VERZENIOS 50 mg Film-Coated Tablets

Зміст інструкції

1. Verzenios 50 mg film-coated tablets, 100 mg film-coated tablets, 150 mg film-coated tablets
   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. How to store Verzenios
   6. Package contents and other information

Verzenios 50 mg film-coated tablets, 100 mg film-coated tablets, 150 mg film-coated tablets

abemaciclib

Read this leaflet carefully before you start taking this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

• 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

1. What is Verzenios and what is it used for

Verzenios is an anti-cancer medicine containing the active substance abemaciclib.
Abemaciclib blocks the effect of proteins called cyclin-dependent kinases 4 and 6. These proteins
are abnormally active in some cancer cells causing uncontrolled growth. Blocking the action of these proteins can slow the growth of cancer cells, reduce and delay
tumor progression.
Verzenios is used to treat some types of breast cancer (hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (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 some characteristics that increase the risk that the cancer will return. Treatment is given in combination with hormone therapy, such as aromatase inhibitors or tamoxifen, to prevent the cancer from returning 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 white blood cells, therefore you may be at greater risk of contracting an infection. Serious infections such as lung infections can be life-threatening;
• cause blood clots in the veins;
• cause a severe or life-threatening inflammation of the lungs;
• affect the function of the liver;
• cause diarrhoea. At the first sign of diarrhoea, start treatment with anti-diarrhoeal agents, such as loperamide. Drink plenty of fluids;
• cause blood clots in the arteries in patients who are also taking hormone therapy.

See section 4 "Possible side effects" and contact your doctor if you experience any symptoms.

What your doctor will check before and during treatment
You will undergo regular blood tests before and during treatment to check if Verzenios
affects your blood (white blood cells, red blood cells, platelets) or the concentration in your blood of
enzymes that come from the liver.

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 the
following:

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

Verzenios with food and drink
Grapefruit and grapefruit juice should be avoided during treatment with
this medicine as they may increase the concentrations of Verzenios in the blood.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, 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 of childbearing potential you should use adequate contraceptive methods (e.g., dual barrier contraception such as a condom together with a diaphragm) during therapy and for at least 3 weeks after
completion of therapy. Talk to your doctor about contraceptive measures if there is a possibility that
you may become pregnant.
You should inform your doctor if you become pregnant.
Breastfeeding
You should not breastfeed while taking Verzenios. It is not known whether Verzenios passes into breast milk.
Fertility
Verzenios may decrease 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 unusually tired or dizzy, be particularly careful when driving or using machines.

Verzenios contains lactose
If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking
this medicine.

Verzenios contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, that is to say it is essentially
“sodium-free”.

3. How to take Verzenios

Recommended dose
Take this medicine exactly as your doctor or pharmacist has told you. If you
have any doubts, ask your doctor or pharmacist.
When administered together with endocrine therapy for the treatment of breast cancer, the recommended dose of Verzenios is 150 mg taken orally twice a day.
If you experience any side effects while taking Verzenios, your doctor may reduce the dose
or interrupt treatment temporarily or permanently.

When and how to take Verzenios
Take Verzenios twice a day, approximately at the same time each day, preferably in the morning
and evening, to always have a sufficient amount of medicine in your body.
You can take the tablets with or without food, just avoid grapefruit and grapefruit juice (see
section 2 "Verzenios with food and beverages").
Swallow the tablet whole with a glass of water. Do not chew, break or divide the tablets
before swallowing.

For how long to take Verzenios
Take Verzenios continuously for the time indicated by your doctor. If you take Verzenios for the
treatment of early-stage breast cancer, you must take it for a maximum of 2 years.

If you take more Verzenios than you should
If you take too many tablets or if someone else takes your medicine, contact a doctor or a
hospital for information/advice. Show the Verzenios packaging and this leaflet.
Medical treatment may be necessary.

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

If you stop taking Verzenios
Do not stop treatment with Verzenios unless your doctor tells you to.
If you have any questions about 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.
Seek medical attention immediately in any of the following cases:

• Symptoms such as chills or fever. These could be signs of a low number of white blood cells (which can affect more than 1 in 10 people) and must be treated immediately. If you have cough, fever and difficulty breathing or chest pain, it could be a sign of lung infection. Serious or life-threatening infections are rare (can affect up to 1 in 100 people).
• Swollen and painful leg, chest pain, shortness of breath, rapid breathing or a fast heartbeat, which can be signs of blood clots in the veins (which can affect up to 1 in 10 people).
• Diarrhea (can affect more than 1 in 10 people).

Refer to paragraph 2 for more information on each 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)

• Infections
• Decreased white blood cells, red blood cells and platelets
• Nausea, vomiting
• Inflammation or painful mouth
• Decreased appetite
• Headache
• Altered sense of taste
• Hair loss
• Fatigue
• Dizziness
• Itching
• Rash
• Abnormal blood tests of liver values

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

• Watery eyes
• Muscle weakness
• Dry skin
• Lung inflammation causing shortness of breath, cough and fever
• Indigestion or stomach discomfort
• Nail disorders such as nails that break or split

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

• Low levels of white blood cells with fever
• Seeing flashes of light or floating spots in your vision
• Keratitis (inflammation of the cornea)

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

• Skin reaction that causes red spots or patches on the skin, which may look like a “target” or be “iris”, with a dark red center surrounded by light red rings (erythema multiforme).

Reporting of side effects
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 through the national reporting system listed in Annex V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store 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 the 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 packaging is damaged or shows signs of tampering.
Do not dispose of any medicine in the wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Verzenios contains

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

Description of the appearance of Verzenios and package contents

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

Verzenios is available in blister packs with a calendar of 14, 28, 42, 56, 70 and 168 film-coated tablets
and in a unit-dose divisible blister of 28 x 1 film-coated tablet.
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer
Eli Lilly Nederland B.V., Papendorpseweg 83, 3528BJ Utrecht, Netherlands.

Manufacturer
Lilly S.A., Avda. de la Industria 30, 28108 Alcobendas, Madrid, Spain
For further information on this medicine, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
Eli Lilly Benelux S.A./N.V.
Tél/Tel: + 32-(0)2 548 84 84

Lietuva
Eli Lilly Lietuva
Tel. +370 (5) 2649600

България
TP "Eli Lilly Nederland" B.V. - България
tel. + 359 2 491 41 40

Luxembourg/Luxemburg
Eli Lilly Benelux S.A./N.V.
Tél/Tel: + 32-(0)2 548 84 84

Česká republika
ELI LILLY ČR, s.r.o.
Tel: + 420 234 664 111

Magyarország
Lilly Hungária Kft.
Tel: + 36 1 328 5100

Danmark
Eli Lilly Danmark A/S
Tlf: +45 45 26 60 00

Malta
Charles de Giorgio Ltd.
Tel: + 356 25600 500

Deutschland
Lilly Deutschland GmbH
Tel. + 49-(0) 6172 273 2222

Nederland
Eli Lilly Nederland B.V.
Tel: + 31-(0) 30 60 25 800

Eesti
Eli Lilly Nederland B.V.
Tel: +372 6 817 280

Norge
Eli Lilly Norge A.S.
Tlf: + 47 22 88 18 00

Ελλάδα
ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε.
Τηλ: +30 210 629 4600

Österreich
Eli Lilly Ges.m.b.H.
Tel: + 43-(0) 1 711 780

España
Lilly S.A.
Tel: + 34-91 663 50 00

Polska
Eli Lilly Polska Sp. z o.o.
Tel: +48 22 440 33 00

France
Lilly France
Tél: +33-(0) 1 55 49 34 34

Portugal
Lilly Portugal Produtos Farmacêuticos, Lda
Tel: + 351-21-4126600

Hrvatska
Eli Lilly Hrvatska d.o.o.
Tel: +385 1 2350 999

Ireland
Eli Lilly and Company (Ireland) Limited
Tel: + 353-(0) 1 661 4377

România
Eli Lilly România S.R.L.
Tel: + 40 21 4023000

Slovenija
Eli Lilly farmacevtska družba, d.o.o.
Tel: +386 (0)1 580 00 10

Ísland
Icepharma hf.
Sími + 354 540 8000

Slovenská republika
Eli Lilly Slovakia s.r.o.
Tel: + 421 220 663 111

Italia
Eli Lilly Italia S.p.A.
Tel: + 39- 055 42571

Suomi/Finland
Oy Eli Lilly Finland Ab
Puh/Tel: + 358-(0) 9 85 45 250

Κύπρος
Phadisco Ltd
Τηλ: +357 22 715000

Sverige
Eli Lilly Sweden AB
Tel: + 46-(0) 8 7378800

Latvija
Eli Lilly (Suisse) S.A. Pārstāvniecība Latvijā
Tel: +371 67364000

United Kingdom (Northern Ireland)
Eli Lilly and Company (Ireland) Limited
Tel: + 353-(0) 1 661 4377

Other sources of information
More detailed information on this medicine is available on the website of the European
Medicines Agency: http://www.ema.europa.eu .

ANNEX IV
SCIENTIFIC CONCLUSIONS AND JUSTIFICATION FOR THE VARIATION OF THE TERMS
OF THE MARKETING AUTHORISATION
Scientific conclusions
Taking into account the evaluation of the Pharmacovigilance and Risk Assessment Committee
(PRAC) of the Periodic Safety Update Report (PSUR) for abemaciclib, the PRAC’s scientific
conclusions are as follows:
In light of the available data on corneal disorders from clinical studies and in light of non-clinical
evidence, the PRAC considers that a causal relationship between abemaciclib and keratitis is at least a
reasonable possibility. The PRAC concluded that the product information for products containing
abemaciclib should be amended accordingly.
Having examined the PRAC recommendation, the Committee for Human Medicinal Products
(CHMP) agrees with the related overall conclusions and with the justification for the recommendation.

Justification for the variation of the terms of the marketing authorisation
Based on the scientific conclusions on abemaciclib, the CHMP considers that the benefit/risk
balance of the medicines containing abemaciclib remains unchanged, subject to the proposed changes
to the product information.
The CHMP recommends the variation of the terms of the marketing authorisation.