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Verzenio

Last reviewed on RxList: 6/11/2020
Verzenio Side Effects Center

What Is Verzenio?

Verzenio (abemaciclib) is a kinase inhibitor indicated in combination with fulvestrant for the treatment of 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; and as monotherapy for the treatment of 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.

What Are Side Effects of Verzenio?

Common side effects of Verzenio include :

Dosage for Verzenio

The recommended starting dose of Verzenio in combination with fulvestrant is 150 mg twice daily. The recommended starting dose of Verzenio as monotherapy is 200 mg twice daily.

What Drugs, Substances, or Supplements Interact with Verzenio?

Verzenio may interact with:

Tell your doctor all medications and supplements you use.

Verzenio During Pregnancy and Breastfeeding

Verzenio is not recommended for use during pregnancy; it may harm a fetus. Pregnancy testing is recommended for females of reproductive potential prior to initiating treatment with Verzenio, and women are advised to use effective contraception during Verzenio treatment and for at least 3 weeks after the last dose. It is unknown if Verzenio passes into breast milk. Breastfeeding is not recommended while taking Verzenio and for at least 3 weeks after the last dose.

Additional Information

Our Verzenio (abemaciclib) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

SLIDESHOW

Breast Cancer Awareness: Symptoms, Diagnosis, and Treatment See Slideshow
Verzenio Professional Information

SIDE EFFECTS

The following adverse reactions are discussed in greater detail in other sections of the labeling:

Clinical Studies Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

MONARCH 3

VERZENIO In Combination With An Aromatase Inhibitor (Anastrozole Or Letrozole) As Initial Endocrine-Based Therapy

Postmenopausal Women with HR-positive, HER2-negative Locoregionally Recurrent Or Metastatic Breast Cancer With No Prior Systemic Therapy In This Disease Setting

MONARCH 3 was a study of 488 women receiving VERZENIO plus an aromatase inhibitor or placebo plus an aromatase inhibitor. Patients were randomly assigned to receive 150 mg of VERZENIO or placebo orally twice daily, plus physician's choice of anastrozole or letrozole once daily. Median duration of treatment was 15.1 months for the VERZENIO arm and 13.9 months for the placebo arm. Median dose compliance was 98% for the VERZENIO arm and 99% for the placebo arm.

Dose reductions due to an adverse reaction occurred in 43% of patients receiving VERZENIO plus anastrozole or letrozole. Adverse reactions leading to dose reductions in ≥5% of patients were diarrhea and neutropenia. VERZENIO dose reductions due to diarrhea of any grade occurred in 13% of patients receiving VERZENIO plus an aromatase inhibitor compared to 2% of patients receiving placebo plus an aromatase inhibitor. VERZENIO dose reductions due to neutropenia of any grade occurred in 11% of patients receiving VERZENIO plus an aromatase inhibitor compared to 0.6% of patients receiving placebo plus an aromatase inhibitor.

Permanent treatment discontinuation due to an adverse event was reported in 13% of patients receiving VERZENIO plus an aromatase inhibitor and in 3% of patients receiving placebo plus an aromatase inhibitor. Adverse reactions leading to permanent discontinuation for patients receiving VERZENIO plus an aromatase inhibitor were diarrhea (2%), ALT increased (2%), infection (1%), venous thromboembolic events (VTE) (1%), neutropenia (0.9%), renal impairment (0.9%), AST increased (0.6%), dyspnea (0.6%), pulmonary fibrosis (0.6%) and anemia, rash, weight decreased and thrombocytopenia (each 0.3%).

Deaths during treatment or during the 30-day follow up, regardless of causality, were reported in 11 cases (3%) of VERZENIO plus an aromatase inhibitor treated patients versus 3 cases (2%) of placebo plus an aromatase inhibitor treated patients. Causes of death for patients receiving VERZENIO plus an aromatase inhibitor included: 3 (0.9%) patient deaths due to underlying disease, 3 (0.9%) due to lung infection, 3 (0.9%) due to VTE event, 1 (0.3%) due to pneumonitis, and 1 (0.3%) due to cerebral infarction.

The most common adverse reactions reported (≥20%) in the VERZENIO arm and ≥2% than the placebo arm were diarrhea, neutropenia, fatigue, infections, nausea, abdominal pain, anemia, vomiting, alopecia, decreased appetite, and leukopenia (Table 6). The most frequently reported (≥5%) Grade 3 or 4 adverse reactions were neutropenia, diarrhea, leukopenia, increased ALT, and anemia. Diarrhea incidence was greatest during the first month of VERZENIO dosing. The median time to onset of the first diarrhea event was 8 days, and the median durations of diarrhea for Grades 2 and for Grade 3 were 11 days and 8 days, respectively. Most diarrhea events recovered or resolved (88%) with supportive treatment and/or dose reductions [see DOSAGE AND ADMINISTRATION and PATIENT INFORMATION]. Nineteen percent of patients with diarrhea required a dose omission and 13% required a dose reduction. The median time to the first dose reduction due to diarrhea was 38 days.

Table 6: Adverse Reactions ≥10% of Patients Receiving VERZENIO Plus Anastrozole or Letrozole and ≥2% Higher Than Placebo Plus Anastrozole or Letrozole in MONARCH 3

  VERZENIO plus Anastrozole or Letrozole
N=327
Placebo plus Anastrozole or Letrozole
N=161
All Grades
%
Grade 3
%
Grade 4
%
All Grades
%
Grade 3
%
Grade 4
%
Gastrointestinal Disorders
  Diarrhea 81 9 0 30 1 0
  Nausea 39 <1 0 20 1 0
  Abdominal pain 29 1 0 12 1 0
  Vomiting 28 1 0 12 2 0
  Constipation 16 <1 0 12 0 0
Infections and Infestations
  Infectionsa 39 4 <1 29 2 <1
Blood and Lymphatic System Disorders
  Neutropenia 41 20 2 2 <1 <1
  Anemia 28 6 0 5 1 0
  Leukopenia 21 7 <1 2 0 <1
  Thrombocytopenia 10 2 <1 2 <1 0
General Disorders and Administration Site Conditions
  Fatigue 40 2 0 32 0 0
  Influenza like illness 10 0 0 8 0 0
Skin and Subcutaneous Tissue Disorders
  Alopecia 27 0 0 11 0 0
  Rash 14 <1 0 5 0 0
  Pruritus 13 0 0 9 0 0
Metabolism and Nutrition Disorders
  Decreased appetite 24 1 0 9 <1 0
Investigations
  Blood creatinine increased 19 2 0 4 0 0
  Alanine aminotransferase increased 16 6 <1 7 2 0
  Aspartate aminotransferase increased 15 3 0 7 1 0
  Weight decreased 10 <1 0 3 <1 0
Respiratory, Thoracic, and Mediastinal Disorders
  Cough 13 0 0 9 0 0
  Dyspnea 12 <1 <1 6 <1 0
Nervous System Disorders
  Dizziness 11 <1 0 9 0 0
a Includes all reported preferred terms that are part of the Infections and Infestations system organ class. Most common infections (>1%) include upper respiratory tract infection, lung infection, and pharyngitis.

Additional adverse reactions in MONARCH 3 include venous thromboembolic events (deep vein thrombosis, pulmonary embolism, and pelvic venous thrombosis), which were reported in 5% of patients treated with VERZENIO plus anastrozole or letrozole as compared to 0.6% of patients treated with anastrozole or letrozole plus placebo.

Table 7: Laboratory Abnormalities ≥10% in Patients Receiving VERZENIO Plus Anastrozole or Letrozole and ≥2% Higher Than Placebo Plus Anastrozole or Letrozole in MONARCH 3

Laboratory Abnormality VERZENIO plus Anastrozole or Letrozole
N=327
Placebo plus Anastrozole or Letrozole
N=161
All Grades
%
Grade 3
%
Grade 4
%
All Grades
%
Grade 3
%
Grade 4
%
Creatinine increased 98 2 0 84 0 0
White blood cell decreased 82 13 0 27 <1 0
Anemia 82 2 0 28 0 0
Neutrophil count decreased 80 19 3 21 3 0
Lymphocyte count decreased 53 7 <1 26 2 0
Platelet count decreased 36 1 <1 12 <1 0
Alanine aminotransferase increased 48 6 <1 25 2 0
Aspartate aminotransferase increased 37 4 0 23 <1 0

Creatinine Increased

Abemaciclib has been shown to increase serum creatinine due to inhibition of renal tubular secretion transporters, without affecting glomerular function [see CLINICAL PHARMACOLOGY]. Across the clinical studies, increases in serum creatinine (mean increase, 0.2- 0.3 mg/dL) occurred within the first 28-day cycle of VERZENIO dosing, remained elevated but stable through the treatment period, and were reversible upon treatment discontinuation. Alternative markers such as BUN, cystatin C, or calculated GFR, which are not based on creatinine, may be considered to determine whether renal function is impaired.

MONARCH 2

VERZENIO In Combination With Fulvestrant

Women with HR-positive, HER2-negative Advanced Or Metastatic Breast Cancer With Disease Progression On Or After Prior Adjuvant Or Metastatic Endocrine Therapy

The safety of VERZENIO (150 mg twice daily) plus fulvestrant (500 mg) versus placebo plus fulvestrant was evaluated in MONARCH 2. The data described below reflect exposure to VERZENIO in 441 patients with HR-positive, HER2-negative advanced breast cancer who received at least one dose of VERZENIO plus fulvestrant in MONARCH 2.

Median duration of treatment was 12 months for patients receiving VERZENIO plus fulvestrant and 8 months for patients receiving placebo plus fulvestrant.

Dose reductions due to an adverse reaction occurred in 43% of patients receiving VERZENIO plus fulvestrant. Adverse reactions leading to dose reductions in ≥5% of patients were diarrhea and neutropenia. VERZENIO dose reductions due to diarrhea of any grade occurred in 19% of patients receiving VERZENIO plus fulvestrant compared to 0.4% of patients receiving placebo and fulvestrant. VERZENIO dose reductions due to neutropenia of any grade occurred in 10% of patients receiving VERZENIO plus fulvestrant compared to no patients receiving placebo plus fulvestrant.

Permanent study treatment discontinuation due to an adverse event were reported in 9% of patients receiving VERZENIO plus fulvestrant and in 3% of patients receiving placebo plus fulvestrant. Adverse reactions leading to permanent discontinuation for patients receiving VERZENIO plus fulvestrant were infection (2%), diarrhea (1%), hepatotoxicity (1%), fatigue (0.7%), nausea (0.2%), abdominal pain (0.2%), acute kidney injury (0.2%), and cerebral infarction (0.2%).

Deaths during treatment or during the 30-day follow up, regardless of causality, were reported in 18 cases (4%) of VERZENIO plus fulvestrant treated patients versus 10 cases (5%) of placebo plus fulvestrant treated patients. Causes of death for patients receiving VERZENIO plus fulvestrant included: 7 (2%) patient deaths due to underlying disease, 4 (0.9%) due to sepsis, 2 (0.5%) due to pneumonitis, 2 (0.5%) due to hepatotoxicity, and one (0.2%) due to cerebral infarction.

The most common adverse reactions reported (≥20%) in the VERZENIO arm were diarrhea, fatigue, neutropenia, nausea, infections, abdominal pain, anemia, leukopenia, decreased appetite, vomiting, and headache (Table 8). The most frequently reported (≥5%) Grade 3 or 4 adverse reactions were neutropenia, diarrhea, leukopenia, anemia, and infections.

Table 8: Adverse Reactions ≥10% in Patients Receiving VERZENIO Plus Fulvestrant and ≥2% Higher Than Placebo Plus Fulvestrant in MONARCH 2

  VERZENIO plus Fulvestrant
N=441
Placebo plus Fulvestrant
N=223
All Grades
%
Grade 3
%
Grade 4
%
All Grades
%
Grade 3
%
Grade 4
%
Gastrointestinal Disorders
  Diarrhea 86 13 0 25 <1 0
  Nausea 45 3 0 23 1 0
  Abdominal paina 35 2 0 16 1 0
  Vomiting 26 <1 0 10 2 0
  Stomatitis 15 <1 0 10 0 0
Infections and Infestations
  Infectionsb 43 5 <1 25 3 <1
Blood and Lymphatic System Disorders
  Neutropeniac 46 24 3 4 1 <1
  Anemiad 29 7 <1 4 1 0
  Leukopeniae 28 9 <1 2 0 0
  Thrombocytopeniaf 16 2 1 3 0 <1
General Disorders and Administration Site Conditions
  Fatigueg 46 3 0 32 <1 0
  Edema peripheral 12 0 0 7 0 0
  Pyrexia 11 <1 <1 6 <1 0
Metabolism and Nutrition Disorders
  Decreased appetite 27 1 0 12 <1 0
Respiratory, Thoracic and Mediastinal Disorders
  Cough 13 0 0 11 0 0
Skin and Subcutaneous Tissue Disorders
  Alopecia 16 0 0 2 0 0
  Pruritus 13 0 0 6 0 0
  Rash 11 1 0 4 0 0
Nervous System Disorders
  Headache 20 1 0 15 <1 0
  Dysgeusia 18 0 0 3 0 0
  Dizziness 12 10 0 6 0 0
Investigations
  Alanine aminotransferase increased 13 4 <1 5 2 0
  Aspartate aminotransferase increased 12 2 0 7 3 0
  Creatinine increased 12 <1 0 <1 0 0
  Weight decreased 10 <1 0 2 <1 0
a Includes abdominal pain, abdominal pain upper, abdominal pain lower, abdominal discomfort, abdominal tenderness.
b Includes upper respiratory tract infection, urinary tract infection, lung infection, pharyngitis, conjunctivitis, sinusitis, vaginal infection, sepsis.
c Includes neutropenia, neutrophil count decreased.
d Includes anemia, hematocrit decreased, hemoglobin decreased, red blood cell count decreased.
e Includes leukopenia, white blood cell count decreased.
f Includes platelet count decreased, thrombocytopenia.
g Includes asthenia, fatigue.

Additional adverse reactions in MONARCH 2 include venous thromboembolic events (deep vein thrombosis, pulmonary embolism, cerebral venous sinus thrombosis, subclavian vein thrombosis, axillary vein thrombosis, and DVT inferior vena cava), which were reported in 5% of patients treated with VERZENIO plus fulvestrant as compared to 0.9% of patients treated with fulvestrant plus placebo.

Table 9: Laboratory Abnormalities ≥10% in Patients Receiving VERZENIO Plus Fulvestrant and ≥2% Higher Than Placebo Plus Fulvestrant in MONARCH 2

  VERZENIO plus Fulvestrant
N=441
Placebo plus Fulvestrant
N=223
All Grades
%
Grade 3
%
Grade 4
%
All Grades
%
Grade 3
%
Grade 4
%
Creatinine increased 98 1 0 74 0 0
White blood cell decreased 90 23 <1 33 <1 0
Neutrophil count decreased 87 29 4 30 4 <1
Anemia 84 3 0 33 <1 0
Lymphocyte count decreased 63 12 <1 32 2 0
Platelet count decreased 53 <1 1 15 0 0
Alanine aminotransferase increased 41 4 <1 32 1 0
Aspartate aminotransferase increased 37 4 0 25 4 <1

Creatinine Increased

Abemaciclib has been shown to increase serum creatinine due to inhibition of renal tubular secretion transporters, without affecting glomerular function [see CLINICAL PHARMACOLOGY]. In clinical studies, increases in serum creatinine (mean increase, 0.2-0.3 mg/dL) occurred within the first 28-day cycle of VERZENIO dosing, remained elevated but stable through the treatment period, and were reversible upon treatment discontinuation. Alternative markers such as BUN, cystatin C, or calculated glomerular filtration rate (GFR), which are not based on creatinine, may be considered to determine whether renal function is impaired.

VERZENIO Administered As A Monotherapy In Metastatic Breast Cancer (MONARCH 1)

Patients with HR-positive, HER2-negative Breast Cancer Who Received Prior Endocrine Therapy And 1-2 Chemotherapy Regimens In The Metastatic Setting

Safety data below are based on MONARCH 1, a single-arm, open-label, multicenter study in 132 women with measurable HR-positive, HER2-negative metastatic breast cancer. Patients received 200 mg VERZENIO orally twice daily until development of progressive disease or unmanageable toxicity. Median duration of treatment was 4.5 months.

Ten patients (8%) discontinued study treatment from adverse reactions due to (1 patient each) abdominal pain, arterial thrombosis, aspartate aminotransferase (AST) increased, blood creatinine increased, chronic kidney disease, diarrhea, ECG QT prolonged, fatigue, hip fracture, and lymphopenia. Forty-nine percent of patients had dose reductions due to an adverse reaction. The most frequent adverse reactions that led to dose reductions were diarrhea (20%), neutropenia (11%), and fatigue (9%).

Deaths during treatment or during the 30-day follow up were reported in 2% of patients. Cause of death in these patients was due to infection.

The most common reported adverse reactions (≥20%) were diarrhea, fatigue, nausea, decreased appetite, abdominal pain, neutropenia, vomiting, infections, anemia, headache, and thrombocytopenia (Table 10). Severe (Grade 3 and 4) neutropenia was observed in patients receiving abemaciclib [see DOSAGE AND ADMINISTRATION].

Table 10: Adverse Reactions (≥10% of Patients) in MONARCH 1

  VERZENIO
N=132
All Grades
%
Grade 3
%
Grade 4
%
Gastrointestinal Disorders
  Diarrhea 90 20 0
  Nausea 64 5 0
  Abdominal pain 39 2 0
  Vomiting 35 2 0
  Constipation 17 <1 0
  Dry mouth 14 0 0
  Stomatitis 14 0 0
Infections and Infestations
  Infections 31 5 2
General Disorders and Administration Site Conditions
  Fatiguea 65 13 0
  Pyrexia 11 0 0
Blood and Lymphatic System Disorders
  Neutropeniab 37 19 5
  Anemiac 25 5 0
  Thrombocytopeniad 20 4 0
  Leukopeniae 17 5 <1
Metabolism and Nutrition Disorders
  Decreased appetite 45 3 0
  Dehydration 10 2 0
Respiratory, Thoracic and Mediastinal Disorders
  Cough 19 0 0
Musculoskeletal and Connective Tissue Disorders
  Arthralgia 15 0 0
Nervous System Disorders
  Headache 20 0 0
  Dysgeusia 12 0 0
  Dizziness 11 0 0
Skin and Subcutaneous Tissue Disorders
  Alopecia 12 0 0
Investigations
  Creatinine increased 13 <1 0
  Weight decreased 14 0 0
a Includes asthenia, fatigue.
b Includes neutropenia, neutrophil count decreased.
c Includes anemia, hematocrit decreased, hemoglobin decreased, red blood cell count decreased.
d Includes platelet count decreased, thrombocytopenia.
e Includes leukopenia, white blood cell count decreased.

Table 11: Laboratory Abnormalities for Patients Receiving VERZENIO in MONARCH 1

  VERZENIO
N=132
All Grades
%
Grade 3
%
Grade 4
%
Creatinine increased 98 <1 0
White blood cell decreased 91 28 0
Neutrophil count decreased 88 22 5
Anemia 68 0 0
Lymphocyte count decreased 42 13 <1
Platelet count decreased 41 2 0
ALT increased 31 3 0
AST increased 30 4 0

Creatinine Increased

Abemaciclib has been shown to increase serum creatinine due to inhibition of renal tubular secretion transporters, without affecting glomerular function [see CLINICAL PHARMACOLOGY]. In clinical studies, increases in serum creatinine (mean increase, 0.2-0.3 mg/dL) occurred within the first 28-day cycle of VERZENIO dosing, remained elevated but stable through the treatment period, and were reversible upon treatment discontinuation. Alternative markers such as BUN, cystatin C, or calculated GFR, which are not based on creatinine, may be considered to determine whether renal function is impaired.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of VERZENIO. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Respiratory disorders: Interstitial lung disease (ILD)/pneumonitis.

Read the entire FDA prescribing information for Verzenio (Abemaciclib Tablets)

QUESTION

A lump in the breast is almost always cancer. See Answer
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