Abemaciclib

Generic name: Abemaciclib
Brand names: Verzenio
Dosage form: oral tablet (100 mg; 150 mg; 200 mg; 50 mg)
Drug class: CDK 4/6 inhibitors

Usage of Abemaciclib

Abemaciclib belongs to a class of medications called kinase inhibitors. Abemaciclib works by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps slow or stop the spread of cancer cells.

Abemaciclib is used in combination with an aromatase inhibitor such as anastrozole (Arimidex), exemestane (Aromasin), or letrozole (Femara) to treat a certain type of hormone receptor-positive, early breast cancer.

Abemaciclib is also used along with fulvestrant (Faslodex) to treat a certain type of hormone receptor-positive, advanced breast cancer (breast cancer that depends on hormones such as estrogen to grow) or breast cancer that has spread to other parts of the body after treatment with an antiestrogen medication such as tamoxifen.

Abemaciclib is also used along with anastrozole (Arimidex), exemestane (Aromasin), or letrozole (Femara) as a first treatment of hormone receptor-positive, advanced breast cancer or breast cancer that has spread to other parts of the body.

Abemaciclib is also used alone to treat a certain type of hormone receptor-positive, advanced breast cancer or breast cancer that has spread to other parts of the body in people who have already been treated with an antiestrogen medication and chemotherapy.

Abemaciclib side effects

Get emergency medical help if you have signs of an allergic reaction to abemaciclib: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Abemaciclib may cause serious side effects. Call your doctor at once if you have:

  • severe or ongoing diarrhea;
  • signs of infection - fever, chills, sore throat, body aches, unusual tiredness, loss of appetite, bruising or bleeding;
  • liver problems - loss of appetite, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • 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 - sudden chest pain, wheezing, dry cough or hack, feeling short of breath; or
  • signs of a blood clot deep in the body or in the lung - chest pain, sudden cough or shortness of breath, dizziness, coughing up blood, or pain, swelling, or warmth in your arms or legs.

    • Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

    Common abemaciclib side effects may include:

  • diarrhea, nausea, vomiting, stomach pain;
  • loss of appetite;
  • hair loss;
  • infections;
  • feeling tired;
  • headache; or
  • 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.

    Before taking Abemaciclib

    Tell your doctor and pharmacist if you are allergic to abemaciclib, any other medications, or any of the ingredients in abemaciclib tablets.

    To make sure abemaciclib is safe for you, tell your doctor if you have ever had:

  • a fever, chills, or other signs of infection;
  • lung or breathing problems;
  • blood clots; or
  • liver or kidney disease.

    • Abemaciclib may harm an unborn baby. You may need a pregnancy test to make sure you are not pregnant. Use effective birth control while using abemaciclib and for at least 3 weeks after your last dose. Tell your doctor right away if you become pregnant.

    It may be harder for you to get a woman pregnant while you are using abemaciclib.

    You should not breastfeed while using this medicine and for at least 3 weeks after your last dose.

    Relate drugs

    How to use Abemaciclib

    Usual Adult Dose of Abemaciclib for Breast Cancer:

    IN COMBINATION WITH FULVESTRANT OR AN AROMATASE INHIBITOR: 150 mg orally 2 times a day MONOTHERAPY: 200 mg orally 2 times a day Duration of Therapy: Until disease progression or unacceptable toxicity Comments: -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. Uses: -In combination with an aromatase inhibitor as initial endocrine-based therapy for postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer -In combination with fulvestrant for women 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 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

    Warnings

    Abemaciclib can cause 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).

    Abemaciclib can cause blood clots, liver problems, and even serious or 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.

    What other drugs will affect Abemaciclib

    Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective.

    Tell your doctor about all your other medicines, especially:

  • ketoconazole.

    • This list is not complete. Other drugs may affect abemaciclib, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

    Popular FAQ

    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

    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

    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

    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 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

    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

    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

    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 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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