Abemaciclib Dosage

Medically reviewed by Drugs.com. Last updated on Mar 30, 2023.

Usual Adult Dose for Breast Cancer

EARLY BREAST CANCER:

• In combination with endocrine therapy (tamoxifen or an aromatase inhibitor): 150 mg orally twice a day
• Duration of Therapy: Until completion of 2 years of treatment or until disease recurrence or unacceptable toxicity

ADVANCED OR METASTATIC BREAST CANCER:

• In combination with fulvestrant or an aromatase inhibitor: 150 mg orally twice a day
• Monotherapy: 200 mg orally twice a day
• Duration of Therapy: Until disease progression or unacceptable toxicity

Comments:

• Refer to the manufacturer product information for the recommended dose of fulvestrant, tamoxifen, or aromatase inhibitor being used.
• If combining this drug with an aromatase inhibitor in pre/perimenopausal women and men, a gonadotropin-releasing hormone (GnRH) agonist should be added to therapy according to current clinical practice standards.
• If combining this drug with fulvestrant in pre/perimenopausal women, a GnRH agonist should be added to therapy according to current clinical practice standards.

Uses:
Early Breast Cancer:

• In combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, early breast cancer at high risk of recurrence

Advanced or Metastatic Breast Cancer:

• In combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of patients with HR-positive, HER2-negative advanced or metastatic breast cancer
• In combination with fulvestrant for the treatment of patients with HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy
• As monotherapy for the treatment of patients with HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting

Renal Dose Adjustments

• Mild to Moderate Renal Dysfunction (CrCl 30 to 89 mL/min): No adjustment recommended.
• Severe Renal Dysfunction (CrCl less than 30 mL/min): Data not available
• End Stage Renal Disease: Data not available

Liver Dose Adjustments

• Mild or Moderate Liver Dysfunction (Child-Pugh A or B): No adjustment recommended.
• Severe Liver Dysfunction (Child-Pugh C): Reduce the dosing frequency to once daily.

MANAGEMENT OF HEPATOTOXICITY:
If grade 1 (ALT and/or AST greater than the upper limit of normal [ULN] to 3 x ULN) OR grade 2 (ALT and/or AST greater than 3 to 5 x ULN) hepatotoxicity occurs without an increase in total bilirubin above 2 x ULN:

• No dose modification is required.

If persistent or recurrent grade 2, or grade 3 (ALT and/or AST greater than 5 to 20 x ULN) hepatotoxicity occurs without an increase in total bilirubin above 2 x ULN:

• Therapy should be suspended until toxicity resolves to baseline or grade 1.
• This drug should be restarted at the next lower dose upon recovery.

If ALT and/or AST is greater than 3 x ULN and total bilirubin is greater than 2 x ULN (in the absence of cholestasis):

• This drug should be discontinued.

If grade 4 (ALT and/or AST greater than 20 x ULN) hepatotoxicity occurs:

• This drug should be discontinued.

Dose Adjustments

Adverse Reactions Should Be Managed As Follows:
If this drug is combined with fulvestrant, tamoxifen, or an aromatase inhibitor:

• The recommended starting dose is 150 mg orally twice a day.
• The recommended first dose reduction is 100 mg orally twice a day.
• The recommended second dose reduction is 50 mg orally twice a day.
• There is no recommended third dose reduction.

If this drug is initiated as a monotherapy:

• The recommended starting dose is 200 mg orally twice a day.
• The recommended first dose reduction is 150 mg orally twice a day.
• The recommended second dose reduction is 100 mg orally twice a day.
• The recommended third dose reduction is 50 mg orally twice a day.

This drug should be discontinued in patients who are unable to tolerate 50 mg orally twice a day.

Refer to Full Prescribing Information for co-administered fulvestrant, tamoxifen, or an aromatase inhibitor for dose modifications and other relevant safety information.

HEMATOLOGIC TOXICITIES:
Adverse Reactions Should Be Managed As Follows:
If blood cell growth factors are required:

• This drug should be suspended for at least 48 hours after the last dose of blood cell growth factor was administered and until toxicity resolves to grade 2 or lower.
• Therapy may be resumed at the next lower dose unless the dose was already reduced for the toxicity that led to the use of the growth factor.

If the severity is at grade 1 or 2:

• No dose modification is required.

If the severity is at grade 3:

• This drug should be suspended until toxicity resolves to grade 2 or less.
• Dose reduction is not required when resuming therapy.

If the severity is at grade 3 (recurrent) or grade 4:

• This drug should be suspended until toxicity resolves to grade 2 or less.
• This drug may be restarted at the next lower dose upon recovery.

DIARRHEA:
At the first sign of loose stools, treatment with antidiarrheal agents should be initiated and oral fluid intake should be increased.
If the severity is at grade 1:

• No dose modification is required.

If the severity is at grade 2:

• This drug should be suspended until resolution if toxicity does not resolve to grade 1 or less within 24 hours of onset.
• Dose reduction is not required when resuming therapy.

If the severity is at grade 2 that persists or recurs after resuming the same dose despite maximal supportive measures:

• This drug should be suspended until toxicity resolves to grade 1 or less.
• This drug may be restarted at the next lower dose upon recovery.

If the severity is at grade 3 or 4 or requires hospitalization:

• This drug should be suspended until toxicity resolves to grade 1 or less.
• This drug may be restarted at the next lower dose upon recovery.

INTERSTITIAL LUNG DISEASE (ILD)/PNEUMONITIS:
If the severity is at grade 1 or 2:

• No dose modification is required.

If persistent or recurrent grade 2 toxicity occurs that does not resolve with maximal supportive measures within 7 days to baseline or grade 1:

• This drug should be suspended until toxicity resolves to baseline or grade 1 or less.
• This drug may be restarted at the next lower dose upon recovery.

If the severity is at grade 3 or 4:

• This drug should be discontinued.

VENOUS THROMBOEMBOLIC EVENTS (VTEs):
For early breast cancer patients with any grade severity:

• This drug should be suspended and VTE should be treated as clinically indicated.
• This drug may be restarted when the patient is clinically stable.

For advanced or metastatic breast cancer patients:

• No dose medication is required for grade 1 or 2 severity.
• If the severity is at grade 3 or 4: This drug should be suspended and VTE should be treated as clinically indicated. Therapy may be resumed when the patient is clinically stable.

OTHER TOXICITIES (excluding diarrhea, hematologic toxicity, hepatotoxicity, ILD/pneumonitis, and VTEs):
If the severity is at grade 1 or 2:

• No dose modification is required.

If persistent or recurrent grade 2 toxicity occurs that does not resolve with maximal supportive measures within 7 days to baseline or grade 1:

• This drug should be suspended until toxicity resolves to baseline or grade 1 or less.
• This drug may be restarted at the next lower dose upon recovery.

If the severity is at grade 3 or 4:

• This drug should be suspended until toxicity resolves to baseline or grade 1 or less.
• This drug may be restarted at the next lower dose upon recovery.

CONCOMITANT USE WITH STRONG CYP450 3A INHIBITORS:

• Avoid concomitant use with ketoconazole.
• When using with other strong CYP450 3A inhibitors:
• In patients with starting doses of 150 to 200 mg orally twice a day: Decrease dose to 100 mg orally twice a day
• In patients who already had a dose reduction to 100 mg orally twice a day due to adverse reactions: Decrease dose to 50 mg orally twice a day
• Once a patient discontinues concomitant use of strong CYP450 3A inhibitor: After 3 to 5 half-lives of the inhibitor, increase the dose of this drug to the dose that was used BEFORE the strong inhibitor was started.

CONCOMITANT USE WITH MODERATE CYP450 3A INHIBITORS:

• In patients taking this drug with a moderate CYP450 3A inhibitor: Monitor for adverse reactions and consider reducing the dose of this drug by 50 mg decrements if necessary.

Precautions

CONTRAINDICATIONS: None

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Doses should be taken at approximately the same time every day with or without food.
• Tablets should be swallowed whole and not chewed, crushed, or split before swallowing.
• Tablets should not be taken if they are broken, cracked, or otherwise not intact.
• In the event of a vomited or missed dose, patients should skip that dose and take the next dose at the usual time.

Storage requirements:

• Store at 20C to 25C (68F to 77F); excursions permitted to 15C to 30C (59F to 86F).

Monitoring:

• Cardiovascular: For signs/symptoms of venous thrombosis and pulmonary embolism (during treatment)
• Hematologic: CBC (prior to initiation, every 2 weeks for the first 2 months, monthly for the next 2 months, and as clinically indicated)
• Hepatic: Liver function tests (prior to initiation, every 2 weeks for the first 2 months, monthly for the next 2 months, and as clinically indicated)
• Respiratory: For pulmonary symptoms indicative of ILD/pneumonitis.

Patient advice:

• Read the US FDA-approved patient labeling (Patient Information).
• Contact your healthcare provider immediately if you have:
• Signs of infection such as fever
• Nausea, vomiting, or severe abdominal pain
• Worsening diarrhea
• New or worsening respiratory symptoms
• Pain or swelling in the extremity, shortness of breath, chest pain, tachypnea, and tachycardia
• Women of reproductive potential should contact their healthcare provider if they become pregnant or suspect a pregnancy.
• Women of reproductive potential should use effective contraception during treatment and for 3 weeks after the last dose.
• Males of reproductive potential should be informed that this drug may impair fertility.
• Breastfeeding is not recommended during treatment and for at least 3 weeks after the last dose.
• Avoid consuming grapefruit products while on treatment with this drug.
• This drug may cause side effects such as dizziness; avoid potentially dangerous activities such as driving and operating machinery until you know how this drug affects you.

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Further information

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