Verzenio (abemaciclib)

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Verzenio (abemaciclib)

Verzenio (abemaciclib) is a medication indicated for the treatment of women with HR-positive, HER2-negative advanced or metastatic breast cancer.

How to buy Verzenio (abemaciclib): you can order Verzenio (abemaciclib) via TheSocialMedwork if the drug has not been approved or is not available in the patients country. TheSocialMedwork processes this import on behalf of its pharmacy licensed partner NA Pharmacy Amsterdam (BIG registration No: 89912008117).

Oncology Breast Cancer
Marketing Authorisation Holder Lilly
Mode of Action Kinase inhibitor (chemotherapy)
Administration Oral
Regulatory agency approval Food and Drug Administration (FDA), USA
Package 14 Tablets

What is Verzenio (abemaciclib)?

Verzenio (abemaciclib) is a kinase inhibitor indicated to treat HR+/HER2 (hormone receptor positive/human epidermal growth factor receptor 2 negative) metastatic breast cancer1. It is also used for the treatment of postmenopausal women whose cancer has progressed after hormonal therapy or chemotherapy1.

Who is Verzenio (abemaciclib) for?

Verzenio (abemaciclib) is for patients with a type of breast cancer called HR+/HER2(hormone receptor positive/human epidermal growth factor receptor 2 negative)1:

  • as initial endocrine-based therapy in combination with an aromatase inhibitor for the treatment of postmenopausal women

  • in women whose disease has progressed after hormonal therapy, in combination with fulvestrant  

  • in women whose disease has progressed after hormone therapy and prior chemotherapy as a monotherapy (not in combination with other medicines).

How does Verzenio (abemaciclib) work?

Verzenio is in a class of drugs known as CDK4 & 6 inhibitors2. CDK4 & 6 proteins control how fast cells grow and divide. CDK4 & 6 proteins are found in both normal and cancer cells2. They are overactive in patients with metastatic breast cancer, causing cells to grow and divide uncontrollably2. This leads to the spread of cancer2.

Verzenio works to stop these proteins and cells as they are moving to grow and divide2. It slows down the cell growth and division, which causes cancer cells to become inactive or even die. In preclinical studies, continuous exposure to Verzenio slowed down CDK4 & 6 proteins, which delayed cancer cells from growing and dividing2.

Where has Verzenio (abemaciclib) been approved?

Verzenio (abemaciclib) was approved for the treatment of patients with metastatic breast cancer by:

  • Food and Drug Administration (FDA), USA,

    • September 28, 20174, as second-line treatment

    • February 26, 20182,3, as first-line treatment.

Please note that this medicine may have also been approved in other regions than the ones we’ve listed. If you have a question about its approval in a specific country feel free to contact our support team.

How is Verzenio (abemaciclib) taken?

Verzenio (abemaciclib) is a tablet that is taken orally, with or without food1. The standard dosage is:

  • 150 mg twice daily as a starting dose in combination with fulvestrant1

  • 200 mg twice daily as a starting dose as monotherapy1

Dosing interruption and/or dose reductions may be required based on individual safety and tolerability1.

Warning:

  • Patients who experience diarrhea should alert their healthcare provider, initiate antidiarrheal therapy, and increase oral fluids1.

  • A patient’s blood counts should also be monitored prior to the start of Verzenio (abemaciclib) therapy, every 2 weeks for the first 2 months, monthly for the next 2 months, and as clinically indicated1.

  • Increases in serum transaminase (liver enzymes) levels have been observed in patients taking Verzenio (abemaciclib). Liver function tests (LFTs) should be performed before initiating treatment. LFTs should be monitored every two weeks for the first two months, monthly for the next 2 months, and as clinically indicated1.

  • Patients should be monitored for signs and symptoms of thrombosis and pulmonary embolism and treat as medically appropriate1.

Complete information about Verzenio (abemaciclib) dosage and administration can be found in the official prescribing information listed in our resources section1.

Note: Please consult with your treating doctor for personalised dosing.

Are there any known side effects or adverse reactions of Verzenio (abemaciclib)?

Common adverse reactions

The most common adverse reactions listed in the prescribing information include1:

  • diarrhea

  • neutropenia

  • nausea

  • abdominal pain

  • infections

  • fatigue

  • anemia

  • leukopenia

  • decreased appetite

  • vomiting

  • headache

  • thrombocytopenia.

Serious adverse reactions

The serious adverse reactions listed in the prescribing information include1:

  • diarrhea

  • alterations in a patient’s blood counts

  • increases in liver enzymes

  • thrombosis and pulmonary embolism.

Use in specific populations

  • Pregnant women: Verzenio (abemaciclib) can cause fetal harm when administered to a pregnant woman, it is advised to avoid pregnancies and breast feeding1.

  • Breastfeeding women: There are no data on the presence of abemaciclib in human milk, or its effects on the breastfed child or on milk production1. Because of the potential for serious adverse reactions in breastfed infants, it’s advised that lactating women do not breastfeed during treatment and for at least 3 weeks after the last dose1.

  • Women with reproductive potential: Verzenio (abemaciclib) can cause fetal harm when administered to a pregnant woman Pregnancy testing is recommended for females of reproductive potential prior to initiating treatment with Verzenio (abemaciclib)1. Women who could possibly become pregnant (have reproductive potential) should be advised to use effective contraception during treatment and for at least 3 weeks after the last dose1.

  • Men: Based on findings in animals, Verzenio (abemaciclib) may impair fertility in males of reproductive potential1.

  • Pediatric use (children): The safety and effectiveness of Verzenio (abemaciclib) have not been established in children1.

  • Geriatric patients (elderly patients): Of the 441 patients who received Verzenio (abemaciclib) in the MONARCH 2 trial, 35% were 65 years of age or older and 9% were 75 years of age or older. Of the 132 patients who received Verzenio (abemaciclib) in MONARCH 1, 32% were 65 years of age or older and 8% were 75 years of age or older. No overall differences in safety or effectiveness of Verzenio (abemaciclib) were observed between older patients and younger patients1.

  • Renal impairment (kidney problems): No dosage adjustment is required for patients with mild or moderate renal impairment1.

  • Hepatic impairment (liver problems): No dosage adjustments are necessary in patients with mild or moderate hepatic impairment (Child-Pugh A or B). Reduce the dosing frequency when administering Verzenio (abemaciclib) to patients with severe hepatic impairment (Child-Pugh C)1.


For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information1.


More Information
Working ingredient abemaciclib
Shipping method Controlled room temperature (temperature controlled)
Package 14
Therapeutic Area Oncology
Oncology Breast Cancer
Indication Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer
Administration Oral
Mode of Action Kinase inhibitor (chemotherapy)
Regulatory agency approval Food and Drug Administration (FDA), USA
Marketing Authorisation Holder Lilly

First line treatment - In combination with an aromatase inhibitor

Postmenopausal women with untreated HR-positive, HER2-negative advanced or metastatic breast cancer.

The Food and Drug Administration (FDA), USA, approval of Verzenio (abemaciclib) in combination with an aromatase inhibitor (anastrozole or letrozole) for the treatment of patients with previously untreated HR+/HER- advanced or metastatic breast cancer was based on MONARCH-3, a randomized, double-blinded, placebo-controlled, multicenter study1. This study involved a total of 493 patients who were randomly assigned to one of two groups and received either placebo plus letrozole or anastrozole, or Verzenio (abemaciclib) plus letrozole or anastrozole. Physicians were free to decide whether letrozole or anastrozole was to be taken1.

Results

Among the efficacy outcome measures were the progression-free survival (PFS) and objective response rate (ORR) for patients with measurable disease1.

The combination of Verzenio (abemaciclib) plus letrozole or anastrozole resulted in better results than placebo plus letrozole or anastrozole1.

The median PFS was1:

  • 28.2 months [95% CI: 23.5, not reached] with Verzenio (abemaciclib) plus letrozole or anastrozole

  • 14.8 months [95% CI: 11.2, 19.2] placebo plus letrozole or anastrozole.

The ORR for patients with measurable disease was1:

  • 55.4% [95% CI: 49.5, 61.4] with Verzenio (abemaciclib) plus letrozole or anastrozole

  • 40.2% [95% CI: 31.8, 48.5] with placebo plus letrozole or anastrozole.

Second line treatment - In combination with fulvestrant

Patients with HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression on or after prior adjuvant or metastatic endocrine therapy.

The Food and Drug Administration (FDA), USA, approval of Verzenio (abemaciclib) in combination with fulvestrant for the treatment of patients with HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression on or after prior adjuvant or metastatic endocrine therapy was based on MONARCH 2, a randomized, placebo-controlled, multicenter study1. This study involved a total of 669 patients with a median age of 60 years (range, 32-91 years), and 37% of patients were older than 651. Patients were randomly assigned to one of two groups and received either Verzenio (abemaciclib) plus fulvestrant, or placebo plus fulvestrant. Patients remained on continuous treatment until development of progressive disease or unmanageable toxicity1.

Results

Among the efficacy outcome measures were the progression-free survival (PFS) and the objective response rate (ORR).

The median PFS was1:

  • 16.4 months [95% CI: 14.4, 19.3] with Verzenio (abemaciclib) plus fulvestrant

  • 9.3 months [95% CI: 7.4, 12.7] with placebo plus fulvestrant.

The ORR was1:

  • 48,1% with Verzenio (abemaciclib) plus fulvestrant

  • 35% with placebo plus fulvestrant.

Second or third line treatment - Monotherapy

Patients with HR-positive, HER2-negative breast cancer who received prior endocrine therapy and 1-2 chemotherapy regimens in the metastatic setting.

The Food and Drug Administration (FDA), USA, approval of Verzenio (abemaciclib) as a monotherapy in metastatic breast cancer patients with HR-positive, HER2-negative breast cancer whose disease progressed during or after endocrine therapy, had received taxane in any setting, and 1-2 chemotherapy regimens in the metastatic setting, was based on MONARCH 1, a single-arm, open-label, multicenter study1.  A total of 132 patients received 200 mg VERZENIO orally twice daily on a continuous schedule until development of progressive disease or unmanageable toxicity1. MONARCH-1 was a single arm study, which means that Verzenio (abemaciclib) was not tested against any other medicine. The median duration of metastatic disease was 27.6 months1. Ninety percent (90%) of patients had visceral metastases, and 51% of patients had 3 or more sites of metastatic disease1.

Results

  • Among the efficacy outcome measures were the objective response rate (ORR) and the median duration of response (mDoR)1.

The ORR in MONARCH 1 was1:

  • 19,7% [95% CI: 13.3, 27.5] as assessed by an investigator assessed

  • 17.4% [95% CI: 11.4, 25] as assessed by an independent reviewer.

The mDoR in MONARCH 1 was1:

  • 8.6 months [95% CI: 5.8, 10.2] as assessed by an investigator

  • 7.2 months [95% CI: 5.6, not reached] as assessed by an independent reviewer.

  1. Highlights of Prescribing Information: Verzenio:(abemaciclib).
    Eli Lilly and Company. February 2018. 

  2. Verzenio.com.
    Cited 20/06/2018.

  3. FDA press release: FDA approves abemaciclib as initial therapy for HR-positive, HER2-negative metastatic breast cancer.
    (Last Updated: 02/26/2018) Cited 20/06/2018.  

  4. FDA press release: FDA approves new treatment for certain advanced or metastatic breast cancers. 
    (Last update: 28/09/2017), cited on 25/06/2018.

Shipping Type Standard
Shipping method Controlled room temperature (temperature controlled)
Dynamic Weight No
This content has been reviewed by our medical doctor Jan de Witt.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Medicine information contained herein may be time sensitive. The absence of a warning for a given medicine or combination thereof in no way should be construed to indicate that the medicine or combination is safe, effective or appropriate for any given patient. Always consult your treating physician before starting a course of treatment.