Abemaciclib tablets

What is this medicine?

ABEMACICLIB (a BEM a SYE klib) is a medicine that targets proteins in cancer cells and stops the cancer cells from growing. It is used to treat breast cancer.

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Do not cut, crush or chew this medicine. 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:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• cough

• diarrhea

• low blood counts - this medicine may decrease the number of white blood cells, red blood cells and platelets. You may be at increased risk for infections and bleeding.

• signs and symptoms of a blood clot such as breathing problems; changes in vision; chest pain; severe, sudden headache; pain, swelling, warmth in the leg; trouble speaking; sudden numbness or weakness of the face, arm or leg

• signs and symptoms of infection like fever or chills; cough; sore throat; pain or trouble passing urine

• 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

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

• changes in taste

• constipation

• dizziness

• dry mouth

• headache

• loss of appetite

• mouth sores

• nausea, vomiting

• red spots on the skin

• stomach pain

• swelling of the ankles, feet, hands

• unusually weak or tired

• weight loss

What may interact with this medicine?

This medicine may interact with the following medications:

• antiviral medicines for hepatitis, HIV or AIDS

• aprepitant

• bosentan

• calcium channel blockers like diltiazem and verapamil

• certain antibiotics like erythromycin and clarithromycin

• certain medicines for fungal infections like fluconazole, itraconazole, ketoconazole, posaconazole, and voriconazole

• certain medicines for seizures like carbamazepine, phenobarbital, phenytoin

• cimetidine

• ciprofloxacin

• crizotinib

• cyclosporine

• dronedarone

• enzalutamide

• fluvoxamine

• grapefruit juice

• imatinib

• mitotane

• modafinil

• rifampin

• St. John's Wort

What if I miss a dose?

If you miss a dose or vomit after taking a dose, do not take another dose. Take your next dose at your regular time.

Where should I keep my medicine?

Keep out of the reach of children.

Store between 20 and 25 degrees C (68 and 77 degrees F). Throw away 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:

• diarrhea

• history of blood clots

• infection (especially a virus infection such as chickenpox, cold sores, or herpes)

• liver disease

• low blood counts, like low white cell, platelet, or red cell counts

• lung or breathing disease, like asthma

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

• pregnant or trying to get pregnant

• breast-feeding

What should I watch for while using this medicine?

Tell your doctor or healthcare professional if your symptoms do not start to get better or if they get worse.

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

Your mouth may get dry. Chewing sugarless gum or sucking hard candy, and drinking plenty of water may help. Contact your doctor if the problem does not go away or is severe.

Do not become pregnant while taking this medicine or for at least 3 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. Men should inform their doctors if they wish to father a child later. This medicine may lower sperm counts. Talk to your health care professional or pharmacist for more information. Do not breast-feed an infant while taking this medicine or for 3 weeks after the last dose.

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

Call your doctor or health care professional for advice if you get a fever, chills or sore throat, or other symptoms of a cold or flu. Do not treat yourself. This drug decreases your body's ability to fight infections. Try to avoid being around people who are sick.

This medicine may increase your risk to bruise or bleed. Call your doctor or health care professional if you notice any unusual bleeding.

This drug 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 doctor tells you to stop.