Prescribing Information for the Patient

Verzenios 50Film-Coated Tablets

Verzenios 100Film-Coated Tablets

Verzenios 150Film-Coated Tablets

abemaciclib

Read this entire prescribing information carefully before starting to take this medication, as it contains important information for you.

• Keep this prescribing information, as you may need to refer to it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed to you alone, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this prescribing information. See section 4.

Verzenios is a medication for cancer treatment that contains the active ingredient 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 uncontrollably. Blocking the action of these proteins may slow down the growth of cancer cells, reduce the tumor, and delay cancer progression.

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

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

Do not take Verzenios:

• if you are allergic to abemaciclib or any of the other ingredients in 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. Serious infections, such as pneumonia, can be life-threatening;
• cause blood clots in the veins;
• cause severe inflammation of the lungs that can be life-threatening;
• affect the way your liver works;
• cause diarrhea.Start treatment with anti-diarrheal agents like loperamide at the first sign of diarrhea. Drink plenty of fluids;
• cause blood clots in the arteries in patients who are also receiving hormone therapy.

See section 4 “Possible side effects”, and inform 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 affects 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 old.

Other medicines and Verzenios

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine.

Particularly, inform your doctor or pharmacist before taking Verzenios if you are taking:

• 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 attacks)
  • Rifampicin(used to treat tuberculosis (TB))
  • Phenytoin(used to treat seizures)
  • St. John's Wort(a medicinal herb 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 plan to become pregnant, consult your doctor or pharmacist before taking this medicine.

Pregnancy

You should not take Verzenios if you are pregnant.

Avoid becoming pregnant while taking Verzenios.

If you are fertile, use suitable contraceptive methods (e.g., double barrier contraception such as condoms and diaphragm) during treatment and for at least 3 weeks after completing treatment. Consult your doctor about the use of contraceptive methods if there is any possibility of becoming pregnant.

Inform your doctor if you become pregnant.

Breastfeeding

You should not breastfeed while taking Verzenios. It is unknown 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 operating machines

Dizziness and fatigue are very common side effects. If you feel exceptionally tired or dizzy, be extra careful when driving or operating machines.

Verzenios contains lactose

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

Verzenios contains sodium

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

Recommended Dose

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose of Verzenios when administered with hormone therapy for the treatment of breast cancer is 150 mg orally twice a day.

If you experience certain adverse 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 medication in your body during treatment.

You can 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 break the tablets before swallowing.

For How Long to Take Verzenios

Take Verzenios continuously for the time your doctor indicates. If you take Verzenios for the treatment of 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 medication, 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 time scheduled. Do not take a double dose to make up for the missed or vomited dose.

If You Interrupt Treatment with Verzenios

Do not interrupt treatment with Verzenios unless your doctor tells you to.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.Contact your doctor immediately if you experience any of the following:

• Symptoms such as chills or fever. These may be a sign of 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 and chest pain, it may be a sign of pneumonia. Severe or life-threatening infections are rare (may affect up to 1 in 100 people).
• Painful leg inflammation, chest pain, difficulty breathing, rapid breathing or rapid heart rate, as these may be signs of blood clots in the vein (which may affect more than 1 in 10 people).
• Diarrhea (which may affect more than 1 in 10 people).

See section 2 for more information on any of the possible side effects described 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 of discomfort), vomiting
• Mouth inflammation or ulcers
• Loss of appetite
• Headache
• Alteration of taste
• Hair loss
• Fatigue
• Dizziness
• Itching
• Rash
• Abnormal liver function in blood tests

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

• Runny eyes
• Muscle weakness
• Dry skin
• Pneumonia causing 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
• Perception of flashes of light or flying insects in vision

Rare side effects (may affect up to 1 in 1000 people)

• A skin reaction that causes red spots or patches on the skin, which may appear as a target or a "bull's eye" with a dark red center surrounded by pale red rings (erythema multiforme).

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a side effect that does not appear in this leaflet. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the blister pack and on the box after “CAD”. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

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

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and the medication that you no longer need. This will help protect the environment.

Composition of Verzenios

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

• 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 components in this medication are:

• Tablet core: hydrated colloidal silica, sodium croscarmellose, lactose monohydrate, microcrystalline cellulose, sodium stearate fumarate (for more information, see section 2 “Verzenios contains sodium”).
• 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].

Appearance of the product and contents of the pack

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

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

Only some pack sizes may be marketed.

Marketing Authorization Holder

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

Responsible for manufacturing

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

For more information about this medication, please contact the local representative of the marketing authorization holder:

Last update of this leaflet:

Other sources of information

More detailed information about this medication is available on the website of the European Medicines Agency:http://www.ema.europa.eu/, and on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)} (http://www.aemps.gob.es/).