Kisqali (Ribociclib)
Complete patient guide for uses, dosage, side effects, and safety information
Prescription RequiredQuick Facts
What Is Kisqali Used For?
Kisqali contains ribociclib, a medication that helps treat certain types of breast cancer by blocking enzymes that signal cancer cells to grow and multiply.
Primary Uses
Kisqali is used to treat hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer in two situations: Early breast cancer that is localized to the breast or has spread to nearby lymph nodes but not to other parts of the body, has been surgically removed, and has characteristics that increase the risk of cancer returning. Advanced or metastatic breast cancer that is locally advanced or has spread to other parts of the body.
How It Works
Kisqali works by blocking cyclin dependent kinases (CDK), which are enzymes that chemically signal cancer cells to grow and multiply. By blocking these enzymes, Kisqali may delay the growth of breast cancer.
How to Take Kisqali
Kisqali is taken in repeating 28-day cycles, once daily for 21 days followed by a 7-day treatment break. It is always used in combination with another hormonal anticancer therapy.
Dosage Instructions
For early breast cancer: the usual starting dose is 400 mg (2 x 200 mg tablets) once daily. For advanced or metastatic breast cancer: the usual starting dose is 600 mg (3 x 200 mg tablets) once daily. Take tablets at the same time each day, preferably in the morning, on days 1-21 of each 28-day cycle. Swallow tablets whole with water – do not chew, crush, or split them. Can be taken with or without food. Continue taking your other prescribed cancer medications as directed by your doctor.
What If You Miss a Dose?
If you miss a dose during days 1-21, skip the missed dose and take your next dose at your regular time the next day. Do not take a double dose to make up for the missed dose. Keep a treatment diary if you have trouble remembering when to take your medication.
Important: Never take a double dose to make up for a missed dose. The 7-day break is essential to help your body recover.
Available Tablet Strengths
Side Effects
Like all medications, this medicine can cause side effects. Most are mild and temporary, but some require medical attention.
Common Side Effects
These side effects occur relatively frequently and usually don’t require emergency care:
- Tiredness, fatigue, pale skin, feeling weak
- Respiratory problems (sore throat, runny nose, blocked nose, sneezing, cough)
- Reduced appetite, nausea, vomiting
- Diarrhea, constipation
- Mouth sores or ulcers with gum inflammation
- Stomach pain, upset stomach, indigestion, heartburn
- Painful and frequent urination
- Back pain
- Hair loss or thinning
- Rash, itching
- Headache
- Swollen hands, ankles or feet
- Dizziness or lightheadedness
- Abdominal pain, bloating
- Strange taste in mouth, dry mouth
- Watering or dry eyes
- Skin reddening, loss of skin color in patches, dry skin
Seek immediate medical attention if you experience:
- Allergic reactions (severe itching, rash, swelling of face/lips/tongue/throat, difficulty breathing)
- Signs of infection (fever, sweats, chills, flu-like symptoms, blood in phlegm, sores on body)
- Heart problems (chest pain, irregular heartbeat, palpitations, fainting, blue lips, shortness of breath, swelling)
- Severe skin reactions (blistering, peeling skin with painful areas, fever)
- Liver problems (yellowing of skin or eyes, nausea, loss of appetite, upper right belly pain, dark urine, easy bleeding/bruising)
- Sepsis (life-threatening blood infection with fever, chills, rapid breathing)
- Severe breathing problems (shortness of breath, cough, anxiety, confusion)
Important Warnings
There are several important warnings and precautions to be aware of before taking Kisqali.
Who Should Not Take Kisqali
Do not take Kisqali if you are allergic to ribociclib, any cyclin dependent kinase inhibitor, soya lecithin, or any other ingredients. Do not take if you have a heart problem known as QT prolongation or conditions that put you at risk for QT prolongation, such as slow heartbeat, low levels of potassium, magnesium, calcium or phosphorous in your blood, family history of QT prolongation, or if you take other medicines that prolong the QT interval.
Medical Conditions to Discuss
Tell your doctor if you have fever, sore throat or mouth ulcers due to infections (signs of low white blood cells), liver problems or previous liver disease, heart failure, heart attack, heart disorders or heart rhythm disorders, low levels of electrolytes in your blood, or if you are still having periods.
Pregnancy and Breastfeeding
Kisqali may harm your unborn baby. Women who can become pregnant should have a negative pregnancy test before starting treatment and use effective birth control during treatment and for at least 21 days after stopping Kisqali. It is not known if Kisqali passes into breast milk. Kisqali may reduce fertility in male patients.
Heart Monitoring Required: Regular heart monitoring with ECG tests is required before and during treatment due to potential heart rhythm effects.
Drug Interactions
Several medications can interfere with Kisqali and affect how it works. Always tell your doctor about all medicines you are taking.
Grapefruit interaction: Do not eat grapefruit, drink grapefruit juice, or consume pomelos, star fruit, or Seville oranges as these may change how Kisqali is absorbed.
- Antifungal medicines (ketoconazole, itraconazole, voriconazole, posaconazole)
- Antibiotics (erythromycin, clarithromycin, azithromycin, moxifloxacin, levofloxacin, norfloxacin, ciprofloxacin)
- HIV/AIDS medicines (ritonavir, saquinavir, indinavir, lopinavir, nelfinavir, telaprevir, efavirenz)
- Anti-seizure medicines (carbamazepine, phenytoin, rifampin, midazolam)
- Heart rhythm medicines (amiodarone, disopyramide, procainamide, quinidine, sotalol)
- St John’s Wort (Hypericum perforatum)
Alcohol & Driving
Kisqali may affect your ability to drive or operate machinery and may interact with alcohol.
Alcohol
Be careful drinking alcohol until you know how Kisqali affects you.
Driving and Operating Machinery
Be careful before you drive or use any machines or tools until you know how Kisqali affects you. Kisqali may cause tiredness, dizziness or vertigo in some people.
Storage
Store Kisqali tablets in the refrigerator between 2°C to 8°C. Do not place in or too near the freezer section. Keep where young children cannot reach it. Take any unwanted or expired medicine to any pharmacy for safe disposal.
Overdose Information
If you think you have taken too much Kisqali, seek urgent medical attention immediately. Phone the Poisons Information Centre (13 11 26), contact your doctor, or go to the Emergency Department at your nearest hospital, even if there are no signs of discomfort or poisoning.
Frequently Asked Questions
Kisqali is a long-term treatment that may continue for many months or years. Your doctor will regularly check your condition to ensure the treatment is having the desired effect.
Yes, Kisqali tablets can be taken with or without food. However, avoid grapefruit, grapefruit juice, pomelos, star fruit, and Seville oranges as these may change how Kisqali is absorbed.
If you miss a dose during days 1-21 of your cycle, skip the missed dose and take your next dose at your regular time the next day. Never take a double dose to make up for the missed dose.
Be careful drinking alcohol until you know how Kisqali affects you, as the medication may cause tiredness, dizziness, or vertigo.
You need regular blood tests to monitor how your liver is working, your blood cell counts, and electrolyte levels. Your doctor will also check your heart function with ECG tests and monitor your lung function.
Do not stop taking Kisqali without talking to your doctor first. This is a long-term treatment, and your doctor will tell you how long to continue taking it based on your condition and response to treatment.
The 7-day break when you don’t take Kisqali tablets helps your body recover and decreases the risk of serious side effects or infections. You should continue taking your other prescribed cancer medications during this break as directed by your doctor.
Important Disclaimer
This information is intended for general educational purposes only and should not be considered medical advice. Always consult your healthcare provider or pharmacist before starting, stopping, or changing any medication.
If you think you may have a medical emergency, call your doctor or emergency services immediately.