Generic name: abemaciclib [ a-BEM-a-SYE-klib ]
Drug class: CDK 4/6 inhibitors
What is Verzenio?
Verzenio is a prescription medicine used to treat certain patients with HR-positive, HER2-negative breast cancer.
Verzenio is a targeted treatment known as a CDK4/6 inhibitor. It works inside the cell to block CDK4/6 activity and help stop the growth of cancer cells.
What is Verzenio used for?
Verzenio is 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 adults 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 Verzenio 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 Verzenio is safe and effective in children.
Verzenio can cause severe severe diarrhea, which can lead to dehydration or infection. Call your doctor right away if you have diarrhea. Drink extra fluids and start taking anti-diarrhea medicine such as loperamide (Imodium).
Verzenio can cause blood clots, liver problems, or serious and sometimes fatal infections. Call your doctor right away if you have symptoms such as: fever, chills, easy bruising or bleeding, unusual tiredness, loss of appetite, right-sided upper stomach pain, chest pain, shortness of breath, rapid breathing, fast heartbeats, or pain or swelling in your arms or legs.
Before taking this medicine
You should not use Verzenio if you are allergic to abemaciclib.
To make sure Verzenio is safe for you, tell your doctor if you have ever had:
a fever, chills, or other signs of infection; or
liver or kidney disease.
You may need to have a negative pregnancy test before starting this treatment.
Using Verzenio during pregnancy could harm the unborn baby. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 3 weeks after your treatment ends. Tell your doctor right away if you become pregnant during this time.
You should not breastfeed while using this medicine and for at least 3 weeks after your last dose.
How should I take Verzenio?
Take Verzenio exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.
Take the medicine at the same time each day, with or without food.
Swallow the tablet whole and do not crush, chew, or break it.
If you vomit shortly after taking Verzenio, do not take another dose. Wait until your next scheduled dose time to take the medicine again.
Drink plenty of liquids while you are taking Verzenio.
Abemaciclib can cause severe diarrhea, which can be life-threatening if it leads to dehydration or infection.
If you have diarrhea while taking Verzenio: start taking anti-diarrhea medicine such as loperamide (Imodium) to quickly treat diarrhea. Drink extra fluids and call your doctor.
Abemaciclib can lower blood cells that help your body fight infections and help your blood to clot. Your blood will need to be tested often. Your cancer treatments may be delayed based on the results of these tests.
Store at room temperature away from moisture and heat.
Usual Adult Dose for Breast Cancer:
-In combination with fulvestrant, tamoxifen, or an aromatase inhibitor: 150 mg orally twice a day
-As Monotherapy: 200 mg orally twice a day
-Duration of Therapy: Until disease progression or unacceptable toxicity
-If using this drug in combination with fulvestrant on pre/perimenopausal women, treat these patients with a gonadotropin-releasing hormone agonist according to current clinical practice standards.
-When used in combination with this drug, the recommended dose of fulvestrant is 500 mg on Days 1, 15, and 29, then once monthly thereafter; refer to the manufacturer product information for fulvestrant.
-in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, early breast cancer at high risk of recurrence.
-in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer.
-in combination with fulvestrant for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer with disease progression following endocrine therapy.
-as monotherapy for the treatment of adult patients with HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting.
What happens if I miss a dose?
Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What to avoid
Grapefruit may interact with abemaciclib and lead to unwanted side effects. Avoid the use of grapefruit products.
Verzenio side effects
Get emergency medical help if you have signs of an allergic reaction to Verzenio: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
severe or ongoing diarrhea;
pain or burning when you urinate;
liver problems - right-sided upper stomach pain, loss of appetite, easy bruising or bleeding, feeling very tired;
low blood cell counts - fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath;
signs of inflammation in the lungs - new or worsening cough, painful or difficult breathing, wheezing, feeling short of breath even while resting; or
signs of a blood clot - pain or swelling in an arm or leg, chest pain, fast heartbeats, feeling short of breath.
Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.
Common Verzenio side effects may include:
loss of appetite;
low blood cell counts.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect Verzenio?
Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.
Tell your doctor about all your other medicines, especially:
This list is not complete. Other drugs may interact with abemaciclib, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.
Verzenio (abemaciclib) is a small molecule drug and kinase inhibitor used to treat patients with early breast cancer, and advanced or metastatic breast cancer. It is used to treat both men and women. Verzenio is an ATP-competitive inhibitor of cyclin-dependent kinases 4 and 6 (CDK 4 and CDK6). Continue reading
Head-to-head trials comparing Verzenio to Ibrance have not been conducted. However, one is currently underway with results expected in 2023. 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 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, it is unknown if there is an 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 2023. 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.
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.
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 by improving rates of invasive disease-free survival (IDFS). 4-year data from the monarchE trial showed 85.5% of patients remained recurrence-free after 4 years compared to 78.6% of those assigned ET alone (an absolute difference of 6.9%). Verzenio plus ET reduces the risk of recurrence by 35% compared to ET alone. Continue reading
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Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Verzenio only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
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