Kryxana Dosage/Direction for Use

Treatment with ribociclib should be initiated by a physician experienced in the use of anticancer therapies.
Dosage regimen: General target population: The recommended dose of ribociclib is 600 mg (3 x 200 mg film-coated tablets) taken orally, once daily for 21 consecutive days followed by 7 days off treatment resulting in a complete cycle of 28 days. Ribociclib can be taken with or without food (see INTERACTIONS).
For dosing and administration with the aromatase inhibitor, refer to the applicable full prescribing information.
Patients should take their dose of ribociclib and the aromatase inhibitor at approximately the same time each day, preferably in the morning.
When co-administered with ribociclib, the recommended dose of fulvestrant is 500 mg administered intramuscularly on days 1, 15 and 29, and once monthly thereafter. Please refer to full prescribing information of fulvestrant.
Treatment of pre- or peri-menopausal women or men, with ribociclib should include co-administration of an LHRH agonist according to local clinical practice standards.
Dose modifications: Management of severe or intolerable adverse drug reactions (ADRs) may require temporary dose interruption/reduction or discontinuation of ribociclib. If dose reduction is required, the recommended dose reduction guidelines for adverse drug reactions (ADRs) are listed in Table 14. (See Table 14.)

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Tables 15, 16, 17, 18 and 19 summarize recommendations for dose interruption, reduction, or discontinuation of ribociclib in the management of specific adverse events. Clinical judgment of the treating physician should guide the management plan of each patient based on individual benefit/risk assessment (see PRECAUTIONS and ADVERSE REACTIONS). (See Tables 15, 16, 17, 18 and 19.)

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Refer to the full prescribing information for the co-administered aromatase inhibitor, fulvestrant or LHRH agonist for dose modification guidelines in the event of toxicity and other relevant safety information.
Dose modification for use of ribociclib (Kryxana) with strong CYP3A inhibitors: Concomitant use of ribociclib should be avoided with strong CYP3A inhibitors and an alternative concomitant medication should be considered with low potential for CYP3A inhibition. If a strong CYP3A inhibitor must be co-administered, the ribociclib dose should be reduced to 200 mg once daily. If the strong inhibitor is discontinued, the ribociclib dose should be changed (after at least 5 elimination half-lives of the strong CYP3A inhibitor) to the dose used prior to the initiation of the strong CYP3A inhibitor (see PRECAUTIONS, INTERACTIONS and PHARMACOLOGY under ACTIONS).
Special populations: Renal impairment: Based on population pharmacokinetic analysis and data from cancer patients in clinical trials, no dose adjustment is necessary in patients with mild or moderate renal impairment (see PHARMACOLOGY under ACTIONS).
Based on a renal impairment study in healthy subjects and non-cancer subjects with severe renal impairment, a starting dose of 200 mg is recommended. Ribociclib has not been studied in breast cancer patients with severe renal impairment (see PHARMACOLOGY under ACTIONS).
Hepatic impairment: Based on a hepatic impairment study in healthy subjects and non-cancer subjects with impaired hepatic function, no dose adjustment is necessary in patients with mild hepatic impairment (Child-Pugh class A). A dose adjustment is required in patients with moderate (Child-Pugh class B) and severe hepatic impairment (Child-Pugh class C) and the starting dose of 400 mg is recommended. Ribociclib has not been studied in breast cancer patients with moderate and severe hepatic impairment (see PHARMACOLOGY under ACTIONS).
Review the full prescribing information for the aromatase inhibitor, fulvestrant or the LHRH agonist for dose modifications related to hepatic impairment.
Pediatric patients: There are limited data in pediatric patients and the safety and efficacy of ribociclib in this population have not been established.
Geriatric patients (65 years of age or older): No dose adjustment is required in patients over 65 years of age (see PHARMACOLOGY under ACTIONS).
Method of administration: Ribociclib should be taken orally once daily at the same time every day, preferably in the morning, with or without food. If the patient vomits after taking the dose or misses a dose, an additional dose should not be taken that day. The next prescribed dose should be taken at the usual time. Ribociclib tablets should be swallowed whole (tablets should not be chewed, crushed or split prior to swallowing). Tablets that are broken, cracked, or otherwise not intact should not be ingested.