Ribociclib

Name: Ribociclib

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Brand names

Kisqali^®

Adverse Effects

>10%

Percentage includes all grades of toxicity unless otherwise stated

Neutropenia (75%)

Nausea (52%)

Neutropenia, grade 3 (50%)

Fatigue (37%)

Diarrhea (35%)

Leukopenia (33%)

Alopecia (33%)

Vomiting (29%)

Constipation (25%)

Headache (22%)

Leukopenia, grade 3 (20%)

Back pain (20%)

Decreased appetite (19%)

Anemia (18%)

Abnormal LFTs (18%)

Rash (17%)

Pruritus (14%)

Pyrexia (13%)

Peripheral edema (12%)

Stomatitis (12%)

Insomnia (12%)

Dyspnea (12%)

Lymphopenia (11%)

Urinary tract infection (11%)

Abdominal pain (11%)

1-10%

Neutropenia, grade 2 (10%)

Ribociclib Brand Names

Ribociclib may be found in some form under the following brand names:

Kisqali

Ribociclib side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

headache with chest pain and severe dizziness, fainting, fast or pounding heartbeats;
low white blood cell counts--fever, swollen gums, painful mouth sores, pain when swallowing, skin sores, cold or flu symptoms, cough, trouble breathing; or
liver problems--loss of appetite, upper stomach pain, tiredness, easy bruising or bleeding, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects may include:

low white blood cells;
nausea, vomiting;
diarrhea, constipation;
feeling tired;
headache, back pain; or
hair loss.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Before Using ribociclib

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For ribociclib, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to ribociclib or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of ribociclib in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of ribociclib in the elderly.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking ribociclib, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using ribociclib with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Amifampridine
Amisulpride
Bepridil
Cisapride
Dronedarone
Fluconazole
Ketoconazole
Mesoridazine
Piperaquine
Posaconazole
Saquinavir
Sparfloxacin
Terfenadine
Thioridazine
Ziprasidone

Using ribociclib with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Alfentanil
Alfuzosin
Amiodarone
Amitriptyline
Anagrelide
Apomorphine
Aripiprazole
Aripiprazole Lauroxil
Arsenic Trioxide
Asenapine
Astemizole
Atazanavir
Azithromycin
Bedaquiline
Boceprevir
Buserelin
Carbamazepine
Chloroquine
Chlorpromazine
Ciprofloxacin
Citalopram
Clarithromycin
Clomipramine
Clozapine
Cobicistat
Conivaptan
Crizotinib
Cyclobenzaprine
Cyclosporine
Dabrafenib
Dasatinib
Degarelix
Delamanid
Desipramine
Deslorelin
Dihydroergotamine
Disopyramide
Dofetilide
Dolasetron
Domperidone
Donepezil
Doxepin
Droperidol
Ebastine
Efavirenz
Enzalutamide
Ergotamine
Eribulin
Erythromycin
Escitalopram
Everolimus
Famotidine
Felbamate
Fentanyl
Fingolimod
Flecainide
Flibanserin
Fluoxetine
Formoterol
Foscarnet
Fosphenytoin
Galantamine
Gatifloxacin
Gemifloxacin
Gonadorelin
Goserelin
Granisetron
Halofantrine
Haloperidol
Histrelin
Hydroquinidine
Hydroxychloroquine
Hydroxyzine
Ibutilide
Idelalisib
Iloperidone
Imipramine
Indinavir
Itraconazole
Ivabradine
Lapatinib
Leuprolide
Levofloxacin
Lopinavir
Lumacaftor
Lumefantrine
Mefloquine
Methadone
Methotrimeprazine
Metronidazole
Midazolam
Mifepristone
Mitotane
Mizolastine
Moricizine
Moxifloxacin
Nafarelin
Nefazodone
Nelfinavir
Nilotinib
Norfloxacin
Octreotide
Ofloxacin
Olanzapine
Ondansetron
Oxycodone
Paliperidone
Panobinostat
Papaverine
Paroxetine
Pasireotide
Pazopanib
Pentamidine
Perphenazine
Phenytoin
Pimavanserin
Pimozide
Pipamperone
Pitolisant
Probucol
Procainamide
Prochlorperazine
Promethazine
Propafenone
Protriptyline
Quetiapine
Quinidine
Quinine
Ranolazine
Rifampin
Risperidone
Ritonavir
Sertindole
Sevoflurane
Sirolimus
Sodium Phosphate
Sodium Phosphate, Dibasic
Sodium Phosphate, Monobasic
Solifenacin
Sorafenib
Sotalol
St John's Wort
Sultopride
Sunitinib
Tacrolimus
Tamoxifen
Telaprevir
Telavancin
Telithromycin
Temsirolimus
Tetrabenazine
Tizanidine
Tolterodine
Toremifene
Trazodone
Trimipramine
Triptorelin
Vandetanib
Vardenafil
Vemurafenib
Venlafaxine
Vilanterol
Vinflunine
Voriconazole
Vorinostat
Zotepine
Zuclopenthixol

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using ribociclib with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use ribociclib, or give you special instructions about the use of food, alcohol, or tobacco.

Grapefruit Juice
Pomegranate
Pomegranate Juice

Precautions While Using ribociclib

It is very important that your doctor check your progress at regular visits to make sure ribociclib is working properly. Blood tests may be needed to check for unwanted effects.

Using ribociclib while you are pregnant can harm your unborn baby. If you are a woman who can bear children, your doctor may give you a pregnancy test before you start using ribociclib to make sure you are not pregnant. Use an effective form of birth control to keep from getting pregnant during treatment and for at least 3 weeks after your last dose. If you think you have become pregnant while using the medicine, tell your doctor right away.

If you plan to have children, talk with your doctor before using ribociclib. Some men using ribociclib have become infertile (unable to have children).

Contact your doctor right away if you have any changes to your heart rhythm. You might feel dizzy or faint, or you might have a fast, pounding, or uneven heartbeat. Make sure your doctor knows if you or anyone in your family has ever had a heart rhythm problem such as QT prolongation.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Ribociclib can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.

What do I need to tell my doctor BEFORE I take Ribociclib?

If you have an allergy to ribociclib or any part of this medicine.
If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
If you have any of these health problems: Electrolyte problems (like calcium, magnesium, phosphorous, or potassium), heart problems like heart failure or a certain type of chest pain (unstable angina), long QT on ECG, or slow or abnormal heartbeat.
If you have had a recent heart attack.
If you are taking any drugs that can cause a certain type of heartbeat that is not normal (prolonged QT interval). There are many drugs that can do this. Ask your doctor or pharmacist if you are not sure.
If you take any drugs (prescription or OTC, natural products, vitamins) that must not be taken with ribociclib, like certain drugs that are used for HIV, infections, or seizures. There are many drugs that must not be taken with this medicine.
If you are taking St. John's wort. Do not take St. John's wort with ribociclib. This medicine may not work as well.
If you are breast-feeding. Do not breast-feed while you take this medicine and for 3 weeks after your last dose.

This is not a list of all drugs or health problems that interact with ribociclib.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some other side effects of Ribociclib?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

Upset stomach or throwing up.
Feeling tired or weak.
Loose stools (diarrhea).
Hard stools (constipation).
Not hungry.
Mouth irritation or mouth sores.
Belly pain.
Hair loss.
Headache.
Back pain.
Not able to sleep.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Pronunciation

(rye boe SYE klib)

Brand Names U.S.

Kisqali 200 Dose
Kisqali 400 Dose
Kisqali 600 Dose

Monitoring Parameters

Complete blood count (baseline, every 2 weeks for the first 2 cycles, at the beginning of each subsequent 4 cycles and as clinically necessary); liver function tests (baseline, every 2 weeks for the first 2 cycles, at the beginning of each subsequent 4 cycles and as clinically necessary); serum electrolytes (including potassium, magnesium, calcium, and phosphorous) prior to treatment, at the beginning of the first 6 cycles, and as clinically indicated; pregnancy test prior to treatment (in females of reproductive potential). ECG (prior to treatment initiation; repeat on day 14 of cycle 1, at the beginning of cycle 2, and as clinically indicated).

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience nausea, vomiting, diarrhea, constipation, lack of appetite, mouth irritation, mouth sores, abdominal pain, hair loss, headache, back pain, or insomnia. Have patient report immediately to prescriber signs of infection, signs of a urinary tract infection (hematuria, burning or painful urination, polyuria, fever, lower abdominal pain, or pelvic pain), signs of liver problems (dark urine, fatigue, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or jaundice), signs of electrolyte problems (mood changes, confusion, muscle pain or weakness, abnormal heartbeat, seizures, lack of appetite, or severe nausea or vomiting), dizziness, passing out, tachycardia, abnormal heartbeat, severe loss of strength and energy, shortness of breath, or swelling in the arms or legs (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.