Generic Name: abemaciclib
Dosage Form: Tablets
Date of Approval: September 28, 2017
Company: Eli Lilly and Company
Treatment for: Breast Cancer
Verzenio Patient Information
Read this Patient Information before you start treatment and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment.
Verzenio may cause serious side effects, including:
- Diarrhea. Diarrhea is common with Verzenio 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 treatment. If you develop diarrhea during treatment, your healthcare provider may tell you to temporarily stop taking Verzenio, stop your treatment, or decrease your dose.
- If you have any loose stools, right away tell your healthcare provider, start taking an antidiarrheal medicine (such as loperamide), and drink more fluids.
- Low white blood cell counts (neutropenia). Low white blood cell counts are common during treatment 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, your healthcare provider may tell you to temporarily stop taking Verzenio, 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.
- Liver problems. Verzenio can cause serious liver problems. Your healthcare provider should do blood tests to check your liver before and during treatment. If you develop liver problems during treatment, 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. Verzenio may cause serious blood clots that have led to death. 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
See Verzenio side effects for more information about side effects.
What is Verzenio?
Verzenio is a prescription medicine used:
- in combination with fulvestrant to treat women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer or breast cancer that has spread to other parts of the body (metastatic), whose disease has progressed after hormonal therapy.
- alone to treat adults with HR-positive, HER2-negative advanced breast cancer or metastatic breast cancer whose disease has progressed after hormonal therapy and prior chemotherapy.
It is not known if this medicine is safe and effective in children.
Before taking Verzenio
Before taking Verzenio, tell your healthcare provider about all of your medical conditions, including if you:
- have fever, chills, or any other signs of an infection.
- have liver or kidney problems.
- are pregnant or plan to become pregnant. Verzenio can harm your unborn baby.
- If you are able to become pregnant, your healthcare provider may do a pregnancy test before you start treatment.
- Females who are able to become pregnant should use effective birth control during treatment, and for at least three weeks after the last dose.
- Talk to your healthcare provider about birth control methods to prevent pregnancy during treatment. If you become pregnant or think you may be pregnant, tell your healthcare provider right away.
- are breastfeeding or plan to breastfeed. It is not known if this medicine passes into your breast milk. Do not breastfeed during treatment, and for at least three weeks after the last dose.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Certain other medicines can affect how Verzenio works and cause 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, such as antibiotics, or medicines that treat fungus or HIV/AIDS, because your dose of Verzenio might need to be changed.
How should I take Verzenio?
- Take Verzenio exactly as your healthcare provider tells you.
- Your healthcare provider may change your dose if needed. Do not stop taking Verzenio or change the dose without talking to your healthcare provider.
- Verzenio tablets may be taken with or without food.
- Swallow the tablets whole. Do not chew, crush, or split the tablets before swallowing. Do not take the tablets if they are broken, cracked, or damaged.
- Take the tablets at about the same time every day.
- If you vomit or miss a dose, take your next dose at your regular time. Do not take two doses at the same time to make up for the missed dose.
- If you take too much or overdose, call your healthcare provider or go to the nearest hospital emergency room right away.
What should I avoid during treatment?
- Avoid taking ketoconazole during treatment. Tell your healthcare provider if you take a medicine that contains ketoconazole.
- Avoid grapefruit and products that contain grapefruit during treatment. Grapefruit may increase the amount of Verzenio in your blood.
Verzenio side effects
Verzenio may cause serious side effects, including:
- See “Important information.
The most common side effects include:
- low red blood cell counts (anemia)
- decreased appetite
- abdominal pain
- low white blood cell counts (leukopenia)
- low platelet count (thrombocytopenia)
Verzenio 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. 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.
How should I store Verzenio?
- Store the tablets at room temperature between 68°F to 77°F (20°C to 25°C).
Keep all medicines out of the reach of children and pets.
General information about the safe and effective use of Verzenio
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use this medicine for a condition for which it was not prescribed. Do not give it to other people, even if they have the same symptoms you have. It may harm them. You can ask your pharmacist or healthcare provider for more information that is written for health professionals.
What are the ingredients in Verzenio?
Active ingredient:strong> abemaciclib.
Inactive ingredients: microcrystalline cellulose 102, microcrystalline cellulose 101, lactose monohydrate, croscarmellose sodium, sodium stearyl fumarate, silicon dioxide.
Color mixture ingredients: polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, iron oxide yellow, and iron oxide red.