Mvasi 25 mg/ml concentrado para solucion para perfusion
Introduction
Prescribing Information for the Patient
MVASI 25 mg/ml Concentrate for Solution for Infusion
bevacizumab
Read this entire prescribing information carefully before starting to use this medication because it contains important information for you.
- Keep this prescribing information, as you may need to refer to it again.
- If you have any questions, consult your doctor, pharmacist, or nurse.
- If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this prescribing information. See section 4.
1. What is MVASI and what is it used for
The active ingredient of MVASI is bevacizumab, a humanized monoclonal antibody (a type of protein that is normally produced by the immune system to help the body defend itself against infections and cancer). Bevacizumab selectively binds to a protein called vascular endothelial growth factor (VEGF, English acronym), which is located in the walls of blood and lymphatic vessels of the body. The VEGF protein causes blood vessels to grow within the tumor, which supplies it with nutrients and oxygen. When bevacizumab binds to VEGF, it prevents tumor growth by blocking the growth of blood vessels, which provide the necessary nutrients and oxygen for the tumor.
MVASI is a medication used for the treatment of adult patients with advanced colorectal or rectal cancer. MVASI will be administered in combination with chemotherapy containing a fluoropyrimidine medication.
MVASI is also used for the treatment of adult patients with metastatic breast cancer. When used in patients with breast cancer, it will be administered with a chemotherapy medication called paclitaxel or capecitabina.
MVASI is also used for the treatment of adult patients with advanced non-small cell lung cancer. MVASI will be administered along with a platinum-based chemotherapy regimen.
MVASI is also used for the treatment of adult patients with advanced non-small cell lung cancer when cancer cells have specific mutations in a protein called the epidermal growth factor receptor (EGFR). MVASI will be administered in combination with erlotinib.
MVASI is also used for the treatment of adult patients with advanced renal cancer. When used in patients with renal cancer, it will be administered with another type of medication called interferon.
MVASI is also used for the treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer. When used in patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer, it will be administered in combination with carboplatin and paclitaxel.
When used in adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who have had a recurrence of their disease at least 6 months after their last treatment with a platinum-based chemotherapy regimen, MVASI will be administered in combination with carboplatin and gemcitabine or with carboplatin and paclitaxel.
When used in adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who have had a recurrence of their disease at least 6 months after their last treatment with a platinum-based chemotherapy regimen, MVASI will be administered in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin.
MVASI is also used for the treatment of adult patients with persistent, recurrent, or metastatic cervical cancer. MVASI will be administered in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum-based therapy.
2. What you need to know before starting to use MVASI
No use MVASI
- Si es alérgico (hipersensible) a bevacizumab o a alguno de los demás componentes de este medicamento (incluidos en la sección 6).
- Si es alérgico (hipersensible) a productos derivados de células de ovario de hámster chino (CHO) o a otros anticuerpos recombinantes humanos o humanizados.
- Si está embarazada.
Advertencias y precauciones
Consulte a su médico, farmacéutico o enfermero antes de empezar a usar MVASI:
- Es posible que MVASI pueda aumentar el riesgo de provocar perforaciones en la pared del intestino. Si tiene alguna enfermedad que cause inflamación en el abdomen (p.ej. diverticulitis, úlcera de estómago, colitis producida por la quimioterapia), consulte con su médico.
- MVASI puede aumentar el riesgo de desarrollar un conducto anormal entre dos órganos o vesículas. El riesgo de desarrollar comunicaciones entre la vagina y cualquier parte del intestino puede aumentar si tiene cáncer de cérvix persistente, recurrente o metastásico.
- MVASI puede aumentar el riesgo de hemorragias o de problemas con la cicatrización de heridas quirúrgicas. Si va a ser operado, ha sido intervenido con cirugía mayor en los últimos 28 días o tiene una herida operatoria sin cicatrizar, no debe usar este medicamento.
- MVASI puede aumentar el riesgo de desarrollar infecciones graves de piel o de las capas profundas de la piel, especialmente si tuvo perforaciones en la pared del intestino o problemas de cicatrización.
- MVASI puede aumentar el riesgo de hipertensión. Si tiene la tensión alta no controlada adecuadamente con los medicamentos para la tensión, consulte a su médico, es importante asegurarse de que su tensión está controlada antes de comenzar el tratamiento con MVASI.
- MVASI aumenta el riesgo de tener proteínas en la orina, especialmente si ya tiene la tensión alta.
- El riesgo de desarrollar trombos o coágulos en sus arterias (un tipo de vaso sanguíneo) puede aumentar si es mayor de 65 años, si tiene diabetes o si ha tenido en el pasado trombos o coágulos en sus arterias. Consulte con su médico, ya que los trombos o coágulos pueden provocar un ataque al corazón y apoplejía.
- MVASI también puede incrementar el riesgo de desarrollar trombos o coágulos en las venas (un tipo de vaso sanguíneo).
- MVASI puede provocar hemorragias, especialmente hemorragias relacionadas con el tumor. Consulte con su médico si tiene tendencia o antecedentes familiares de trastornos de la coagulación (hemorragias) o está tomando medicamentos que diluyen la sangre por cualquier razón.
- Es posible que MVASI provoque hemorragias en, y alrededor, de su cerebro. Consulte con su médico si tiene cáncer metastásico que afecte a su cerebro.
- Es posible que MVASI pueda aumentar el riesgo de hemorragia en sus pulmones, incluyendo tos o expectoración de sangre. Consulte con su médico si ha notado esto previamente.
- MVASI puede incrementar el riesgo de que el corazón se debilite. Es importante que informe a su médico si alguna vez ha sido tratado con antraciclinas (un tipo específico de quimioterapia utilizada para el tratamiento de algunos tipos de cáncer, como por ejemplo doxorrubicina) o ha recibido radioterapia en el tórax, o si tiene una enfermedad del corazón.
- MVASI puede provocar infecciones y disminuir el número de neutrófilos (un tipo de células sanguíneas importantes para su protección frente a bacterias).
- Es posible que MVASI pueda provocar hipersensibilidad (incluyendo reacciones anafilácticas) y/o reacciones tras la perfusión (reacciones relacionadas con la inyección del medicamento). Consulte con su médico, farmacéutico o enfermero si ha experimentado previamente problemas tras inyecciones, como mareo/sensación de desvanecimiento, dificultad para respirar, hinchazón o erupción cutánea.
- Un raro efecto adverso neurológico llamado síndrome de encefalopatía reversible posterior (SERP) ha sido asociado con el tratamiento con MVASI. Si tiene dolor de cabeza, alteraciones en la visión, estado de confusión o ataques (convulsiones) con o sin tensión alta, consulte a su médico.
- Si tiene o ha tenido un aneurisma (aumento y debilitamiento de la pared de un vaso sanguíneo) o un desgarro en la pared de un vaso sanguíneo.
Por favor, consulte a su médico incluso si cualquiera de las situaciones arriba indicadas le afecta o le ha ocurrido en el pasado.
Antes de comenzar un tratamiento con MVASI o durante el tratamiento con MVASI:
- Si tiene o ha tenido dolor en la boca, los dientes y/o la mandíbula, hinchazón o llagas en la boca, adormecimiento o sensación de pesadez de la mandíbula, o pérdida de un diente, informe inmediatamente a su médico y a su dentista.
- Si necesita someterse a un tratamiento dental invasivo o a una cirugía dental, informe a su dentista que está siendo tratado con MVASI (bevacizumab), en particular cuando también está recibiendo o ha recibido una inyección de bisfosfonatos en su sangre.
Antes de que comience el tratamiento con MVASI puede que le aconsejen hacerse una revisión dental.
Niños y adolescentes
No se recomienda el uso de MVASI en niños y adolescentes menores de 18 años ya que no se ha establecido la seguridad y el beneficio en estos pacientes.
Se han notificado casos de muerte de tejido óseo (osteonecrosis) en huesos distintos a la mandíbula en pacientes menores de 18 años tratados con bevacizumab.
Otros medicamentos y MVASI
Informe a su médico, farmacéutico o enfermero si está utilizando, ha utilizado recientemente o podría tener que utilizar cualquier otro medicamento.
La combinación de MVASI con otro medicamento llamado maleato de sunitinib (prescrito para cáncer renal y gastrointestinal) puede provocar graves efectos adversos. Consulte con su médico para asegurarse que no combina estos medicamentos.
Consulte a su médico si está recibiendo tratamiento basado en platino o taxanos para cáncer metastásico de mama o pulmón. Estas terapias en combinación con MVASI pueden incrementar el riesgo de efectos adversos graves.
Informe a su médico si ha recibido recientemente o está recibiendo radioterapia.
Embarazo, lactancia y fertilidad
No debe usar MVASI si está embarazada. MVASI puede dañar al feto, ya que puede frenar la formación de nuevos vasos sanguíneos. Su médico le debe advertir que utilice un método anticonceptivo durante el tratamiento con MVASI y al menos hasta 6 meses después de la última dosis de MVASI.
Informe de inmediato a su médico si ya está embarazada, si se queda embarazada durante el tratamiento con este medicamento o si planea estarlo en un futuro próximo.
No debe dar el pecho a su bebé durante el tratamiento con MVASI y al menos hasta 6 meses después de la última dosis de MVASI, ya que este medicamento puede interferir en el crecimiento y desarrollo de su bebé.
MVASI puede afectar la fertilidad femenina. Consulte con su médico para más información.
Consulte a su médico, farmacéutico o enfermero antes de utilizar cualquier medicamento.
Conducción y uso de máquinas
No se ha observado que MVASI pueda disminuir su capacidad para conducir o manejar herramientas o máquinas. Sin embargo, se han comunicado somnolencia y desmayos con el uso de MVASI. Si usted experimenta síntomas que afectan su visión o concentración, o su capacidad de reacción, no conduzca ni utilice máquinas hasta que los síntomas desaparezcan.
MVASI contiene sodio
MVASI 25 mg/ml concentrado para solución para perfusión (4 ml)
Este medicamento contiene 5,4 mg de sodio (componente principal de la sal de mesa/para cocinar) en cada vial de 4 ml. Esto equivale al 0,3% de la ingesta diaria máxima de sodio recomendada para un adulto.
MVASI 25 mg/ml concentrado para solución para perfusión (16 ml)
Este medicamento contiene 21,7 mg de sodio (componente principal de la sal de mesa/para cocinar) en cada vial de 16 ml. Esto equivale al 1,1% de la ingesta diaria máxima de sodio recomendada para un adulto.
3. How to use MVASI
Dosage and Administration Frequency
The required dose of MVASI depends on your weight and the type of cancer being treated. The recommended dose is 5 mg, 7.5 mg, 10 mg, or 15 mg per kilogram of body weight. Your doctor will prescribe the most suitable dose of MVASI for your case, and you will be treated with MVASI once every 2 or 3 weeks. The number of infusions you receive will depend on how you respond to treatment and you should continue it until MVASI can no longer slow down tumor growth. Your doctor will discuss these aspects with you.
Form and Route of Administration
Do not shake the vial. MVASI is a concentrate for solution for infusion. Depending on the dose prescribed, a fraction or the entire contents of the MVASI vial will be diluted with sodium chloride solution before administration. A doctor or nurse will administer this diluted MVASI solution as an intravenous infusion (through a drip in your veins). The first infusion will be administered over 90 minutes. If you tolerate this infusion well, the second can be administered over 60 minutes. Subsequent infusions can be administered over 30 minutes.
Administration of MVASI should be temporarily interrupted:
- if you develop severe hypertension that requires treatment with antihypertensive medications,
- if you have wound healing problems after surgery,
- if you have undergone surgery.
Administration of MVASI should be permanently discontinued if you have:
- severe hypertension that cannot be controlled with antihypertensive medications; or in the event of a sudden and severe increase in blood pressure,
- protein in the urine accompanied by body swelling,
- a perforation in the intestinal wall,
- an abnormal communication of a tubular or fistulous type between the trachea and esophagus (the passage to the stomach), between internal organs and the skin, between the vagina and any part of the intestine or between other tissues that are normally not connected (fistula), and which your doctor considers severe,
- severe skin or deep skin layer infections,
- arterial embolism (blood clot),
- pulmonary vein embolism,
- any severe bleeding.
If you use more MVASI than you should
- you may experience severe migraine. If this occurs, you must inform your doctor, pharmacist, or nurse immediately.
If you forget to use MVASI
- Your doctor will decide when the next dose of MVASI should be administered. You must inform your doctor of this omission.
If you interrupt treatment with MVASI
Stopping treatment with MVASI may suppress its effect on tumor growth. Do not stop treatment with MVASI unless you have consulted with your doctor.
If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.
4. Possible Adverse Effects
If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are side effects that do not appear in this leaflet.
The side effects listed below have been observed when MVASI is administered with chemotherapy. This does not necessarily mean that these side effects were strictly caused by MVASI.
Allergic reactions
If you have an allergic reaction, consult your doctor or healthcare professional immediately. Symptoms may include: difficulty breathing or chest pain. You may also experience skin redness or flushing, rashes, chills, and tremors, dizziness or nausea, swelling, dizziness, tachycardia, and loss of consciousness.
You must seek immediate help if you experience any of the following side effects.
Severe side effects that may be very common (may affect more than 1 in 10 people) include:
- high blood pressure,
- sensation of numbness or tingling in hands or feet,
- decrease in the number of blood cells, including white blood cells that help fight infections (this may be accompanied by fever), and platelets that help blood to clot,
- sensation of weakness and lack of energy,
- fatigue,
- diarrhea, nausea, vomiting, and abdominal pain.
Severe side effects that may be common (may affect up to 1 in 10 people) include:
- intestinal perforation,
- bleeding, including hemoptysis in patients with non-small cell lung cancer,
- embolism of arteries,
- embolism of veins,
- embolism of pulmonary arteries,
- embolism of leg veins,
- heart failure,
- problems with wound healing after surgery,
- redness, peeling, sensitivity, pain, or blisters on fingers or feet,
- decrease in the number of red blood cells,
- lack of energy,
- gastrointestinal and intestinal alterations,
- muscle and joint pain, muscle weakness,
- dry mouth combined with thirst and/or reduced urine output or dark-colored urine,
- inflammation of the mucous membrane of the mouth and intestines, lungs, and airways, reproductive system, and urinary tract,
- mouth sores and esophageal tube that may be painful and cause difficulty swallowing,
- pain, including headache, back pain, pelvic pain, and anal pain,
- localized pus foci,
- infection, and particularly blood or urinary tract infection,
- decrease in cerebral blood flow or stroke,
- drowsiness,
- nasal bleeding,
- increased heart rate (pulse),
- intestinal obstruction,
- abnormal urine test (protein in urine),
- difficulty breathing or decreased oxygen levels in blood,
- skin infections or deep tissue infections,
- fistula: abnormal communication of a tubular type between internal organs and the skin or other tissues that are normally not connected, including communication between the vagina and intestine in patients with cervical cancer,
- allergic reactions (symptoms may include difficulty breathing, facial redness, skin rash, low blood pressure or high blood pressure, low oxygen levels in blood, chest pain, or nausea/vomiting).
Severe side effects that may be rare (may affect up to 1 in 1000 patients) include:
severe and sudden allergic reaction with difficulty breathing, swelling, dizziness, tachycardia, sweating, and loss of consciousness (anaphylactic shock).
Severe side effects of unknown frequency (cannot be estimated from available data) include:
- severe skin infections or deep tissue infections, especially if you had intestinal perforations or problems with wound healing,
- negative effect on the woman's ability to have children (see below for more recommendations),
- brain disease with symptoms such as seizures (convulsions), headache, confusion, and visual disturbances (reversible posterior leukoencephalopathy syndrome or RPLS),
- symptoms suggesting changes in normal brain function (headache, visual disturbances, confusion, or convulsions), and high blood pressure,
- obstruction of small blood vessels in the kidney,
- abnormally high blood pressure in the pulmonary blood vessels that makes the right side of the heart work harder than normal,
- perforation in the cartilage wall that separates the nasal openings,
- perforation in the stomach or intestine,
- ulcer or perforation in the stomach or small intestine lining (these symptoms may include abdominal pain, sensation of swelling, black stools, stools with blood, or blood in vomit),
- bleeding from the lower part of the large intestine,
- gum lesions, with exposed jawbone that do not heal and may be associated with pain and inflammation of surrounding tissues (see below for more recommendations),
- perforation of the gallbladder (symptoms and signs may include abdominal pain, fever, nausea, and vomiting),
- increase and weakening of the wall of a blood vessel or tearing of the wall of a blood vessel (aneurysms and arterial dissections).
If you experience any of these side effects mentioned, seek medical attention as soon as possible.
Side effects that are very common (may affect more than 1 in 10 people) that were not severe are:
- constipation,
- loss of appetite,
- fever,
- eye problems (including increased tear production),
- speech alterations,
- taste alterations,
- nasal secretion,
- dry skin, peeling, and inflammation of the skin, skin color changes,
- weight loss,
- nosebleed.
Side effects that are common (may affect up to 1 in 10 people) that were not severe are:
- voice changes and hoarseness.
Patients over 65 years old have a higher risk of experiencing the following:
- embolism in the arteries that may cause stroke or heart attack,
- decrease in the number of white blood cells and platelets (which help to clot) in blood,
- diarrhea,
- malaise,
- headache,
- fatigue,
- high blood pressure.
MVASI may also cause changes in laboratory tests that your doctor will perform. These changes may include a decrease in the number of white blood cells, particularly neutrophils (a type of white blood cell that helps to protect against infections), presence of protein in urine, decrease in potassium, sodium, or phosphorus in blood, increase in blood sugar, increase in alkaline phosphatase (an enzyme) in blood, decrease in hemoglobin (which is found in red blood cells and transports oxygen), which may be severe.
Mouth pain, teeth, and/or jaw pain, swelling, or sores in the mouth, numbness or heaviness of the jaw, or tooth loss. These may be signs and symptoms of jawbone damage (osteonecrosis). Immediately report to your doctor and dentist if you experience any of them.
Pre-menopausal women (women with menstrual cycle) may notice that their periods become irregular or disappear and may experience fertility problems. If you are thinking of having children, consult your doctor before starting your treatment.
MVASI has been developed and manufactured to treat cancer through intravenous injection. It has not been developed or manufactured for injection into the eye. Therefore, it is not authorized for use in this way. When bevacizumab is injected directly into the eye (unapproved use), the following side effects may occur:
- infection or inflammation of the eyeball,
- eye redness, small particles or spots in vision (floaters), eye pain,
- vision of flashes of light with floaters, progressing to partial loss of vision,
- increased intraocular pressure,
- bleeding in the eye.
Reporting of side effects
If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly (see details below). By reporting side effects, you can contribute to providing more information on the safety of this medicine.
Spanish System for Pharmacovigilance of Medicines for Human Use:
5. Conservation of MVASI
Keep this medication out of the sight and reach of children.
Do not use this medication after the expiration date that appears on the packaging and on the vial label after CAD. The expiration date is the last day of the month indicated.
Store in refrigerator (between 2°C and 8°C).
Do not freeze.
Store the vial in the outer packaging to protect it from light.
The infusion solution must be administered immediately after dilution. If it is not administered immediately, storage times and conditions in use are the responsibility of the user and are normally not more than 24 hours between 2°C and 8°C, unless the infusion solutions have been prepared in a sterile environment. When the dilution has been prepared in a sterile environment, MVASI remains stable for 35 days between 2°C and 8°C plus an additional 48 hours at temperatures not exceeding 30°C.
Do not use MVASI if you observe any foreign particles or discoloration before administration.
Medications should not be disposed of through drains or trash. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.
6. Contents of the packaging and additional information
- The active ingredient is bevacizumab. Each milliliter of concentrate contains 25 mg of bevacizumab.
- Each vial of 4 ml of concentrate contains 100 mg of bevacizumab, corresponding to 1.4 mg/ml when diluted as recommended.
- Each vial of 16 ml of concentrate contains 400 mg of bevacizumab, corresponding to 16.5 mg/ml when diluted as recommended.
- The other components are trehalose dihydrate, sodium phosphate, polisorbate 20, and water for injection (see MVASI contains sodiumin the section 2).
Appearance of the product and contents of the package
MVASI is a concentrate for solution for infusion. The concentrate is a transparent to slightly opalescent, colorless to slightly yellow liquid contained in a glass vial with a rubber stopper. Each vial contains either 100 mg of bevacizumab in 4 ml of solution or 400 mg of bevacizumab in 16 ml of solution. Each package of MVASI contains one vial.
Marketing authorization holder and responsible manufacturer
Amgen Technology (Ireland) UC,
Pottery Road,
Dun Laoghaire,
Co. Dublin,
Ireland
Marketing authorization holder
Amgen Technology (Ireland) UC,
Pottery Road,
Dun Laoghaire,
Co. Dublin,
Ireland
Manufacturer
Amgen NV
Telecomlaan 5-7
1831 Diegem
Belgium
You can request more information about this medication by contacting the local representative of the marketing authorization holder:
België/Belgique/Belgien s.a. Amgen n.v. Tél/Tel: +32 (0)2 7752711 | Lietuva Amgen Switzerland AG Vilniaus filialas Tel: +370 5 219 7474 |
???????? ?????? ???????? ???? ???.: +359 (0)2 424 7440 | Luxembourg/Luxemburg s.a. Amgen Belgique/Belgien Tél/Tel: +32 (0)2 7752711 |
Ceská republika Amgen s.r.o. Tel: +420 221 773 500 | Magyarország Amgen Kft. Tel.: +36 1 35 44 700 |
Danmark Amgen, filial af Amgen AB, Sverige Tlf: +45 39617500 | Malta Amgen S.r.l. Italy Tel: +39 02 6241121 |
Deutschland Amgen GmbH Tel: +49 89 1490960 | Nederland Amgen B.V. Tel: +31 (0)76 5732500 |
Eesti Amgen Switzerland AG Vilniaus filialas Tel: +372 586 09553 | Norge Amgen AB Tlf: +47 23308000 |
Ελλ?δα Amgen Ελλ?ς Φαρμακευτικ? Ε.Π.Ε. Τηλ: +30 210 3447000 | Österreich Amgen GmbH Tel: +43 (0)1 50 217 |
España Amgen S.A. Tel: +34 93 600 18 60 | Polska Amgen Biotechnologia Sp. z o.o. Tel.: +48 22 581 3000 |
Francia Amgen S.A.S. Tél: +33 (0)9 69 363 363 | Portugal Amgen Biofarmacêutica, Lda. Tel: +351 21 4220606 |
Hrvatska Amgen d.o.o. Tel: + 385 (0)1 562 57 20 | România Amgen România SRL Tel: +4021 527 3000 |
Ireland Amgen Ireland Limited Tel: +353 1 8527400 | Slovenija AMGEN zdravila d.o.o. Tel: +386 (0)1 585 1767 |
Ísland Vistor hf. Sími: +354 535 7000 | Slovenská republika Amgen Slovakia s.r.o. Tel: +421 2 321 114 49 |
Italia Amgen S.r.l. Tel: +39 02 6241121 | Suomi/Finland Amgen AB, sivuliike Suomessa/Amgen AB, filial i Finland Puh/Tel: +358 (0)9 54900500 |
K?προς C.A. Papaellinas Ltd Τηλ: +357 22741 741 | Sverige Amgen AB Tel: +46 (0)8 6951100 |
Latvija Amgen Switzerland AG Rigas filiale Tel: +371 257 25888 | United Kingdom (Northern Ireland) Amgen Limited Tel: +44 (0)1223 420305 |
Last review date of this leaflet:
Other sources of information
The detailed information about this medication is available on the website of the European Medicines Agency (EMA)http://www.ema.europa.eu.
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