50 mg, 100 mg, and 150 mg film-coated tablets
abemaciclib
WHAT VERZENIOS IS AND WHAT IT IS USED FOR
Verzenios is a cancer medicine that contains the active substance abemaciclib.
Abemaciclib blocks the action of the proteins called cyclin-dependent kinase 4 and 6. These proteins are abnormally active in some cancer cells and can cause the cancer cells to grow uncontrollably. By blocking these proteins, you can slow the growth of cancer cells, shrink the size of the tumor and delay the development of cancer.
Verzenios is used to treat certain types of hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative ( HER2- ) breast cancer, where the breast cancer;
- has spread to lymph nodes in the armpits without further demonstrable spread to other parts of the body,
- is removed by surgery,
- and shows signs of increased risk of cancer returning.
- treatment is given together with hormonal treatment, such as aromatase inhibitors or tamoxifen, to prevent cancer from returning after surgery (treatment after surgery is called adjuvant treatment)
- has spread beyond the original tumor and/or to other organs. It is given in combination with hormone treatments, e.g. aromatase inhibitor or fulvestrant.
BEFORE USING VERZENIOS
Do not take Verzenios:
- if you are allergic to abemaciclib or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Verzenios can:
- reduce the number of white blood cells, which can lead to a higher risk of getting an infection. Serious infections, e.g. pneumonia, can be life-threatening.
- cause blood clots in the veins;
- cause severe or life-threatening pneumonia;
- affect liver function;
- cause diarrhea. Start treatment with diarrhea medicine, e.g. loperamide, already at the first signs of diarrhea. Drink a lot.
See section 4 “Possible side effects” and talk to your doctor if you get any symptoms.
Checks are done before and during treatment
Before and during treatment, blood samples are taken at regular intervals to see if Verzenios affects your blood (white and red blood cells and platelets ) and to check the number of liver enzymes in the blood.
Children and young people
Verzenios should not be used in children and adolescents under 18 years of age.
Use of other medicines
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
It is especially important that, before taking Verzenios, you tell your doctor or pharmacist if you are taking the following:
- medicines that can increase the concentration of Verzenios in the blood:
- clarithromycin ( antibiotic to treat bacterial infections)
- itraconazole, ketoconazole , posaconazole, voriconazole (used to treat fungal infections)
- lopinavir/ritonavir (used to treat HIV/AIDS)
- digoxin (to treat heart disease)
- dabigatran etexilate (to reduce the risk of stroke and blood clots).
- medicines that can reduce the effect of Verzenio:
- carbamazepine (antiepileptics for the treatment of seizures)
- rifampicin (for the treatment of tuberculosis )
- phenytoin (to treat seizures)
- St. John’s wort (herbal medicine for treating mild depression and anxiety).
Verzenios with food and drink
Avoid grapefruit and grapefruit juice while taking this medicine because they can increase the concentration of Verzenios in the blood.
Pregnancy, breastfeeding, and fertility
Discuss birth control with the doctor if there is a possibility that you could become pregnant. 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.
Pregnancy
You should not use Verzenios if you are pregnant.
You should avoid becoming pregnant while taking Verzenios.
If you can become pregnant, you must use suitable contraception (eg double barrier in the form of condoms and pessaries ) during treatment and for at least 3 weeks after the end of treatment.
If you become pregnant, you must tell the doctor.
Breast-feeding
You should not breastfeed while taking Verzenios. It is not known whether Verzenios passes into breast milk.
Fertility
Verzenios may reduce fertility in men.
Driving ability and use of machinery
Fatigue and dizziness are very common side effects. If you feel unusually tired or dizzy, take extra care when driving a vehicle or using machinery.
Important information about any ingredient(s) in Verzenios
Verzenios contains lactose
If you have an intolerance to some sugars, you should contact your doctor before taking this medicine.
Verzenios contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per tablet, i.e. is almost “sodium-free”.
HOW TO USE VERZENIOS
Recommended dose
Always take this medicine as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.
When Verzenios is given in combination with hormonal therapy for breast cancer, the recommended dose is one Verzenios 150 mg by mouth twice daily.
If you experience certain side effects from Verzenios, the doctor may lower the dose or interrupts the treatment temporarily or permanently.
When and how to take Verzenios
Take Verzenios twice daily, at about the same time each day. Preferably take it morning and evening so that you have sufficient amounts of medication in your body throughout the day.
You can take the tablets with or without food, but be sure to avoid grapefruit and grapefruit juice (see section 2 “Verzenios with food and drink”).
Swallow the tablet whole with a glass of water. The tablets must not be chewed, crushed, or split before swallowing.
How long to take Verzenios
Take Verzenios as long as your doctor tells you to. If you take Verzenios as an adjuvant treatment, you must take it for up to 2 years.
If you use too much Verzenios
If you take too many tablets, or if another person takes your tablets, contact a doctor or hospital for advice. Show the Verzenios package and this leaflet. Medical treatment may be necessary.
If you forget to take Verzenios
If you vomit after taking a dose or forget to take a dose, take the next dose at the usual time. Do not take a double dose to make up for the forgotten or vomited dose.
If you stop using Verzenios
Do not stop taking Verzenios unless your doctor tells you to.
If you have any further questions about this medicine, ask your doctor or pharmacist.
POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them. Contact your doctor immediately if you experience any of the following:
- Chills or fever. It may indicate a low white blood cell count (which may affect more than 1 in 10 people) and should be treated immediately. If you have a cough, fever or difficulty breathing, or chest pain, this could be a sign of a chest infection. Serious or life-threatening infections are less common (may affect up to 1 in 100 people).
- Painful swelling in a leg, chest pain, shortness of breath, rapid breathing, or rapid pulse. This may indicate blood clots in a vein (may affect up to 1 in 10 people).
- Diarrhea (may affect more than 1 in 10 people).
In section 2 there is more information about the possible side effects listed above. Other side effects of Verzenios can be:
Very common side effects (may affect more than 1 in 10 people)
- Infection you
- Decreased number of white blood cells, red blood cells, and platelets
- Nausea, vomiting
- Inflammation or soreness in the oral cavity
- Reduced appetite
- Headache
- Altered sense of taste
- Hair loss
- Fatigue
- Dizziness
- Itching
- Rash
- Abnormal liver values in blood tests
Common side effects (may affect up to 1 in 10 people)
- Watery eyes
- Muscle weakness
- Dry skin
- Pneumonia leads to shortness of breath, cough, and fever
- Indigestion or upset stomach
- Nail problems such as cracks or cracked nails
HOW TO STORE VERZENIOS
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the blister card and carton after “EXP”. The expiration date is the last day of the specified month.
No special storage instructions.
Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
PACKAGING CONTENTS AND OTHER INFORMATION
Contents declaration
The active substance is abemaciclib. Verzenio’s film-coated tablet is available in different strengths:
- Verzenios 50 mg film-coated tablets: each tablet contains 50 mg abemaciclib.
- Verzenios 100 mg film-coated tablets: each tablet contains 100 mg abemaciclib.
- Verzenios 150 mg film-coated tablets: each tablet contains 150 mg abemaciclib.
- Other ingredients are:
- Tablet core: colloidal hydrogenated silica gel, croscarmellose sodium, lactose monohydrate, microcrystalline cellulose, sodium stearyl fumarate
- Film coating: titanium dioxide (E171), talc (E553b), polyvinyl alcohol (E1203), macrogol 3350 (E1521), yellow iron oxide (E172) [only in the 50 mg and 150 mg tablets), red iron oxide (E172) [only in the 50 mg tablets ]
Appearance and package sizes of the medicine
- Verzenio 50 mg film-coated tablets are beige, oval tablets marked with “Lilly” on one side and “50” on the other.
- Verzenio 100 mg film-coated tablets are white, oval tablets marked with “Lilly” on one side and “100” on the other.
- Verzenio 150 mg film-coated tablets are yellow, oval tablets marked with “Lilly” on one side and “150” on the other.
Verzenios is available in calendar blisters of 14, 28, 42, 56, 70, and 168 film-coated tablets and perforated unit-dose blisters of 28 x 1 film-coated tablet.
Not all pack sizes may be marketed.
Lilly SA, Avda. de la Industria 30, 28108 Alcobendas, Madrid, Spain