Important Safety Information
Verzenio may cause serious side effects, including:
Diarrhea. Diarrhea is common with Verzenio and may sometimes be severe. Diarrhea may cause you to develop dehydration or infection. The most common time to develop diarrhea is during the first month of Verzenio treatment. Your doctor may stop your treatment, lower your dose, or tell you to wait to begin your treatment cycle if you have diarrhea.
- At the first sign of loose stools, tell your doctor. You may be advised to 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 when taking Verzenio and may cause serious infections that can lead to death. Your doctor should check your white blood cell counts before and during treatment.
If you develop low white blood cell counts during treatment with Verzenio, your doctor may stop your treatment, decrease your dose, or may tell you to wait to begin your treatment cycle. Tell your doctor right away if you have signs and symptoms of low white blood cell counts or infections, such as fever and chills.
Liver problems. Your doctor should do blood tests before and during treatment to check your liver. Your doctor may stop your treatment, decrease your dose, or may tell you to wait to begin your treatment cycle if you develop liver problems. Tell your doctor right away if you have any of the following:
- 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. Talk to your doctor if you have the following signs and symptoms of a blood clot:
- Pain or swelling in your arms or legs
- Shortness of breath
- Chest pain
- Fast breathing
- Fast heart rate
Verzenio can harm your unborn baby. If you are able to become pregnant, you should use effective birth control during treatment with Verzenio and for at least 3 weeks after the last dose of Verzenio. Verzenio may affect the ability of males to father a child.
What are the possible side effects of Verzenio?
The most common side effects of Verzenio include: nausea, infections, decreased appetite, headache, abdominal pain, tiredness and vomiting.
The most common changes to blood tests were low red blood cell count (anemia), low white blood cell counts (leukopenia) and low platelet count (thrombocytopenia).
You are encouraged to report negative side effects of prescription drugs to the Food and Drug Administration (FDA). Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
What should I tell my doctor before taking Verzenio?
Tell your doctor if you:
- are pregnant or plan to become pregnant. If you become pregnant during your treatment, discuss this with your doctor.
- are breastfeeding or plan to breastfeed. It is not known if Verzenio passes into your breast milk. Do not breastfeed during treatment with Verzenio and for at least 3 weeks after your last dose. You and your doctor should decide if you will take Verzenio or breastfeed. You should not do both.
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Verzenio and certain other medicines can affect each other, causing serious side effects and may require you to change your dose. Especially tell your doctor if you take a medicine that contains ketoconazole. Avoid grapefruit products while taking Verzenio. Grapefruit may increase the amount of Verzenio in your blood.
Verzenio is available by prescription only.
AL DTC ISI 02OCT2017