Verzenios 100 mg film-coated tablets

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

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

• if you are allergic to abemaciclib or any of the other ingredients of this medicine (listed in section 6).

Verzenios may:

• reduce the number of your white blood cells, and you may be at greater risk of getting an infection. Serious infections such as lung infections can be life-threatening;
• cause blood clots in the veins;
• cause severe or life-threatening inflammation of the lungs;
• affect the way your liver works;
• cause diarrhoea. At the first sign of diarrhoea, start treatment with antidiarrhoeal agents, such as loperamide. Drink plenty of fluids;
• cause blood clots in the arteries in patients also receiving hormone therapies.

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:

• medicines that may increase the concentration of Verzenios in the blood:
  • Clarithromycin (antibiotic used to treat bacterial infections)
  • Itraconazole, ketoconazole, posaconazole, voriconazole (used to treat fungal infections)
  • Lopinavir/ritonavir (used to treat HIV/AIDS)
  • Digoxin (used to treat heart disorders)
  • Dabigatran etexilate (used to reduce the risk of stroke and blood clots)
• medicines that may reduce the effectiveness of Verzenios:
  • Carbamazepine (anti-epileptic used to treat seizures or fits)
  • Rifampicin, used to treat tuberculosis (TB)
  • Phenytoin (used to treat seizures)
  • St. John’s wort (a herbal product used to treat mild depression and anxiety)

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.

Pregnancy

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.

Breast-feeding

You should not breast-feed while taking Verzenios. It is not known if Verzenios passes into breast milk.

Fertility

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 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.

• The active substance is abemaciclib. Verzenios film-coated tablets come in different strengths:
  • Verzenios 50 mg film-coated tablet: each tablet contains 50 mg abemaciclib.
  • Verzenios 100 mg film-coated tablet: each tablet contains 100 mg abemaciclib.
  • Verzenios 150 mg film-coated tablet: each tablet contains 150 mg abemaciclib.
• The other ingredients in this medicine are:
  • Tablet core: colloidal hydrated silica, croscarmellose sodium, lactose monohydrate, microcrystalline cellulose, sodium stearyl fumarate (see section 2 under ‘Verzenios contains sodium’ for further information).
  • Film-coating: titanium dioxide (E171), talc (E553b), polyvinyl alcohol (E1203), macrogol 3350 (E1521), iron oxide yellow (E172) [50 mg and 150 mg tablets only], iron oxide red (E172) [50 mg tablets only].

• Verzenios 50 mg film-coated tablets are beige, oval tablets debossed with “Lilly” on one side and “50” on the other.
• Verzenios 100 mg film-coated tablets are white, oval tablets debossed with “Lilly” on one side and “100” on the other.
• Verzenios 150 mg film-coated tablets are yellow, oval tablets debossed with “Lilly” on one side and “150” on the other.

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: