Verzenio

Verzenio Dosage/Direction for Use

abemaciclib

Manufacturer:

Eli Lilly

Distributor:

Zuellig
Full Prescribing Info
Dosage/Direction for Use
Verzenio therapy should be initiated and supervised by physicians experienced in the use of anti-cancer therapies.
Posology: Verzenio in combination with endocrine therapy: The recommended dose of abemaciclib is 150 mg twice daily when used in combination with endocrine therapy. Please refer to the Summary of Product Characteristics of the endocrine therapy combination partner for the recommended posology.
Verzenio should be taken continuously as long as the patient is deriving clinical benefit from therapy or until unacceptable toxicity occurs.
If a patient vomits or misses a dose of Verzenio, the patient should be instructed to take the next dose at its scheduled time; an additional dose should not be taken.
Dose adjustments: Management of some adverse reactions may require dose interruption and/or dose reduction as shown in Tables 3-7. (See Table 3.)

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Complete blood counts should be monitored prior to the start of Verzenio therapy, every two weeks for the first two months, monthly for the next two months, and as clinically indicated. Before treatment initiation, absolute neutrophil counts (ANC) ≥1500/mm3, platelets ≥100,000/mm3, and haemoglobin ≥8 g/dL are recommended. (See Table 4.)

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Treatment with antidiarrhoeal agents, such as loperamide, should be started at the first sign of loose stools. (See Table 5.)

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Alanine aminotransferase (ALT) and aspartate aminostransferase (AST) should be monitored prior to the start of Verzenio therapy, every two weeks for the first two months, monthly for the next two months, and as clinically indicated. (See Tables 6 and 7.)

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CYP3A4 inhibitors: Concomitant use of strong CYP3A4 inhibitors should be avoided. If strong CYP3A4 inhibitors cannot be avoided, the abemaciclib dose should be reduced to 100 mg twice daily.
In patients who have had their dose reduced to 100 mg abemaciclib twice daily and in whom co-administration of a strong CYP3A4 inhibitor cannot be avoided, the abemaciclib dose should be further reduced to 50 mg twice daily.
In patients who have had their dose reduced to 50 mg abemaciclib twice daily and in whom co-administration of a strong CYP3A4 inhibitor cannot be avoided, the abemaciclib dose may be continued with close monitoring of signs of toxicity. Alternatively, the abemaciclib dose may be reduced to 50 mg once daily or discontinued.
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).
Special populations: Elderly: No dose adjustment is required based on age (see Pharmacology: Pharmacokinetics under Actions).
Renal impairment: No dose adjustments are necessary in patients with mild or moderate renal impairment. There are no data regarding abemaciclib administration in patients with severe renal impairment, end stage renal disease, or in patients on dialysis (see Pharmacology: Pharmacokinetics under Actions). Abemaciclib should be administered with caution in patients with severe renal impairment, with close monitoring for signs of toxicity.
Hepatic impairment: No dose adjustments are necessary in patients with mild (Child Pugh A) or moderate (Child Pugh B) hepatic impairment. In patients with severe (Child Pugh C) hepatic impairment, a decrease in dosing frequency to once daily is recommended (see Pharmacology: Pharmacokinetics under Actions).
Paediatric population: The safety and efficacy of abemaciclib in children and adolescents aged less than 18 years has not been established.
No data are available.
Method of administration: Verzenio is for oral use.
The dose can be taken with or without food. It should not be taken with grapefruit or grapefruit juice (see Interactions).
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).
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