Kisqali

The active ingredient in Kisqali is ribociclib. It is considered a cyclin-dependent kinase 4 and 6 (CDK 4/6) inhibitor. CDK 4 and 6 are proteins that regulate the growth of both healthy and malignant cells. In cancer cells, these proteins may become hyperactive, leading to the malignancy's unchecked growth and division. Kisqali (ribociclib) inhibits CDK 4/6, which reduces the growth and spread of cancer cells.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Kisqali. However, the following is a synopsis of the general guidelines for the use of Kisqali:

• Typically, Kisqali is taken once a day for 21 days, followed by seven days of no therapy.
• You can take Kisqali with or without food.
• Kisqali is typically administered alongside a fulvestrant or an aromatase inhibitor.
• Completely swallow the Kisqali pills. Before ingesting Kisqali tablets, avoid chewing, crushing, or splitting them.
• Never take any Kisqali tablets that are damaged, cracked, or broken.
• Before taking Kisqali, you will need to have liver function tests.
• Both before and during your treatment, you will have a test called an ECG (electrocardiogram), which takes an electrical recording of your heart.

The most common side effects of Kisqali seen in clinical trials include:

• Nausea or vomiting.
• Tiredness.
• Infection.
• Joint pain.
• Hair loss.
• Low white blood cell count (neutropenia).
• Constipation.
• Diarrhea.
• Itchy skin.
• Low red blood cells.
• Dizziness.
• Low appetite.
• Back pain.

Some individuals may experience serious side effects while using Kisqali. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Lung problems: chest pain, shortness of breath, coughing, and breathing difficulties..
• Allergic reactions: skin rash, itching, hives, and swelling of the face, lips, tongue, or throat.
• Changes in heart rhythm: a rapid or erratic heartbeat, lightheadedness or fainting, chest pain, and difficulty breathing.
• Increased risk of infection: fever, chills, coughing, or sore throat.
• Symptoms of liver injury: light-colored feces, dark yellow or brown urine, right upper abdominal pain, nausea, loss of appetite, yellowing of the skin or eyes, and unusual tiredness or exhaustion.

These are not all of the possible side effects of Kisqali. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Kisqali, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including if you have:

• Any cardiac conditions, including QT prolongation, QT interval, irregular heartbeats, or heart failure.
• A previous heart attack.
• Bradycardia (slow heart rate).
• Uncontrolled high blood pressure.
• Hypothyroidism or reduced thyroid gland function.
• Issues with your blood's levels of magnesium, calcium, phosphorus, or potassium.
• Chills, a fever, or any other infection-related symptoms.
• Interstitial lung disease/pneumonitis. Severe, life-threatening, or fatal interstitial lung disease (ILD) and/or pneumonitis can occur in patients treated with Kisqali.
• Low platelets, which helps the blood to clot. You’ll have regular blood tests both before and throughout your cancer treatment to check your blood count.

You should not take Kisqali if you are allergic to ribociclib or any of the inactive ingredients in the product.

As soon as you begin taking Kisqali, it will begin to work. Six weeks after you begin taking your medication, your doctor will often do a scan to assess how your cancer is reacting to the treatment.

When Kisqali is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Strong CYP3A inhibitors, including clarithromycin, erythromycin, diltiazem, itraconazole, ketoconazole, ritonavir, verapamil, goldenseal, and grapefruit juice, should not be taken concurrently with Kisqali. Lower the Kisqali dosage if powerful inhibitors cannot be avoided.
• CYP3A4 inducers, including glucocorticoids, rifampicin, phenytoin, phenobarbital, and St. John's Wort. Steer clear of concurrent use.
• When taken with Kisqali, the dosage of CYP3A substrates, including midazolam, felodipine, buspirone, lovastatin, eletriptan, sildenafil, simvastatin, triazolam, dexamethasone, antipyrine, and quinine, may need to be lowered.
• Haloperidol, ziprasidone, quetiapine, thioridazine, olanzapine, risperidone, droperidol, amiodarone, sotalol, dofetilide, procainamide, quinidine, flecainide, macrolides, and fluoroquinolones are among the medications that are known to lengthen the QT interval.

If you have kidney or liver issues, experience certain adverse effects, or are taking drugs that interact with Kisqali (ribociclib), the dosage may change.

The usual initial dosage is 600 mg taken orally once daily for the first three weeks (21 days) of the cycle. You won't take any Kisqali (ribociclib) for the last seven days. The cycle repeats itself after the month.

As part of your treatment, you will also need to take fulvestrant (Faslodex) or an aromatase inhibitor. Additionally, your doctor may advise you to take a luteinizing hormone-releasing hormone (LHRH) agonist if you are a woman or man who has not had menopause.

Do not take another dose of Kisqali on the same day if you miss a dose or throw up after taking one. At your usual time, take your next dose.

Kisqali should be stored at room temperature and out of reach of children.

Novartis Pharmaceuticals Corporation is the company that manufactures Kisqali.

There is no generic version of Kisqali available.

Unless instructed by your doctor, do not stop taking Kisqali or alter your dosage. Kisqali can be taken with or without food. Find out from your doctor how much of your fulvestrant or nonsteroidal aromatase inhibitor (NSAI) is advised.

Kisqali may be harmful to your unborn child. Before beginning Kisqali medication, your doctor should do a pregnancy test to see if you are capable of getting pregnant. Effective birth control should be used by females who are capable of becoming pregnant while taking Kisqali and for at least three weeks following the last dose.

It is not known if Kisqali passes into your breast milk. Because of the possible adverse effects to your infant, breastfeeding is not recommended while taking Kisqali. Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. They will know or recommend what is best for you.