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Abemaciclib Dosage

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

Applies to the following strengths: 50 mg; 100 mg; 150 mg; 200 mg

Usual Adult Dose for:

Additional dosage information:

Usual Adult Dose for Breast Cancer

IN COMBINATION WITH FULVESTRANT OR AN AROMATASE INHIBITOR:
150 mg orally 2 times a day

MONOTHERAPY:
200 mg orally 2 times a day

Duration of Therapy: Until disease progression or unacceptable toxicity

Comments:

  • If using this drug in combination with fulvestrant on pre/perimenopausal women, treat these patients with a gonadotropin-releasing hormone agonist according to current clinical practice standards.
  • When used in combination with this drug, the recommended dose of fulvestrant is 500 mg on Days 1, 15, and 29, then once monthly thereafter; refer to the manufacturer product information for fulvestrant.

Uses:
  • In combination with an aromatase inhibitor as initial endocrine-based therapy for postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer
  • In combination with fulvestrant for women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer with disease progression following endocrine therapy
  • As monotherapy for adult 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 Impairment (CrCl 30 to 89 mL/min): No adjustment recommended.
  • Severe Renal Impairment (CrCl less than 30 mL/min): Data not available
  • End Stage Renal Disease: Data not available

Liver Dose Adjustments

  • Mild or Moderate Hepatic Impairment (Child-Pugh A or B): No adjustment recommended.
  • Severe Hepatic Impairment (Child-Pugh C): Reduce the dosing frequency to once a day.

Management of Hepatotoxicity:
  • Grade 1 (greater than upper limit of normal [ULN] to 3 x ULN) OR Grade 2 (greater than 3 to 5 x ULN); WITHOUT increase in total bilirubin above 2 x ULN: No adjustment recommended.
  • Persistent or recurrent Grade 2 OR Grade 3 (greater than 5 to 20 x ULN); WITHOUT increase in total bilirubin above 2 x ULN: Suspend dose until toxicity resolves to baseline or Grade 1; resume at next lower dose.
  • Elevation in AST and/or ALT greater than 3 x ULN WITH total bilirubin greater than 2 x ULN in the absence of cholestasis OR Grade 4 (greater than 20 x ULN): Discontinue therapy.

Comments: Monitor ALT, AST, and serum bilirubin prior to therapy initiation, every 2 weeks for the first 2 months, monthly for the next 2 months, and as clinically indicated.

Dose Adjustments

  • Discontinue therapy in patients unable to tolerate 50 mg 2 times a day.
  • Refer to the manufacturer product information aromatase inhibitor or fulvestrant for dose modifications.

DOSE MODIFICATIONS FOR ADVERSE REACTIONS:
STARTING DOSE:
  • Combination therapy: 150 mg 2 times a day
  • Monotherapy: 200 mg orally 2 times a day
FIRST DOSE REDUCTION:
  • Combination therapy: 100 mg orally 2 times a day
  • Monotherapy: 150 mg orally 2 times a day
SECOND DOSE REDUCTION:
  • Combination therapy: 50 mg orally 2 times a day
  • Monotherapy: 100 mg orally 2 times a day
THIRD DOSE REDUCTION:
  • Combination Therapy: N/A
  • Monotherapy: 50 mg orally 2 times a day

HEMATOLOGIC TOXICITIES (monitor complete blood counts prior to the start of therapy, every 2 weeks for the first 2 months, monthly for the next 2 months, and as indicated):
  • Grade 1 or 2: No dose modification required.
  • Grade 3: Suspend dose until toxicity resolves to Grade 2 or less; dose reduction not required.
  • Recurrent Grade 3 OR Grade 4: Suspend dose until toxicity resolves to Grade 2 or less; resume at next lower dose.
  • If blood cell growth factors (BCGF) are required: Suspend dose for at least 48 hours after the last dose of BCGF and until toxicity resolves to Grade 2 or less; resume at next lower dose unless already performed for the toxicity that led to the use of the growth factor; use growth factor per current treatment guidelines.

DIARRHEA (at the first sign of loose stools, start treatment with antidiarrheal agents and increase intake of oral fluids):
  • Grade 1: No adjustment recommended.
  • Grade 2: If toxicity does not resolve within 24 hours to Grade 1 or less, suspend dose until resolution; dose reduction not required.
  • Persistent or Recurrent Grade 2 (persists or recurs after resuming the same dose despite supportive measures): Suspend dose until toxicity resolves to Grade 1 or less; resume at next lower dose.
  • Grade 3 or 4 or hospitalization required: Suspend dose until toxicity resolves to Grade 1 or less; resume at next lower dose.

INTERSTITIAL LUNG DISEASE (ILD)/PNEUMONITIS:
  • Grade 1 or 2: No adjustment recommended.
  • Persistent or recurrent Grade 2 toxicity that does not resolve with maximal supportive measures within 7 days to baseline or Grade 1: Suspend dose until toxicity resolves to baseline or Grade 1 or less; resume at next lower dose.
  • Grade 3 or 4: Discontinue therapy.

OTHER TOXICITIES (excluding diarrhea, hematologic toxicity, hepatotoxicity and ILD/pneumonitis):
  • Grade 1 or 2: No adjustment recommended.
  • Persistent or Recurrent Grade 2 that does not resolve within 7 days to baseline or Grade 1 despite supportive measures: Suspend dose until toxicity resolves to baseline or Grade 1 or less; resume at next lower dose.
  • Grade 3 or 4: Suspend dose until toxicity resolves to baseline or Grade 1 or less; resume at next lower dose.

CONCOMITANT USE of OTHER STRONG CYP450 3A INHIBITORS (excluding ketoconazole):
  • In patients with starting doses of 150 to 200 mg twice a day: 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: 50 mg orally twice a day
  • Once 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.

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:

  • Instruct patients not to ingest drug tablets if they are broken, cracked, or otherwise not intact.
  • Instruct patients to take their doses at approximately the same times every day with or without food.
  • Advise patients to swallow the drug tablets whole and not to chew, crush, or split them before swallowing.
  • In the event of a vomited or missed dose, direct patients to skip that dose and to take the next dose at the usual time.

Storage Requirements:
  • Store at 20 to 25 degrees Celsius (68 to 77 degrees Fahrenheit); excursions permitted to 15 to 30 degrees Celsius (59 to 86 degrees Fahrenheit).

General:
  • There is no known antidote for this drug; use general supportive measures to treat overdose.

Monitoring:
  • Cardiovascular: Signs/symptoms of venous thrombosis and pulmonary embolism (during treatment)
  • Hematologic: CBC (prior to initiation of this drug, every 2 weeks for the first 2 months, monthly for the next 2 months, and as clinically indicated)
  • Hepatic: ALT, AST, and serum bilirubin (prior to initiation of this drug, every 2 weeks for the first 2 months, monthly for the next 2 months, and as clinically indicated)
  • Respiratory: Monitor patients for pulmonary symptoms indicative of ILD/pneumonitis.

Patient Advice:
  • Avoid eating and drinking grapefruit products while taking 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.
  • Advise patients to immediately report new or worsening respiratory symptoms.

Frequently asked questions

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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