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  • Verzenio
    / Eli Lilly


    Active Ingredient
    Abemaciclib 50, 100, 150, 200 mg

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Film Coated Tablets

    14 X 50 mg

    partial basket chart 26045

    Film Coated Tablets

    14 X 100 mg

    partial basket chart 26046

    Film Coated Tablets

    14 X 150 mg

    partial basket chart 26047

    Related information


    Dosage

    Recommended Dose and Schedule: When used in combination with fulvestrant or a non-steroidal aromatase inhibitor, the recommended dose of VERZENIO is 150 mg taken orally twice daily.
    – When given with VERZENIO, refer to the Full Prescribing Information for the recommended dose of the nonsteroidal aromatase inhibitor being used.
    – When given with VERZENIO, the recommended dose of fulvestrant is 500 mg administered on Days 1, 15, and 29; and once monthly thereafter. Refer to the Full Prescribing Information for fulvestrant. Pre/perimenopausal
    women treated with the combination of VERZENIO plus fulvestrant should be treated with a gonadotropinreleasing hormone agonist according to current clinical practice standards.
    When used as monotherapy, the recommended dose of VERZENIO is 200 mg taken orally twice daily.
    Continue treatment until disease progression or unacceptable toxicity.
    Method of administration: VERZENIO may be taken with or without food.
    Instruct patients to take their doses of VERZENIO at approximately the same times every day.
    If the patient vomits or misses a dose of VERZENIO, instruct the patient to take the next dose at its scheduled time.
    Instruct patients to swallow VERZENIO tablets whole and not to chew, crush, or split tablets before swallowing. Instruct patients not to ingest VERZENIO tablets if broken, cracked, or otherwise not intact.
    Dose Modification
    Dose Modifications for Adverse Reactions: The recommended VERZENIO dose modifications for adverse reactions are provided in Tables 1-5 at the attached doctor’s leaflet. Discontinue VERZENIO for patients unable to tolerate 50 mg twice daily.
    Dose Modification for Use with Strong and Moderate CYP3A Inhibitors: Avoid concomitant use of the strong CYP3A inhibitor ketoconazole.
    With concomitant use of strong CYP3A inhibitors other than ketoconazole, in patients with recommended starting doses of 200 mg twice daily or 150 mg twice daily, reduce the VERZENIO dose to 100 mg twice daily. In patients who have had a dose reduction to 100 mg twice daily due to adverse reactions, further reduce the VERZENIO dose to 50 mg twice daily. If a patient taking VERZENIO discontinues a CYP3A inhibitor, increase the VERZENIO dose (after 3-5 half-lives of the inhibitor) to the dose that was used before starting the strong inhibitor.
    With concomitant use of moderate CYP3A inhibitors, monitor for adverse reactions and consider reducing the VERZENIO dose in 50 mg decrements as demonstrated in Table 1 at the attached doctor’s leaflet, if necessary.
    Dose Modification for Patients with Severe Hepatic Impairment: For patients with severe hepatic impairment (Child Pugh-C), reduce the VERZENIO dosing frequency to once daily.
    Refer to the Full Prescribing Information for coadministered non-steroidal aromatase inhibitor or fulvestrant for dose modification requirements for severe hepatic impairment.
    Pediatric Use: The safety and effectiveness of VERZENIO have not been established in pediatric patients.
    Geriatric Use: Of the 900 patients who received VERZENIO in MONARCH 1, MONARCH 2, AND MONARCH 3, 38% were 65 years of age or older and 910% were 75 years of age or older. The most common adverse reactions (≥5%) Grade 3 or 4 in patients ≥65 years of age across MONARCH 1, 2, and 3 were neutropenia, diarrhea, fatigue, nausea, dehydration, leukopenia, anemia, infections, and ALT increased. No overall differences in safety or effectiveness of VERZENIO were observed between these patients and younger patients.
    Renal Impairment: No dosage adjustment is required for patients with mild or moderate renal impairment (CLcr ≥30-89 mL/min, estimated by Cockcroft-Gault [C-G]). The pharmacokinetics of abemaciclib in patients with severe renal impairment (CLcr <30 mL/min, C-G), end stage renal disease, or in patients on dialysis is unknown.
    Hepatic Impairment: 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 to patients with severe hepatic impairment (Child-Pugh C).
    See prescribing information for full details.


    Indications

    – In combination with a non-steroidal aromatase inhibitor as initial endocrine-based therapy for the treatment of 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 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.
    – As monotherapy for the treatment of adult patients with HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy in the metastatic setting and prior chemotherapy in the metastatic setting including taxane in adjuvant or metastatic setting.
    Verzenio should not be used in women after prior treatment with cyclin-dependent kinases 4 and 6 (CDK4 and CDK6) inhibitor.


    Contra-Indications

    Hypersensitivity to the active substance or to any of the excipients.


    Special Precautions

    Diarrhea: Instruct patients that at the first sign of loose stools, they should start antidiarrheal therapy such as loperamide, increase oral fluids, and notify their healthcare provider for further instructions and appropriate follow up. For Grade 3 or 4 diarrhea, or diarrhea that requires hospitalization, discontinue VERZENIO until toxicity resolves to ≤Grade 1, and then resume VERZENIO at the next lower dose.
    Neutropenia: Monitor complete blood counts prior to the start of VERZENIO therapy, every 2 weeks for the first 2 months, monthly for the next 2 months, and as clinically indicated. Dose interruption, dose reduction, or delay in starting treatment cycles is recommended for patients who develop Grade 3 or 4 neutropenia.
    Febrile neutropenia has been reported in <1% of patients exposed to VERZENIO in MONARCH studies. Two deaths due to neutropenic sepsis were observed in MONARCH 2. Inform patients to promptly report any episodes of fever to their healthcare provider.
    Hepatotoxicity: Monitor liver function tests (LFTs) prior to the start of VERZENIO therapy, every 2 weeks for the first 2 months, monthly for the next 2 months, and as clinically indicated. Dose interruption, dose reduction, dose discontinuation, or delay in starting treatment cycles is recommended for patients who develop persistent or recurrent Grade 2, or Grade 3 or 4, hepatic transaminase elevation.
    Venous Thromboembolism: Monitor patients for signs and symptoms of venous thrombosis and pulmonary embolism and treat as medically appropriate.
    Embryo-Fetal Toxicity: Based on findings from animal studies and the mechanism of action, VERZENIO can cause fetal harm when administered to a pregnant woman. In animal reproduction studies, administration of abemaciclib to pregnant rats during the period of organogenesis caused teratogenicity and decreased fetal weight at maternal exposures that were similar to the human clinical exposure based on area under the curve (AUC) at the maximum recommended human dose.
    Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with VERZENIO and for at least 3 weeks after the last dose.
    See prescribing information for full details.


    Side Effects

    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. The most frequently reported (≥5%) Grade 3 or 4 adverse reactions were neutropenia, diarrhea, leukopenia, increased ALT, and anemia.
    See prescribing information for full details.


    Drug interactions

    CYP3A Inhibitors
    Strong and moderate CYP3A4 inhibitors increased the exposure of abemaciclib plus its active metabolites to a clinically meaningful extent and may lead to increased toxicity.
    Ketoconazole: Avoid concomitant use of ketoconazole. Ketoconazole is predicted to increase the AUC of abemaciclib by up to 16-fold.
    Other Strong CYP3A Inhibitors: In patients with recommended starting doses of 200 mg twice daily or 150 mg twice daily, reduce the VERZENIO dose to 100 mg twice daily with concomitant use of strong CYP3A inhibitors other than ketoconazole. In patients who have had a dose reduction to 100 mg twice daily due to adverse reactions, further reduce the VERZENIO dose to 50 mg twice daily with concomitant use of strong CYP3A inhibitors. If a patient taking VERZENIO discontinues a strong CYP3A inhibitor, increase the VERZENIO dose (after 3-5 half-lives of the inhibitor) to the dose that was used before starting the inhibitor.
    Patients should avoid grapefruit products.
    Moderate CYP3A Inhibitors: With concomitant use of moderate CYP3A inhibitors, monitor for adverse reactions and consider reducing the VERZENIO dose in 50 mg decrements as demonstrated in Table 1 at the attached doctor’s leaflet, if necessary.
    Strong and Moderate CYP3A Inducers
    Coadministration of strong or moderate CYP3A inducers decreased the plasma concentrations of abemaciclib plus its active metabolites and may lead to reduced activity. Avoid concomitant use of strong or moderate CYP3A inducers and consider alternative agents.


    Pregnancy and Lactation

    Pregnancy: Based on findings in animals and its mechanism of action, VERZENIO can cause fetal harm when administered to a pregnant woman. There are no available human data informing the drug-associated risk. Advise pregnant women of the potential risk to a fetus.
    Lactation: There are no data on the presence of abemaciclib in human milk, or its effects on the breastfed child or on milk production. Because of the potential for serious adverse reactions in breastfed infants from VERZENIO, advise lactating women not to breastfeed during VERZENIO treatment and for at least 3 weeks after the last dose.
    See prescribing information for full details.


    Overdose

    There is no known antidote for VERZENIO. The treatment of overdose of VERZENIO should consist of general supportive measures.


    Important notes

    Storage: Store below 30°C.


    Manufacturer
    Eli Lilly & Company Ltd. USA
    Licence holder
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