- What is Kisqali (ribociclib) and how is it used?
- What are the most important side effects and other facts about Kisqali (ribociclib)?
- Other side effects of Kisqali (ribociclib)
- What is the dosage for Kisqali (ribociclib)?
- Kisqali (ribociclib) contraindications, pregnancy safety and drug interactions
What is Kisqali (ribociclib) and how is it used?
Kisqali is a prescription medicine used in combination with:
- an aromatase inhibitor to treat pre/perimenopausal or postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer that has spread to other parts of the body (metastatic), as the first endocrine based therapy; or
- fulvestrant to treat postmenopausal women with HR-positive, HER2-negative metastatic breast cancer as the first endocrine based therapy or with disease progression following endocrine therapy.
What are the most important side effects and other facts about Kisqali (ribociclib)?
Kisqali may cause serious side effects, including:
- Lung problems. Kisqali may cause severe or life-threatening inflammation of the lungs during treatment that may lead to death. Tell your healthcare provider right away if you have any new or worsening symptoms, including:
- trouble breathing or shortness of breath
- cough with or without mucus
- chest pain
- Heart rhythm problems (QT prolongation). Kisqali can cause a heart problem known as QT prolongation. This condition can cause an abnormal heartbeat and may lead to death. Your healthcare provider should check your heart and do blood tests before and during treatment with Kisqali. Tell your healthcare provider right away if you have a change in your heartbeat (a fast or irregular heartbeat), or if you feel dizzy or faint.
- Liver problems. Kisqali can cause serious liver problems. Your healthcare provider should do blood tests to check your liver before and during treatment with Kisqali. Tell your healthcare provider right away if you get any of the following signs and symptoms of liver problems:
- yellowing of your skin or the whites of your eyes (jaundice)
- dark or brown (tea-colored) urine
- feeling very tired
- loss of appetite
- pain on the upper right side of your stomach area (abdomen)
- bleeding or bruising more easily than normal
- Low white blood cell counts (neutropenia). Low white blood cell counts are very common when taking Kisqali and may result in infections that may be severe. Your healthcare provider should check your white blood cell counts before and during treatment with Kisqali. Tell your healthcare provider right away if you have signs and symptoms of low white blood cell counts or infections such as fever and chills.
Your healthcare provider may tell you to decrease your dose, temporarily stop or completely stop taking Kisqali if you develop certain serious side effects during treatment with Kisqali.
Other side effects of Kisqali (ribociclib)
The most common side effects of Kisqali include:
Kisqali may cause fertility problems if you are male and take Kisqali. This may affect your ability to father a child. Talk to your healthcare provider if this is a concern for you.
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all of the possible side effects of Kisqali. For more information, ask your healthcare provider or pharmacist.
What is the dosage for Kisqali (ribociclib)?
- Take Kisqali exactly as your healthcare provider tells you.
- Do not change your dose or stop taking Kisqali unless your healthcare provider tells you.
- Take Kisqali each day at about the same time, preferably in the morning.
- You may take Kisqali with or without food.
- Swallow Kisqali tablets whole. Do not chew, crush, or split Kisqali tablets before swallowing them.
- Do not take any Kisqali tablets that are broken, cracked, or that look damaged. If you miss a dose of Kisqali or vomit after taking a dose of Kisqali, do not take another dose on that day. Take your next dose at your regular time.
- If you take too much Kisqali, call your healthcare provider right away or go to the nearest hospital emergency room.
- Inform your healthcare provider if you are pre-or perimenopausal.
What should I avoid while taking Kisqali?
Avoid eating grapefruit and drinking grapefruit juice during treatment with Kisqali since these may increase the amount of Kisqali in your blood.
Kisqali (ribociclib) contraindications, pregnancy safety and drug interactions
It is not known if Kisqali is safe and effective in children.
What should I tell my healthcare provider before taking Kisqali?
Before you take Kisqali, tell your healthcare provider if you:
- have any heart problems, including heart failure, irregular heartbeats, and QT prolongation
- have ever had a heart attack
- have a slow heartbeat (bradycardia)
- have problems with the amount of potassium, calcium, phosphorus, or magnesium in your blood
- have fever, chills, or any other signs or symptoms of infection
- have liver problems
- have any other medical conditions
- are pregnant, or plan to become pregnant. Kisqali can harm your unborn baby.
- If you are able to become pregnant, your healthcare provider should do a pregnancy test before you start treatment with Kisqali.
- Females who are able to become pregnant and who take Kisqali should use effective birth control during treatment and for at least 3 weeks after the last dose of Kisqali.
- Talk to your healthcare provider about birth control methods that may be right for you during this time.
- If you become pregnant or think you are pregnant, tell your healthcare provider right away.
- are breastfeeding or plan to breastfeed. It is not known if Kisqali passes into your breast milk. Do not breastfeed during treatment with Kisqali and for at least 3 weeks after the last dose of Kisqali.
Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Kisqali and other medicines may affect each other causing side effects. Know the medicines you take. Keep a list of them to show your healthcare provider or pharmacist when you get a new medicine.
Kisqali (ribociclib) is a prescription medicine used in combination with an aromatase inhibitor to treat pre/perimenopausal or postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer that has spread to other parts of the body (metastatic), as the first endocrine based therapy; or fulvestrant to treat postmenopausal women with HR-positive, HER2-negative metastatic breast cancer as the first endocrine based therapy or with disease progression following endocrine therapy. The most common side effects of Kisqali include neutropenia, diarrhea, headache, nausea, leukopenia, constipation, infections, vomiting, rash, fatigue, hair loss, and cough. Serious side effects of Kisqali include lung problems, heart rhythm problems, liver problems, and low white blood cell counts.
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Male Breast Cancer
Male breast cancer accounts for 1% of all breast cancers, and most cases are found in men between the ages of 60 and 70. A man's risk of developing breast cancer is one in 1,000. Signs and symptoms include a firm mass located below the nipple and skin changes around the nipple, including puckering, redness or scaling, retraction and ulceration of the nipple. Treatment depends upon staging and the health of the patient.
Breast cancer is an invasive tumor that develops in the mammary gland. Breast cancer is detected via mammograms, breast self-examination (BSE), biopsy, and specialized testing on breast cancer tissue. Treatment of breast cancer may involve surgery, radiation, hormone therapy, chemotherapy, and targeted therapy. Breast cancer risk may be lowered by managing controllable risk factors. What you should know about breast cancer Breast cancer is the most common cancer among American women. One in every eight women in the United States develops breast cancer. There are many types of breast cancer that differ in their capability of spreading (metastasize) to other body tissues. The causes of breast cancer are unknown, although medical professionals have identified a number of risk factors. There are 11 common types of breast cancer and 4 uncommon types of breast cancer. Breast cancer early signs and symptoms include a lump in the breast or armpit, bloody nipple discharge, inverted nipple, orange-peel texture or dimpling of the breast's skin (peau d'orange), breast pain or sore nipple, swollen lymph nodes in the neck or armpit, and a change in the size or shape of the breast or nipple. Breast cancer can also be symptom free, which makes following national screening recommendations an important practice. Breast cancer is diagnosed during a physical exam, by a self-exam of the breasts, mammography, ultrasound testing, and biopsy. Treatment of breast cancer depends on the type of cancer and its stage (0-IV) and may involve surgery, radiation, or chemotherapy.
Triple-Negative Breast Cancer
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Inflammatory breast cancer is an accelerated form of breast cancer that is not usually detected by mammogram or ultrasound. Symptoms of inflammatory breast cancer include pain in the breast, skin change in the breast area, bruise on the breast,sudden swelling of the breast, nipple retraction or discharge, and swelling of the lymph nodes.
Breast Cancer Prevention
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Being diagnosed with breast cancer is stressful. Learning relaxation techniques, exercising, eating well, getting adequate sleep, receiving psychotherapy, and maintaining a positive attitude can help you cope. Creating documents, such as an advance directive, living will, and durable power of attorney will outline your wishes in the event that you are no longer able to make decisions regarding your care.
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.