenofovir (Stribild), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), nelfinavir (Viracept), ritonavir (Norvir), and saquinavir (Invirase)
• Immunosuppressants such as cyclosporine (Gengraf, Neoral, Sandimmune) and tacrolimus (Astagraf, Prograf, Protopic)
• Lumacaftor/ivacaftor (Orkambi)
• Medicines to treat or prevent blood clots such as apixaban (Eliquis), clopidogrel (Plavix), dabigatran (Pradaxa), dipyridamole (Persantine), fondaparinux (Arixtra), prasugrel (Effient), rivaroxaban (Xarelto), ticlopidine, and warfarin (Coumadin)
• Mifepristone (Korlym, Mifeprex)
• Mirabegron (Myrbetriq)
• Nausea medicines such as aprepitant (Emend), netupitant/palonosetron (Akynzeo), and rolapitant (Varubi)
• Nefazodone
• Quinine
• St. John's wort
• Stimulants such as armodafinil (Nuvigil) and modafinil (Provigil)

Do NOT eat or drink products that contain grapefruit, Seville oranges, and tangelos at any time while you are taking this medicine. These fruits and juices affect the way this medicine works and increase your risk of serious side effects. Talk with your healthcare provider or pharmacist about this.

Also, do not have any vaccines without getting your healthcare provider's approval first.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.