Verzenios

Patient Information Leaflet

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

abemaciclib
Please read all of this leaflet carefully before taking this medicine because 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 give it to others, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effects, including 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 taking 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 Verzenios is and what it is used for

Verzenios is an anticancer medicine that contains the active substance abemaciclib.
Abemaciclib blocks the action of proteins called cyclin-dependent kinases 4 and 6. These proteins
are abnormally active in certain cancer cells, causing uncontrolled cell growth.
By inhibiting these proteins, Verzenios can slow down cancer cell growth, and reduce and delay tumour progression.
Verzenios is used to treat certain 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 certain features that increase the risk of cancer recurrence. Treatment is given in combination with hormonal therapy, such as aromatase inhibitors or tamoxifen, to prevent cancer from returning after surgery (treatment after surgery is called adjuvant therapy)
• have spread beyond the original tumour and/or to other organs. It is given in combination with hormonal therapies, such as aromatase inhibitors or fulvestrant.

2. What you need to know before taking Verzenios

Do not take Verzenios

• if you are allergic to abemaciclib or to 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 increasing your risk of developing 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 liver function;
• 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 hormonal therapies.

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 have regular blood tests before and during treatment to monitor whether Verzenios affects your blood (white blood cells, red blood cells, platelets) or the levels in your blood of liver-derived enzymes.
Children and adolescents
Verzenios must 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 may increase the concentration of Verzenios in the blood: o Clarithromycin (an 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 conditions) o Dabigatran etexilate (used to reduce the risk of stroke and blood clots)
• medicines that may reduce the effectiveness of Verzenios: o Carbamazepine (an antiepileptic used to treat seizures or epileptic fits) o Rifampicin, used to treat 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 drinks
Grapefruit or grapefruit juice should be avoided during treatment with this medicine, as they may increase Verzenios blood concentrations.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine.
Pregnancy
You must not use Verzenios during pregnancy.
You must avoid becoming pregnant while taking Verzenios.
If you are of childbearing age, you must use adequate contraceptive methods (e.g., double-barrier contraception such as condoms together with a diaphragm) during treatment and for at least 3 weeks after completing therapy. Discuss contraceptive measures with your doctor if there is any possibility you could become pregnant.
You must inform your doctor if you become pregnant.
Breastfeeding
You must not breastfeed while taking Verzenios. It is not known whether Verzenios passes into breast milk.
Fertility
Verzenios may reduce fertility in men. Speak with your doctor for advice on fertility before starting treatment.
Driving and using machines
Fatigue and dizziness are very common side effects. If you feel unusually tired or experience dizziness, take particular care when driving or operating machinery.
Verzenios contains lactose
If your doctor has informed you that you have an intolerance to certain sugars, contact your doctor before taking this medicine.
Verzenios contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., essentially “sodium-free”.

3. How to take Verzenios

Recommended dose
Take this medicine exactly as instructed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
If administered together with endocrine therapy for the treatment of breast cancer, the recommended
dose of Verzenios is 150 mg taken orally twice daily.
If you experience certain adverse effects while taking Verzenios, your doctor may reduce the dose
or temporarily or permanently discontinue treatment.
When and how to take Verzenios
Take Verzenios twice daily, approximately at the same time each day, preferably in the morning
and evening, to maintain a consistent level of medicine in your body.
You may take the tablets with or without food, but 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.
How long to take Verzenios
Take Verzenios continuously for the duration prescribed by your doctor. If you are taking Verzenios for the
treatment of early-stage breast cancer, you should 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
hospital for 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 a dose or miss a dose, take the next dose at your usual time.
Do not take a double dose to make up for a missed or vomited dose.
If you stop taking Verzenios
Do not stop treatment with Verzenios unless instructed by your doctor.
If you have any questions about using this medicine, consult 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 could be signs of a low white blood cell count (which may affect more than 1 in 10 people) and must be treated immediately. If you have cough, fever, and difficulty breathing or chest pain, this could be a sign of a lung infection. Serious or life-threatening infections are rare (may affect up to 1 in 100 people).
• Swollen and painful leg, chest pain, shortness of breath, rapid breathing, or fast heartbeat, which could be signs of blood clots in the veins (may affect up to 1 in 10 people).
• Diarrhoea (may affect more than 1 in 10 people).

Refer to section 2 for further information on each of the possible side effects listed above.
Other side effects with Verzenios may include:
Very common side effects (may affect more than 1 in 10 people)

• Infections
• Reduction in white blood cells, red blood cells, and platelets
• Nausea, vomiting
• Mouth inflammation or sore mouth
• Loss of appetite
• Headache
• Altered sense of taste
• Hair loss
• Fatigue
• Dizziness
• Itching
• Rash
• Abnormal liver blood test results

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 white blood cell levels with fever
• Perception of flashes of light or moving objects in the visual field
• Keratitis (inflammation of the cornea)

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

• Skin reaction causing red spots or patches on the skin, which may look like a "target" or "bull's eye", with a dark red centre surrounded by lighter red rings (erythema multiforme).

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. 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 stated on the blister and carton after "Exp.". The expiry date refers to the last day of that month.
This medicine requires no 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 via 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 substance is abemaciclib. Verzenios film-coated tablets are available in different strengths:
  • 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 ingredients in this medicine are:
  • Tablet core: hydrated colloidal silica, sodium croscarmellose, lactose monohydrate, microcrystalline cellulose, sodium stearyl fumarate (see section 2 “Verzenios contains lactose” and “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 Contents of the Pack

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

Verzenios is available in calendar blister packs containing 14, 28, 42, 56, 70 and 168 film-coated tablets and in unit-dose divisible blisters containing 28 x 1 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Eli Lilly Nederland B.V., Orteliuslaan 1000, 3528 BD Utrecht, The Netherlands.
Manufacturer
Lilly S.A., Avda. de la Industria 30, 28108 Alcobendas, Madrid, Spain
For further information about this medicine, please contact the local representative of the Marketing Authorization Holder:
België/Belgique/Belgien Lietuva
Eli Lilly Benelux S.A./N.V. Eli Lilly Lietuva
Tél/Tel: + 32-(0)2 548 84 84 Tel: + 370 (5) 2649600
България Luxembourg/Luxemburg
TP "Eli Lilly Nederland" B.V. - Bulgaria Eli Lilly Benelux S.A./N.V.
tel.: + 359 2 491 41 40 Tél/Tel: + 32-(0)2 548 84 84
Česká republika Magyarország
ELI LILLY ČR, s.r.o. Lilly Hungária Kft.
Tel: + 420 234 664 111 Tel.: + 36 1 328 5100
Danmark Malta
Eli Lilly Danmark A/S Charles de Giorgio Ltd.
Tlf.: + 45 45 26 60 00 Tel: + 356 25600 500
Deutschland Nederland
Lilly Deutschland GmbH Eli Lilly Nederland B.V.
Tel: + 49-(0) 6172 273 2222 Tel: + 31-(0) 30 60 25 800
Eesti Norge
Eli Lilly Nederland B.V. Eli Lilly Norge A.S.
Tel: + 372 6 817 280 Tlf: + 47 22 88 18 00
Ελλάδα Österreich
FARMASERV-LILLY S.A.E. Eli Lilly Ges.m.b.H.
Tel: + 30 210 629 4600 Tel: + 43-(0) 1 711 780
España Polska
Lilly S.A. Eli Lilly Polska Sp. z o.o.
Tel: + 34-91 663 50 00 Tel.: + 48 22 440 33 00
France Portugal
Lilly France Lilly Portugal Produtos Farmacêuticos, Lda
Tél: + 33-(0) 1 55 49 34 34 Tel: + 351-21-4126600
Hrvatska România
Eli Lilly Hrvatska d.o.o. Eli Lilly România S.R.L.
Tel: + 385 1 2350 999 Tel: + 40 21 4023000
Ireland Slovenija
Eli Lilly and Company (Ireland) Limited Eli Lilly farmacevtska družba, d.o.o.
Tel: + 353-(0) 1 661 4377 Tel: + 386 (0)1 580 00 10
Ísland Slovenská republika
Icepharma hf. Eli Lilly Slovakia s.r.o.
Sími: + 354 540 8000 Tel: + 421 220 663 111
Italia Suomi/Finland
Eli Lilly Italia S.p.A. Oy Eli Lilly Finland Ab
Tel: + 39- 055 42571 Puh/Tel: + 358-(0) 9 85 45 250
Κύπρος Sverige
Phadisco Ltd Eli Lilly Sweden AB
Tel: + 357 22 715000 Tel: + 46-(0) 8 7378800
Latvija
Eli Lilly (Suisse) S.A. Pārstāvniecība Latvijā
Tel: + 371 67364000
Other Sources of Information
More detailed information on this medicine is available on the website of the European Medicines Agency: https://www.ema.europa.eu.