VERZENIOS 100 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Verzenios 50mg film-coated tablets

Verzenios 100mg film-coated tablets

Verzenios 150mg film-coated tablets

abemaciclib

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• 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.

Contents of the pack

1. What is Verzenios and what is it used for
2. What you need to know before you take Verzenios
3. How to take Verzenios
4. Possible side effects
5. Storage of Verzenios
6. Contents of the pack and other information

1. What is Verzenios and what is it used for

Verzenios is a medicine used to treat cancer that contains the active substance abemaciclib.

Abemaciclib blocks the effects of certain proteins called cyclin-dependent kinases 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 the growth of cancer cells, reduce the tumor, and delay the progression of cancer.

Verzenios is used to treat certain types of breast cancer (positive for the hormone receptor (HR+) and negative for the human epidermal growth factor receptor 2 (HER2-)) that:

• have spread to the lymph nodes in the armpit, without detectable spread to other parts of the body, have been surgically removed, and have certain characteristics that increase the risk of the cancer coming back. The treatment is given in combination with hormone therapy, such as aromatase inhibitors or tamoxifen, to prevent the cancer from coming back after surgery (treatment after surgery is called adjuvant therapy)
• have spread beyond the original tumor and/or to other organs. It is given together with hormone therapies, such as aromatase inhibitors or fulvestrant.

2. What you need to know before you take 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 may:

• reduce the number of your white blood cells, and you may have a higher risk of getting an infection. Severe infections, such as pneumonia, can be life-threatening;
• cause blood clots in the veins;
• cause severe or life-threatening inflammation of the lungs;
• affect how your liver works;
• cause diarrhea. At the first sign of diarrhea, start treatment with anti-diarrheal agents such as loperamide. Drink plenty of fluids;
• cause blood clots in the arteries in patients who are also receiving hormone therapies.

See section 4 “Possible side effects”, and tell your doctor if you have any symptoms.

What your doctor will check before and during your treatment

You will have regular blood tests before and during treatment to check if Verzenios is affecting your blood (white blood cells, red blood cells, and platelets) or the concentration of liver enzymes in your blood.

Children and adolescents

Verzenios should not be used in children and adolescents under 18 years of age.

Other medicines and Verzenios

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

In particular, tell your doctor or pharmacist before taking Verzenios if you are taking any of the following:

• medicines that may increase the concentration of Verzenios in the blood:
• • Clarithromycin(an 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 conditions)
  • Dabigatran etexilate(used to reduce the risk of stroke and blood clots)
• medicines that may reduce the effectiveness of Verzenios:
• • Carbamazepine(an antiepileptic used to treat seizures or fits)
  • Rifampicin(used to treat tuberculosis (TB))
  • Phenytoin(used to treat seizures)
  • St. John's Wort(a herbal medicine used to treat mild depression and anxiety)

Verzenios with food and drink

Avoid grapefruit or grapefruit juice while taking this medicine, as it may increase the concentration of Verzenios in the blood.

Pregnancy, breastfeeding, and fertility

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

Do not take Verzenios if you are pregnant.

Avoid becoming pregnant while taking Verzenios.

If you are of childbearing age, you should use adequate contraceptive measures (such as double-barrier contraception like condoms and diaphragms) during treatment and for at least 3 weeks after finishing treatment. Consult your doctor about the use of contraceptive methods if there is any possibility that you may become pregnant.

Tell your doctor if you become pregnant.

Breastfeeding

Do not breastfeed while taking Verzenios. It is not known if Verzenios passes into breast milk.

Fertility

Verzenios may reduce fertility in men. Talk to your doctor for advice on fertility before treatment.

Driving and using machines

Fatigue and dizziness are very common side effects. If you feel exceptionally tired or dizzy, be extra careful when driving or using machines.

Verzenios contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Verzenios contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet; this is essentially “sodium-free”.

3. How to take Verzenios

Recommended dose

Follow exactly the instructions of your doctor or pharmacist for taking this medicine. If you are unsure, ask your doctor or pharmacist again.

The recommended dose of Verzenios when given with hormone therapy to treat your breast cancer is 150 mg by mouth twice a day.

If you experience certain side effects while taking Verzenios, your doctor may reduce your dose or interrupt treatment, temporarily or permanently.

When and how to take Verzenios

Take Verzenios twice a day, approximately at the same time every day, preferably in the morning and evening, to have the right amount of medicine in your body during treatment.

You can take the tablets 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 break the tablets before swallowing.

How long to take Verzenios

Take Verzenios continuously for the time your doctor tells you. If you are taking Verzenios for early breast cancer, you should take it for up to 2 years.

If you take more Verzenios than you should

If you take too many tablets, or if someone else takes your medicine, contact your doctor or go to a hospital. Show the Verzenios packaging and this leaflet. You may need medical treatment.

If you forget to take Verzenios

If you vomit after taking the dose or if you forget to take a dose, take the next dose at the usual scheduled time. Do not take a double dose to make up for the forgotten or vomited dose.

If you stop taking Verzenios

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.

4. 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:

• Symptoms such as chills or fever. These can be a sign of a low white blood cell count (which can affect more than 1 in 10 people) and should be treated immediately. If you have a cough, fever, or difficulty breathing and chest pain, it can be a sign of pneumonia. Severe or life-threatening infections are uncommon (may affect up to 1 in 100 people).
• Painful inflammation of the leg, chest pain, difficulty breathing, rapid breathing, or rapid heartbeat, as these can be signs of blood clots in the vein (which can affect more than 1 in 10 people).
• Diarrhea (which can affect more than 1 in 10 people).

See section 2 for more information on any of the possible side effects listed above.

Other side effects of Verzenios may include:

Very common side effects (may affect more than 1 in 10 people)

• Infections
• Reduced number of white blood cells, red blood cells, and platelets
• Nausea (feeling sick), vomiting
• Inflammation or ulcers in the mouth
• Decreased appetite
• Headache
• Altered sense of taste
• Hair loss
• Fatigue
• Dizziness
• Itching
• Rash
• Liver changes in blood tests

Common side effects (may affect up to 1 in 10 people)

• Tearful eyes
• Muscle weakness
• Dry skin
• Inflammation of the lungs that causes shortness of breath, cough, and increased temperature
• Indigestion or stomach pain
• Nail changes, such as breaking or brittle nails

Uncommon side effects (may affect up to 1 in 100 people)

• Low white blood cell count with fever
• Seeing flashes of light or floaters in the vision

Rare side effects (may affect up to 1 in 1,000 people)

• A skin reaction that causes red spots or patches on the skin, which can look like a target or a “bull's eye” with a dark red center surrounded by lighter red rings (erythema multiforme).

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Surveillance System for Human Use: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Verzenios

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 is the last day of the month shown.

This medicine does not require any special storage conditions.

Do not take this medicine if you notice any damage to the packaging or if it shows any signs of tampering.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Verzenios

• The active substance is abemaciclib. Verzenios film-coated tablets are available in different strengths:

• Verzenios 50 mg film-coated tablets: each tablet contains 50 mg of abemaciclib.
• Verzenios 100 mg film-coated tablets: each tablet contains 100 mg of abemaciclib.
• Verzenios 150 mg film-coated tablets: each tablet contains 150 mg of abemaciclib.

• The other ingredients in this medicine are:

• Tablet core: hydrated colloidal silica, sodium croscarmellose, lactose monohydrate, microcrystalline cellulose, sodium stearyl fumarate (for more information see section 2 “Verzenios contains sodium”).
• Film coating: titanium dioxide (E171), talc (E553b), polyvinyl alcohol (E1203), macrogol 3350 (E1521), yellow iron oxide (E172) [only 50 mg and 150 mg tablets], red iron oxide (E172) [only 50 mg tablets].

Appearance and packaging

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

Verzenios is available in calendar packs for the blister of 14, 28, 42, 56, 70, and 168 film-coated tablets and single-dose precut blisters of 28 x 1 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Eli Lilly Nederland B.V., Papendorpseweg 83, 3528BJ Utrecht, Netherlands

Manufacturer

Lilly S.A., Avda. de la Industria 30, 28108 Alcobendas, Madrid, Spain

You can ask for more information about this medicine from your local representative of the Marketing Authorisation Holder:

Date of last revision of this leaflet:

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu/, and on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).