Prescribing Information for the Patient

Kisqali 200 mg Film-Coated Tablets

ribociclib

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 only for you, and you should not give it to otherseven 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, evenif they are not listed in this prescribing information. See section4.

What is Kisqali

Kisqali contains the active ingredient ribociclib, which belongs to a group of medications called cyclin-dependent kinase (CDK) 4 and 6 inhibitors.

How is Kisqali used

Kisqali is used in patients with a type of breast cancer called hormone receptor-positive and human epidermal growth factor receptor 2 (HER2)-negative breast cancer, who:

• have cancer located in the breast or has spread to the lymph nodes in the breast region, without being detected in other parts of the body, has been surgically removed, and has certain characteristics that increase the risk of it coming back. It is used in combination with an aromatase inhibitor, which is used as hormone therapy for cancer (early breast cancer). Women who have not reached menopause and men will also be treated with a medication called a luteinizing hormone-releasing hormone (LHRH) agonist that blocks the production of certain hormones.
• is advanced or metastatic. This means that the cancer has grown outside the breast and has spread to the lymph nodes in the breast (locally advanced) or has spread to other parts of the body (metastatic). Kisqali is used in combination with an aromatase inhibitor or with fulvestrant, which are used as hormone treatments against cancer. Women who have not reached menopause will also be treated with a medication called a luteinizing hormone-releasing hormone (LHRH) agonist that blocks the production of certain hormones.

How Kisqali works

Kisqali works by blocking the growth signals transmitted by CDK 4 and 6 proteins, and thereby prevents the growth and spread of cancer cells. In early breast cancer, it may prevent cancer from coming back after surgery (the treatment after surgery is called adjuvant therapy). In advanced or metastatic breast cancer, it may slow down the progression of cancer.

If you have any doubts about how Kisqali works or why you have been prescribed this medication, consult your doctor, pharmacist, or nurse.

Follow your doctor's instructions carefully. They may be different from the general information in this prospectus.

Do not take Kisqali

• if you are allergic to ribociclib, peanuts, soy, or any of the other components of this medication (including those listed in section6).

If you think you may be allergic, consult your doctor.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Kisqali.

If you are in any of the following situations before taking Kisqali, consult your doctor or pharmacist:

• If you have fever, sore throat, or mouth sores due to infections (signs of low white blood cell count).
• If you have any liver problems or have had liver disease in the past.
• If you have or have had heart problems or irregular heart rhythms, including a condition called prolonged QT syndrome (prolongation of the QT interval) or low levels of potassium, magnesium, calcium, or phosphate in the blood.

If you are in any of the following situations during your treatment with Kisqali, inform your doctor or pharmacist:

• If you experience a combination of any of the following symptoms: rash, skin redness, blisters on the lips, eyes, or mouth, skin peeling, high fever, flu-like symptoms, and swollen lymph nodes (may be signs of a severe skin reaction).

In the event of a severe skin reaction, your doctor will instruct you to stop taking Kisqali immediately.

• Difficulty breathing, coughing, and shortness of breath (may be signs of lung or respiratory problems).

If necessary, your doctor may interrupt or reduce your Kisqali dose or decide to permanently discontinue treatment with Kisqali.

Monitoring during Kisqali treatment

Before and during treatment with Kisqali, you will have periodic blood tests to check liver function and the number of blood cells (white blood cells, red blood cells, and platelets) and electrolytes (salts in the blood, including potassium, calcium, magnesium, and phosphate) in your body. Your heart activity will also be monitored before and during treatment with Kisqali with an electrocardiogram (ECG) test.If necessary, additional tests will be performed to evaluate kidney function during treatment with Kisqali.If necessary, your doctor may reduce your Kisqali dose or temporarily suspend it to allow your liver, kidneys, blood cells, electrolyte levels, or heart activity to recover. Your doctor may decide to permanently discontinue treatment with Kisqali.

Children and adolescents

Kisqali should not be used in children and adolescents under 18years.

Other medications and Kisqali

Before taking Kisqali, inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including prescription and over-the-counter medications, herbal medications, or supplements, as they may affect the effect of Kisqali. Always inform your doctor if you have been prescribed a new medication after starting Kisqali treatment.

This includes, in particular:

• Tamoxifen, another medication for breast cancer treatment.
• Some medications used to treat fungal infections, such as ketoconazole, itraconazole, voriconazole, or posaconazole.
• Some medications used to treat HIV/AIDS, such as ritonavir, saquinavir, indinavir, lopinavir, nelfinavir, telaprevir, and efavirenz.
• Some medications used to treat seizures or attacks (antiepileptics) such as carbamazepine and phenytoin.
• St. John's Wort (also known asHypericum perforatum) – a herbal medication used to treat depression and other diseases.
• Some medications used to treat heart rhythm problems or high blood pressure, such as amiodarone, disopyramide, procainamide, quinidine, sotalol, and verapamil.
• Antimalarial medications such as chloroquine.
• Antibiotics such as clarithromycin, telithromycin, moxifloxacin,rifampicin, ciprofloxacin, levofloxacin, and azithromycin.
• Some medications used for sedation or anesthesia, such as midazolam.
• Some medications used as antipsychotics, such as haloperidol.
• Medications used to treat angina, such as bepridil.
• Methadone, used to treat pain or opioid addiction.
• Medications such as ondansetron intravenous,used to prevent nausea and vomiting caused by chemotherapy (cancer treatment).

Kisqali may increase or decrease the levels of other medications in the blood. This includes, in particular:

• Medications used to treat symptoms of benign prostatic hyperplasia, such asalfuzosin.
• Tamoxifen, another medication for breast cancer treatment.
• Antiarrhythmics such as amiodarone or quinidine.
• Antipsychotics such as pimozide or quetiapine.
• Medications used to improve blood lipid levels, such as simvastatin or lovastatin, pitavastatin, pravastatin, or rosuvastatin.
• Medications used to treat high blood sugar levels (e.g., diabetes) such as metformin.
• Medications used to treat heart disease, such as digoxin.
• Medications used to treat pulmonary hypertension and erectile dysfunction, such as sildenafil.
• Medications used to treat low blood pressure or migraines, such as ergotamine or dihydroergotamine.
• Some medications used to treat seizures or that are used for sedation or anesthesia, such as midazolam.
• Medications used to treat sleep disorders, such as triazolam.
• Analgesics such as alfentanil and fentanyl.
• Medications used to treat gastrointestinal disorders, such as cisapride.
• Medications used to prevent organ transplant rejection, such as tacrolimus, sirolimus, and cyclosporine (also used to treat rheumatoid arthritis and psoriasis).
• Everolimus, used for various types of cancer and tuberous sclerosis (also used to prevent organ transplant rejection).

Consult your doctor or pharmacist if you are unsure if your medication is one of the above.

Taking Kisqali with food and drink

Do not eat grapefruit or foods containing grapefruit or drink grapefruit juiceduring your treatment with Kisqali. It may change how Kisqali is processed in your body and may increase the amount of Kisqali in your blood, making it less effective.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, or plan to become pregnant, consult your doctor before using this medication.

Your doctor will discuss the possible risks of taking Kisqali during pregnancy.

Pregnancy and fertile women

Kisqali should not be used during pregnancy as it may harm the fetus. If you are a fertile woman, you should have a negative pregnancy test before starting treatment with Kisqali. You should use effective contraception (e.g., double barrier methods such as condoms and diaphragm) while taking Kisqali and for at least 21days after the last dose. Consult your doctor about effective contraception options.

Breastfeeding

You should not breastfeed while taking Kisqali and for at least 21days after the last dose.

Driving and operating machinery

Treatment with Kisqali may cause fatigue, dizziness, or a feeling of spinning. Therefore, you should exercise caution when driving or operating machinery during Kisqali treatment.

Kisqali contains soy lecithin

If you are allergic to peanuts or soy, do not take this medication.

Follow exactly the administration instructions of this medication as indicated by your doctor, pharmacist or nurse. Your doctor, pharmacist or nurse will inform you exactly how many tablets to take and which days to take them. In case of doubt, consult your doctor, pharmacist or nurse again. Do not change the dose of Kisqali or the treatment schedule without speaking with your doctor.

Do not exceed the recommended dose prescribed by your doctor.

How much Kisqali to take

• The Kisqali package includes a calendar that allows you to track your daily dose of Kisqali by marking a circle for each tablet you take during the 28day cycle.

• Your doctor will inform you exactly how many tablets of Kisqali to take. In certain situations (e.g. in case of liver or kidney problems) your doctor will indicate that you take a lower dose of Kisqali.

It is very important to follow your doctor's instructions. If you experience any side effects, your doctor may decide that you take a lower dose, interrupt treatment with Kisqali or stop taking it permanently.

When to take Kisqali

Take Kisqali once a day at the same time every day, preferably in the morning. This will help you remember to take your medication and detect any side effects that may occur so that you can contact your doctor quickly.

How to take Kisqali

Kisqali tablets should be swallowed whole (do not crush, chew or break tablets before swallowing). Do not take a tablet that is broken, cracked or damaged.

Taking Kisqali with food and drink

You should take Kisqali once a day every day at the same time, preferably in the morning. You can take it with or without food.

For how long to take Kisqali

Take Kisqali once a day from days 1 to 21 of a 28day cycle. Continue treatment with Kisqali for the time indicated by your doctor.

In early-stage breast cancer, a maximum treatment duration of 3years is recommended. In advanced or metastatic breast cancer, this is a long-term treatment. Your doctor will monitor your situation periodically to check that the treatment is having the desired effect.

If you take more Kisqali than you should

If you take too many tablets, or if someone else takes your medication, contact a doctor or go to the hospital immediately. Show the Kisqali package. You may need medical treatment.

If you forget to take a dose of Kisqali

If you experience vomiting after taking the dose or if you forget to take a dose, do not take the missed dose on that day. Take the next dose the following day at the prescribed time.

Do not take a double dose to compensate for the missed doses. Instead, wait until the time to take the next dose and then take the dose as usual.

If you interrupt treatment with Kisqali

If you think the dose you are taking is too high or too low, contact your doctor. Do not interrupt treatment with Kisqali unless your doctor tells you to. Stopping treatment with Kisqali may cause your cancer to worsen.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them. Read this section carefully. The serious side effects that may occur are listed first (“Some side effects may be serious”), and then all the other side effects (“Other possible side effects”) are described in descending order of frequency.

Early breast cancer

Some side effects may be serious

Your doctor may tell you to take a lower dose, stop treatment with Kisqali, or permanently discontinue treatment. Inform your doctor immediately if you experience any of the following symptoms during treatment with Kisqali:

• Fever, sweating or chills, cough, flu-like symptoms, weight loss, difficulty breathing, blood in sputum, body aches, hot or painful parts of the body, diarrhea or stomach pain, or feeling extremely tired (signs or symptoms of infections).Very common (may affect more than 1 in 10patients).
• Fever, chills, weakness, and frequent infections with symptoms such as sore throat or mouth sores. These may be signs of low white blood cell count (muy frecuentes, may affect more than 1 in 10patients)or low lymphocyte count, a type of white blood cell(common, may affect 1 in 10patients).
• Abnormal results in blood tests that provide information about liver health (abnormal liver function tests).Very common (may affect more than 1 in 10patients).
• Spontaneous bleeding or appearance of bruises (signs of low platelet count).Common (may affect 1 in 10patients).
• Decreased potassium level in the blood, which may alter heart rhythm.Common (may affect 1 in 10patients).
• Chest pain or discomfort, changes in heart rate (fast or slow), palpitations, dizziness, fainting, lightheadedness, blue discoloration of the lips, difficulty breathing, swelling (edema) of the lower extremities or skin (these may be signs of heart problems).Common (may affect up to 1 in 10patients).
• Fatigue, yellow skin with itching, or yellow discoloration of the white part of the eyes, nausea or vomiting, loss of appetite, pain in the upper right abdomen, dark or brown urine, or if you bleed or bruise more easily than normal (these may be signs of liver problems).Common (may affect up to 1 in 10patients).
• Pneumonitis, which may cause dry cough, chest pain, fever, shortness of breath, and difficulty breathing (these may be signs of interstitial lung disease/neumonitis that, in severe cases, may be fatal).Common (may affect up to 1 in 10patients).

• Sore throat or mouth sores with a single episode of fever of at least 38.3°C or fever above 38°C for more than one hour and/or with infection (febrile neutropenia).Uncommon (may affect up to 1 in 100patients).

Other possible side effects

Other side effects include the following, which are listed below. If these side effects become serious, inform your doctor, pharmacist, or nurse.

Very common(may affect more than 1 in 10patients)

• Sore throat, rhinitis, fever (signs of respiratory tract infection)
• Painful urination and frequent urination (signs of urinary tract infection)

• Nausea (feeling unwell)
• Headache
• Fatigue (tiredness)
• Asthenia (weakness)
• Alopecia (hair loss or weakened hair)
• Diarhea
• Constipation
• Cough
• Abdominal pain (in the stomach)

• Fever

Common(may affect up to 1 in 10patients)

• Rash
• Dizziness or lightheadedness
• Fatigue, pale skin (potential sign of low red blood cell count, anemia)
• Vomiting
• Pruritus (itching)
• Peripheral edema (swollen hands, ankles, or feet)
• Shortness of breath
• Stomatitis (mouth sores with inflammation of the gums)
• Pharyngitis (sore throat)
• Low calcium level in the blood, which may cause cramps in some cases
• Reduced appetite
• Abnormal results in blood tests for kidney function (high creatinine level in the blood)

Early breast cancer or metastatic breast cancer

Some side effects may be serious

Your doctor may tell you to take a lower dose, stop treatment with Kisqali, or permanently discontinue treatment. Inform your doctor immediately if you experience any of the following symptoms during treatment with Kisqali:

• Fever, sweating or chills, cough, flu-like symptoms, weight loss, difficulty breathing, blood in sputum, body aches, hot or painful parts of the body, diarrhea or stomach pain, or feeling extremely tired (signs or symptoms of infections).Very common (may affect 1 in 10patients).
• Fever, chills, weakness, and frequent infections with symptoms such as sore throat or mouth sores (signs of low white blood cell count or low lymphocyte count, a type of white blood cell).Very common (may affect more than 1 in 10patients).
• Abnormal results in blood tests that provide information about liver health (abnormal liver function tests).Very common (may affect more than 1 in 10patients).
• Spontaneous bleeding or appearance of bruises (signs of low platelet count).Common (may affect 1 in 10patients)
• Sore throat or mouth sores with a single episode of fever of at least 38.3°C or fever above 38°C for more than one hour and/or with infection (febrile neutropenia).Common (may affect up to 1 in 10patients).
• Fatigue, yellow skin with itching, or yellow discoloration of the white part of the eyes, nausea or vomiting, loss of appetite, pain in the upper right abdomen, dark or brown urine, or if you bleed or bruise more easily than normal (these may be signs of liver problems).Common (may affect up to 1 in 10patients).
• Decreased potassium level in the blood, which may alter heart rhythm.Common (may affect 1 in 10patients).
• Chest pain or discomfort, changes in heart rate (fast or slow), palpitations, dizziness, fainting, lightheadedness, blue discoloration of the lips, difficulty breathing, swelling (edema) of the lower extremities or skin (these may be signs of heart problems).Common (may affect up to 1 in 10patients).
• Pneumonitis, which may cause dry cough, chest pain, fever, shortness of breath, and difficulty breathing (these may be signs of interstitial lung disease/neumonitis that, in severe cases, may be fatal).Common (may affect up to 1 in 10patients).
• Severe infection with increased heart rate, difficulty breathing or rapid breathing, fever, and chills (these may be signs of sepsis, a life-threatening infection in the bloodstream).Uncommon (may affect up to 1 in 100patients).
• Severe skin reaction that may include a combination of some of the following symptoms: rash, skin redness, blisters on the lips, eyes, or mouth, skin peeling, high fever, flu-like symptoms, swollen lymph nodes (necrotizing epidermal toxic [NET]).Unknown frequency (cannot be estimated from available data).

Other possible side effects

Other side effects include the following, which are listed below. If these side effects become serious, inform your doctor, pharmacist, or nurse.

Very common(may affect more than 1 in 10patients)

• Fatigue, pale skin (potential sign of low red blood cell count, anemia)
• Sore throat, rhinitis, fever (signs of respiratory tract infection)
• Painful urination and frequent urination (signs of urinary tract infection)

• Reduced appetite
• Headache
• Dizziness or lightheadedness
• Shortness of breath
• Cough
• Nausea (feeling unwell)
• Diarhea
• Vomiting
• Constipation
• Abdominal pain (in the stomach)
• Stomatitis (mouth sores with inflammation of the gums)
• Dispepsia (stomach discomfort, bad digestion, heartburn)
• Alopecia (hair loss or weakened hair)
• Rash

• Pruritus (itching)
• Back pain
• Fatigue (tiredness)
• Peripheral edema (swollen hands, ankles, or feet)
• Fever
• Asthenia (weakness)

Common(may affect up to 1 in 10patients)

• Abdominal pain, nausea, vomiting, and diarrhea (signs of gastroenteritis, a gastrointestinal infection)
• Reduced calcium level in the blood, which may cause cramps in some cases
• Reduced phosphate level in the blood
• Dizziness (sensation of spinning)
• Watery eyes
• Dry eyes
• Reduced potassium level in the blood, which may alter heart rhythm
• Disgeusia (strange taste in the mouth)
• Dry skin
• Erythema (skin redness)
• Vitiligo (loss of skin color in patches)
• Sore throat
• Dry mouth
• Abnormal results in blood tests for kidney function (high creatinine level in the blood)

Rare(may affect up to 1 in 100,000patients)

A skin reaction that causes red spots or patches on the skin, which may resemble 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 type of side effect, consult your doctor, pharmacist, or nurse, even if it is not listed in this prospectus. You can also report them directly through thenational notification system included in theAppendixV. By reporting side effects, you can contribute to providing more information about 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 box and the blister pack. The expiration date is the last day of the month indicated.

Pharmacy: Store in refrigerator (between 2°C and 8°C) for a period of up to 10 months.

Patient: Store below 25°C for a period of up to 2 months. Store in the original packaging.

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

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 ofKisqali

• The active ingredient is ribociclib. Each film-coated tablet contains ribociclib succinate equivalent to 200mg of ribociclib.
• The other components are:

Tablet core: microcrystalline cellulose; crospovidone typeA; low-substituted hydroxypropyl cellulose; magnesium stearate;anhydrous colloidal silica.

Film-coating material: iron oxide black (E172); iron oxide red (E172); soy lecithin (E322) (see “Kisqali contains soy lecithin” in section2); partially hydrolyzed polyvinyl alcohol; talc; titanium dioxide (E171); xanthan gum.

Appearance ofKisqaliand packaging contents

Kisqali is presented as film-coated tablets in blisters.

The film-coated tablets are light violet-gray, unnotched, round, engraved with “RIC” on one face and “NVR” on the other face.

They are available in the following packaging sizes: Packs containing 21, 42 or 63film-coated tablets and multiple packs containing 63 (3packs of 21), 126 (3packs of 42) or 189 (3packs of 63) film-coated tablets.

Packs of Kisqali containing 63film-coated tablets, intended for patients taking the daily dose of ribociclib 600mg (3film-coated tablets once a day).

Packs of Kisqali containing 42film-coated tablets, intended for patients taking the daily dose of ribociclib 400mg (2film-coated tablets once a day).

Packs of Kisqali containing 21film-coated tablets, intended for patients taking the lowest daily dose of ribociclib 200mg (1film-coated tablet once a day).

Only some packaging sizes may be marketed.

Marketing Authorization Holder

Novartis Europharm Limited

Vista Building

Elm Park, Merrion Road

Dublín 4

Irlanda

Responsible Person

Novartis Pharma GmbH

Roonstrasse 25

90429 Nuremberg

Alemania

Lek Pharmaceuticals d.d.

VerovškovaUlica 57

1526 Ljubljana

Eslovenia

Novartis Pharmaceutical Manufacturing LLC

VerovškovaUlica 57

1000 Ljubljana

Eslovenia

Novartis Pharma GmbH

Sophie-Germain-Strasse 10

90443 Nürnberg

Alemania

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

Last update of the summary of product characteristics

Other sources of information

The detailed information on this medicinal product is available on the website of the European Medicines Agency:https://www.ema.europa.eu