The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PLGB 14895/0265.
Verzenios® 50 mg film-coated tablets
Verzenios® 100 mg film-coated tablets
Verzenios® 150 mg film-coated tablets
1. What Verzenios is and what it is used for
2. What you need to know before you take Verzenios
3. How to take Verzenios
4. Possible side effects
5. How to store Verzenios
6. Contents of the pack and other information
Verzenios is a cancer medicine containing the active substance abemaciclib.
Abemaciclib blocks the effects of proteins called cyclin-dependent kinase 4 and 6. These proteins are abnormally active in some cancer cells and make them grow out of control. Blocking the action of these proteins can slow down growth of cancer cells, shrink the tumour and delay progression of the cancer.
Verzenios is used to treat certain types of breast cancer (hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-)) which have:
See section 4 “Possible side effects”, and talk to your doctor if you have any symptoms.
You will have regular blood tests before and during treatment to check whether Verzenios affects your blood (white blood cells, red blood cells, platelets) or the concentration in your blood of enzymes from your liver.
Verzenios is not to be used in children and adolescents under 18 years of age.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
In particular, tell you doctor or pharmacist before taking Verzenios if you are taking the following:
Avoid grapefruit or grapefruit juice while you are taking the medicine as they may increase the concentration of Verzenios in the blood.
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
You should not use Verzenios if you are pregnant.
You should avoid becoming pregnant while taking Verzenios.
If you are able to have children, you should use adequate contraceptive methods (e.g., double –barrier contraception such as condom and diaphragm) during therapy and for at least 3 weeks after completing therapy. Discuss contraception with your doctor if there is any possibility that you may become pregnant.
You must tell your doctor if you become pregnant.
You should not breast-feed while taking Verzenios. It is not known if Verzenios passes into breast milk.
Verzenios may decrease fertility in men. Talk to your doctor to seek advice about fertility prior to treatment.
Tiredness and dizziness are very common side effects. If you feel unusually tired or dizzy, take special care when driving or using machines.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
When given together with endocrine therapy to treat your breast cancer, the recommended dose of Verzenios is 150 mg taken by mouth twice daily.
If you get certain side effects while you are taking Verzenios your doctor may lower your dose or stop treatment temporarily or permanently.
Take Verzenios twice daily, at about the same time every day, preferably in the morning and evening, so there is enough medicine in your body all the time.
You can take the tablets either with or without food, just avoid grapefruit and grapefruit juice (see section 2 “Verzenios with food and drink”).
Swallow the tablet whole with a glass of water. Do not chew, crush or split the tablets before swallowing.
Take Verzenios continuously for as long as your doctor tells you to. If you take Verzenios for early breast cancer treatment, you should take it for up to 2 years.
If you take too many tablets, or if someone else takes your medicine, contact a doctor or hospital for advice. Show the Verzenios carton and this leaflet. Medical treatment may be necessary.
If you vomit after taking the dose or forget a dose, take your next dose at your usual time. Do not take a double dose to make up for the forgotten or vomited dose.
Do not stop taking Verzenios unless your doctor tells you to.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side-effects, although not everybody gets them. Contact your doctor immediately for any of the following:
Refer to section 2 for more information on any of the possible effects listed above.
Other side effects with Verzenios may include:
Very common side effects (may affect more than 1 in 10 people)
Common side effects (may affect up to 1 in 10 people)
Uncommon side effects (may affect up to 1 in 100 people)
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme, website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and carton after “EXP”. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not use this medicine if you notice that the pack is damaged or shows signs of tampering.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
Verzenios is available in calendar blister packs of 14, 28, 42, 56, 70 and 168 film-coated tablets and perforated unit dose blisters of 28 x 1 film-coated tablets.
Not all the pack sizes may be marketed.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
This leaflet was last revised in December 2023