Verzenios ® (abemaciklib)

För fullständig produktresumé för Verzenios se FASS.

Denna information är endast avsedd för sjukvårdspersonal verksam i Sverige och som svar på din fråga. Informationen nedan är på engelska

Verzenios® ▼ (abemaciclib): Dosering och administreringssätt

Den rekommenderade dosen abemaciklib är 150 mg två gånger dagligen vid användning i kombination med endokrin behandling.

Recommended Dosing

The recommended dose of abemaciclib is 150 mg twice daily when used in combination with endocrine therapy. 1

Please refer to the Summary of Product Characteristics of the endocrine therapy combination partner for the recommended posology. 1

Abemaciclib  should be taken continuously as long as the patient is deriving clinical benefit from therapy or until unacceptable toxicity occurs.1

Administration

Abemaciclib  is for oral use.1

The dose can be taken with or without food. It should not be taken with grapefruit or grapefruit juice.1

Patients should take the doses at approximately the same times every day.

The tablet should be swallowed whole (patients should not chew, crush, or split tablets before swallowing).1

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.2

Dose Modification

Management of some adverse reactions may require dose interruption and/or dose reduction.1

CYP3A Inducers and Inhibitors

Abemaciclib is primarily metabolised by CYP3A4.1

Concomitant use of CYP3A4 inducers should be avoided due to the risk of decreased efficacy of abemaciclib.1

Use of strong CYP3A4 inhibitors together with abemaciclib should be avoided. If strong CYP3A4 inhibitors need to be co-administered, the dose of abemaciclib should be reduced, followed by careful monitoring of toxicity.1


If the CYP3A4 inhibitor is discontinued, the abemaciclib dose should be increased to the dose used prior to the initiation of the CYP3A4 inhibitor (after 3 to 5 half-lives of the CYP3A4 inhibitor).1

Please see Summary of Product Characteristics for instructions for dose modification, which may be needed for patients taking CYP3A4 inhibitors. 1

Hepatic Impairment

No dose adjustments are necessary in patients with mild (Child Pugh A) or moderate (Child Pugh B) hepatic impairment.1 

In patients with severe (Child Pugh C) hepatic impairment, a decrease in dosing frequency to once daily is recommended.1

Overdose

In the event of an abemaciclib overdose, fatigue and diarrhoea may occur. General supportive care should be provided.1

There is no known antidote for abemaciclib overdose.2

References

1. Verzenios [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.

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

Glossary

CYP = cytochrome P450

IV = intravenous

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

Datum fӧr senaste ӧversyn 2018 M08 07

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