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Abemaciclib (Verzenio)

Trade Name : Verzenio

Eli Lilly and Company

TABLET

Strength 50 mg/1

ABEMACICLIB Kinase Inhibitors [MoA],Kinase Inhibitor [EPC]

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Product information is meant for

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Abemaciclib (Verzenio) which is also known as Verzenio and Manufactured by Eli Lilly and Company. It is available in strength of 50 mg/1 per ml. Read more

Abemaciclib (Verzenio) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • No data
  • VERZENIO (abemaciclib) is indicated:n
  • VERZENIO is a kinase inhibitor indicated:n
  • in combination with an 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. ()n
  • 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. ()n
  • 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. ()n
  • VERZENIO tablets are taken orally with or without food. ()n
  • Recommended starting dose in combination with fulvestrant or an aromatase inhibitor: 150u00a0mg twice daily. ()n
  • Recommended starting dose as monotherapy: 200u00a0mg twice daily. ()n
  • Dosing interruption and/or dose reductions may be required based on individual safety and tolerability. ()n
  • 50u00a0mg tablets: oval beige tablet with u201cLillyu201d debossed on one side and u201c50u201d on the other side.n
  • 100u00a0mg tablets: oval white to practically white tablet with u201cLillyu201d debossed on one side and u201c100u201d on the other side.n
  • 150u00a0mg tablets: oval yellow tablet with u201cLillyu201d debossed on one side and u201c150u201d on the other side.n
  • 200u00a0mg tablets: oval beige tablet with u201cLillyu201d debossed on one side and u201c200u201d on the other side.n
  • Tablets: 50u00a0mg, 100u00a0mg, 150u00a0mg, and 200u00a0mg. ()n
  • None.n
  • None. ()n
  • No data
  • Diarrhea: Instruct patients at the first sign of loose stools to initiate antidiarrheal therapy, increase oral fluids, and notify their healthcare provider. ()n
  • 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. (, )n
  • Interstitial Lung Disease (ILD)/Pneumonitis: Severe and fatal cases of ILD/pneumonitis have been reported. Monitor for clinical symptoms or radiological changes indicative of ILD/pneumonitis. Permanently discontinue VERZENIO in all patients with Grade 3 or 4 ILD or pneumonitis. (, )n
  • Hepatotoxicity: Increases in serum transaminase levels have been observed. Perform liver function tests (LFTs) before initiating treatment with VERZENIO. Monitor LFTs every two weeks for the first two months, monthly for the next 2 months, and as clinically indicated. (, )n
  • Venous Thromboembolism: Monitor patients for signs and symptoms of thrombosis and pulmonary embolism and treat as medically appropriate. ()n
  • Embryo-Fetal Toxicity: Can cause fetal harm. Advise patients of potential risk to a fetus and to use effective contraception. (, , )n
  • The following adverse reactions are discussed in greater detail in other sections of the labeling:n
  • Most common adverse reactions (incidence u226520%) were diarrhea, neutropenia, nausea, abdominal pain, infections, fatigue, anemia, leukopenia, decreased appetite, vomiting, headache, alopecia, and thrombocytopenia. ()n
  • To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • No data
  • CYP3A Inhibitors: Avoid concomitant use of ketoconazole. Reduce the VERZENIO dose with concomitant use of other strong and moderate CYP3A inhibitors. (, )n
  • CYP3A Inducers: Avoid concomitant use of strong and moderate CYP3A inducers. ()n
  • Lactation: Advise not to breastfeed. ()n
  • There is no known antidote for VERZENIO. The treatment of overdose of VERZENIO should consist of general supportive measures.n
  • Abemaciclib is a kinase inhibitor for oral administration. It is a white to yellow powder with the empirical formula CHFN and a molecular weight 506.59.n
  • The chemical name for abemaciclib is 2-Pyrimidinamine, -[5-[(4-ethyl-1-piperazinyl)methyl]-2-pyridinyl]-5-fluoro-4-[4-fluoro-2-methyl-1-(1-methylethyl)-1-benzimidazol-6-yl]-. Abemaciclib has the following structure:n
  • VERZENIO (abemaciclib) tablets are provided as immediate-release oval white, beige, or yellow tablets. Inactive ingredients are as follows: Excipientsu2014microcrystalline cellulose 102, microcrystalline cellulose 101, lactose monohydrate, croscarmellose sodium, sodium stearyl fumarate, silicon dioxide. Color mixture ingredientsu2014polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, iron oxide yellow, and iron oxide red.n
  • No data
  • Carcinogenicity studies have not been conducted with abemaciclib.n
  • Abemaciclib and its active human metabolites M2 and M20 were not mutagenic in a bacterial reverse mutation (Ames) assay or clastogenic in an in vitro chromosomal aberration assay in Chinese hamster ovary cells or human peripheral blood lymphocytes. Abemaciclib was not clastogenic in an in vivo rat bone marrow micronucleus assay.n
  • Studies to assess the effects of abemaciclib on fertility have not been performed. In repeat-dose toxicity studies up to 3-months duration, abemaciclib-related findings in the testis, epididymis, prostate, and seminal vesicle at doses u226510u00a0mg/kg/day in rats and u22650.3u00a0mg/kg/day in dogs included decreased organ weights, intratubular cellular debris, hypospermia, tubular dilatation, atrophy, and degeneration/necrosis. These doses in rats and dogs resulted in approximately 2 and 0.02 times, respectively, the exposure (AUC) in humans at the maximum recommended human dose.n
  • No data
  • No data
  • Advise patients to read the .n
  • No data
  • PACKAGE CARTON u2013 VERZENIO 50 mg 14ct
  • 14 tabletsn
  • NDC 0002-4483-54n
  • Rx onlyn
  • Verzeniou2122n
  • (abemaciclib) tabletsn
  • 50 mg dosen
  • 7-Day Supplyn
  • This 50 mg Dose Pack contains fourteen 50 mg tablets.n
  • www.verzenio.comn
  • LIFT TO OPENn
  • Lillyn
  • PACKAGE CARTON u2013 VERZENIO 100 mg 14ct
  • 14 tabletsn
  • NDC 0002-4815-54n
  • Rx onlyn
  • Verzeniou2122n
  • (abemaciclib) tabletsn
  • 100 mg dosen
  • 7-Day Supplyn
  • This 100 mg Dose Pack contains fourteen 100 mg tablets.n
  • www.verzenio.comn
  • LIFT TO OPENn
  • Lillyn
  • PACKAGE CARTON u2013 VERZENIO 150 mg 14ct
  • 14 tabletsn
  • NDC 0002-5337-54n
  • Rx onlyn
  • Verzeniou2122n
  • (abemaciclib) tabletsn
  • 150 mg dosen
  • 7-Day Supplyn
  • This 150 mg Dose Pack contains fourteen 150 mg tablets.n
  • www.verzenio.comn
  • LIFT TO OPENn
  • Lillyn
  • PACKAGE CARTON u2013 VERZENIO 200 mg 14ct
  • 14 tabletsn
  • NDC 0002-6216-54n
  • Rx onlyn
  • Verzeniou2122n
  • (abemaciclib) tabletsn
  • 200 mg dosen
  • 7-Day Supplyn
  • This 200 mg Dose Pack contains fourteen 200 mg tablets.n
  • www.verzenio.comn
  • LIFT TO OPENn
  • Lillyn

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