Abemaciclib tablets

What is this medication?

ABEMACICLIB (a BEM a SYE klib) targets proteins in cancer cells and stops the cancer cells from growing. It treats certain types of breast cancer.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): VERZENIO

What should I tell my care team before I take this medication?

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

• blood clots
• diarrhea
• infection
• kidney disease
• liver disease
• low white blood cell counts
• lung disease
• an unusual or allergic reaction to abemaciclib, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

Take this medicine by mouth. Take it as directed on the prescription label at the same time every day. Do not cut, crush or chew this medicine. Swallow the tablets whole. You can take it with or without food. If it upsets your stomach, take it with food. Your health care provider may change your dose or tell you to stop taking this medicine if you get side effects. Do not change your dose or stop taking it unless your health care provider tells you to.

Do not take this medicine with grapefruit juice.

Talk to your health care provider about the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, skip it. Take your next dose at the normal time. Do not take extra or 2 doses at the same time to make up for the missed dose.

What may interact with this medication?

• bosentan
• certain antibiotics like erythromycin or clarithromycin
• certain antivirals for HIV or hepatitis
• certain medicines for fungal infections like ketoconazole, itraconazole, or posaconazole
• certain medicines for seizures like carbamazepine, phenobarbital, phenytoin
• diltiazem
• efavirenz
• grapefruit juice
• modafinil
• rifampin
• verapamil

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

This medicine may make you feel generally unwell. This is not uncommon as chemotherapy can affect healthy cells as well as cancer cells. Report any side effects. Continue your course of treatment even though you feel ill unless your health care provider tells you to stop.

You may need blood work while you are taking this medicine.

Do not become pregnant while taking this medicine or for 3 weeks after stopping it. Women should inform their health care provider if they wish to become pregnant or think they might be pregnant. There is a potential for serious harm to an unborn child. Talk to your health care provider for more information. Do not breast-feed an infant while taking this medicine or for 3 weeks after stopping it.

This medicine may make it more difficult to father a child. Talk to your health care provider if you are concerned about your fertility.

This medicine may increase your risk of getting an infection. Call your health care provider for advice if you get a fever, chills, sore throat, or other symptoms of a cold or flu. Do not treat yourself. Try to avoid being around people who are sick.

Avoid taking medicines that contain aspirin, acetaminophen, ibuprofen, naproxen, or ketoprofen unless instructed by your health care provider. These medicines may hide a fever.

Be careful brushing or flossing your teeth or using a toothpick because you may get an infection or bleed more easily. If you have any dental work done, tell your dentist you are receiving this medicine.

What side effects may I notice from receiving this medication?

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

• allergic reactions (skin rash, itching or hives; swelling of the face, lips, or tongue)
• blood clot (chest pain; shortness of breath; pain, swelling, or warmth in leg)
• cough
• diarrhea
• infection (fever, chills, cough, sore throat, pain or trouble passing urine)
• light-colored stool
• liver injury (dark yellow or brown urine; general ill feeling or flu-like symptoms; loss of appetite, right upper belly pain; unusually weak or tired, yellowing of the eyes or skin)
• stroke (changes in vision; confusion; trouble speaking or understanding; severe headaches; sudden numbness or weakness of the face, arm or leg; trouble walking; dizziness; loss of balance or coordination)
• trouble breathing

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

• constipation
• headache
• loss of appetite
• nausea, vomiting
• stomach pain
• unusual bruising or bleeding

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Get rid of any unused medicine after the expiration date.

To get rid of medicines that are no longer needed or have expired:

• Take the medicine to a medicine take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medicine, check the label or package insert to see if the medicine should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your health care provider. If it is safe to put in the trash, take the medicine out of the container. Mix the medicine with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.