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Kisqali Femara Co-Pack Side Effects

Generic Name: letrozole / ribociclib

Note: This document contains side effect information about letrozole / ribociclib. Some of the dosage forms listed on this page may not apply to the brand name Kisqali Femara Co-Pack.

For the Consumer

Applies to letrozole / ribociclib: oral tablet therapy pack

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 this drug?

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.

For Healthcare Professionals

Applies to letrozole / ribociclib: oral tablet

General

The most common adverse reactions and laboratory abnormalities (20% or more frequency) were decreased leukocyte count (93%), decreased neutrophil count (93%), neutropenia (75%), decreased hemoglobin count (57%), nausea (52%), decreased lymphocyte count (51%), increased ALT (46%), increased AST (44%), fatigue (37%), diarrhea (35%), alopecia (33%), leukopenia (33%), decreased platelet count (29%), vomiting (29%), constipation (25%), headache (22%), back pain (20%), and increased creatinine (20%).[Ref]

Hematologic

Very common (10% or more): Decreased leukocyte count (93%), decreased neutrophil count (93%), neutropenia (75%), decreased hemoglobin count (57%), decreased lymphocyte count (51%), leukopenia (33%), decreased platelet count (29%), anemia (18%), lymphopenia (11%)[Ref]

Gastrointestinal

Very common (10% or more): Nausea (52%), diarrhea (35%), vomiting (29%), constipation (25%), stomatitis (12%), abdominal pain (11%)[Ref]

Hepatic

Very common (10% or more): Increased ALT (46%), increased AST (44%), abnormal liver function tests (18%)
Frequency not reported: Increased blood bilirubin[Ref]

Other

Very common (10% or more): Fatigue (37%), pyrexia (13%), peripheral edema (12%)
Uncommon (0.1% to 1%): On-treatment death[Ref]

Dermatologic

Very common (10% or more): Alopecia (33%), rash (17%), pruritus (14%)[Ref]

Nervous system

Very common (10% or more): Headache (22%)
Common (1% to 10%): Syncope[Ref]

Musculoskeletal

Very common (10% or more): Back pain (20%)
Common (1% to 10%): Fractures
Uncommon (0.1% to 1%): Osteoporosis[Ref]

Renal

Very common (10% or more): Increased creatinine (20%)[Ref]

Metabolic

Very common (10% or more): Decreased appetite (19%), decreased phosphorus (13%), decreased potassium (11%)
Frequency not reported: Hypokalemia[Ref]

Psychiatric

Very common (10% or more): Insomnia (12%)[Ref]

Respiratory

Very common (10% or more): Dyspnea (12%)[Ref]

Genitourinary

Very common (10% or more): Urinary tract infection (11%)[Ref]

Cardiovascular

Common (1% to 10%): QT interval prolongation[Ref]

References

1. "Product Information. Kisqali Femara Co-Pack (letrozole-ribociclib)." Novartis Pharmaceuticals, East Hanover, NJ.

Some side effects of Kisqali Femara Co-Pack may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. 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 substances you are taking, check with your doctor, nurse, or pharmacist.

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