ABEVMY 25 мг/мл Концентрат для инфузионного раствора

Содержание инструкции

1. Abevmy 25 mg/mL concentrate for solution for infusion
   1. What is Abevmy and what is it used for
   2. What you need to know before you receive Abevmy
   3. How Abevmy is administered
   4. Possible side effects
   5. How to store Abevmy
   6. Contents of the pack and other information

Abevmy 25 mg/mL concentrate for solution for infusion

bevacizumab

Medicinal product subject to additional monitoring. This will allow the rapid identification of
new safety information. You can contribute by reporting any adverse effects
experienced during the use of this medicine. See the end of section 4 for
information on how to report adverse effects.

Read this leaflet carefully before using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• If you experience any side effects, including those not listed in this leaflet, ask your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

• 1. What Abevmy is and what it is used for
• 2. What you need to know before you are given Abevmy
• 3. How Abevmy is given
• 4. Possible side effects
• 5. How to store Abevmy
• 6. Contents of the pack and other information

1. What is Abevmy and what is it used for

Abevmy contains the active substance bevacizumab, a humanized monoclonal antibody (a type of
protein that is normally produced by the immune system to help the body defend itself
against infection and cancer). Bevacizumab selectively binds to a protein called “vascular endothelial growth factor” (VEGF), which is present on the lining of the body's blood and
lymphatic vessels. The VEGF protein causes the growth of blood vessels within the
tumor; these blood vessels provide the tumor with nutrients and oxygen. Once
bevacizumab binds to VEGF, tumor growth is prevented by blocking the development of the blood
vessels that supply nutrients and oxygen to the tumor.
Abevmy is a medicine used for the treatment of adult patients with advanced stage carcinoma of the
colon or rectum. Abevmy will be administered in association
with a chemotherapeutic treatment based on fluoropyrimidines.
Abevmy is also used for the treatment of adult patients with metastatic breast cancer. In patients with this type of tumor, bevacizumab will be administered with a
chemotherapeutic regimen based on paclitaxel or capecitabine.
Abevmy is also used for the treatment of adult patients with advanced non-small cell lung cancer. Abevmy will be administered together with a chemotherapeutic regimen based on
platinum.
Abevmy is also used for the treatment of adult patients with advanced non-small cell lung cancer when the tumor cells present certain mutations of a protein
called epidermal growth factor receptor (EGFR). Abevmy will be administered in
association with erlotinib.
Abevmy is also used for the treatment of adult patients with advanced kidney cancer.
In patients with this type of tumor, bevacizumab will be administered with another type of medicine
called interferon.
Abevmy is also used for the treatment of adult patients with epithelial ovarian cancer,
fallopian tube cancer or primary peritoneal cancer in an advanced stage. In patients
with these types of tumors, bevacizumab will be administered in association with carboplatin and paclitaxel.
Abevmy will be administered in association with carboplatin and gemcitabine or carboplatin and paclitaxel
when used in adult patients with epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer in an advanced stage whose disease has recurred at least
6 months after the last time they were treated with a chemotherapeutic regimen containing a
platinum-based agent.
Abevmy will be administered in association with paclitaxel, topotecan or liposomal pegylated doxorubicin
when used in adult patients with epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer in an advanced stage whose disease has recurred
within 6 months of the last time they were treated with a chemotherapeutic regimen containing a
platinum-based agent.
Abevmy is also used for the treatment of adult patients with persistent, recurrent or metastatic cervical cancer. Abevmy will be administered in association with paclitaxel and
cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot undergo
platinum-based therapy.

2. What you need to know before you receive Abevmy

You must not receive Abevmy

• if you are allergic (hypersensitive) to bevacizumab or any of the other ingredients of this medicine (listed in section 6)
• if you are allergic (hypersensitive) to products derived from Chinese hamster ovary (CHO) cells or other recombinant human or humanized antibodies
• if you are pregnant. Warnings and precautionsTalk to your doctor, pharmacist or nurse before you receive Abevmy:
• Abevmy may increase the risk of developing perforations in the intestinal wall. If you have conditions that cause inflammation in the abdomen (e.g. diverticulitis, gastric ulcers, chemotherapy-associated colitis), discuss this with your doctor;
• Abevmy may increase the risk of developing an abnormal connection or passage between two organs or vessels. The presence of persistent, recurrent or metastatic cervical carcinoma may determine an increased risk of developing connections between the vagina and any section of the gastrointestinal tract;
• this medicine may increase the risk of bleeding or increase the risk of problems with wound healing after surgery. If you are to undergo surgery, if you have had major surgery in the last 28 days or if you have a surgical wound that has not yet healed, you should not take this medicine;
• Abevmy may increase the risk of developing serious skin infections or infections of deeper layers under the skin, especially if you have perforations in the intestinal wall or have problems with wound healing;
• Abevmy may increase the incidence of high blood pressure. If you suffer from high blood pressure that is not well controlled with blood pressure medication, discuss this with your doctor. It is important to ensure that blood pressure is under control before starting treatment with Abevmy;
• if you have or have had an aneurysm (dilation and weakening of the wall of a blood vessel) or a tear in the wall of a blood vessel;
• this medicine increases the risk of having protein in the urine, especially if you already suffer from high blood pressure;
• the risk of developing blood clots in the arteries (a type of blood vessel) may increase if you are over 65 years of age, if you have diabetes and if you have had previous blood clots in the arteries. Talk to your doctor because blood clots can lead to heart attacks and strokes.
• Abevmy may also increase the risk of developing blood clots in the veins (a type of blood vessel);
• this medicine may cause bleeding, in particular bleeding related to the tumor. Consult your doctor if you or other family members tend to suffer from coagulation problems or if you are taking medicines to thin the blood for any reason;
• Abevmy may cause bleeding inside the brain and around the brain. Consult your doctor if you have a metastatic tumor that affects the brain;
• Abevmy may increase the risk of bleeding in the lungs, including blood in your cough or saliva. Discuss with your doctor if you have noticed these events in the past;
• Abevmy may increase the risk of developing heart failure. It is important that the doctor knows if you have previously undergone therapy with anthracyclines (e.g. doxorubicin, a particular type of chemotherapy used to treat some tumors) or thoracic radiotherapy, or if you have heart disease;
• this medicine may cause infections and a reduction in the number of neutrophils (a type of blood cell important for protection against bacteria);
• Abevmy may cause hypersensitivity (including anaphylactic shock) and/or infusion reactions (reactions related to the injection of the medicine). Inform your doctor, pharmacist or nurse if you have already had problems after injections, such as dizziness/feeling faint, shortness of breath, swelling or skin rashes;
• a rare neurological adverse effect called reversible posterior encephalopathy syndrome (PRES) has been associated with treatment with Abevmy. If you have headache, vision disturbances, confusion or seizures with or without increased pressure, contact your doctor. Also contact your doctor if the above has occurred in the past. Before starting treatment with Abevmy or during treatment with Abevmy:
• if you have had or have pain in the mouth, teeth and/or jaw/mandible, or swelling or inflammation in the mouth, or numbness or heaviness in the jaw/mandible, or lose a tooth, report it immediately to your doctor and dentist;
• if you are to undergo invasive dental treatment or dental surgery, tell your dentist that you are being treated with Abevmy, especially if you have received or are receiving a bisphosphonate injection into the blood. Your doctor or dentist may suggest you have a dental check-up before starting treatment with Abevmy. Children and adolescentsTherapy with Abevmy is not recommended in children and adolescents under the age of 18 years as neither safety nor benefits have been established in this population of patients. Bone tissue death (osteonecrosis) in bones other than the mandible/jaw has been observed in patients under the age of 18 years treated with Abevmy.

Other medicines and Abevmy
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or may
take any other medicine.
Combinations of Abevmy with another medicine, called sunitinib malate (prescribed for
renal and gastrointestinal tumors), may cause serious side effects. Discuss this with your doctor to
ensure you do not combine these drugs.
Tell your doctor if you are using platinum-based or taxane therapies for metastatic lung or
breast cancer. These therapies in combination with Abevmy may increase the risk of
serious side effects.
Tell your doctor if you have recently received or are receiving radiotherapy.

Pregnancy, breastfeeding and fertility
If you are pregnant, you must not use this medicine. Abevmy may harm the unborn baby,
as it may interrupt the formation of new blood vessels. Your doctor will advise you to use
appropriate contraceptive measures during therapy with Abevmy and for at least 6 months after
taking the last dose of Abevmy.
If you are pregnant, if you suspect you are pregnant during treatment with this medicine
or are planning a pregnancy in the near future, tell your doctor immediately.
You must not breastfeed during treatment with Abevmy and for at least
6 months after taking the last dose of Abevmy, as this medicine may interfere with the
growth and development of the baby.
Abevmy may reduce female fertility. Consult your doctor for further information.
Ask your doctor, pharmacist or nurse before taking any medicine.

Driving and using machines
Abevmy has not been shown to reduce the ability to drive vehicles or use tools or machines.
However, drowsiness and fainting have been reported with the use of Abevmy. If you experience symptoms
affecting vision or concentration, or the ability to react, do not drive vehicles and do not use
machinery until the symptoms have disappeared.

Abevmy contains sodium
This medicine contains 4.196 mg of sodium (the main component of table salt) in each
4 mL vial. This is equivalent to 0.21% of the recommended maximum daily intake
with diet for an adult.
This medicine contains 16.784 mg of sodium (the main component of table salt) in each
16 mL vial. This is equivalent to 0.84% of the recommended maximum daily intake
with diet for an adult.

3. How Abevmy is administered

Dosage and frequency of administration
The dose of Abevmy needed depends on body weight and the type of cancer to be treated.
The recommended dose is 5 mg, 7.5 mg, 10 mg or 15 mg per kilogram of body weight. Your doctor
will prescribe Abevmy at the appropriate dose for you. Treatment with Abevmy will be administered
once every 2 or 3 weeks. The number of infusions you will receive will depend on your response to
treatment; however, you should continue to receive this treatment until Abevmy is no longer able to
block tumor growth. Your doctor will discuss this with you.

Method and route of administration
Do not shake the vial.
Abevmy is a concentrate for solution for infusion. Depending on the dose you are prescribed, a
portion of the contents of the vial or the entire vial of Abevmy will be diluted with a solution of
sodium chloride before use. Your doctor or nurse will administer this diluted solution of
Abevmy with an intravenous infusion (a drip into a vein). The first infusion will be administered
over 90 minutes. If this is well tolerated, the second infusion may be administered
over 60 minutes. Subsequent infusions may be administered over
30 minutes.

The administration of Abevmy must be temporarily interrupted

• if severe high blood pressure problems occur, requiring treatment with medications to control blood pressure,
• if you have problems with wound healing after surgery,
• if you are to undergo surgery. The administration of Abevmy must be permanently interrupted if one of thefollowing problems occurs
• severe high blood pressure that cannot be controlled with anti-hypertensive drugs, or a sudden and severe increase in blood pressure,
• presence of protein in the urine associated with body swelling (edema),
• perforation of the intestinal wall,
• an abnormal connection or passage between the trachea and esophagus, internal organs and skin, vagina and any section of the gastrointestinal tract, or between other tissues that are not normally connected (fistula), and which are considered severe by the doctor,
• severe infections of the skin or deeper layers under the skin,
• blood clots in the arteries,
• blood clots in the pulmonary blood vessels,
• severe bleeding of any kind. If an excessive dose of Abevmy is administered
• You may experience a severe migraine. In this case, contact your doctor, pharmacist or nurse immediately. If you forget to take a dose of Abevmy
• The doctor will decide the most appropriate time to give you the next dose of Abevmy. Discuss this with your doctor. If you stop treatment with AbevmyStopping treatment with Abevmy may stop the action of containing tumor growth. Do not stop treatment with Abevmy before talking to your doctor. If you have any questions about the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
If you get any side effect, including those not listed in this leaflet, tell your
doctor, pharmacist or nurse.
The side effects listed below have been observed in patients treated with Abevmy associated
with chemotherapy. This does not mean that these side effects were necessarily caused
by Abevmy.

Allergic reactions
If you should have an allergic reaction, tell your doctor or a member of medical
staff immediately. Signs may include: difficulty breathing or chest pain. They may also
include redness of the skin or flushing or rash, chills and shivering, feeling unwell (nausea) or
vomiting, swelling, dizziness, fast heartbeat and loss of consciousness.

If you should experience any of the side effects described below, seek immediate
medical help.
Serious side effects, which can be very common(may affect more than 1 in
10 people), include:

• high blood pressure,
• feeling of numbness or tingling in the hands or feet,
• decreased number of blood cells, including white blood cells, which fight infections (this may be accompanied by fever), and cells that help the blood to clot,
• feeling weak and lacking energy,
• fatigue,
• diarrhoea, nausea, vomiting and abdominal pain. Serious side effects, which can be common(may affect up to 1 in 10 people), include:
• intestinal perforation,
• bleeding, including bleeding in the lungs in patients with non-small cell lung cancer,
• blocked arteries by a blood clot,
• blocked veins by a blood clot,
• blocked pulmonary blood vessels by a blood clot,
• blocked leg veins by a blood clot,
• heart failure,
• problems with wound healing after surgery,
• redness, peeling, soreness, pain or blistering on the fingers or toes,
• decreased number of red blood cells,
• lack of energy,
• stomach and intestinal disorders,
• muscle and joint pain, muscle weakness,
• dry mouth associated with thirst and/or decreased or dark urine,
• inflammation of the oral mucosa, intestine, lungs and airways, reproductive and urinary tract,
• ulcers in the mouth and esophagus that can cause pain and difficulty swallowing,
• pain, including headache, back pain and pain in the pelvic area and anus,
• localized abscesses,
• infection, and in particular infection in the blood or bladder,
• reduced blood flow to the brain or stroke,
• drowsiness,
• nosebleeds,
• increased heart rate (pulse),
• bowel obstruction,
• changes in urine tests (presence of protein in the urine),
• shortness of breath or reduced oxygen levels in the blood,
• skin or deep skin layer infections,
• fistulas: abnormal tubular connection between internal organs and skin or other tissues that are not normally connected to each other, including connections between the vagina and the gastrointestinal tract in patients with cervical cancer,
• allergic reactions (signs may include difficulty breathing, facial redness, rash, low or high blood pressure, low blood oxygen level, chest pain, or nausea/ vomiting). Serious side effects of rarefrequency (may affect up to 1 in 1000 people), include:
• sudden and severe allergic reaction with difficulty breathing, swelling, dizziness, fast heartbeat, sweating and loss of consciousness (anaphylactic shock). Serious side effects of not knownfrequency (frequency cannot be estimated from the available data) include:
• serious skin or deep skin layer infections, especially if you have had perforations in the intestinal wall or problems with wound healing,
• a negative effect on women's ability to have children (see paragraphs following the list of side effects for further recommendations),
• a condition of the brain with symptoms such as seizures (convulsions), headache, confusion and changes in vision (reversible posterior encephalopathy syndrome (PRES)),
• symptoms suggesting changes in normal brain function (headache, visual disturbances, confusion or seizures) and high blood pressure,
• dilation and weakening of the wall of a blood vessel or a tear in the wall of a blood vessel (aneurysms and arterial dissections),
• blockage of a small (i) blood vessel(s) in the kidney,
• abnormally high blood pressure in the vessels of the lungs that makes the right side of the heart work harder than normal,
• perforation of the cartilage separating the nostrils,
• perforation of the stomach or intestine,
• an open wound or perforation in the lining of the stomach or small intestine (signs may include abdominal pain, feeling of fullness, black tarry stools, blood in the stools or blood in the vomit),
• bleeding from the lower part of the large intestine,
• gum injuries, with exposure of jaw/maxilla bone that does not heal, which may be associated with pain and inflammation of the surrounding tissue (see paragraphs following the list of side effects for further recommendations),
• perforation of the gallbladder (symptoms and signs may include abdominal pain, fever and nausea/vomiting). If you should experience any of the side effects described below, seek help as soon as possibleSerious side effects very common(may affect more than 1 in 10 people), that have not been serious, include:
• constipation,
• loss of appetite,
• fever,
• eye problems (including increased tearing),
• changes in speech,
• altered sense of taste,
• runny nose,
• dry skin, scaling and inflammation of the skin, change in skin color,
• weight loss,
• nosebleeds. Serious side effects common(may affect up to 1 in 10 people), that have not been serious, include:
• changes in voice and hoarseness.

Patients over 65 years of age have a higher risk of experiencing the following side
effects:

• blood clots in the arteries, which can lead to stroke or heart attack,
• decreased number of white blood cells and cells that help the blood to clot,
• diarrhoea,
• feeling unwell,
• headache,
• fatigue,
• high blood pressure. Abevmy can also cause changes in laboratory test results prescribed by the doctor. These include: a decrease in the number of white blood cells, especially neutrophils (a type of white blood cell that helps protect against infections) in the blood, presence of protein in the urine, decreased potassium, sodium or phosphorus (a mineral) in the blood, increased blood sugar, increased alkaline phosphatase (an enzyme) in the blood; increased serum creatinine (a protein measured through blood tests to assess how the kidneys are functioning); decreased hemoglobin (found in red blood cells and carries oxygen), which may be severe. Pain in the mouth, teeth and/or jaw/maxilla, swelling or blisters in the mouth, numbness or heaviness in the jaw/maxilla or loss of a tooth. These may be signs and symptoms of damage to the jaw/maxilla bone (osteonecrosis). Tell your doctor and dentist immediately if you experience any of these effects. Women in premenopause (women who have their menstrual cycle) may notice irregularities in their menstrual cycles, absence of menstruation and may have negative consequences on fertility. If you are considering having children, you should discuss this with your doctor before starting treatment. Abevmy has been developed and manufactured for the treatment of cancer by intravenous injection. It has not been developed or manufactured for administration by injection into the eye. Therefore, the use of this route of administration is not authorized. When Abevmy is injected directly into the eye (unapproved use), the following side effects may occur:
• infection or inflammation of the eyeball,
• redness of the eye, appearance of particles or floating spots in the field of vision (“floaters”), eye pain,
• flashes of light and “floaters” progressing to loss of part of the field of vision,
• increased pressure in the eye,
• eye bleeding.

Reporting of side effects
If you get any side effect, including those not listed in this leaflet, tell your
doctor, pharmacist or nurse. You can also report side effects directly
through the national reporting system reported in Annex V. By reporting side
effects you can help provide more information on the safety of this medicine.

5. How to store Abevmy

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the outer packaging and
on the vial label after the abbreviation “Exp.”. The expiry date refers to the last
day of that month.
Store in a refrigerator (2 °C-8 °C).
Do not freeze.
Keep the vial in the outer packaging to protect the medicine from light.
Infusion solutions must be used immediately after they have been diluted.
If they are not used immediately, the storage times and conditions in use are
the responsibility of the user and should normally not exceed 24 hours at a temperature
between 2°C and 8°C, unless the infusion solutions have been prepared in a
sterile environment. When dilution has taken place in a sterile environment, Abevmy is stable for a period
of up to 70 days at a temperature between 2°C and 8°C and for a period of up to 15 days at a
temperature between 23°C and 27°C.
Do not use Abevmy if you notice particles or colour changes before administration.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Abevmy contains

• The active substance is bevacizumab. Each mL of concentrate contains 25 mg of bevacizumab, corresponding to 1.4-16.5 mg/mL when diluted as recommended. Each 4 mL vial contains 100 mg of bevacizumab, corresponding to 1.4 mg/mL when diluted as recommended. Each 16 mL vial contains 400 mg of bevacizumab, corresponding to 16.5 mg/mL when diluted as recommended.
• The other ingredients are sodium phosphate (E339), α, α-trehalose dihydrate, polysorbate 20 (E432) and water for injections. See section 2 “Abevmy contains sodium”. Description of the appearance of Abevmy and contents of the packAbevmy is a concentrate for solution for infusion. The concentrate is a liquid appearing from clear to slightly opalescent and from colourless to light brown, free from visible particles. It is placed in a glass vial with a rubber stopper. The 4 mL vials are available in packs containing 1 or 5 vials. The 16 mL vials are available in packs containing 1, 2 or 3 vials. Not all pack sizes may be marketed. Marketing Authorisation HolderBiosimilar Collaborations Ireland Limited Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13 DUBLIN Ireland D13 R20R ManufacturersBiosimilar Collaborations Ireland Limited Block B, The Crescent Building, Santry Demesne Dublin D09 C6X8

Ireland
For further information on this medicinal product, contact the local representative of the marketing authorisation holder:

België/Belgique/Belgien
Biocon Biologics Belgium BV
Tél/Tel: 0080008250910

Lietuva
Biosimilar Collaborations Ireland Limited
Tel: 0080008250910

България
Biosimilar Collaborations Ireland Limited
Тел: 0080008250910

Luxembourg/Luxemburg
Biocon Biologics France S.A.S
Tél/Tel: 0080008250910

Česká republika
Biocon Biologics Germany GmbH
Tel: 0080008250910

Magyarország
Biosimilar Collaborations Ireland Limited
Tel.: 0080008250910

Danmark
Biocon Biologics Finland OY
Tlf: 0080008250910

Malta
Biosimilar Collaborations Ireland Limited
Tel.: 0080008250910

Deutschland
Biocon Biologics Germany GmbH
Tel: 0080008250910

Nederland
Biocon Biologics France S.A.S
Tel: 0080008250910

Eesti
Biosimilar Collaborations Ireland Limited
Tel: 0080008250910

Norge
Biocon Biologics Finland OY
Tlf: +47 800 62 671

Ελλάδα
Biocon Biologics Greece ΜΟΝΟΠΡΟΣΩΠΗ
Ι.Κ.Ε
Τηλ.: 0080008250910

Österreich
Biocon Biologics Germany GmbH
Tel: 0080008250910

España
Biocon Biologics Spain S.L.
Tel: 0080008250910

Polska
Biosimilar Collaborations Ireland Limited
Tel: 0080008250910

France
Biocon Biologics France S.A.S
Tel: 0080008250910

Portugal
Biocon Biologics Spain S.L.
Tel: 0080008250910

Hrvatska
Biocon Biologics Germany GmbH
Tel: 0080008250910

România
Biosimilar Collaborations Ireland Limited
Tel: 0080008250910

Ireland
Biosimilar Collaborations Ireland Limited
Tel: 1800 777 794

Slovenija
Biosimilar Collaborations Ireland Limited
Tel: 0080008250910

Ísland
Biocon Biologics Finland OY
Sími: +345 800 4316

Slovenskárepublika
Biocon Biologics Germany GmbH
Tel: 0080008250910

Italia
Biocon Biologics Spain S.L .
Tel: 0080008250910

Suomi/Finland
Biocon Biologics Finland OY
Puh/Tel: 99980008250910

Κύπρος
Biosimilar Collaborations Ireland Limited
Τηλ: 0080008250910

Sverige
Biocon Biologics Finland OY
Tel: 0080008250910

Latvija
Biosimilar Collaborations Ireland Limited
Tel: 0080008250910

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency, http://www.ema.europa.eu.