Kisqali Femara Co-Pack

Generic name: Ribociclib And Letrozole
Drug class: Antineoplastic combinations

Usage of Kisqali Femara Co-Pack

Ribociclib and letrozole combination is used to treat hormone receptor (HR)-positive, HER-2 negative advanced or metastatic (cancer that has spread) breast cancer in pre/perimenopausal women, postmenopausal women, or men.

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.

Kisqali Femara Co-Pack side effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Black, tarry stools

bladder pain

bleeding gums

bloating or swelling of the face, arms, hands, lower legs, or feet

bloody or cloudy urine

chest tightness

chills

cough

decrease in height

difficult, burning, or painful urination

fever

frequent urge to urinate

lower back or side pain

pain in the back, ribs, arms, or legs

pale skin

pinpoint red spots on the skin

sore throat

tingling of the hands or feet

trouble breathing

ulcers, sores, or white spots in the mouth

unusual bleeding or bruising

unusual tiredness or weakness

unusual weight gain or loss

Less common

Chest pain

confusion

dark urine

fainting

general feeling of discomfort or illness

irregular heartbeat

loss of appetite

mood or mental changes

muscle cramps in the hands, arms, feet, legs, or face

nausea

numbness and tingling around the mouth, fingertips, or feet

pain or tenderness in the upper stomach

pale stools

seizures

stomach cramps

thickening of bronchial secretions

tremor

vomiting

yellow eyes or skin

Incidence not known

Blistering, peeling, loosening of skin

diarrhea

joint or muscle pain

rash or itching skin

red irritated eyes

red skin lesions, often with a purple center

swollen glands

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Back pain

constipation

dry skin

headache

lack or loss of strength

loss or thinning of the hair

mouth or throat pain

swelling or inflammation of the mouth

trouble sleeping

Less common

Belching

dry eye

heartburn

increased tearing

indigestion

patchy loss of skin color

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Before taking Kisqali Femara Co-Pack

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.

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 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.

Bepridil

Cisapride

Colchicine

Dronedarone

Fluconazole

Gepirone

Ketoconazole

Levoketoconazole

Mavacamten

Mesoridazine

Pimozide

Piperaquine

Posaconazole

Saquinavir

Sparfloxacin

Terfenadine

Thioridazine

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

Adagrasib

Alfentanil

Alfuzosin

Amiodarone

Amisulpride

Amitriptyline

Anagrelide

Apomorphine

Aprepitant

Aripiprazole

Aripiprazole Lauroxil

Arsenic Trioxide

Asenapine

Astemizole

Atazanavir

Azithromycin

Bedaquiline

Boceprevir

Bosutinib

Buprenorphine

Buserelin

Carbamazepine

Ceritinib

Chloroquine

Chlorpromazine

Cilostazol

Ciprofloxacin

Citalopram

Clarithromycin

Clofazimine

Clomipramine

Clothiapine

Clozapine

Cobicistat

Conivaptan

Crizotinib

Cyclobenzaprine

Cyclosporine

Dabrafenib

Daridorexant

Dasatinib

Degarelix

Delamanid

Desipramine

Deslorelin

Dexmedetomidine

Dihydroergotamine

Disopyramide

Dofetilide

Dolasetron

Domperidone

Donepezil

Doxepin

Droperidol

Ebastine

Efavirenz

Elexacaftor

Encorafenib

Entrectinib

Enzalutamide

Ergotamine

Eribulin

Erythromycin

Escitalopram

Etrasimod

Everolimus

Famotidine

Fedratinib

Felbamate

Fentanyl

Fexinidazole

Fingolimod

Flecainide

Flibanserin

Fluoxetine

Fluticasone

Formoterol

Fosaprepitant

Foscarnet

Fosphenytoin

Fostemsavir

Galantamine

Gatifloxacin

Gemifloxacin

Glasdegib

Gonadorelin

Goserelin

Granisetron

Halofantrine

Haloperidol

Histrelin

Hydroquinidine

Hydroxychloroquine

Hydroxyzine

Ibutilide

Idelalisib

Iloperidone

Imipramine

Indinavir

Inotuzumab Ozogamicin

Itraconazole

Ivabradine

Ivacaftor

Ivosidenib

Lapatinib

Lefamulin

Lenvatinib

Leuprolide

Levofloxacin

Levomilnacipran

Lofexidine

Lopinavir

Lumacaftor

Lumefantrine

Lurbinectedin

Macimorelin

Mefloquine

Methadone

Methotrimeprazine

Metronidazole

Midazolam

Mifepristone

Mirtazapine

Mitotane

Mizolastine

Mobocertinib

Moricizine

Moxifloxacin

Nafarelin

Nefazodone

Nelfinavir

Nifedipine

Nilotinib

Norfloxacin

Octreotide

Ofloxacin

Olanzapine

Omaveloxolone

Ondansetron

Osilodrostat

Osimertinib

Oxaliplatin

Oxycodone

Ozanimod

Pacritinib

Paliperidone

Palovarotene

Panobinostat

Papaverine

Paroxetine

Pasireotide

Pazopanib

Pentamidine

Perphenazine

Phenobarbital

Phenytoin

Pimavanserin

Pipamperone

Pitolisant

Ponesimod

Pralsetinib

Primidone

Probucol

Procainamide

Prochlorperazine

Promethazine

Propafenone

Protriptyline

Quetiapine

Quinidine

Quinine

Quizartinib

Ranolazine

Relugolix

Rifampin

Risperidone

Ritonavir

Selpercatinib

Sertindole

Sertraline

Sevoflurane

Simvastatin

Siponimod

Sirolimus

Sodium Phosphate

Sodium Phosphate, Dibasic

Sodium Phosphate, Monobasic

Solifenacin

Sorafenib

Sotalol

St John's Wort

Sultopride

Sunitinib

Tacrolimus

Tamoxifen

Tegafur

Telaprevir

Telavancin

Telithromycin

Temsirolimus

Tetrabenazine

Tezacaftor

Tocilizumab

Tolterodine

Toremifene

Trazodone

Triclabendazole

Trimipramine

Triptorelin

Valbenazine

Vamorolone

Vandetanib

Vardenafil

Vemurafenib

Venlafaxine

Vilanterol

Vilazodone

Vinflunine

Voclosporin

Voriconazole

Vorinostat

Zolpidem

Zotepine

Zuclopenthixol

Zuranolone

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

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 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

Relate drugs

How to use Kisqali Femara Co-Pack

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 metastatic breast cancer:

Adults—

Ribociclib: 600 milligrams (mg) (three 200 mg tablets) taken as a single dose, once a day for 21 days in a row, followed by 7 days without medicine. Your doctor may adjust your dose as needed and tolerated.

Letrozole: 2.5 milligrams (mg) once a day for 28 days.

Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you vomit after you take this medicine, do not take another dose the same day. Wait and take your next dose when you normally would.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Store the medicine in its original package.

Warnings

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

It is unlikely that a postmenopausal woman may become pregnant. But, using this medicine 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 this medicine 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 this medicine. Some men and women using this medicine have become infertile (unable to have children).

Interstitial lung disease or pneumonitis can occur while using this medicine. This can be life-threatening and requires immediate medical attention. Check with your doctor right away if you have chest pain, cough, difficulty with breathing, fever or chills.

Serious skin reactions, including Stevens-Johnson Syndrome, toxic epidermal necrolysis, or drug reaction with eosinophilia and systemic symptoms (DRESS) can occur with this medicine. Check with your doctor right away if you have black, tarry stools, blistering, peeling, or loosening of the skin, chest pain, chills, cough, fever, painful or difficult urination, red skin lesions, sore throat, sores, ulcers, or white spots on the lips or in the mouth, swollen glands, unusual bleeding or bruising, or unusual tiredness or weakness with this medicine.

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 including 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 and letrozole combination can temporarily lower the number of some types of blood cells in your blood. Because of this, you may bleed or get infections more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.

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.

Disclaimer

Every effort has been made to ensure that the information provided by Drugslib.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Drugslib.com information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Drugslib.com does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Drugslib.com's drug information does not endorse drugs, diagnose patients or recommend therapy. Drugslib.com's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Drugslib.com does not assume any responsibility for any aspect of healthcare administered with the aid of information Drugslib.com provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.