Kisqali Femara Co-Pack (ribociclib and letrozole) - Uses, Side Effects, and More

What are the most common side effects of Kisqali Femara Co-Pack?

The most common side effects of Kisqali Femara Co-Pack are listed below. Tell your healthcare provider if you have any of these side effects that bother you.

• Blood disorders, including low white blood cells, low red blood cells, and low platelets
• Liver damage (see below)
• Infections
• Nausea and vomiting
• Tiredness
• Diarrhea
• Headache
• Hair loss
• Back pain
• Constipation
• Cough
• Rash
• Kidney damage
• Stomach pain

There may be other side effects of Kisqali Femara Co-Pack that are not listed here. Contact your healthcare provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Kisqali Femara Co-Pack?

While less common, the most serious side effects of Kisqali Femara Co-Pack are described below, along with what to do if they happen.

Severe Allergic Reactions. Kisqali Femara Co-Pack may cause allergic reactions, which can be serious. Stop taking Kisqali Femara Co-Pack and get help right away if you have any of the following symptoms of a serious allergic reaction.

• Breathing problems or wheezing
• Racing heart
• Fever or general ill feeling
• Swollen lymph nodes
• Swelling of the face, lips, mouth, tongue, or throat
• Trouble swallowing or throat tightness
• Itching, skin rash, or pale red bumps on the skin called hives
• Nausea or vomiting
• Dizziness, feeling lightheaded, or fainting
• Stomach cramps
• Joint pain

Lung Inflammation. Kisqali Femara Co-Pack can cause inflammation in your lungs, also called interstitial lung disease or pneumonitis. This can be serious or even life-threatening. Get emergency help if you have trouble breathing. You may also have a cough, fever, or chest pain. 

Severe Skin Reactions. Kisqali Femara Co-Pack can cause severe skin reactions, called Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN), and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), that can lead to death if not treated. DRESS is also sometimes called multi-organ hypersensitivity. This is a reaction that can affect multiple parts of the body including your liver, kidneys, and heart. If you develop a rash, stop Kisqali Femara Co-Pack and call your healthcare provider right away. Get emergency help right away if you have any of the following symptoms of SJS, TEN, or DRESS.

• Painful red or purple skin that looks burned and peels off
• Flat red rash or blisters on your skin, mouth, nose, and genitals
• Red, painful, watery eyes
• Breathing problems or wheezing
• Racing heart
• Itching, skin rash, or pale red bumps on the skin called hives
• Fever or general ill feeling
• Swollen lymph nodes
• Swelling of the face, lips, mouth, tongue, or throat
• Shortness of breath, trouble swallowing, or throat tightness
• Swelling in your feet, ankles, or legs
• Nausea or vomiting
• Dizziness, feeling lightheaded, or fainting
• Stomach cramps
• Joint pain
• Dark-colored pee
• Your skin or the whites of your eyes turning yellowish in color (also called jaundice)

Heart Rhythm Changes. Kisqali Femara Co-Pack may cause a rare, dangerous heart rhythm problem called QT prolongation and torsade de pointes. Some people have a higher risk of this, including people who are older, have other people in their family who have had these conditions, have low potassium or magnesium levels, or who take some medicines that can cause QT prolongation. Tell your healthcare provider right away if you faint or have changes in your heart rate or rhythm, such as a fast or skipping heartbeat.

Liver Damage. Liver damage, also called hepatotoxicity, can happen when taking Kisqali Femara Co-Pack. Call your healthcare provider right away if you have any of the following symptoms of liver damage.

• Nausea or vomiting
• Stomach or belly pain
• Fever
• Weakness or unusual tiredness
• Itching
• Loss of appetite
• Light-colored poop
• Dark-colored urine (pee)
• Your skin or the whites of your eyes turning yellowish in color (also called jaundice)

Low Neutrophil Levels (Neutropenia). Kisqali Femara Co-Pack may cause low levels of a type of white blood cell (called neutrophils), which is known as neutropenia. Neutrophils help prevent infection. Having a low level of neutrophils may increase your risk of infection. Tell your healthcare provider right away  if you have any of the following symptoms of low neutrophil levels.

• Fever, chills, or sweats
• Tiredness
• Sore throat, cough, or shortness of breath
• Mouth or throat sores
• Swollen lymph nodes

Weak Bones. Taking letrozole (Femara) for a long time may cause your bones to become weaker, leading to reduced bone density (osteopenia). Letrozole is one of the medicines in Kisqali Femara Co-Pack. It may also cause a more serious condition called osteoporosis, which can cause bones to break (fracture) more easily. If you take letrozole, your healthcare provider may monitor your bone density. Tell your healthcare provider if you break a bone, and get a bone mineral density test if one is ordered for you.

High Cholesterol. Taking letrozole (Femara) may cause levels of cholesterol (fat) in your blood to go up. If you take letrozole, your healthcare provider may monitor your cholesterol levels. Keep all appointments to have your blood cholesterol checked.