Brand Name
Kisqali Femara Co-Pack
Description
Ribociclib and letrozole combination is used to treat hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER-2)-negative breast cancer. It is used in combination with an aromatase inhibitor to treat stage II and III early breast cancer with a high risk of coming back. This medicine is also used to treat advanced (has gotten worse) or metastatic (has spread throughout the body) breast cancer in combination with an aromatase inhibitor as the first endocrine-based treatment.
Ribociclib belongs to the group of medicines called antineoplastics. It interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal cells may also be affected by the medicine, other unwanted effects will also occur. Some of these may be serious and must be reported to your doctor.
Some hormones that occur naturally in the body can increase the growth of some breast cancers. Letrozole works by decreasing the amounts of these hormones in the body.
This medicine is available only with your doctor’s prescription.
This product is available in the following dosage forms:
- Tablet
Before Using
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 this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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 and letrozole combination 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 and letrozole combination in the elderly.
Breastfeeding
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.
Drug Interactions
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 this medicine, 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 this medicine 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.
- Alprazolam
- Bepridil
- Cisapride
- Colchicine
- Conivaptan
- Dihydroergotamine
- Dronedarone
- Eletriptan
- Eplerenone
- Ergotamine
- Finerenone
- Flibanserin
- Fluconazole
- Gepirone
- Isavuconazonium Sulfate
- Ivabradine
- Ketoconazole
- Levoketoconazole
- Lomitapide
- Lonafarnib
- Lovastatin
- Lurasidone
- Mavacamten
- Mesoridazine
- Naloxegol
- Pacritinib
- Pimozide
- Piperaquine
- Posaconazole
- Saquinavir
- Silodosin
- Simvastatin
- Sparfloxacin
- Terfenadine
- Thioridazine
- Tolvaptan
- Ubrogepant
- Voclosporin
- Ziprasidone
Using this medicine 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.
- Abametapir
- Abemaciclib
- Acalabrutinib
- Adagrasib
- Alfentanil
- Alfuzosin
- Amiodarone
- Amisulpride
- Amitriptyline
- Anagrelide
- Apomorphine
- Aprepitant
- Aripiprazole
- Aripiprazole Lauroxil
- Arsenic Trioxide
- Asciminib
- Asenapine
- Astemizole
- Atazanavir
- Avacopan
- Axitinib
- Azithromycin
- Bedaquiline
- Benzhydrocodone
- Berotralstat
- Bictegravir
- Boceprevir
- Bosutinib
- Brigatinib
- Budesonide
- Buprenorphine
- Buserelin
- Capivasertib
- Carbamazepine
- Ceritinib
- Chloroquine
- Chlorpromazine
- Cilostazol
- Ciprofloxacin
- Citalopram
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Amlodipine
Other Interactions
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 this medicine 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 this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
- Grapefruit Juice
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Angina (severe chest pain), unstable or
- Congestive heart failure or
- Electrolyte imbalance (eg, high or low potassium, calcium, phosphorus, magnesium in the blood) or
- Heart attack, recent or
- Heart rhythm problems (eg, long QT syndrome, slow, fast, or irregular heartbeat) or
- Hypertension (high blood pressure), uncontrolled or
- Hypothyroidism (underactive thyroid), uncontrolled—Avoid use. May cause side effects to become worse.
- Infection or
- Neutropenia (low white blood cells)—May decrease your body’s ability to fight infection.
- Kidney disease, severe or
- Liver disease, severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
- Lung problems (eg, interstitial lung disease, pneumonitis)—Use with caution. May make these conditions worse.
Proper Use
Medicines used to treat cancer are very strong and can have many side effects. Before taking this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.
This medicine comes with a patient information insert. Read and follow the instructions carefully. Ask your doctor if you have any questions.
It is important that you take both medicines at the same time each day, preferably in the morning.
Your doctor may also give you luteinizing hormone-releasing hormone medicine together with this medicine.
Swallow the tablet whole. Do not crush, break, or chew it. You may take this medicine with or without food.
Do not eat grapefruit or drink grapefruit juice while you are using this medicine.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For oral dosage form (tablets):
- For early breast cancer:
- Adults—
- Ribociclib: 400 milligrams (mg) (two 200 mg tablets) taken as a single dose, once a day for 21 consecutive days, followed by 7 days without medicine. Your doctor may adjust
- Adults—
- For early breast cancer:
