Verzenio

The active ingredient in Verzenio is abemaciclib, which is a kinase inhibitor that specifically targets cyclin-dependent kinases 4 and 6 (CDK4 and CDK6). CDK 4/6 inhibitor proteins regulate cell development in both normal and cancerous cells. These proteins can become hyperactive in cancer cells, causing them to divide and proliferate uncontrollably. Verzenio, which inhibits CDK 4/6, decreases breast cancer cell proliferation. It can be used alone or together with medications like tamoxifen or an aromatase inhibitor (eg, anastrozole, exemestane, letrozole).

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide, before using Verzenio. However, the following is a synopsis of the general guidelines for the use of Verzenio:

• Verzenio is typically taken twice a day and can be taken with or without food.
• Swallow the pills whole, without crushing, chewing, or breaking. Do not take a tablet that is cracked, fractured, or damaged.
• If you vomit soon after taking Verzenio, don't take another dose. Take the next dose as scheduled.
• If you get loose stools (diarrhea) while using Verzenio, contact your doctor and start taking an antidiarrheal medication such as loperamide. Drink plenty of fluids to stay hydrated.
• Your blood will need to be examined frequently, and your cancer treatments may be postponed depending on the results.
• Verzenio is used until your breast cancer progresses despite treatment or the negative effects become unbearable.

The most common side effects of Verzenio seen in clinical trials include:

• Lower white blood cell count (neutropenia or leukopenia) and red blood cell count (anemia).
• Low platelet counts (thrombocytopenia).
• Nausea or vomiting.
• Signs of stress to the kidney or liver in blood tests.
• Hair loss (alopecia).
• Dry mouth.
• Abdominal pain.
• Headache.
• Diarrhea.
• Fatigue.
• Decreased appetite or complete loss of appetite.

Some individuals may experience serious side effects while using Verzenio. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Serious infections cause fever, chills, and fatigue.
• Severe or life-threatening inflammation of the lungs (interstitial lung disease) during treatment that can lead to death. Symptoms include coughing, shortness of breath, and chest pain.
• Symptoms of a blood clot include arm or leg pain or swelling, difficulty breathing, chest pain, and a rapid heartbeat.
• Allergic reaction to the medication, including hives, swelling of your face, tongue, or throat, and trouble breathing.

These are not all of the possible side effects of Verzenio. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Verzenio treatment, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including whether you have:

• Fever, chills, or other indications of infection.
• Lung or respiratory issues.
• A history of blood clots.
• Liver problems
• Kidney issues.
• Take any drugs, such as ketoconazole, clarithromycin, itraconazole, lopinavir/ritonavir, posaconazole, or voriconazole, since these may impact Verzenio levels.
• Are pregnant or planning to get pregnant.
• Are breastfeeding or planning to breastfeed.

There are no contraindications with Verzenio.

Verzenio (abemaciclib) is a targeted medication that inhibits the growth and spread of cancer cells in the body. In combination with endocrine therapy (tamoxifen or an aromatase inhibitor), it can be used to treat adults with HR-positive HER2-negative breast cancer, node-positive, early breast cancer at high risk of recurrence. It could also be utilized to treat advanced or metastatic HR+ (hormone receptor-positive) HER2- (human epidermal growth factor receptor 2-negative) breast cancer.

In early-stage breast cancer, Verzenio combined with hormone therapy showed a significant reduction in the risk of cancer recurrence after 2 years. In metastatic breast cancer, it helps increase your progression-free survival when compared to other treatments.

When Verzenio is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Ketoconazole is a strong CYP3A4 inhibitor, and the coadministration of Verzenio with strong CYP3A4 inhibitors should be avoided because they can increase Verzenio concentrations. Other medications that are strong CYP3A4 inhibitors include clarithromycin, itraconazole, lopinavir/ritonavir, posaconazole, and voriconazole.
• Grapefruit or grapefruit juice should also be avoided.

Typical dose for Verzenio:

When used with additional drugs (such as tamoxifen, fulvestrant, or an aromatase inhibitor), the typical starting dose is 150 mg administered orally twice a day.

If administered alone (in metastatic breast cancer when other therapies have failed), the typical starting dose is 200 mg administered orally twice a day.

If you have specific adverse effects, liver problems, or are taking medications that may interfere with Verzenio, your dose may be adjusted.

If you are using Verzenio with other medications and are a man or woman who has not gone through menopause, your doctor may additionally advise you to take a gonadotropin-releasing hormone (GnRH) agonist for ovarian suppression.

Store at room temperature and keep out of reach of children.

Eli Lilly is the pharmaceutical company that manufactures Verzenio.

There are no lower-cost generic versions available of Verzenio.

You should not stop Verzenio or change your dose without talking to your doctor first. Verzenio is a cancer medication, and quitting it without consulting them is dangerous and potentially harmful.

Verzenio may harm an unborn child. Before beginning Verzenio medication, your healthcare practitioner will perform a pregnancy test on females who can conceive. You should use effective birth control (contraception) while using Verzenio and for three weeks following the last dosage. If you become pregnant or suspect that you are pregnant while taking Verzenio, notify your healthcare professional immediately.

It is not advised to breastfeed while using this medicine and for at least 3 weeks after your last dose.