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Verzenios is a brand name for Abemaciclib. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Early breast cancer Verzenios in combination with endocrine therapy is indicated for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive early breast cancer at high risk of recurrence (see section 5.1). In pre- or…
Verbatim from this product's EMA label. Tap a section to expand.
Verzenios therapy should be initiated and supervised by physicians experienced in the use of anti-cancer therapies. Posology The recommended dose of abemaciclib is 150 mg twice daily when used in combination with endocrine therapy. Please refer to the summary of product characteristics of the endocrine therapy combination partner for the recommended posology.
Duration of treatment Early breast cancer Verzenios should be taken continuously for two years, or until disease recurrence or unacceptable toxicity occurs. Advanced or metastatic breast cancer Verzenios should be taken continuously as long as the patient is deriving clinical benefit from therapy or until unacceptable toxicity occurs.
If a patient vomits or misses a dose of Verzenios, the patient should be instructed to take the next dose at its scheduled time; an additional dose should not be taken. Dose adjustments Management of some adverse reactions may require dose interruption and/or dose reduction as shown in Tables 1-7.
4 Table 1. Dose adjustment recommendations for adverse reactions Verzenios dose combination therapy Recommended dose 150 mg twice daily First dose adjustment 100 mg twice daily Second dose adjustment 50 mg twice daily Table 2. Management recommendations for haematologic toxicities Complete blood counts should be monitored prior to the start of Verzenios therapy, every two weeks for the first two months, monthly for the next two months, and as clinically indicated.
Before treatment initiation, absolute neutrophil counts (ANC) ≥ 1 500 / mm3, platelets ≥ 1 00 000 / mm3, and haemoglobin ≥ 8 g/dL are recommended. Toxicitya, b Management recommendations Grade 1 or 2 No dose adjustment required. Grade 3 Suspend dose until toxicity resolves to Grade 2 or less.
Dose reduction is not required. Grade 3, recurrent; or Grade 4 Suspend dose until toxicity resolves to Grade 2 or less. Resume at next lower dose. Patient requires administration of blood cell growth factors Suspend abemaciclib dose for at least 48 hours after the last dose of blood cell growth factors was administered and until toxicity resolves to Grade 2 or less.
Resume at next lower dose unless the dose was already reduced for the toxicity that led to the use of the growth factor. a NCI Common Terminology Criteria for Adverse Events (CTCAE) b ANC: Grade 1: ANC < LLN – 1 500 / mm3; Grade 2: ANC 1 000 - < 1 500 / mm3; Grade 3: ANC 500 - < 1 000 / mm3; Grade 4: ANC < 500 / mm3 LLN = lower limit of normal Table 3.
Summary of the safety profile The most commonly occurring adverse reactions are diarrhoea, infections, neutropenia, leukopenia, anaemia, fatigue, nausea, vomiting, alopecia and decreased appetite. Of the most common adverse reactions, Grade ≥ 3 events were less than 5 % with the exception of neutropenia, leukopenia, and diarrhoea.
Tabulated list of adverse reactions In the following table, adverse reactions are listed in order of MedDRA body system organ class and frequency. Frequency gradings are: very common (≥1 / 10), common (≥1 / 100 to < 1 / 10), uncommon (≥1 / 1 000 to < 1 / 100), rare (≥1 / 10 000 to < 1 / 1 000), very rare (< 1 / 10 000), and not known (cannot be estimated from the available data).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. Table 8. Adverse reactions reported in the phase 3 studies of abemaciclib in combination with endocrine therapya (N = 3 559) and during post-marketing experience System organ class Very common Common Uncommon Rare Infections and infestations Infections b Blood and lymphatic system disorders Neutropenia Leukopenia Anaemia Thrombocytopenia Lymphopenia h Febrile neutropenia e Metabolism and nutrition disorders Decreased appetite Nervous system disorders Headache f Dysgeusia g Dizziness g Eye disorders Lacrimation increased Photopsia Keratitis Vascular disorders Venous thromboembolism c Respiratory, thoracic and mediastinal disorders ILD/pneumonitis d Gastrointestinal disorders Diarrhoea Vomiting Nausea Stomatitis f Dyspepsia f Skin and subcutaneous tissue disorders Alopecia g Pruritus g Rash g Nail disorder f Dry skin e Erythema multiforme Musculoskeletal and connective tissue disorders Muscular weakness e General disorders and administration site conditions Pyrexia e Fatigue 11 a Abemaciclib in combination with anastrozole, letrozole, exemestane, tamoxifen, or fulvestrant.
b Infections include all reported preferred terms that are part of the system organ class infections and infestations. c Venous thromboembolic events include deep vein thrombosis (DVT), pulmonary embolism, cerebral venous sinus thrombosis, subclavian, axillary vein thrombosis, DVT inferior vena cava and pelvic venous thrombosis.
Neutropenia Neutropenia was reported in patients receiving abemaciclib. 2). Fatal events of neutropenic sepsis occurred in < 1 % of patients with metastatic breast cancer. Patients should be instructed to report any episode of fever to their healthcare provider.
Infections/infestations Infections were reported in patients receiving abemaciclib plus endocrine therapy at a higher rate than in patients treated with endocrine therapy. Lung infection was reported in patients receiving abemaciclib without concurrent neutropenia.
Fatal events occurred in < 1 % of patients with metastatic breast cancer. Patients should be monitored for signs and symptoms of infection and treated as medically appropriate. Venous thromboembolism Venous thromboembolic events were reported in patients treated with abemaciclib plus endocrine therapy.
Patients should be monitored for signs and symptoms of deep vein thrombosis and pulmonary embolism and treated as medically appropriate. 2). Arterial Thromboembolic Events A potential increased risk for serious arterial thromboembolic events (ATEs), including ischemic stroke and myocardial infarction, has been observed in metastatic breast cancer studies when abemaciclib was administered in combination with endocrine therapies.
The benefits and risks of continuing abemaciclib in patients who experience a serious ATE should be considered. Increased aminotransferases Increases in ALT and AST were reported in patients receiving abemaciclib. 2). Diarrhoea Diarrhoea is the most common adverse reaction.
Across clinical studies, median time to onset of the first diarrhoea event was approximately 6 to 8 days, and median duration of diarrhoea was 7 to 12 days (Grade 2) and 5 to 8 days (Grade 3). Diarrhoea can be associated with dehydration.
Patients should start treatment with antidiarrhoeal agents such as loperamide at the first sign of loose stools, increase oral fluids and notify their healthcare provider. 2). 8 ILD/Pneumonitis ILD/pneumonitis was reported in patients receiving abemaciclib.
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Management recommendations for diarrhoea Treatment with antidiarrhoeal agents, such as loperamide, should be started at the first sign of loose stools. Toxicity a Management recommendations Grade 1 No dose adjustment required. Grade 2 If toxicity does not resolve within 24 hours to Grade 1 or less, suspend dose until resolution.
Dose reduction is not required. Grade 2 that persists or recurs after resuming the same dose despite maximal supportive measures Suspend dose until toxicity resolves to Grade 1 or less. Resume at next lower dose. Grade 3 or 4 or requires hospitalisation a NCI CTCAE 5 Table 4.
Management recommendations for increased aminotransferases Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) should be monitored prior to the start of Verzenios therapy, every two weeks for the first two months, monthly for the next two months, and as clinically indicated.
0 x ULN) No dose adjustment required. 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.
0 x ULN) Discontinue abemaciclib. a NCI CTCAE ULN = upper limit of normal Table 5. Management recommendations for interstitial lung disease (ILD)/pneumonitis Toxicitya Management recommendations Grade 1 or 2 No dose adjustment required.
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. Resume at next lower dose. Grade 3 or 4 Discontinue abemaciclib.
a NCI CTCAE Table 6. Management recommendations for venous thromboembolic events (VTEs) Toxicitya Management recommendations Early breast cancer All Grades (1, 2, 3, or 4) Suspend dose and treat as clinically indicated. Abemaciclib may be resumed when the patient is clinically stable.
Advanced or metastatic breast cancer Grade 1 or 2 No dose modification is required. Grade 3 or 4 Suspend dose and treat as clinically indicated. Abemaciclib may be resumed when the patient is clinically stable. a NCI CTCAE 6 Table 7. Management recommendations for non-haematologic toxicities (excluding diarrhoea, increased aminotransferases, and ILD/pneumonitis and VTEs) Toxicity a Management recommendations Grade 1 or 2 No dose adjustment required.
Persistent or recurrent Grade 2 toxicity that does not resolve with maximal supportive measures to baseline or Grade 1 within 7 days Suspend dose until toxicity resolves to Grade 1 or less. Resume at next lower dose. Grade 3 or 4 a NCI CTCAE CYP3A4 inhibitors Concomitant use of strong CYP3A4 inhibitors should be avoided.
If strong CYP3A4 inhibitors cannot be avoided, the abemaciclib dose should be reduced to 100 mg twice daily. In patients who have had their dose reduced to 100 mg abemaciclib twice daily and in whom co-administration of a strong CYP3A4 inhibitor cannot be avoided, the abemaciclib dose should be further reduced to 50 mg twice daily.
In patients who have had their dose reduced to 50 mg abemaciclib twice daily and in whom co-administration of a strong CYP3A4 inhibitor cannot be avoided, the abemaciclib dose may be continued with close monitoring of signs of toxicity.
Alternatively, the abemaciclib dose may be reduced to 50 mg once daily […]
d ILD/pneumonitis for early breast cancer (EBC) include all reported preferred terms that are part of the MedDRA SMQ interstitial lung disease. For metastatic breast cancer (mBC) preferred terms include interstitial lung disease, pneumonitis, organising pneumonia, pulmonary fibrosis and bronchiolitis obliterans.
e Considered ADRs in the mBC setting only (MONARCH 2 and MONARCH 3). f Considered ADRs in the EBC setting only (monarchE). g Common frequency in the EBC setting (monarchE), very common in the mBC setting (MONARCH 2 and MONARCH 3). h Common frequency in mBC setting (MONARCH 2 and MONARCH 3), very common in the EBC setting (monarchE).
Description of selected adverse reactions Neutropenia Neutropenia was reported frequently across studies. 8 % of patients. 1 % of patients receiving abemaciclib in combination with endocrine therapy with a median time to onset of 30 days, and median time to resolution of 16 days.
3 % patients. 1 % of patients. 2 % of patients receiving abemaciclib in combination with aromatase inhibitors or fulvestrant. The median time to onset of Grade 3 or 4 neutropenia was 29 to 33 days, and median time to resolution was 11 to 15 days.
9 % patients. 2). Diarrhoea Diarrhoea was the most commonly reported adverse reaction (see Table 8). Incidence was greatest during the first month of abemaciclib treatment and was lower subsequently. In the monarchE study, the median time to onset of the first diarrhoea event of any grade was 8 days.
The median duration of diarrhoea was 7 days for Grade 2 and 5 days for Grade 3. In MONARCH 2 and MONARCH 3 studies, the median time to onset of the first diarrhoea event of any grade was approximately 6 to 8 days. The median duration of diarrhoea was 9 to 12 days for Grade 2 and 6 to 8 days for Grade 3.
2). 8 %, respectively) in patients receiving abemaciclib in combination with endocrine therapy. 6 % patients. 5 days. 5 days, and median time to resolution was 11 days. 2 %, respectively) in patients receiving abemaciclib in combination with aromatase inhibitors or fulvestrant.
2 % patients. The median time to onset of Grade 3 Investigations Alanine aminotransferase increased g Aspartate aminotransferase increased g 12 or 4 ALT elevation was 57 to 61 days, and median time to resolution was 14 days. The median time to onset of Grade 3 or 4 AST elevation was 71 to 185 days, and median time to resolution was 13 to 15 days.
2). Creatinine Although not an adverse reaction, abemaciclib has […]
Patients should be monitored for pulmonary symptoms indicative of ILD/pneumonitis and treated as medically appropriate. 2). Permanently discontinue abemaciclib in patients with Grade 3 or 4 ILD/pneumonitis. 5). Visceral crisis There are no data on the efficacy and safety of abemaciclib in patients with visceral crisis.
Lactose Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine. Sodium This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially “sodium-free”.