Abemaciclib (a-bem-a-SYE-klib)

Treats breast cancer.

Brand Name(s):

Verzenio

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Swallow the tablet whole. Do not crush, break, or chew it.
• Take this medicine at the same time each day.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: If you miss a dose or vomit after you take this medicine, do not take another dose on the same day. Wait and take your next dose when you normally would.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how abemaciclib works. Tell your doctor if you are using bosentan, clarithromycin, diltiazem, efavirenz, ketoconazole, loperamide, metformin, modafinil, rifampin, or verapamil.
• Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant. If you are a woman who can bear children, your doctor may give you a pregnancy test before you start using this medicine to make sure you are not pregnant. Women should use an effective form of birth control during treatment with this medicine and for at least 3 weeks after your last dose.
• Do not breastfeed while you are taking this medicine and for at least 3 weeks after your last dose.
• Tell your doctor if you have kidney disease, liver disease, lung problems, or any type of infection.
• This medicine may cause the following problems:
  • Diarrhea, which may be severe
  • Lung or breathing problems, including interstitial lung disease or pneumonitis (which can be life-threatening)
  • Liver problems
  • Increased risk of blood clots in the lungs, brain, heart, or veins
• This medicine lowers the number of white blood cells. This weakens your immune system, so you may get infections more easily. Wash your hands often. Avoid people who are sick.
• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
• Talk with your doctor before using this medicine if you plan to have children. Some men who use this medicine have become infertile (unable to have children).
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Chest pain, trouble breathing, coughing up blood
• Dark urine or pale stools, nausea, vomiting, diarrhea, loss of appetite, stomach pain, yellow skin or eyes
• Fever, chills, cough, runny or stuffy nose, sore throat, body aches
• Numbness or weakness in your arm or leg, or on one side of your body, pain in your lower leg (calf)
• Sudden or severe headache, problems with vision, speech, or walking
• Unusual bleeding, bruising, or weakness

If you notice these less serious side effects, talk with your doctor:

• Hair loss
• Headache, dizziness
• Tiredness

If you notice other side effects that you think are caused by this medicine, tell your doctor

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