Kisqali Dosage/Direction for Use

Recommended Dosage: Important Administration Instructions: KISQALI can be taken with or without food [see Pharmacology: Pharmacokinetics under Actions].
Pre/perimenopausal women, or men, treated with the combination KISQALI plus an aromatase inhibitor or fulvestrant, should be treated with a luteinizing hormone-releasing hormone (LHRH) agonist according to current clinical practice standards.
Patients should take their dose of KISQALI at approximately the same time each day, preferably in the morning.
If the patient vomits after taking the dose, or misses a dose, no additional dose should be taken that day. The next prescribed dose should be taken at the usual time. KISQALI tablets should be swallowed whole (tablets should not be chewed, crushed or split prior to swallowing). No tablet should be ingested if it is broken, cracked, or otherwise not intact.
Early Breast Cancer: The recommended dosage of KISQALI is 400 mg (two 200 mg film-coated tablets) taken orally, once daily for 21 consecutive days followed by 7 days off in 28-day treatment cycles. KISQALI should be given in combination with an aromatase inhibitor. Refer to the Full Prescribing Information for the recommended dosage of the aromatase inhibitor.
In patients with early breast cancer, treatment with KISQALI should continue for 3 years or until disease recurrence or unacceptable toxicity occurs.
Advanced or Metastatic Breast Cancer: The recommended dosage of KISQALI is 600 mg (three 200 mg film-coated tablets) taken orally, once daily for 21 consecutive days followed by 7 days off in 28-day treatment cycles. KISQALI should be given in combination with endocrine therapy (fulvestrant or an aromatase inhibitor). Refer to the Full Prescribing Information for the recommended dose of endocrine therapy.
Dose Modifications: Dose Modifications for Adverse Reactions: The recommended dose modifications for adverse reactions are listed in Table 5. (See Table 5.)

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Tables 6, 7, 8, 9, 10, and 11 summarize recommendations for dose interruption, reduction, or discontinuation of KISQALI in the management of specific adverse reactions. Dose modification of KISQALI is recommended based on individual patient safety and tolerability. (See Tables 6, 7, 8, 9, 10 and 11.)

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Refer to the Full Prescribing Information for the coadministered aromatase inhibitor or fulvestrant for dose modification guidelines in the event of toxicity and other relevant safety information.
Dose Modification for Use with Strong CYP3A Inhibitors: Avoid concomitant use of KISQALI with strong CYP3A inhibitors and consider an alternative concomitant medication with less potential for CYP3A inhibition [see Drugs That May Increase Ribociclib Plasma Concentrations under Interactions].
If a strong CYP3A inhibitor must be coadministered, reduce the KISQALI dose as shown in Table 12. (See Table 12.)

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If the strong inhibitor is discontinued, change the KISQALI dose (after at least 5 half-lives of the strong CYP3A inhibitor) to the dose used prior to the initiation of the strong CYP3A inhibitor [see Drugs That May Increase Ribociclib Plasma Concentrations under Interactions and Pharmacology: Pharmacokinetics under Actions].
Dose Modification for Hepatic Impairment: The recommended dose modifications for patients with hepatic impairment are shown in Table 13 [see Hepatic Impairment under Precautions and Pharmacology: Pharmacokinetics under Actions]. (See Table 13.)

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Review the Full Prescribing Information for the co-administered aromatase inhibitor or fulvestrant for dose modifications related to hepatic impairment.
Dose Modification for Severe Renal Impairment: The recommended starting dose is 200 mg KISQALI once daily for patients with severe renal impairment [see Renal Impairment under Precautions and Pharmacology: Pharmacokinetics under Actions].