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One 4 mL single-use vial of 100 mg dose (25mg/ml)

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    AVASTIN (bevacizumab)

    • Generic Name: bevacizumab
    • Pronounced: bev a CIZ oo mab
    • Brand Names: Avastin, Mvasi, Zirabev

    DESCRIPTION

    Humanized monoclonal antibody against vascular endothelial growth factor Used for metastatic colorectal cancer, renal cell cancer, non-small cell lung cancer, cervical cancer, recurrent glioblastoma, and epithelial ovarian, fallopian tube, or primary peritoneal cancer
    May cause infusion-related reactions that require a reduced infusion rate or discontinuation of therapy; also associated with wound healing complications requiring treatment interruption for 28 days before and after surgery

    COMMON BRAND NAMES

    Avastin, MVASI

    HOW SUPPLIED

    Avastin/Bevacizumab (Hamster)/MVASI Ophthalmic Sol: 1mL, 25mg
    Avastin/MVASI Intravenous Inj Sol: 1mL, 25mg

    DOSAGE & INDICATIONS

    For the treatment of metastatic colorectal cancer.

    NOTE: Bevacizumab is not indicated for the adjuvant treatment of colorectal cancer due to lack of efficacy in 2 randomized, open-label clinical trials.

    For the first-line treatment of metastatic colorectal cancer in combination with capecitabine and oxaliplatin†.Intravenous dosage

    Adults:
    7.5 mg/kg IV over 90 minutes on day 1 in combination with oxaliplatin (130 mg/m2 IV on day 1) and capecitabine (1,000 mg/m2 PO twice daily on days 1 to 14), repeated every 3 weeks. If the first bevacizumab infusion is tolerated over 90 minutes, the second infusion may be given over 60 minutes and if well-tolerated, subsequent bevacizumab infusions may be given over 30 minutes. In a phase 3 clinical trial (n = 1,401), the addition of bevacizumab to oxaliplatin-based therapy (CapeOx or FOLFOX4) provided a significant increase in the primary endpoint of progression-free survival (9.4 months vs. 8 months). Overall survival and response rate were not significantly improved in the bevacizumab containing arms.[41609] The primary endpoint of treatment-related grade 3 or 4 adverse reactions in the first 12 weeks occurred in 67% of patients with previously untreated metastatic or recurrent colorectal cancer treated with CapeOx compared to 56% of those who received CapeOx plus bevacizumab in 2 sequentially conducted, open-label cohorts (TREE-1 and TREE-2). The addition of bevacizumab to CapeOx improved the overall response rate (ORR) (46% vs. 27%), the median time to progression (TTP) (10.3 months vs. 5.9 months), and median overall survival (OS) (24.6 months vs. 17.2 months) compared to CapeOx without bevacizumab.[47464]

    MAXIMUM DOSAGE

    Adults

    Oncology: 15 mg/kg IV every 3 weeks or 10 mg/kg IV every 2 weeks.
    Ocular: The maximum tolerated intraocular dose has not been determined; in clinical trials, the highest dose was 2.5 mg/0.1 mL monocular.

    Geriatric

    Oncology: 15 mg/kg IV every 3 weeks or 10 mg/kg IV every 2 weeks.
    Ocular: The maximum tolerated intraocular dose has not been determined; in clinical trials, the highest dose was 2.5 mg/0.1 mL monocular.

    Adolescents

    Safety and efficacy have not been established.

    Children

    Safety and efficacy have not been established.

    Infants

    Safety and efficacy have not been established.

    ADMINISTRATION

    Injectable Administration

    Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit.

    Intravenous Administration

    Do NOT administer bevacizumab as an IV push or bolus.
    Administer the first infusion of bevacizumab intravenously (IV) over 90 minutes.
    If the first infusion is tolerated, the second dose may be given IV over 60 minutes.
    All subsequent infusions may be administered IV over 30 minutes if the 60-minute infusion is tolerated.[60402] [62350] [64400]
    Rapid infusion rate†: Bevacizumab has been administered IV at a standard infusion rate of 0.5 mg/kg/minute for all doses incuding the initial infusion (i.e. 5 mg/kg IV over 10 minutes; 10 mg/kg IV over 20 minutes; 15 mg/kg IV over 30 minutes) in one trial (n = 370; 2,311 doses).[41625] In other data, both bevacizumab 5 mg/kg and 7.5 mg/kg have been administered over 10 minutes.

    Infusion preparation:
    Withdraw the appropriate amount of bevacizumab and dilute in a total volume of 100 mL of 0.9% Sodium Chloride Injection.
    Do not administer or mix with Dextrose Injection.
    Discard any unused portion left in the preservative-free vial.
    Store diluted bevacizumab under refrigeration at 2 to 8 degrees C (36 to 46 degrees F) for up to 8 hours.

    Other Administration Route(s)

    Intravitreous administration
    NOTE: Bevacizumab is not approved by the FDA for intravitreous administration
    Bevacizumab has been given off-label by intravitreal administration. Only for use by ophthalmologists trained in these specialized administration techniques.
    Adequate anesthesia (e.g., 2% lidocaine subconjunctival or 2 to 4% lidocaine topically) plus povidone-iodine and/or a broad-spectrum microbicide should be given prior to intravitreal injection.
    Use controlled aseptic conditions, which include the use of sterile gloves, a sterile drape, and a sterile eyelid speculum (or equivalent).
    Inspect product visually for particulate matter and discoloration prior to administration.
    Using aseptic technique, withdraw approximately 0.12 mL of bevacizumab from the vial contents into a 1 ml polypropylene tuberculin syringe. Avoid using a filter needle to withdraw the drug, doing so may cause the large proteins to adhere to the filter.
    Before injection in a single eye, a sterile standard 30-gauge needle (5/8 inch) should be placed on the syringe, and the plunger advanced to 0.05 mL so that all the dead space is removed. If the contralateral eye requires treatment, the sterile field, syringe, gloves, drapes, eyelid speculum, filter, and injection needles should be changed before administration to the other eye.
    Following the injection, monitor patient for elevation in intraocular pressure (IOP) and for endophthalmitis.

    STORAGE

    Avastin:
    - Discard unused portion. Do not store for later use.
    - Protect from light
    - Store between 36 to 46 degrees F
    MVASI:
    - Discard product if it contains particulate matter, is cloudy, or discolored
    - Discard unused portion. Do not store for later use.
    - Do not freeze
    - Protect from light
    - Refrigerate (between 36 and 46 degrees F)
    - Store in carton until time of use

    MECHANISM OF ACTION

    Bevacizumab binds to vascular endothelial growth factor (VEGF) and prevents the binding of VEGF with its receptors, VEGFR-1 (Flt-1) and VEGFR-2 (Flk-1/KDR), found on the surface of endothelial cells. The interaction of VEGF with its receptors leads to endothelial cell proliferation and new blood vessel formation in in vitro models of angiogenesis. Administration of bevacizumab to xenotransplant models of colon cancer in nude (athymic) mice caused a reduction of microvascular growth and inhibition of metastatic disease progression.

    In the body, VEGF functions in angiogenesis by regulating both vascular proliferation and permeability. VEGF is unique due to its specificity and potency for vascular endothelium. Also, VEGF has anti-apoptotic effects on cells in newly formed vessels by inducing bcl-2 and A1, anti-apoptotic proteins. Other members of the VEGF gene family have been identified; however, their function has not been fully characterized. VEGF is expressed in tumor cells, macrophages, T-cells, smooth muscle cells, kidney cells, mesangial cells, keratinocytes, astrocytes, and osteoblasts. Expression of VEGF is regulated by differentiation, transformation, cytokines, hormones, and growth factors (e.g., epidermal growth factor, transforming growth factor-beta, keratinocyte growth factor, interleukin-1 beta, prostaglandin E2, and insulin-like growth factor-1), and oxygen deprivation. Under hypoxic conditions, hypoxia-inducible factor-I activates transcription of the VEGF-A gene. VEGF-A promotes the proliferation of endothelial cells and chemotaxis of endothelial cells and monocytes. Also, VEGF-A can cause differentiation of monocytes into endothelial-like cells and inhibit the maturation of dendritic cells. These effects can deplete host immune cells and could lead to immunosuppression. VEGF-A also increases vascular permeability leading to a leakage of plasma proteins that results in the formation of an extravascular fibrin gel. The increased vascular permeability results in increased intratumoral interstitial fluid pressure, which reduces the delivery of antineoplastic therapies. During fetal development and the early post-natal period, VEGF-A is critical for normal maturation; however, its function evolves with age. In mice, at about 4 weeks, vascularization becomes VEGF-independent. In adult animals, VEGF-A inactivation has little effect on the vasculature; although, it is required during the development of the corpus luteum and for wound healing. Reduced levels of VEGF may cause neurodegeneration by impairing neural tissue perfusion.

    PHARMACOKINETICS

    Bevacizumab is administered as an intravenous infusion. The estimated half-life was 20 days (range, 11 to 50 days), the mean central volume of distribution was 2.9 L (coefficient of variance (CV), 22%), and the mean clearance was 0.23 L/day (CV, 33%) in patients who received 1 to 20 mg/kg of bevacizumab weekly, every 2 weeks, or every 3 weeks in a population pharmacokinetic (PK) analysis (n = 491). Bevacizumab exhibits linear pharmacokinetics (PK), with the predicted time to reach greater than 90% of steady state concentration is 84 days.

    Affected cytochrome P450 isoenzymes and drug transporters: None.

    Intravenous Route

    In PK simulations, the median trough level (Cmin) was 80.3 mcg/mL on day 84 following a bevacizumab dose of 5 mg/kg IV given once every 2 weeks. The accumulation ratio was 2.8 following a bevacizumab dose of 10 mg/kg IV given once every 2 weeks.


    What is the most important information I should know about bevacizumab?

    Bevacizumab can make it easier for you to bleed. Seek emergency medical attention if you have any bleeding that will not stop. You may also have bleeding on the inside of your body.

    Call your doctor if you have: signs of bleeding in your digestive tract--feeling very weak or dizzy, severe stomach pain, black or bloody stools, coughing up blood or vomit that looks like coffee grounds; or signs of bleeding in the brain--sudden numbness or weakness, slurred speech, severe headache, problems with vision or balance.

    Do not use this medicine within 28 days before or after a planned surgery.

    What is bevacizumab?

    Bevacizumab is used to treat a certain type of brain tumor, and certain types of cancers of the kidney, liver, lung, colon, rectum, cervix, ovary, or fallopian tube. Bevacizumab is also used to treat cancer of the membrane lining the internal organs in your abdomen. It is usually given as part of a combination of cancer medicines.


    Avastin, BEVACIZUMAB is a monoclonal antibody. It is used to treat many types of cancers; in combination with intravenous fluorouracil-based chemotherapy, is indicated for the first-or second-line treatment of patients with metastatic colorectal cancer (mCRC).
    Vascular Endothelial Growth Factor Inhibitor [EPC],Vascular Endothelial Growth Factor-directed Antibody Interactions [MoA],Vascular Endothelial Growth Factor Inhibitors [MoA]

    Adult Dosing

    Dosage forms: INJ

    Special Note

    [uses, dosing may vary]
    Info: refer to institution protocols and pkg insert prior to prescribing for uses and dosing incl. toxicity-related dose adjustments; D/C >28 days before elective surgery, restart >28 days after major surgery when wound fully healed

    colorectal CA, metastatic

    [combo w/ bolus-IFL]
    Dose: 5 mg/kg/dose IV x1 on day 1 of 14-day cycle
    [combo w/ FOLFOX4]
    Dose: 10 mg/kg/dose IV x1 on day 1 of 14-day cycle[combo w/ fluoropyrimidine-irinotecan or fluoropyrimidine-oxaliplatin]Dose: 5 mg/kg/dose IV x1 on day 1 of 14-day cycle; Alt: 7.5 mg/kg/dose IV x1 on day 1 of 21-day cycle; Info: for pts w/ progressive dz on bevacizumab-containing regimen

    nonsquamous non-small cell lung CA, first-line tx

    [15 mg/kg/dose IV x1 on day 1 of 21-day cycle]Info: for pts w/ unresectable, locally advanced, recurrent or metastatic dz; part of multi-drug chemo regimen

    glioblastoma multiforme, recurrent

    [10 mg/kg/dose IV x1 on day 1 of 14-day cycle]


    renal cell CA, metastatic

    [10 mg/kg/dose IV x1 on day 1 of 14-day cycle]Info: use w/ interferon alfa


    cervical CA, recurrent or metastatic

    [15 mg/kg/dose IV x1 on day 1 of 21-day cycle]Info: part of multi-drug chemo regimen


    ovarian CA

    [stage III-IV dz]Dose: 15 mg/kg/dose IV x1 on day 1 of 21-day cycle for up to 22 cycles; Info: for epithelial ovarian, fallopian tube, or primary peritoneal CA following initial surgical resection; part of multi-drug chemo regimen for up to 1st 6 cycles[*first-line tx, advanced homologous recombination deficiency-positive dz]Dose: 15 mg/kg/dose IV x1 on day 1 of 21-day cycle x15mo; Info: for epithelial ovarian, fallopian tube, or primary peritoneal CA; use w/ platinum-based chemo for at least 4 cycles, then use w/ olaparib maintenance tx for total of 15mo[recurrent, platinum-sensitive dz]Dose: 15 mg/kg/dose IV x1 on day 1 of 21-day cycle; Info: for epithelial ovarian, fallopian tube, or primary peritoneal CA; part of multi-drug chemo regimen for 1st 6-10 cycles[recurrent, platinum-resistant dz, 14-day cycle]Dose: 10 mg/kg/dose IV x1 on day 1 of 14-day cycle; Info: for epithelial ovarian, fallopian tube, or primary peritoneal CA; use w/ paclitaxel, doxorubicin liposomal, or topotecan[recurrent, platinum-resistant dz, 21-day cycle]Dose: 15 mg/kg/dose IV x1 on day 1 of 21-day cycle; Info: for epithelial ovarian, fallopian tube, or primary peritoneal CA; use w/ topotecan


    unresectable or metastatic hepatocellular CA, first-line tx

    [15 mg/kg/dose IV x1 on day 1 of 21-day cycle]Info: use w/ atezolizumab


    *age-related macular degeneration, neovascular

    [1.25 mg intravitreally qmo]Info: may decr. to 1.25 mg intravitreally x1 prn after 3 doses


    breast CA, metastatic

    [indication withdrawn in US]Info: drug not shown to be safe and effective in breast CA pts


    renal dosing

    [not defined]renal impairment: not definedHD/PD: not defined


    hepatic dosing

    [not defined]


    Peds Dosing

    Peds dosing is currently unavailable or not applicable for this drug.

    Manufacturer/Pricing .

    Manufacturer: Genentech, Inc.

    DEA/FDA: Rx

    AVASTIN (bevacizumab)


    • Generic Name: bevacizumab
    • Pronounced: bev a CIZ oo mab
    • Brand Names: Avastin, Mvasi, Zirabev

    DESCRIPCION

    Anticuerpo monoclonal humanizado contra el factor de crecimiento endotelial vascular Utilizado para cáncer colorrectal metastásico, cáncer de células renales, cáncer de pulmón de células no pequeñas, cáncer de cuello uterino, glioblastoma recurrente y cáncer epitelial de ovario, trompa de falopio o peritoneal primario

    Puede causar reacciones relacionadas con la perfusión que requieren una velocidad de perfusión reducida o la interrupción del tratamiento; también se asocia con complicaciones de cicatrización de heridas que requieren la interrupción del tratamiento durante 28 días antes y después de la cirugía

    NOMBRES DE MARCA COMUNES:
    Avastin, MVASI

    CÓMO SE SUMINISTRA

    Avastin / Bevacizumab (Hámster)/MVASI Sol Oftálmico: 1 ml, 25 mg

    Inyección intravenosa Sol de Avastin / MVASI: 1mL, 25mg

    DOSIS E INDICACIONES

    Para el tratamiento del cáncer colorrectal metastásico.

    NOTA: Bevacizumab no está indicado para el tratamiento adyuvante del cáncer colorrectal debido a la falta de eficacia en 2 ensayos clínicos aleatorizados y abiertos.

    Para el tratamiento de primera línea del cáncer colorrectal metastásico en combinación con capecitabina y oxaliplatino†.Dosificación intravenosa

    DOSIS MÁXIMA

    Adulto
    Oncología: 15 mg / kg IV cada 3 semanas o 10 mg / kg IV cada 2 semanas.
    Ocular: No se ha determinado la dosis intraocular máxima tolerada; en ensayos clínicos, la dosis más alta fue monocular de 2,5 mg/0,1 mL.

    Geriátrico
    Oncología: 15 mg / kg IV cada 3 semanas o 10 mg / kg IV cada 2 semanas.
    Ocular: No se ha determinado la dosis intraocular máxima tolerada; en ensayos clínicos, la dosis más alta fue monocular de 2,5 mg/0,1 mL.

    Adolescente
    No se ha establecido la seguridad y eficacia.

    Niño
    No se ha establecido la seguridad y eficacia.

    Bebé
    No se ha establecido la seguridad y eficacia.

    MECANISMO DE ACCIÓN

    Bevacizumab se une al factor de crecimiento endotelial vascular (VEGF) e impide la unión del VEGF con sus receptores, VEGFR-1 (Flt-1) y VEGFR-2 (Flk-1/KDR), que se encuentran en la superficie de las células endoteliales. La interacción del VEGF con sus receptores conduce a la proliferación de células endoteliales y a la formación de nuevos vasos sanguíneos en modelos in vitro de angiogénesis. La administración de bevacizumab a modelos de xenotrasplante de cáncer de colon en ratones desnudos (atímicos) causó una reducción del crecimiento microvascular y la inhibición de la progresión de la enfermedad metastásica.

    ADMINISTRACIÓN
    Administración Inyectable
    Inspeccione visualmente los productos parenterales en busca de partículas y decoloración antes de la administración siempre que la solución y el envase lo permitan.

    Administración Intravenosa
    NO administre bevacizumab como inyección intravenosa o bolo.
    Administrar la primera perfusión de bevacizumab por vía intravenosa (IV) durante 90 minutos.
    Si se tolera la primera perfusión, la segunda dosis puede administrarse por vía intravenosa durante 60 minutos.
    Todas las perfusiones posteriores pueden administrarse IV durante 30 minutos si se tolera la perfusión de 60 minutos.
    †: Bevacizumab se ha administrado IV a una velocidad de perfusión estándar de 0,5 mg/kg/minuto para todas las dosis incluyendo la perfusión inicial (es decir, 5 mg/kg IV durante 10 minutos; 10 mg/kg IV durante 20 minutos; 15 mg / kg IV durante 30 minutos) en un ensayo (n = 370; 2.311 dosis).[41625] En otros datos, se administraron 5 mg/kg y 7,5 mg/kg de bevacizumab durante 10 minutos.

    Preparación de la perfusión:
    Extraer la cantidad apropiada de bevacizumab y diluir en un volumen total de 100 mL de Cloruro Sódico Inyectable al 0,9%.
    No administrar ni mezclar con la inyección de dextrosa.
    Desechar cualquier porción no utilizada que quede en el vial sin conservantes.
    Almacene el bevacizumab diluido bajo refrigeración a 2 a 8 grados C (36 a 46 grados F) durante un máximo de 8 horas.

    Otra Vía(s) de Administración)
    Administración intravítrea
    NOTA: El bevacizumab no está aprobado por la FDA para la administración intravítrea
    Bevacizumab se ha administrado de forma no autorizada por vía intravítrea. Solo para uso de oftalmólogos capacitados en estas técnicas de administración especializadas.
    Se debe administrar anestesia adecuada (por ejemplo, lidocaína subconjuntival al 2% o lidocaína tópica al 2-4%) más povidona yodada y/o un microbicida de amplio espectro antes de la inyección intravítrea.
    Utilice condiciones asépticas controladas, que incluyen el uso de guantes estériles, una cortina estéril y un espéculo estéril del párpado (o equivalente).
    Inspeccione visualmente el producto en busca de partículas y decoloración antes de la administración.
    Utilizando una técnica aséptica, extraer aproximadamente 0,12 ml de bevacizumab del contenido del vial a una jeringa de tuberculina de polipropileno de 1 ml. Evite usar una aguja de filtro para retirar el medicamento, ya que hacerlo puede hacer que las proteínas grandes se adhieran al filtro.
    Antes de la inyección en un solo ojo, se debe colocar una aguja estándar estéril de calibre 30 (5/8 pulgadas) en la jeringa, y el émbolo avanzó a 0,05 ml para eliminar todo el espacio muerto. Si el ojo contralateral requiere tratamiento, el campo estéril, la jeringa, los guantes, las cortinas, el espéculo del párpado, el filtro y las agujas de inyección deben cambiarse antes de la administración al otro ojo.
    Después de la inyección, controlar la elevación de la presión intraocular (PIO) y la endoftalmitis.

    ALMACENAMIENTO
    Avastin:
    - Desechar la porción no utilizada. No conservar para su uso posterior.
    - Proteger de la luz
    - Almacenar entre 36 a 46 grados F
    MVASI:
    - Desechar el producto si contiene partículas, está turbio o
    - Desechar la porción no utilizada. No conservar para su uso posterior.
    - No congelar
    - Proteger de la luz
    - Refrigerar (entre 36 y 46 grados F)
    - Conservar en caja hasta el momento de su uso

    One (1) 4 mL Single-use vial of 100 mg dose (25mg/ml)
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    Un (1) vial de un-solo-uso de 4 mL de 100 mg dosis (25mg/ml)