Kryxana Dosage/Direction for Use

Dosing and Administration: The recommended dose of KRYXANA is 600 mg (three 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. KRYXANA can be taken with or without food [see Pharmacology: Pharmacokinetics under Actions].
When given with KRYXANA, refer to the Full Prescribing Information for the recommended dose of the aromatase inhibitor being used.
When given with KRYXANA, the recommended dose of fulvestrant is 500 mg administered on Days 1, 15, 29, and once monthly thereafter. Refer to the Full Prescribing Information of fulvestrant.
Pre/perimenopausal women treated with the combination KRYXANA plus an aromatase inhibitor should be treated with a luteinizing hormone-releasing hormone (LHRH) agonist according to current clinical practice standards.
Men treated with the combination of KRYXANA plus fulvestrant should be treated with a luteinizing hormone-releasing hormone (LHRH) agonist according to current clinical practice standards.
Patients should take their dose of KRYXANA 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. KRYXANA 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.
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 KRYXANA in the management of specific adverse reactions. Dose modification of KRYXANA is recommended based on individual 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 KRYXANA 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 KRYXANA dose to 400 mg once daily. If the strong inhibitor is discontinued, change the KRYXANA 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: No dose adjustment is necessary in patients with mild hepatic impairment (Child-Pugh class A). The recommended starting dose is 400 mg KRYXANA once daily for patients with moderate (Child-Pugh class B) and severe hepatic impairment (Child-Pugh class C) [see Hepatic Impairment under Precautions and Pharmacology: Pharmacokinetics under Actions].
Review the Full Prescribing Information for the coadministered aromatase inhibitor or fulvestrant for dose modifications related to hepatic impairment.
Dose Modification for Renal Impairment: No dose adjustment is necessary in patients with mild or moderate renal impairment. The recommended starting dose is 200 mg KRYXANA once daily for patients with severe renal impairment [see Renal Impairment under Precautions and Pharmacology: Pharmacokinetics under Actions].