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Kisqali Femara Co-Pack

Generic Name: Ribociclib and Letrozole (rye boe SYE klib & LET roe zole)
Brand Name: Kisqali Femara Co-Pack

Uses of Kisqali Femara Co-Pack:

  • It is used to treat breast cancer in women after change of life.

What do I need to tell my doctor BEFORE I take Kisqali Femara Co-Pack?

  • If you have an allergy to Kisqali Femara Co-Pack (ribociclib and letrozole) or any part of this medicine.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you have any of these health problems: Electrolyte problems (like calcium, magnesium, phosphorous, or potassium), heart problems like heart failure or a certain type of chest pain (unstable angina), long QT on ECG, or slow or abnormal heartbeat.
  • If you have had a recent heart attack.
  • If you are taking any drugs that can cause a certain type of heartbeat that is not normal (prolonged QT interval). There are many drugs that can do this. Ask your doctor or pharmacist if you are not sure.
  • If you take any drugs (prescription or OTC, natural products, vitamins) that must not be taken with Kisqali Femara Co-Pack, like certain drugs that are used for HIV, infections, or seizures. There are many drugs that must not be taken with this medicine.
  • If you are taking St. John's wort. Do not take St. John's wort with Kisqali Femara Co-Pack. This medicine may not work as well.
  • If you are breast-feeding. Do not breast-feed while you take this medicine and for 3 weeks after your last dose.

This is not a list of all drugs or health problems that interact with Kisqali Femara Co-Pack.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Kisqali Femara Co-Pack?

  • Tell all of your health care providers that you take Kisqali Femara Co-Pack. This includes your doctors, nurses, pharmacists, and dentists.
  • An unsafe heartbeat that is not normal (long QT on ECG) has happened with this medicine. This may raise the chance of sudden death. Talk with the doctor.
  • You will need an ECG before starting Kisqali Femara Co-Pack and during treatment. Talk with your doctor.
  • If you have upset stomach, throwing up, loose stools (diarrhea), or are not hungry, talk with your doctor. There may be ways to lower these side effects.
  • You may have more chance of getting an infection. Wash hands often. Stay away from people with infections, colds, or flu.
  • This medicine may cause weak bones. This may happen more often if used for a long time. This may raise the chance of broken bones. Call your doctor right away if you have bone pain.
  • Have a bone density test as you have been told by your doctor. Talk with your doctor.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • Take calcium and vitamin D as you were told by your doctor.
  • Avoid star fruit, pomegranate or pomegranate juice, and grapefruit or grapefruit juice while you take this medicine.
  • This medicine may affect how much of some other drugs are in your body. If you are taking other drugs, talk with your doctor. You may need to have your blood work checked more closely while taking Kisqali Femara Co-Pack with your other drugs.
  • This medicine may affect fertility. Fertility problems may lead to not being able to get pregnant or father a child. Talk with the doctor.
  • This medicine may cause harm to the unborn baby if you take it while you are pregnant.
  • If you are able to get pregnant, a pregnancy test will be done to show that you are NOT pregnant before starting this medicine. Talk with your doctor.
  • Use birth control that you can trust to prevent pregnancy while taking Kisqali Femara Co-Pack (ribociclib and letrozole) and for at least 3 weeks after your last dose.
  • If you get pregnant while taking this medicine or within 3 weeks after your last dose, call your doctor right away.

How is this medicine (Kisqali Femara Co-Pack) best taken?

Use Kisqali Femara Co-Pack as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • Follow how to take this medicine as you have been told by your doctor. Do not use more than you were told to use.
  • Take with or without food.
  • Take in the morning.
  • Take Kisqali Femara Co-Pack at the same time of day.
  • Swallow whole. Do not chew, break, or crush.
  • Do not take chipped or broken tablets.
  • To gain the most benefit, do not miss doses.
  • If you throw up after taking a dose, do not repeat the dose. Take your next dose at your normal time.
  • Keep taking this medicine as you have been told by your doctor or other health care provider, even if you feel well.

What do I do if I miss a dose?

  • Skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.

See also: Dosage Information (in more detail)

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
  • Signs of a urinary tract infection (UTI) like blood in the urine, burning or pain when passing urine, feeling the need to pass urine often or right away, fever, lower stomach pain, or pelvic pain.
  • Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
  • Signs of electrolyte problems like mood changes, confusion, muscle pain or weakness, a heartbeat that does not feel normal, seizures, not hungry, or very bad upset stomach or throwing up.
  • Dizziness or passing out.
  • A fast heartbeat.
  • A heartbeat that does not feel normal.
  • Feeling very tired or weak.
  • Shortness of breath.
  • Swelling in the arms or legs.
  • Any unexplained bruising or bleeding.

What are some other side effects of Kisqali Femara Co-Pack?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Feeling tired or weak.
  • Headache.
  • Upset stomach or throwing up.
  • Back pain.
  • Hard stools (constipation).
  • Loose stools (diarrhea).
  • Not hungry.
  • Not able to sleep.
  • Mouth irritation or mouth sores.
  • Belly pain.
  • Hair loss.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

See also: Side effects (in more detail)

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Kisqali Femara Co-Pack?

  • Store in the original container at room temperature.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.

Consumer Information Use and Disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Kisqali Femara Co-Pack, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Kisqali Femara Co-Pack. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using Kisqali Femara Co-Pack.

Review Date: December 6, 2017

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