Drug name: Abemaciclib
Description:
Abemaciclib
Generic name: abemaciclib
Brand name: Verzenio
Dosage form: tablet
Drug class: CDK 4/6 inhibitors
Medically reviewed by Melisa Puckey, BPharm. Last updated on Apr 19, 2022.
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.
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.
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.
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
Popular FAQ
Head-to-head trials comparing Verzenio to Ibrance have not been conducted. However, one is currently underway with results expected in 2022. Verzenio is taken twice daily, every day. Ibrance is taken every day for 21 days followed by a 7-day break. Verzenio can be used as monotherapy or in combination with other treatments. Ibrance is always taken in combination with either an aromatase inhibitor or fulvestrant. Verzenio is more likely than Ibrance to cause severe diarrhea. Both Verzenio and Ibrance can be used as combination treatment to treat breast cancer in men. Verzenio is also approved to treat adults with early breast cancer at high risk of recurrence and a Ki 67 score of at least 20% (by FDA approved test) in combination with endocrine treatment (tamoxifen or an aromatase inhibitor). Continue reading
Both Verzenio and Ibrance belong to the same class of medicine, called CDK 4/6 inhibitors, therefore, because they are both in the same class of medicines, clinically, there seems no advantage in switching from one to another if one fails. However, research has shown breast cancer cells can acquire resistance to CDK 4/6 inhibitors by producing higher amounts of CDK6. Laboratory trials have shown that a “treatment holiday” of 28 days reversed this resistance, which implies that there may be some benefit of either stopping Ibrance temporarily or switching from Ibrance to Verzenio after a treatment break. Comparative trials comparing Verzenio to Ibrance are currently underway with results expected in 2022. Continue reading
You will typically continue your Verzenio treatment until you have unacceptable side effects or the disease progresses. Do not stop taking your medicine or change your dose unless your doctor tells you to. Take Verzenio exactly as prescribed. Continue reading
Although Verzenio starts inhibiting CDK4/6 enzymes quickly, it may take up two to four months before any change in outcomes, such as progression-free survival, are noted. Side effects, such as diarrhea usually occur within the first week or month of treatment. Verzenio reaches consistent blood levels within five days of taking it twice a day.
Continue reading
Verzenio is considered a targeted treatment, rather than being a chemo drug, but it may be used to treat certain types of breast cancer. Verzenio belongs to the class of medicines known as CDK 4/6 inhibitors which help to reduce the growth and spread of cancer cells in the body.
Continue reading
Trials have indicated that Verzenio plus endocrine therapy (ET) is more effective than ET alone at decreasing the risk of breast cancer recurrence and death improving rates of invasive disease-free survival (IDFS). For example, Verzenio plus ET decreased the risk of breast cancer recurrence and death by 37% and showed an absolute benefit in invasive disease-free survival (IDFS) rate of 7.1% at 3 years in men and women with early breast cancer and high-risk clinical and pathological factors and a Ki-67 score ≥20%. Women taking Verzenio plus aromatase inhibitors experienced a longer progression-free survival than those taking placebo (28.2 months compared to 14.8 months). 55% of women experienced a complete or partial response to Verzenio plus an aromatase inhibitor. Women taking Verzenio plus fulvestrant were less likely to experience an “event” that impacted on their disease progression (49.8% vs 70.4%). For women taking Verzenio as monotherapy, 19.7% saw their tumors shrink by 30% or more. Continue reading
View more FAQ
References
- Food and Drug Administration (FDA) Verzenio Product Label
- Stephen R. D. Johnston, MD, PhD, Nadia Harbeck, MD, PhD, Roberto Hegg, MD, PhD et al. Abemaciclib Combined With Endocrine Therapy for the Adjuvant Treatment of HR+, HER2−, Node-Positive, High-Risk, Early Breast Cancer (monarchE). J Clin Oncol. 2020 Dec 1; 38(34): 3987–3998. doi: 10.1200/JCO.20.02514
More about abemaciclib
- Check interactions
- Reviews (7)
- Latest FDA alerts (1)
- Side effects
- Dosage information
- During pregnancy
- Drug class: CDK 4/6 inhibitors
- Breastfeeding
- En español
Patient resources
Other brands
Verzenio
Professional resources
- Prescribing Information
Related treatment guides
- Breast Cancer
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Medical Disclaimer