Abemaciclib is the generic name for the brand name drug Verzenio. In some cases, healthcare professionals may use the brand name Verzenio when referring to the generic name of the drug abemaciclib.
Updated results from a large study indicate that the drug abemaciclib (Verzenio) may be a new treatment option for people with the most common type of breast cancer.
Almost 90% of breast cancer cases are diagnosed early. Most of them are classified as positive for hormone receptors (HR) and negative for human epidermal growth factor receptor 2 (HER2). Although the therapies available for this type of breast cancer are very effective, there are patients who are at high risk of the cancer recurring (coming back) in the years after treatment.
New results from the clinical study (called monarchE) indicate that, for people at high risk of recurrence, adding abemaciclib to the treatment regimen may decrease the chance that the cancer will come back.
Study participants who received abemaciclib for 2 years along with hormone therapy after surgery (adjuvant or standard) were about 30% less likely to have the cancer become invasive Exit Report, compared to participants who received only the standard adjuvant hormone therapy.
Composition
Verzenios 50 mg film-coated tablets
Each film-coated tablet contains 50 mg of abemaciclib.
Excipients with known effect Each film-coated tablet contains 14 mg of lactose monohydrate.
Verzenios 100 mg film-coated tablets
Each film-coated tablet contains 100 mg of abemaciclib.
Excipients with known effect Each film-coated tablet contains 28 mg of lactose monohydrate.
Verzenios 150 mg film-coated tablets
Each film-coated tablet contains 150 mg of abemaciclib.
Excipients with known effect Each film-coated tablet contains 42 mg of lactose monohydrate.
What Abemeciclib is used for
Advanced or metastatic breast cancer
Clinical data
Therapeutic indications
Verzenios is indicated for the treatment of women with locally advanced or metastatic breast cancer, hormone receptor (HR) positive and human epidermal growth factor receptor 2 (HER2) negative, in combination with an aromatase inhibitor or fulvestrant as initial hormone therapy or in women who have received prior hormone therapy. In pre or perimenopausal women, hormone therapy should be combined with a luteinizing hormone releasing hormone (LHRH) agonist.
How abemaciclib is given
- One tablet by mouth twice a day at around the same time every day.
- If you miss a dose, take the next dose at the next scheduled time.
- Swallow the tablets whole. Do not chew, crush, or divide the tablet before swallowing it.
- It can be taken with or without food.
- Avoid grapefruit during treatment with abemaciclib.
- The amount of abemaciclib that you will receive depends on many factors, including your general health and other health problems, as well as the type of cancer or disease you have. Your doctor will determine the exact dose for you and the drug administration schedule.
Special warnings and precautions for use
Neutropenia
Neutropenia was reported in patients receiving abemaciclib. A dose modification is recommended for patients who develop Grade 3 or 4 neutropenia. Fatal cases occurred in <1% of patients. Patients should be instructed to report any episode of fever to their healthcare professional.
Infections / infestations
A higher proportion of infections were reported in patients receiving abemaciclib with hormone therapy than in patients receiving placebo with hormone therapy. 7 lung infection was reported in patients receiving abemaciclib without concomitant neutropenia. Fatal cases occurred in <1% of patients. Patients should be closely monitored for signs and symptoms of infection and appropriate medical treatment should be administered.
Venous thromboembolism
Venous thromboembolism was reported in 5.3% of patients treated with abemaciclib with fulvestrant or aromatase inhibitors, compared to 0.8% of patients treated with placebo with fulvestrant or aromatase inhibitors. Patients should be closely monitored for signs and symptoms of deep venous thromboembolism and pulmonary embolism and appropriate medical treatment should be administered.
Increased aminotransferases
Increases in ALT and AST were reported in patients receiving abemaciclib. Dose modification or suspension of abemaciclib may be required depending on the level of elevation of ALT or AST.
Diarrhea
The most common adverse reaction is diarrhea. Across clinical trials, the median time to first diarrhea was approximately 6 to 8 days, and the median duration of diarrhea was 9 to 12 days (Grade 2) and 6 to 8 days ( 3rd grade). Diarrhea can be associated with dehydration. Patients should begin treatment with an antidiarrheal agent such as loperamide at the first sign of loose stools, increase oral fluids, and notify their healthcare professionals. A dose modification is recommended for patients who develop ≥ Grade 2 diarrhea.
Interstitial Pulmonary Disease (ILD) / Pneumonitis
Cases of interstitial lung disease (ILD) / pneumonitis have been reported in patients receiving abemaciclib. Patients should be monitored for symptoms indicative of PID / pneumonitis and given appropriate medical treatment. Based on the degree of PID / pneumonitis, a dose adjustment of abemaciclib may be required. Permanently discontinue abemaciclib in patients with Grade 3 or 4 ILD / pneumonitis.
Concomitant treatment with inducers of CYP3A4
Concomitant use of CYP3A4 inducers should be avoided due to the risk of diminishing the efficacy of abemaciclib.
Visceral crisis
There are no data on the efficacy and safety of abemaciclib in patients with visceral crisis.
Lactose
Patients with hereditary galactose intolerance, total lactase deficiency, or glucose or galactose absorption problems should not take this medicine.
Sodium
This medicine contains less than 1 mmol (23 mg) sodium per tablet; this is essentially “sodium-free”.
Precautions
- Before starting abemaciclib treatment, make sure you tell your doctor about any other medications you are taking (including prescription, over-the-counter, vitamins, herbal remedies, etc.). Do not take aspirin or products that contain aspirin unless specifically allowed by your doctor.
- Do not receive any type of immunization or vaccination without your doctor’s approval while taking abemaciclib.
- Avoid getting pregnant while taking abemaciclib. If you are pregnant or think you might be, tell your healthcare professional before starting treatment. Abemaciclib can be dangerous to the fetus. Pregnant women or women who become pregnant during treatment should be informed about the possible risk to the fetus. If a woman becomes pregnant while taking abemaciclib, the drug should be stopped immediately and the woman should receive appropriate counseling.
- For both men and women: Use birth control and avoid conception (getting pregnant) while taking abemaciclib. Barrier methods of contraception, such as condoms, are recommended for up to 3 weeks after the last dose of abemaciclib.
- Do not breastfeed when taking abemaciclib or for 3 weeks after stopping the medicine.
Practical advice on personal care
- Take antidiarrheal medications strictly according to the instructions of your healthcare professional. You should start taking anti-diarrhea medicine at the first sign of loose stools.
- Drink a minimum of 2 to 3 quarts (8 to 12 glasses) of liquid daily, unless otherwise directed.
- You may be at risk of infection, so try to avoid crowds or people with colds, and tell your healthcare provider immediately if you have a fever or see other signs of infection.
- Wash your hands frequently.
- To minimize the chance of bleeding, use an electric razor and a soft-bristle toothbrush.
- To reduce nausea, take antiemetic medications according to your doctor’s instructions and eat small portions of food frequently.
- Eat foods that can help control diarrhea (see Managing Chemotherapy Side Effects – Diarrhea).
- In general, the consumption of alcoholic beverages should be minimized or completely avoided. You should talk about this with your doctor.
- Get plenty of rest.
- Maintain good nutrition.
- As much as possible, stay active. It is recommended that you do light exercise, such as taking a walk every day.
- If you experience symptoms or side effects, be sure to discuss them with members of your health care team. They can prescribe medications and / or offer other tips that are effective in managing these types of problems.