Abemaciclib

Aug 3, 2022

Generic name: abemaciclib
Brand name:  Verzenio
Dosage form: tablet
Drug class:  CDK 4/6 inhibitors

What is abemaciclib?

Abemaciclib is an FDA approved medicine used to treat certain types of HR+/HER2– (hormone receptor positive/human epidermal growth factor receptor 2 negative) breast cancers. This drug was developed by Eli Lilly & Co.

Abemaciclib is from a class of medicines called CDK 4/6 inhibitors, they block the CDK4 and CDK6 enzymes, which stops the signal that causes growth of cancerous cells. This helps reduce the growth and spread of cancer cells in the body. 

Depending on the type and stage of your breast cancer, Abemaciclib may need to be taken in combination with other cancer treatments.  

What is abemaciclib used for?

Abemaciclib is a prescription medicine used:

  • in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) to treat adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, early breast cancer with a high risk of coming back as determined by your healthcare provider.
  • in combination with an aromatase inhibitor as the first endocrine-based therapy to treat women who have gone through menopause (postmenopausal), and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer that has worsened or that has spread to other parts of the body (metastatic).
  • in combination with fulvestrant to treat adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer that has worsened or spread to other parts of the body (metastatic) and whose disease has progressed after endocrine therapy.
  • alone to treat adults with HR-positive, HER2-negative breast cancer that has worsened or that has spread to other parts of the body (metastatic) and whose disease has progressed after endocrine therapy and prior chemotherapy.

When abemaciclib is used in combination with fulvestrant, tamoxifen, or an aromatase inhibitor, also read the Patient Information for the prescribed product. Ask your healthcare provider if you are not sure.

It is not known if abemaciclib is safe and effective in children.

Warnings

Abemaciclib may cause serious side effects including:

  • Diarrhea. Diarrhea is common with abemaciclib treatment and may sometimes be severe. Diarrhea may cause you to develop dehydration or an infection. The most common time to develop diarrhea is during the first month of abemaciclib treatment. If you develop diarrhea during treatment with abemaciclib, your healthcare provider may tell you to temporarily stop taking abemaciclib, stop your treatment, or decrease your dose.
    • If you have any loose stools, start taking an antidiarrheal medicine (such as loperamide), drink more fluids, and tell your healthcare provider right away.
  • Low white blood cell counts (neutropenia). Low white blood cell counts are common during treatment with abemaciclib and may cause serious infections that can lead to death. Your healthcare provider should check your white blood cell counts before and during treatment. If you develop low white blood cell counts during treatment with abemaciclib, your healthcare provider may tell you to temporarily stop taking abemaciclib, decrease your dose, or wait before starting your next month of treatment. Tell your healthcare provider right away if you have signs and symptoms of low white blood cell counts or infections, such as fever and chills.
  • Lung problems. Abemaciclib may cause severe or life-threatening inflammation of the lungs during treatment that can lead to death. If you develop lung problems during treatment with abemaciclib, your healthcare provider may tell you to temporarily stop taking abemaciclib, decrease your dose, or stop your treatment. Tell your healthcare provider right away if you have any new or worsening symptoms, including:
    • trouble breathing or shortness of breath
    • cough with or without mucus
    • chest pain
  • Liver problems. Abemaciclib can cause serious liver problems. Your healthcare provider should do blood tests to check your liver before and during treatment with abemaciclib. If you develop liver problems during treatment with abemaciclib, your healthcare provider may reduce your dose or stop your treatment. Tell your healthcare provider right away if you have any of the following signs and symptoms of liver problems:
    • feeling very tired
    • pain on the upper right side of your stomach area (abdomen)
    • loss of appetite
    • bleeding or bruising more easily than normal
  • Blood clots in your veins, or in the arteries of your lungs. abemaciclib may cause serious blood clots that have led to death. If you develop blood clots during treatment with abemaciclib, your healthcare provider may tell you to temporarily stop taking abemaciclib. Tell your healthcare provider right away if you get any of the following signs and symptoms of a blood clot:
    • pain or swelling in your arms or legs
    • shortness of breath
    • chest pain
    • rapid breathing
    • rapid heart rate

Before taking this medicine

Before taking abemaciclib, tell your healthcare provider about all of your medical conditions, including if you:

  • have fever, chills, or any other signs of an infection.
  • have a history of blood clots in your veins.
  • have lung or breathing problems.
  • have liver or kidney problems.
  • are pregnant or plan to become pregnant. Abemaciclib can harm your unborn baby. See more information below about abemaciclib and pregnancy.
  • are breastfeeding or plan to breastfeed. It is not known if abemaciclib passes into your breast milk. Do not breastfeed during treatment with abemaciclib and for at least 3 weeks after the last dose of abemaciclib.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. abemaciclib may affect the way other medicines work, and other medicines may affect how abemaciclib works, causing serious side effects.

Especially tell your healthcare provider if you take a medicine that contains ketoconazole.

Know the medicines you take. Keep a list of them to show your healthcare provider or pharmacist when you get a new medicine.

Dosing information

Your dose will depend on whether you are taking abemaciclib on its own (without another cancer therapy) or if you are taking it in combination with another therapy.

The usual starting dose, when taken on its own, is 200mg twice a day.

If you are taking it with fulvestrant, tamoxifen, or an aromatase inhibitor your starting dose will be 150mg twice daily.

Your dose may be reduced or treatment paused if you have side effects or if you are unable to tolerate abemaciclib.

Detailed Abemaciclib dosage information

How should I take abemaciclib?

  • Take abemaciclib exactly as your healthcare provider tells you.
  • Do not stop taking abemaciclib or change the dose without talking to your healthcare provider.
  • Abemaciclib may be taken with or without food.
  • Swallow abemaciclib tablets whole. Do not chew, crush, or split the tablets before swallowing. Do not take abemaciclib tablets if they are broken, cracked, or damaged.
  • Take your doses of abemaciclib at about the same time every day.
  • If you vomit or miss a dose of abemaciclib, take your next dose at your regular time. Do not take 2 doses of abemaciclib at the same time to make up for the missed dose.

What should I avoid during treatment with abemaciclib?

  • Avoid taking ketoconazole during treatment with abemaciclib. Tell your healthcare provider if you take a medicine that contains ketoconazole.
  • Avoid grapefruit and products that contain grapefruit during treatment with abemaciclib. Grapefruit may increase the amount of abemaciclib in your blood.

What are the possible side effects of abemaciclib?

Abemaciclib may cause serious side effects, including:

See “Warnings” information above on this page.

The most common side effects of abemaciclib include:

  • nausea
  • infections
  • low red blood cell counts (anemia)
  • decreased appetite
  • headache
  • hair thinning or hair loss (alopecia)
  • abdominal pain
  • tiredness
  • low white blood cell counts (leukopenia)
  • vomiting
  • low platelet count (thrombocytopenia)

Abemaciclib may cause fertility problems in males. This may affect your ability to father a child. Talk to your healthcare provider if this is a concern for you.

These are not all the possible side effects of abemaciclib. For more information, ask your healthcare provider or pharmacist.

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

Abemaciclib side effects  (more detail)

Interactions

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Abemaciclib may affect the way other medicines work, and other medicines may affect how abemaciclib works, causing serious side effects.

Especially tell your healthcare provider if you take a medicine that contains ketoconazole.

Know the medicines you take. Keep a list of them to show your healthcare provider or pharmacist when you get a new medicine.

Abemaciclib drug interactions  (more detail)

Pregnancy and breastfeeding

Pregnancy

Females should not take abemaciclib if you are pregnant or planning a pregnancy, as it can harm your unborn baby.

  • Your healthcare provider will do a pregnancy test before you start treatment with abemaciclib.
  • You should use effective birth control (contraception) during treatment with abemaciclib and for 3 weeks after the last dose of abemaciclib.
  • Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with abemaciclib.

Males

  • Abemaciclib may cause fertility problems in males. This may affect your ability to father a child. Talk to your healthcare provider if this is a concern for you.

Breastfeeding

Abemaciclib and breastfeeding:

  • It is not known if abemaciclib passes into your breast milk. Do not breastfeed during treatment with abemaciclib and for at least 3 weeks after the last dose of abemaciclib.

Storage

How should I store abemaciclib?

Store abemaciclib at room temperature between 68°F to 77°F (20°C to 25°C).

Keep abemaciclib and all medicines out of the reach of children.

What are the ingredients in abemaciclib?

Active ingredient: abemaciclib

Verzenio Inactive ingredients: microcrystalline cellulose 102, microcrystalline cellulose 101, lactose monohydrate, croscarmellose sodium, sodium stearyl fumarate, silicon dioxide.

Verzenio Color mixture ingredients: polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, iron oxide yellow, iron oxide red.

Marketed by

Verzenio is marketed by Lilly USA, LLC, Indianapolis, IN 46285, USA

source :: https://www.drugs.com/abemaciclib.html