Cobimetinib oral tablets

What is this medicine?

COBIMETINIB (koe bi me ti nib) is a medicine that targets proteins in cancer cells and stops the cancer cells from growing. It is used to treat certain types of melanoma, a skin cancer.

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. You can take it with or without food. If it upsets your stomach, take it with food. Do not take with grapefruit juice. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor's advice.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• changes in skin including blistering, peeling of the skin

• changes in vision including blurred vision

• fast heartbeat

• shortness of breath

• signs and symptoms of bleeding such as bloody or black, tarry stools; red or dark-brown urine; spitting up blood or brown material that looks like coffee grounds; red spots on the skin; unusual bruising or bleeding from the eye, gums, or nose

• signs and symptoms of liver injury like dark yellow or brown urine; general ill feeling or flu-like symptoms; light-colored stools; loss of appetite; nausea; right upper belly pain; unusually weak or tired; yellowing of the eyes or skin

• signs and symptoms of muscle injury like dark urine; trouble passing urine or change in the amount of urine; unusually weak or tired; muscle pain or side or back pain; muscle weakness

• swelling of the ankles, feet, hands

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• diarrhea

• fever

What may interact with this medicine?

This medicine may interact with the following medications:

• certain medicines for fungal infections like ketoconazole and itraconazole

• certain medicines for seizures like carbamazepine, phenobarbital, phenytoin

• ciprofloxacin

• efavirenz

• erythromycin

• grapefruit juice

• rifampin

• St. John's Wort

What if I miss a dose?

If you miss a dose or if you vomit after taking your medicine, do not take another dose. Take the next dose at your regular time. Do not take double or extra doses.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Dispose of any unused medicine after the expiration date.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• eye disease, vision problems

• heart disease

• increased risk of bleeding, such as bleeding disorders or history of bleeding

• liver disease

• muscle aches or weakness

• skin conditions or sensitivity

• an unusual or allergic reaction to cobimetinib, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular checks on your progress. You may need blood work done while you are taking this medicine.

Tell your doctor or health care professional right away if you have any change in your eyesight.

Talk to your doctor about your risk of cancer. You may be more at risk for certain types of cancers if you take this medicine.

This medicine can make you more sensitive to the sun. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and use sunscreen. Do not use sun lamps or tanning beds/booths.

Do not become pregnant while taking this medicine or for 2 weeks after stopping it. Women should inform their doctor if they wish to become pregnant or think they might be pregnant. There is a potential for serious side effects to an unborn child. Talk to your health care professional or pharmacist for more information. Do not breast-feed an infant while taking this medicine or for 2 weeks after stopping it.

This medicine may interfere with the ability to have a child. You should talk with your doctor or health care professional if you are concerned about your fertility.