Abevmy 25 mg/ml concentrado para solucion para perfusion

Prospect: Patient Information

Abevmy 25 mg/ml Concentrate for Solution for Infusion

bevacizumab

This medicine is subject to additional monitoring, which will expedite the detection of new information about its safety. You may contribute by reporting any adverse effects you experience. The final part of section 4 includes information on how to report these adverse effects.

Read this prospect carefully before starting to use this medicine because it contains important information for you.

• Keep this prospect, as you may need to refer to it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this prospect. See section 4.

The active ingredient of Abevmy 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.

Abevmy is a medication used for the treatment of adult patients with advanced colorectal or rectal cancer. Abevmy will be administered in combination with a chemotherapy regimen containing a fluoropyrimidine medication.

Abevmy 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 capecitabine.

Abevmy is also used for the treatment of adult patients with advanced non-small cell lung cancer. Abevmy will be administered along with a platinum-based chemotherapy regimen.

Abevmy 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). Abevmy will be administered in combination with erlotinib.

Abevmy 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.

Abevmy 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 of at least 6 months since the last time they were treated with a platinum-based chemotherapy regimen, Abevmy 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 of at least 6 months since the last time they were treated with a platinum-based chemotherapy regimen, Abevmy will be administered in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin.

Abevmy is also used for the treatment of adult patients with persistent, recurrent, or metastatic cervical cancer. Abevmy will be administered in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum-based therapy.

Do not use Abevmy if:

• you are allergic (hypersensitive) to bevacizumab or any of the other components of this medication (listed in section 6).
• you are allergic (hypersensitive) to products derived from Chinese hamster ovary cells (CHO) or to other recombinant human or humanized antibodies.
• you are pregnant.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before they administer Abevmy to you:

• Abevmy may increase the risk of causing perforations in the intestinal wall. If you have any disease that causes inflammation in the abdomen (e.g. diverticulitis, stomach ulcer, chemotherapy-induced colitis), consult your doctor.
• Abevmy may increase the risk of developing an abnormal communication between two organs or vesicles. The risk of developing communications between the vagina and any part of the intestine may increase if you have persistent, recurrent, or metastatic cervical cancer.
• This medication may increase the risk of bleeding or problems with wound healing. If you are to be operated on, have had major surgery in the last 28 days, or have an unhealed surgical wound, do not use this medication.
• Abevmy may increase the risk of developing severe skin infections or deep tissue infections, especially if you have had intestinal perforations or wound healing problems.
• Abevmy may increase the risk of high blood pressure. If you have uncontrolled high blood pressure, consult your doctor, it is essential to ensure that your blood pressure is controlled before starting treatment with Abevmy.
• If you have or have had an aneurysm (enlargement and weakening of a blood vessel wall) or a tear in the wall of a blood vessel.
• This medication increases the risk of having protein in your urine, especially if you already have high blood pressure.
• The risk of developing thrombi or clots in your arteries (a type of blood vessel) may increase if you are over 65 years old, if you have diabetes, or if you have had thrombi or clots in your arteries in the past. Consult your doctor, as thrombi or clots can cause heart attacks and strokes.
• Abevmy may also increase the risk of developing thrombi or clots in your veins (a type of blood vessel).
• This medication may cause bleeding, especially bleeding related to the tumor. Consult your doctor if you have a tendency or family history of bleeding disorders or are taking medications that thin the blood for any reason.
• Abevmy may cause bleeding in and around your brain. Consult your doctor if you have metastatic cancer that affects your brain.
• Abevmy may increase the risk of bleeding in your lungs, including coughing or expectoration of blood. Consult your doctor if you have noticed this previously.
• Abevmy may increase the risk of heart failure. It is essential to inform your doctor if you have ever been treated with anthracyclines (a specific type of chemotherapy used to treat certain types of cancer, such as doxorubicin) or have received radiation therapy in the chest, or if you have a heart disease.
• This medication may cause infections and decrease the number of neutrophils (a type of blood cell important for protecting you from bacteria).
• Abevmy may cause hypersensitivity (including anaphylactic shock) and/or reactions after infusion (reactions related to the injection of the medication).
• Consult your doctor, pharmacist, or nurse if you have previously experienced problems after injections, such as dizziness/dizziness, difficulty breathing, swelling, or skin rash.
• A rare neurological side effect called reversible posterior leukoencephalopathy syndrome (RPLS) has been associated with treatment with Abevmy. If you have headaches, vision changes, confusion, or seizures (convulsions) with or without high blood pressure, consult your doctor.

Please consult your doctor even if any of the above situations affect you or have occurred in the past.

Before starting treatment with Abevmy or during treatment with Abevmy:

• if you have or have had mouth pain, teeth, and/or jaw pain, swelling, or sores in the mouth, numbness, or a feeling of heaviness in the jaw, or tooth loss, inform your doctor and dentist immediately.
• if you need to undergo invasive dental treatment or dental surgery, inform your dentist that you are being treated with Abevmy, especially when you are also receiving or have received an injection of bisphosphonates in your blood.

You may be advised to have a dental check-up before starting treatment with Abevmy.

Children and adolescents

Abevmy is not recommended for use in children and adolescents under 18 years old as its safety and efficacy have not been established in these patients.

Cases of osteonecrosis (death of bone tissue) in bones other than the jaw have been reported in patients under 18 years old treated with Abevmy.

Other medications and Abevmy

Inform your doctor, pharmacist, or nurse if you are using, have used recently, or may need to use any other medication.

The combination of Abevmy with another medication called sunitinib malate (prescribed for renal and gastrointestinal cancer) may cause severe side effects. Consult your doctor to ensure that you do not combine these medications.

Consult your doctor if you are receiving platinum-based or taxane-based cancer treatment for metastatic breast or lung cancer. These therapies in combination with Abevmy may increase the risk of severe side effects.

Inform your doctor if you have recently received or are receiving radiation therapy.

Pregnancy, breastfeeding, and fertility

You must not use Abevmy if you are pregnant. Abevmy may harm the fetus, as it may slow down the formation of new blood vessels. Your doctor should advise you to use a contraceptive method during treatment with Abevmy and at least 6 months after the last dose of Abevmy.

Inform your doctor immediately if you are already pregnant, if you become pregnant during treatment with Abevmy, or if you plan to become pregnant in the future.

You must not breastfeed your baby during treatment with Abevmy and at least 6 months after the last dose of Abevmy, as this medication may interfere with your baby's growth and development.

Abevmy may affect female fertility. Consult your doctor for more information.

Consult your doctor, pharmacist, or nurse before using any medication.

Driving and operating machinery

Abevmy has not been observed to decrease your ability to drive or operate tools or machines. However, drowsiness and fainting have been reported with the use of Abevmy. If you experience symptoms that affect your vision or concentration, or your reaction time, do not drive or operate machines until the symptoms disappear.

Abevmy contains sodium.

This medication contains 4,196 mg of sodium (main component of table salt/for cooking) in each 4 ml vial. This is equivalent to 0.21% of the maximum daily sodium intake recommended for an adult.

This medication contains 16,784 mg of sodium (main component of table salt/for cooking) in each 16 ml vial. This is equivalent to 0.84% of the maximum daily sodium intake recommended for an adult.

Dose and administration frequency

The dose of Abevmy required 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 pc. Your doctor will prescribe an appropriate dose of Abevmy for you. You will receive treatment with Abevmy 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 Abevmy can no longer stop tumor growth. Your doctor will discuss these aspects with you.

Form and route of administration

Do not shake the vial.

Abevmy is a concentrate for infusion solution. Depending on the dose prescribed, a fraction or the entire contents of the Abevmy vial will be diluted with sodium chloride solution before administration. A doctor or nurse will administer this diluted Abevmy solution as intravenous infusion (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.

Abevmy administration must be temporarily interrupted:

• if you develop severe hypertension requiring treatment with antihypertensive medications,
• if you have wound healing problems after surgery,
• if you have undergone surgery.

Abevmy administration must 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 (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 hemorrhage.

If you use more Abevmy 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 Abevmy

• Your doctor will decide when you should receive the next dose of Abevmy. You must inform your doctor of this omission.

If you interrupt treatment with Abevmy

Stopping treatment with Abevmy may suppress its effect on tumor growth.

Do not stop treatment with Abevmy unless you have consulted with your doctor.

If you have any other doubts about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a side effect that does not appear in this leaflet.

The side effects listed below have been observed when Abevmy is administered with chemotherapy. This does not necessarily mean that these side effects were strictly caused by Abevmy.

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 bevery 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 becommon(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 vessels,
• 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, which may be painful and cause difficulty swallowing,
• pain, including headache, back pain, pelvic, and anal regions,
• localized pus foci,
• infection, and particularly blood or urinary tract infection,
• decrease in cerebral blood flow or apoplexy,
• 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 skin 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 berare(may affect up to 1 in 1000 people), include:

• sudden and severe allergic reaction with difficulty breathing, swelling, dizziness, rapid heartbeats, 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 skin 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,
• increase and weakening of the wall of a blood vessel or rupture of the wall of a blood vessel (aneurysms and arterial dissections).
• obstruction of small blood vessels in the kidney,
• abnormally high blood pressure in the pulmonary 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 signs 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).

If you experience any of these side effects mentioned, seek medical attention as soon as possible.

Side effectsvery 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 effectscommon(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 arteries that may cause apoplexy or heart attack,
• decrease in the number of white blood cells and platelets (which help to clot) in blood,
• diarrhea,
• unwellness,
• headache,
• fatigue,
• high blood pressure.

Abevmy 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 facilitates protection 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.

Abevmy has been developed and manufactured to treat cancer by injection into the bloodstream. It has not been developed or manufactured for injection into the eye. Therefore, it is not authorized for use in this way. When Abevmy 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,
• Light flashes with floaters, progressing to partial vision loss,
• Increased intraocular pressure,
• Bleeding in the eye.

Reporting of side effects

If you experience side effects, consult your doctor, pharmacist, or nurse, even if it is a side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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 not used immediately, the storage times and conditions in use are the responsibility of the user and should not normally exceed 24 hours between 2 °C and 8 °C, unless the infusion solutions have been prepared in a sterile environment. When the dilution has been made in a sterile environment, Abevmy is stable for a period of up to 70 days between 2 °C and 8 °C and a period of up to 15 days between 23 °C and 27 °C.

Do not use Abevmy if you observe any foreign particles or discoloration before administration.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you do not need. This will help protect the environment.

Composition of Abevmy

• The active ingredient is bevacizumab. Each milliliter of concentrate contains 25 mg of bevacizumab, corresponding to 1.4 or 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 components are sodium phosphate (E339), α, α-trehalose dihydrate, polisorbate 20 (E432) and water for injection preparations. See section 2 “Abevmy contains sodium”.

Appearance of the product and contents of the package

Abevmy is a concentrate for solution for infusion. The concentrate is a colorless to pale brown liquid that is transparent to slightly opalescent with no visible particles. It comes 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.

Only some pack sizes may be marketed.

Marketing Authorization Holder

Biosimilar Collaborations Ireland Limited

Unit 35/36

Grange Parade,

Baldoyle Industrial Estate,

Dublin 13

DUBLIN

Ireland D13 R20R

Manufacturers

Biosimilar Collaborations Ireland Limited

Block B, The Crescent Building, Santry Demesne

Dublin

D09 C6X8

Ireland

For more information about this medicine, please contact the local representative of the marketing authorization holder:

Last update of this leaflet: 09/2024

Other sources of information

The detailed information on this medicine is available on the website of the European Medicines Agencyhttp://www.ema.europa.eu.