Description and Brand Names

Drug information provided by: IBM Micromedex

US Brand Name

  1. Verzenio

Descriptions


Abemaciclib is used together with other medicines (eg, anastrozole, exemestane, letrozole) as initial hormonal treatment to treat postmenopausal women with hormone receptor (HR)-positive, HER-2 negative advanced or metastatic (cancer that has spread) breast cancer. It is also used alone or together with fulvestrant to treat (HR)-positive, HER-2 negative advanced or metastatic breast cancer in women who have received hormonal treatment or other cancer medicines that did not work well.

Abemaciclib belongs to the group of medicines called antineoplastics. It interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal cells may also be affected by the medicine, other unwanted effects will also occur. Some of these may be serious and must be reported to your doctor.

This medicine is available only with your doctor's prescription.

This product is available in the following dosage forms:

  • Tablet

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of abemaciclib in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of abemaciclib in the elderly.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Carbamazepine
  • Enzalutamide
  • Fosphenytoin
  • Ketoconazole
  • Lumacaftor
  • Mitotane
  • Phenytoin
  • Rifampin
  • St John's Wort

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

  • Grapefruit Juice

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Infection—May decrease your body's ability to fight infection.
  • Liver disease, severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
  • Lung problems (eg, interstitial lung disease, pneumonitis)—Use with caution. May make these conditions worse.

Proper Use

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.

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine comes with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Swallow the tablet whole. Do not crush, break, or chew it.

Take this medicine at the same time each day, with or without food.

Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (tablets):
    • For advanced or metastatic breast cancer with anastrozole, exemestane, fulvestrant, or letrozole:
      • Adults—At first, 150 milligrams (mg) 2 times a day. Your doctor may adjust your dose as needed or tolerated.
      • Children—Use and dose must be determined by your doctor.
    • For advanced or metastatic breast cancer used alone:
      • Adults—At first, 200 milligrams (mg) 2 times a day. Your doctor may adjust your dose as needed or tolerated.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you miss a dose or vomit after you take this medicine, do not take another dose on the same day. Wait until your next dose and take it when you normally would.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant during treatment with this medicine and for at least 3 weeks after your last dose. If you think you have become pregnant while using the medicine, tell your doctor right away.

If you plan to have children, talk with your doctor before using this medicine. Some men using this medicine have become infertile (unable to have children).

This medicine may cause diarrhea, which may be severe and lead to dehydration or infections. You may take antidiarrheal medicines (eg, loperamide) if you start to have loose stools. Check with your doctor right away for additional instructions.

Abemaciclib can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.

Interstitial lung disease or pneumonitis can occur while using this medicine. This can be life-threatening and requires immediate medical attention. Check with your doctor right away if you have chest pain, cough, difficulty with breathing, fever or chills.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine may increase your risk of developing blood clots, which may be life-threatening. Check with your doctor right away if you or your child have swelling and pain in your arms, legs, pelvis, or stomach, chest pain, shortness of breath, loss of sensation, confusion, or problems with muscle control or speech.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

  1. Black, tarry stools
  2. bleeding gums
  3. bloating or swelling of the face, arms, hands, lower legs, or feet
  4. blood in the urine or stools
  5. chest pain
  6. chills
  7. confusion
  8. cough
  9. decreased urination
  10. diarrhea
  11. difficulty with breathing
  12. dizziness
  13. dry mouth
  14. fainting
  15. fever
  16. hoarseness
  17. increased heart rate
  18. irregular heartbeat
  19. lightheadedness
  20. lower back or side pain
  21. pain in the chest, groin, or legs, especially the calves
  22. painful or difficult urination
  23. pale skin
  24. pinpoint red spots on the skin
  25. rapid breathing
  26. rapid weight gain
  27. severe, sudden headache
  28. slurred speech
  29. sore throat
  30. sores, ulcers, or white spots on the lips or in the mouth
  31. stomach pain
  32. sudden loss of coordination
  33. sudden, severe weakness or numbness in the arm or leg
  34. sunken eyes
  35. swollen glands
  36. thirst
  37. tingling of the hands or feet
  38. troubled breathing with exertion
  39. unusual bleeding or bruising
  40. unusual tiredness or weakness
  41. unusual weight gain or loss
  42. vision changes
  43. wrinkled skin

Rare

  1. Blurred vision
  2. clay-colored stools
  3. dark urine
  4. decreased appetite
  5. fast heartbeat
  6. general feeling of discomfort or illness
  7. itching or skin rash
  8. loss of appetite
  9. nausea
  10. numbness or tingling in the face, arms, or legs
  11. rapid, shallow breathing
  12. severe headache
  13. stomach pain or tenderness
  14. swelling of the feet or lower legs
  15. thickening of bronchial secretions
  16. trouble speaking or walking
  17. vomiting
  18. yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

  1. Change in taste
  2. dry mouth
  3. loss of taste
  4. loss or thinning of the hair
  5. swelling or inflammation of the mouth

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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