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

Hur hanteras levertoxicitet hos Verzenios® ▼ (abemaciklib) behandlade patienter?

Dosavbrott, minskning, utsättning eller fördröjd start av behandlingscykler rekommenderas för ihållande eller återkommande grad 2, 3 eller 4, förhöjda levertransaminas. Vänligen hitta detaljerad information nedan.

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Management Recommendations for Hepatic Toxicities

Monitor alanine aminotransferase (ALT) and aspartate aminostransferase (AST)

  • prior to the start of abemaciclib therapy
  • every two weeks for the first two months
  • monthly for the next two months, and
  • as clinically indicated.1

Please find management recommendations for increased aminotransferases in   Management recommendations for increased aminotransferases.

  Management recommendations for increased aminotransferases1

Toxicitya

Management recommendations

Grade 1 (>ULN-3.0 x ULN)

Grade 2 (>3.0-5.0 x ULN)

No dose adjustment required.

Persistent or Recurrent Grade 2, or Grade 3 (>5.0-20.0 x ULN)

Suspend dose until toxicity resolves to baseline or Grade 1.

Resume at next lower dose.

Elevation in AST and/or ALT >3 x ULN WITH total bilirubin >2 x ULN, in the absence of cholestasis

Discontinue abemaciclib.

Grade 4 (>20.0 x ULN)

Discontinue abemaciclib.

 Abbreviations: ALT = alanine aminotransferase; AST = aspartate aminotransferase; ULN = upper limit of normal

aNCI CTCAE

In the metastatic breast cancer trials, the increases in hepatic transaminases were manageable by dose reduction or suspension and resolved after discontinuing abemaciclib.2

Incidence and Duration of Hepatic Toxicities in Clinical 

For ALT

  • the median time to onset of Grade 3 or 4 ALT elevation was 57 to 61 days, and
  • following management recommendations the median time to resolution was 14 days.

For AST

  • the median time to onset of Grade 3 or 4 AST elevation was 71 to 185 days, and
  • the median time to resolution was 13 to 15 days.1 

Please find ALT, AST and blood bilirubin increases in MONARCH 2 and MONARCH 3 in ALT and AST Increases in MONARCH 2 and MONARCH 3, Blood Bilirubin Increased in MONARCH 2 andBlood Bilirubin Increased in MONARCH 3.

ALT and AST Increases in MONARCH 2 and MONARCH 32

Abemaciclib + NSAI
N=327

Placebo + NSAI
N=161

Abemaciclib + Fulvestrant
N=441

Placebo + Fulvestrant
N=223

Event

MONARCH 3 

MONARCH 2

Grade ≥3 ALT increase

6%

2%

4%

2%

Median time to onset

64 days

---

57 days

---

Median time to resolutiona

14 days

---

14 days

---

Grade ≥3 AST increase

4%

1%

2%

3%

Median time to onset

87 days

---

185 days

---

Median time to resolutiona

15 days

---

13 days

---

Abbreviations: ALT = alanine aminotransferase; AST = aspartate aminotransferase; NSAI = nonsteroidal aromatase inhibitor.

aTo normalization or grade <3.

Blood Bilirubin Increased in MONARCH 22

CTCAE, %

All Grades

Grade 1

Grade 2

Grade 3

Grade 4

Grade 5

Abemaciclib + Fulvestrant, N=441

Blood bilirubin increased

1.6

0

0.7

0.9

0

0

 

Placebo + Fulvestrant, N=223

Blood bilirubin increased

0.9

0.4

0.4

0

0

0

Abbreviation: CTCAE = Common Terminology Criteria for Adverse Events.

Blood Bilirubin Increased in MONARCH 32

CTCAE, %

All Grades

Grade 1

Grade 2

Grade 3

Grade 4

Grade 5

 

Abemaciclib + NSAI, N=327

Blood bilirubin increased

1.8

0.6

0.3

0.9

0

0

 

Placebo + NSAI, N=161

Blood bilirubin increased

0.6

0.6

0

0

0

0

Abbreviations: CTCAE = Common Terminology Criteria for Adverse Events; NSAI = nonsteroidal aromatase inhibitor.

References

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

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

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 2019 M10 23


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