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Ribociclib/Letrozole is copackaged containing:

• KISQALI: 200 mg
• FEMARA: 2.5 mg

Ribociclib/Letrozole, a co-packaged product containing ribociclib, a kinase inhibitor, and letrozole, an aromatase inhibitor, is indicated as initial endocrine-based therapy for the treatment of pre/perimenopausal or postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic
breast cancer.

Ribociclib/Letrozole contains two medications. Ribociclib works by slowing or stopping the growth of cancer cells. Letrozole works by decreasing the amount of estrogen the body makes, which helps slow down or reverse the growth of some breast cancers.

Ribociclib/Letrozole is dosed as follows:
Ribociclib/Letrozole contains both ribociclib and letrozole (an aromatase inhibitor) packaged together. It’s taken in a 1 month (28 days) cycle. For the first 3 weeks (21 days) of the cycle, the typical starting dose is 600 mg of ribociclib by mouth once daily. During the last week (7 days), you won’t take any ribociclib. At the end of the month, the cycle starts over again. During that last week when you aren’t taking ribociclib, you’ll still continue to use letrozole 2.5 mg by mouth daily.

Ribociclib/Letrozole is a safe and effective treatment when used for FDA licensed indications. However, like all medications, they may give you unwanted side effects. You should always discuss potential side effects with your physician to ensure the medication is suitable and right for you.

Common side effects of Ribociclib/Letrozole:

• Neutropenia
• Nausea
• Infections
• Fatigue
• Leukopenia
• Diarrhea
• Hair loss
• Vomiting
• Headache
• Constipation
• Back pain
• Rash
• Anemia

Serious side effects are rare with Ribociclib/Letrozole. Contact your healthcare provider immediately if you experience any of the following.

• Lung problems: cough, trouble breathing, shortness of breath, chest pain
• Severe skin reactions: severe rash or rash that keeps getting worse, reddened skin, flu-like symptoms, skin pain/burning, blistering of the lips, eyes or mouth,
  blisters on the skin or skin peeling, with or without fever
• Heart rhythm problems (QT prolongation): change in your heartbeat (a fast or irregular heartbeat), or if you feel dizzy or faint
• Liver problems: yellowing of your skin or the whites of your eyes (jaundice), dark or brown (tea-colored) urine, feeling very tired, loss of appetite, pain on the upper right side of your stomach area (abdomen)
• Low white blood cell counts (neutropenia): symptoms of infections such as fever and chills

The following medications may interact with Ribociclib/Letrozole:

• CYP3A4 Inhibitors: Avoid concomitant use of KISQALI FEMARA COPACK with strong CYP3A inhibitors. If strong inhibitors cannot be avoided, reduce KISQALI dose
• CYP3A4 Inducers: Avoid concomitant use of KISQALI FEMARA COPACK with strong CYP3A inducers.
• CYP3A Substrates: The dose of sensitive CYP3A substrates with narrow therapeutic indices may need to be reduced when given concurrently with Ribociclib/Letrozole
• Drugs Known to Prolong QT Interval: Avoid concomitant use of drugs known to prolong QT interval, such as anti-arrhythmic medicines

Various FDA-approved generic manufacturers

Ribociclib/Letrozole can harm your unborn baby. If you are able to become pregnant, your healthcare provider should do a pregnancy test before you start treatment with Ribociclib/Letrozole. Females who are able to become pregnant and who take Ribociclib/Letrozole should use effective birth control during treatment and for at least 3 weeks after the last dose of Ribociclib/Letrozole. Talk to your healthcare provider about birth control methods that may be right for you during this time. If you become pregnant or think you are pregnant, tell your healthcare provider right away.

• Kisqali Femara Co-Pack