Verzenio® (Abemaciclib)

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Abemaciclib: dosificación y administración

La dosis recomendada de Abemaciclib en combinación con la terapia endocrina es de 150 mg por vía oral dos veces al día; o como monoterapia, 200 mg por vía oral dos veces al día.

Recommended Dosing

The recommended dose of abemaciclib in combination with ET is 150 mg orally, twice daily. Administer the recommended dose of ET when given with abemaciclib. The recommended dose of abemaciclib as a single agent is 200 mg orally, twice daily. It is recommended that treatment be continued until disease progression or unacceptable toxicity.1

Administration

Abemaciclib may be taken with or without food. Patients should avoid grapefruit products.1 Patients should take the doses at approximately the same times every day. If a patient vomits or misses a dose of abemaciclib, instruct the patient to take the next dose at its scheduled time. Abemaciclib tablets should be swallowed whole (do not chew, crush, or split them prior to swallowing). No tablet should be ingested if it is broken, cracked, or otherwise not intact.2

Abemaciclib tablets are not scored and are not designed to be split or divided into smaller doses. Abemaciclib is approved for oral administration only. It is not available as a parenteral product for IV administration.1

Dose Modification

Abemaciclib dose modification is recommended based on individual safety and tolerability. Management of some adverse reactions (eg, diarrhea, hematologic toxicities, or hepatotoxicity) may require dose interruption and/or dose reduction.2 If dose reduction is necessary, please see local labeling for instructions for dose reduction.

CYP3A Inducers and Inhibitors

Abemaciclib is primarily metabolized by CYP3A.1

Avoid concomitant use of CYP3A inducers. Consider alternative agents without CYP3A induction.1

Avoid concomitant use of strong CYP3A inhibitors and use caution with coadministered moderate or weak CYP3A inhibitors.1 Please see local labeling for instructions for dose modification, which may be needed for patients taking CYP3A inhibitors.

Hepatic Impairment

In patients with severe hepatic impairment (Child-Pugh C), decrease the dosing frequency to once daily. No dosage adjustments are necessary in patients with mild or moderate hepatic impairment (Child-Pugh A or B).1

Overdose

In case of overdose, use general supportive measures. There is no known antidote for abemaciclib overdose.1

References

1. Data on file, Eli Lilly and Company and/or one of its subsidiaries.

2. Verzenio [package insert]. Indianapolis, IN: Eli Lilly and Company; 2018.

Glossary

CYP = cytochrome P450

ET = endocrine therapy

IV = intravenous

Fecha de la última revisión: 2018 M08 07


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