Bortezomib Aurovitas 3.5 mg powder for injection solution EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Bortezomib Aurovitas 3.5 mg powder for solution for injection EFG

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.

• If you have any questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.

• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

1. What Bortezomib Aurovitas is and what it is used for
2. What you need to know before using Bortezomib Aurovitas
3. How to use Bortezomib Aurovitas
4. Possible side effects
5. How to store Bortezomib Aurovitas
6. Contents of the pack and other information

1. What Bortezomib Aurovitas is and what it is used for

Bortezomib Aurovitas contains the active substance bortezomib, a "proteasome inhibitor". Proteasomes play an important role in regulating cell function and growth. Bortezomib can destroy cancer cells by interfering with their normal function.

Bortezomib is used in the treatment of multiple myeloma (a cancer of the bone marrow) in patients over 18 years of age:

• Alone or in combination with pegylated liposomal doxorubicin or dexamethasone, for patients whose disease is progressing after having received at least one prior therapy, and for those patients for whom stem cell transplantation has failed or is not suitable.
• In combination with melphalan and prednisone, for patients who have not previously received treatment and for whom high-dose chemotherapy followed by stem cell transplantation is not considered appropriate.
• In combination with dexamethasone or with dexamethasone and thalidomide, for patients who have not previously received treatment and who are receiving high-dose chemotherapy prior to stem cell transplantation (induction therapy).

Bortezomib is also used in the treatment of mantle cell lymphoma (a type of cancer affecting the lymph nodes) in patients aged 18 years or older, in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone, for patients who have not previously received treatment and for whom stem cell transplantation is not considered appropriate.

2. What you need to know before using Bortezomib Aurovitas

Do not use Bortezomib Aurovitas

• If you are allergic to bortezomib, to boron, or to any of the other ingredients of this medicine (listed in section 6).
• If you have certain severe lung or heart problems.

Warnings and precautions

Tell your doctor if you have any of the following:

• Low red or white blood cell counts.
• Bleeding problems and/or low platelet count in the blood.
• Diarrhea, constipation, nausea, or vomiting.
• History of fainting, dizziness, or lightheadedness.
• Kidney problems.
• Moderate to severe liver problems.
• Past history of numbness, tingling, or pain in hands or feet (neuropathy).
• Heart problems or blood pressure issues.
• Difficulty breathing or cough.
• Seizures.
• Shingles (localized including around the eyes or widespread throughout the body).
• Symptoms of tumor lysis syndrome, such as muscle cramps, muscle weakness, confusion, vision loss or changes, and difficulty breathing.
• Memory loss, changes in thinking, difficulty walking, or vision loss. These may be signs of a serious brain infection, and your doctor may recommend further tests and monitoring.

You will need to have regular blood tests before and during treatment with bortezomib to monitor your blood cell counts regularly.

Tell your doctor if you have mantle cell lymphoma and are receiving rituximab together with bortezomib:

• If you currently have or have previously had hepatitis infection. In some cases, patients with a history of hepatitis B may experience reactivation of the infection, which can be fatal. If you have a history of hepatitis B infection, your doctor will closely monitor you for signs of active hepatitis.

Before starting treatment with bortezomib, you should read the package leaflets of all the medicines you are to take in combination with bortezomib to review information related to these medicines.

When using thalidomide, special attention must be paid to pregnancy testing and preventive measures (see Pregnancy and breastfeeding in this section).

Children and adolescents

Bortezomib must not be used in children and adolescents because it is unknown how the medicine will affect them.

Other medicines and Bortezomib Aurovitas

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

In particular, inform your doctor if you are taking medicines containing any of the following active substances:

• Ketoconazole, used to treat fungal infections.
• Ritonavir, used to treat HIV infection.
• Rifampicin, an antibiotic used to treat bacterial infections.
• Carbamazepine, phenytoin, or phenobarbital, used to treat epilepsy.
• St. John’s wort (Hypericum perforatum), used for depression or other conditions.
• Oral antidiabetic medicines.

Pregnancy and breastfeeding

You must not use bortezomib during pregnancy unless clearly necessary.

Women of childbearing potential must use effective contraception during treatment and for at least 8 months after stopping treatment. Speak with your doctor if you wish to freeze your eggs before starting treatment.

Men must not father a child while using bortezomib and must use effective contraception during treatment and for at least 5 months after stopping treatment. Speak with your doctor if you wish to preserve your sperm before starting treatment.

You must not breastfeed while using bortezomib. Consult your doctor about when it is safe to restart breastfeeding after completing your treatment.

Thalidomide causes birth defects and fetal death. When bortezomib is administered in combination with thalidomide, the thalidomide pregnancy prevention programme must be followed (refer to the thalidomide package leaflet).

Driving and using machines

Bortezomib may cause fatigue, dizziness, fainting, or blurred vision. Do not drive or operate tools or machinery if you experience these side effects. Even if you do not experience them, you should still exercise caution.

3. How to use Bortezomib Aurovitas

Your doctor will determine the dose of bortezomib based on your height and weight (body surface area). The usual starting dose of bortezomib is 1.3 mg/m² of body surface area administered twice weekly.

Your doctor may adjust the dose and the total number of treatment cycles depending on your response to treatment, the occurrence of certain adverse effects, and your underlying condition (e.g., liver problems).

Relapsed multiple myeloma

When bortezomib is given alone, you will receive 4 doses of bortezomib intravenously or subcutaneously on days 1, 4, 8, and 11, followed by a 10-day “rest” period without treatment. This 21-day period (3 weeks) constitutes one treatment cycle. You may receive up to 8 cycles (24 weeks).

You may also receive bortezomib in combination with pegylated liposomal doxorubicin or dexamethasone.

When bortezomib is administered with pegylated liposomal doxorubicin, you will receive bortezomib intravenously or subcutaneously in a 21-day treatment cycle and 30 mg/m² of pegylated liposomal doxorubicin administered intravenously on day 4 of the 21-day bortezomib treatment cycle, via intravenous infusion after bortezomib injection. You may receive up to 8 cycles (24 weeks).

When bortezomib is administered with dexamethasone, you will receive bortezomib intravenously or subcutaneously in a 21-day treatment cycle and 20 mg of dexamethasone administered orally on days 1, 2, 4, 5, 8, 9, 11, and 12 of the 21-day bortezomib treatment cycle. You may receive up to 8 cycles (24 weeks).

Previously untreated multiple myeloma

If you have not previously been treated for multiple myeloma and are not eligible for blood stem cell transplantation, you will receive bortezomib in combination with two other medicines: melphalan and prednisone.

In this case, the duration of one treatment cycle is 42 days (6 weeks). You will receive 9 cycles (54 weeks).

• In cycles 1 to 4, bortezomib is administered twice weekly on days 1, 4, 8, 11, 22, 25, 29, and 32.
• In cycles 5 to 9, bortezomib is administered once weekly on days 1, 8, 22, and 29. Melphalan (9 mg/m²) and prednisone (60 mg/m²) are administered orally on days 1, 2, 3, and 4 of the first week of each cycle.

If you have not previously received treatment for multiple myeloma and are eligible for blood stem cell transplantation, you will receive bortezomib intravenously or subcutaneously in combination with dexamethasone, or with dexamethasone and thalidomide, as induction therapy.

When bortezomib is administered with dexamethasone, you will receive bortezomib intravenously or subcutaneously in a 21-day treatment cycle, and dexamethasone is administered orally at a dose of 40 mg on days 1, 2, 3, 4, 8, 9, 10, and 11 of the 21-day bortezomib treatment cycle. You will receive 4 cycles (12 weeks).

When bortezomib is administered with thalidomide and dexamethasone, the duration of a treatment cycle is 28 days (4 weeks).

Dexamethasone 40 mg is administered orally on days 1, 2, 3, 4, 8, 9, 10, and 11 of the 28-day bortezomib treatment cycle, and thalidomide is administered orally once daily at a dose of 50 mg up to day 14 of the first cycle; if tolerated, the thalidomide dose is increased to 100 mg from days 15–28, and from the second cycle onward, it may be further increased to 200 mg daily. You may receive up to 6 cycles (24 weeks).

Previously untreated mantle cell lymphoma

If you have not previously been treated for mantle cell lymphoma, you will receive bortezomib intravenously or subcutaneously in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone.

Bortezomib is administered intravenously or subcutaneously on days 1, 4, 8, and 11, followed by a “rest period” without treatment. The duration of a treatment cycle is 21 days (3 weeks). You may receive up to 8 cycles (24 weeks).

The following medicines are administered by intravenous infusion on day 1 of the 21-day bortezomib treatment cycle:

Rituximab at a dose of 375 mg/m², cyclophosphamide at a dose of 750 mg/m², and doxorubicin at a dose of 50 mg/m².

Prednisone is administered orally at a dose of 100 mg/m² on days 1, 2, 3, 4, and 5 of the bortezomib treatment cycle.

How bortezomib is administered

This medicine is administered intravenously or subcutaneously. Bortezomib will be given to you by a healthcare professional experienced in the use of cytotoxic medicines.

The bortezomib powder must be dissolved before administration. This will be done by a healthcare professional. The reconstituted solution is then injected into a vein or under the skin. The intravenous injection is rapid and lasts between 3 and 5 seconds. The subcutaneous injection is administered in the thighs or abdomen.

If you receive more Bortezomib Aurovitas than you should

This medicine will be administered by your doctor or nurse, so it is unlikely that you will receive too much. In the unlikely event of an overdose, your doctor will monitor you for any adverse effects.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount administered.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them. Some of these effects may be serious.

If you are administered bortezomib for multiple myeloma or mantle cell lymphoma, inform your doctor immediately if you notice any of the following symptoms:

• Muscle cramps, muscle weakness.
• Confusion, loss or changes in vision, blindness, seizures, headaches.
• Difficulty breathing, swelling of the feet, or changes in heart rhythm, high blood pressure, fatigue, fainting.
• Cough and difficulty breathing or chest tightness.

Treatment with bortezomib may very commonly cause a decrease in the number of red blood cells, white blood cells, and platelets in the blood. Therefore, you will need to have regular blood tests before and during treatment with bortezomib to monitor your blood cell counts. You may experience a reduction in the number of:

• Platelets, which may make you more prone to bruising (contusions) or bleeding without evident injury (for example, intestinal, stomach, mouth, or gum bleeding, or bleeding in the brain or liver).
• Red blood cells, which may cause anemia, with symptoms such as fatigue and paleness.
• White blood cells, which may make you more susceptible to infections or flu-like symptoms.

If you are administered bortezomib for the treatment of multiple myeloma, the adverse effects you may experience are listed below:

Very common adverse effects (may affect more than 1 in 10 people)

• Sensitivity, numbness, tingling, or burning sensation in the skin, or pain in hands or feet due to nerve damage.
• Reduction in the number of red and/or white blood cells (see above).
• Fever.
• Feeling unwell (nausea) or vomiting, loss of appetite.
• Constipation with or without bloating (may be severe).
• Diarrhea: if it occurs, it is important to drink more fluids than usual. Your doctor may prescribe another medicine to control the diarrhea.
• Exhaustion (fatigue), feeling of weakness.
• Muscle pain, bone pain.

Common adverse effects (may affect up to 1 in 10 people)

• Low blood pressure, sudden drop in blood pressure upon standing, which could lead to fainting.
• High blood pressure.
• Decreased kidney function.
• Headache.
• General feeling of discomfort, pain, dizziness, lightheadedness, feeling of weakness, or loss of consciousness.
• Chills.
• Infections, including pneumonia, respiratory infections, bronchitis, fungal infections, cough with phlegm, flu-like illness.
• Herpes zoster (localized, including around the eyes, or widespread).
• Chest pain or difficulty breathing during exercise.
• Various types of rashes.
• Itching, skin lumps, or dry skin.
• Facial flushing or rupture of small capillaries.
• Redness of the skin.
• Dehydration.
• Stomach burning, bloating, belching, flatulence, stomach pain, intestinal or stomach bleeding.
• Impaired liver function.
• Mouth or lip sores, dry mouth, mouth ulcers, or sore throat.
• Weight loss, loss of taste.
• Muscle cramps, muscle spasms, muscle weakness, limb pain.
• Blurred vision.
• Infection of the outer layer of the eye and the inner surface of the eyelids (conjunctivitis).
• Nosebleeds.
• Difficulty or problems sleeping, sweating, anxiety, mood changes, depressed mood, restlessness or agitation, changes in mental state, disorientation.
• Swelling of the body, including around the eyes and other body parts.

Uncommon adverse effects (may affect up to 1 in 100 people)

• Heart failure, heart attack, chest pain, chest discomfort, increased or decreased heart rate.
• Kidney failure.
• Inflammation of a vein, blood clots in veins and lungs.
• Blood clotting problems.
• Poor circulation.
• Inflammation of the lining of the heart or fluid around the heart.
• Infections, including urinary tract infections, flu, herpes virus infection, ear infection, and cellulitis.
• Bloody stools or bleeding from mucous membranes, for example, from the mouth or vagina.
• Cerebrovascular disorders.
• Paralysis, seizures, falls, movement disorders, alterations or changes in, or decreased sensitivity (touch, hearing, taste, smell), attention disorders, tremors, jerking movements.
• Arthritis, including inflammation of the joints in the fingers, toes, and jaw.
• Disorders affecting the lungs, preventing the body from receiving sufficient oxygen. Some of these include difficulty breathing, shortness of breath, breathlessness without exertion, breathing that may become shallow, difficult, or stop, labored breathing.
• Hiccups, speech disorders.
• Increased or decreased urine production (due to kidney injury), pain when urinating, or blood/proteins in the urine, fluid retention.
• Altered level of consciousness, confusion, memory impairment or loss.
• Hypersensitivity.
• Hearing loss, deafness, or ringing in the ears, ear discomfort.
• Hormonal disorders that may affect salt and water absorption.
• Overactivity of the thyroid gland.
• Inability to produce enough insulin or resistance to normal insulin levels.
• Eye irritation or inflammation, excessively watery eyes, eye pain, dry eyes, eye infections, eyelid cyst (chalazion), red and swollen eyelids, watery eyes (lacrimation), abnormal vision, eye bleeding.
• Swelling of lymph nodes.
• Stiffness of joints or muscles, feeling of heaviness, groin pain.
• Hair loss and abnormal hair texture.
• Allergic reactions.
• Redness or pain at the injection site.
• Mouth pain.
• Infections or inflammation of the mouth, esophagus, stomach, and intestine, sometimes associated with pain or bleeding, reduced intestinal movement (including obstruction), abdominal or esophageal discomfort, difficulty swallowing, vomiting blood.
• Skin infections.
• Bacterial and viral infections.
• Dental infection.
• Pancreatitis, obstruction of bile ducts.
• Genital pain, difficulty achieving an erection.
• Weight gain.
• Thirst.
• Hepatitis.
• Injection site reactions or device-related disorders.
• Skin reactions and disorders (which may be severe and life-threatening), skin ulcers.
• Bruising, falls, and injuries.
• Inflammation or bleeding of blood vessels, appearing as small red or purple spots (usually on the legs) up to large bruise-like areas under the skin or tissue.
• Benign cysts.
• A serious and reversible brain disorder including seizures, high blood pressure, headaches, fatigue, confusion, blindness, or other vision problems.

Rare adverse effects (may affect up to 1 in 1,000 people)

• Heart problems, including heart attack, angina.
• Severe nerve inflammation, which may cause paralysis and breathing difficulties (Guillain-Barré syndrome).
• Flushing.
• Discoloration of veins.
• Inflammation of spinal nerves.
• Ear problems, ear bleeding.
• Underactivity of the thyroid gland.
• Budd-Chiari syndrome (clinical symptoms caused by obstruction of the hepatic veins).
• Changes or abnormalities in intestinal function.
• Cerebral hemorrhage.
• Yellowing of the eyes and skin (jaundice).
• Severe allergic reaction (anaphylactic shock), whose signs may include difficulty breathing, chest pain or tightness, and/or dizziness/fainting, intense skin itching or skin lumps, swelling of the face, lips, tongue, and/or throat, which may cause difficulty swallowing, collapse.
• Breast disorders.
• Vaginal tear.
• Genital inflammation.
• Inability to tolerate alcohol consumption.
• Wasting or loss of body mass.
• Increased appetite.
• Fistula.
• Joint effusion.
• Cysts in the joint lining (synovial cysts).
• Fracture.
• Breakdown of muscle fibers causing other complications.
• Liver swelling, liver bleeding.
• Kidney cancer.
• Skin disease resembling psoriasis.
• Skin cancer.
• Paleness of the skin.
• Increase in platelets or plasma cells (a type of white blood cell) in the blood.
• Blood clot in small blood vessels (thrombotic microangiopathy).
• Abnormal reaction to blood transfusions.
• Partial or complete loss of vision.
• Loss of libido.
• Drooling.
• Protruding eyes.
• Light sensitivity.
• Rapid breathing.
• Rectal pain.
• Gallstones.
• Hernia.
• Wounds.
• Weak or brittle nails.
• Abnormal deposits of proteins in vital organs.
• Coma.
• Intestinal ulcers.
• Multi-organ failure.
• Death.

The following are the adverse effects you may experience if you are administered bortezomib in combination with other medicines for the treatment of mantle cell lymphoma:

Very common adverse effects (may affect more than 1 in 10 people)

• Pneumonia.
• Loss of appetite.
• Sensitivity, numbness, tingling, or burning sensation in the skin, or pain in hands or feet due to nerve damage.
• Nausea or vomiting.
• Diarrhea.
• Mouth ulcers.
• Constipation.
• Muscle pain, bone pain.
• Hair loss and abnormal hair texture.
• Exhaustion, feeling of weakness.
• Fever.

Common adverse effects (may affect up to 1 in 10 people)

• Herpes zoster (localized, including around the eyes, or widespread).
• Herpes virus infection.
• Bacterial and viral infections.
• Respiratory infections, bronchitis, cough with phlegm, flu-like illness.
• Fungal infections.
• Hypersensitivity (allergic reaction).
• Inability to produce enough insulin or resistance to normal insulin levels.
• Fluid retention.
• Difficulty or problems sleeping.
• Loss of consciousness.
• Altered level of consciousness, confusion.
• Dizziness.
• Increased heart rate, high blood pressure, sweating.
• Abnormal vision, blurred vision.
• Heart failure, heart attack, chest pain, chest discomfort, increased or decreased heart rate.
• High or low blood pressure.
• Sudden drop in blood pressure upon standing, which could lead to fainting.
• Difficulty breathing during exercise.
• Cough.
• Hiccups.
• Ringing in the ears, ear discomfort.
• Intestinal or stomach bleeding.
• Stomach burning.
• Stomach pain, bloating.
• Difficulty swallowing.
• Infection or inflammation of stomach and intestine.
• Stomach pain.
• Mouth or lip sores, sore throat.
• Impaired liver function.
• Itching.
• Redness of the skin.
• Rash.
• Muscle spasms.
• Urinary tract infection.
• Limb pain.
• Swelling of the body, including around the eyes and other body parts.
• Chills.
• Redness and pain at the injection site.
• General feeling of discomfort.
• Weight loss.
• Weight gain.

Uncommon adverse effects (may affect up to 1 in 100 people)

• Hepatitis.
• Severe allergic reaction (anaphylactic reaction), whose signs may include difficulty breathing, chest pain or tightness, and/or dizziness/fainting, intense skin itching or skin lumps, swelling of the face, lips, tongue, and/or throat, which may cause difficulty swallowing, collapse.
• Movement disorders, paralysis, jerking movements.
• Dizziness.
• Hearing loss, deafness.
• Disorders affecting the lungs, preventing the body from receiving sufficient oxygen. Some of these include difficulty breathing, shortness of breath, breathlessness without exertion, breathing that may become shallow, difficult, or stop, labored breathing.
• Blood clots in the lungs.
• Yellowing of the eyes and skin (jaundice).
• Eyelid cyst (chalazion), red and swollen eyelids.

Rare adverse effects (may affect up to 1 in 1,000 people)

• Blood clot in small blood vessels (thrombotic microangiopathy).
• Severe nerve inflammation, which may cause paralysis and breathing difficulties (Guillain-Barré syndrome).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if these are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Bortezomib Aurovitas

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the vial and outer carton following EXP.

Store the vial in the outer packaging to protect it from light.

Intravenous administration:

Solution after reconstitution at 1 mg/ml.

Do not refrigerate.

Chemical and physical in-use stability has been demonstrated for 7 days at 25°C.

From a microbiological standpoint, the medicine should be used immediately unless the method of opening/reconstitution/dilution prevents the risk of microbiological contamination.

If not used immediately, the duration and conditions of storage prior to use are the responsibility of the user.

Subcutaneous administration:

Solution after reconstitution at 2.5 mg/ml.

Do not refrigerate.

Chemical and physical in-use stability has been demonstrated for 7 days at 25°C.

From a microbiological standpoint, the medicine should be used immediately unless the method of opening/reconstitution/dilution prevents the risk of microbiological contamination.

If not used immediately, the duration and conditions of storage prior to use are the responsibility of the user.

Bortezomib is for single use only. Any unused product or waste material must be disposed of in accordance with local regulations.

6. Contents of the pack and other information

Composition of Bortezomib Aurovitas

• The active substance is bortezomib. Each vial contains 3.5 mg of bortezomib (as boric acid ester of mannitol).
• The other component is: mannitol.

Reconstitution for intravenous administration:

After reconstitution, 1 ml of the intravenous injection solution contains 1 mg of bortezomib.

Reconstitution for subcutaneous administration:

After reconstitution, 1 ml of the subcutaneous injection solution contains 2.5 mg of bortezomib.

Appearance of the product and contents of the container

White or almost white lyophilised powder or paste.

Each pack of Bortezomib Aurovitas 3.5 mg powder for injectable solution EFG contains 10 ml Type I transparent glass vials, closed with grey bromobutyl rubber stoppers and sealed with aluminium caps with polypropylene discs.

Pack sizes: 1, 3, 5 or 10 vials with or without protective overwrap.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Eugia Pharma (Malta) Limited
Vault 14, Level 2, Valletta Waterfront
Floriana, FRN 1914
Malta

Manufacturer

APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta

Or

Generis Farmacêutica, S.A.
Rua João de Deus, nº 19, Venda Nova
2700-487 Amadora
Portugal

Or

Arrow Génériques
26 Avenue Tony Garnier
69007 Lyon
France

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Aurovitas Spain, S.A.U.
Avda. de Burgos, 16-D
28036 Madrid
Spain

This medicinal product is authorised in the European Economic Area member states under the following names:

Germany: Bortezomib PUREN 3.5 mg Powder for solution for injection
Belgium: Bortezomib Eugia 3.5 mg powder for injection solution / poudre pour solution injectable / Pulver zur Herstellung einer Injektionslösung
Spain: Bortezomib Aurovitas 3.5 mg powder for injectable solution EFG
France: Bortezomib Arrow 3.5 mg poudre pour solution injectable
Italy: Bortezomib Aurobindo
Netherlands: Bortezomib Eugia 3.5 mg, powder for injection solution
Poland: Bortezomib Eugia
Portugal: Bortezomib Generis

Date of latest review of this leaflet: July 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).

This information is intended for healthcare professionals only:

1. RECONSTITUTION FOR INTRAVENOUS INJECTION

Note: Bortezomib Aurovitas is a cytotoxic agent. Therefore, caution should be exercised during handling and preparation. The use of gloves and other protective clothing is recommended to prevent skin contact.

SINCE BORTEZOMIB DOES NOT CONTAIN PRESERVATIVES, STRICT ASEPTIC TECHNIQUE SHOULD BE FOLLOWED DURING HANDLING.

1.1 Preparation of a 3.5 mg vial: carefully add 3.5 ml of sterile 9 mg/ml (0.9%) sodium chloride injection solution to the vial containing Bortezomib Aurovitas powder, using an appropriately sized syringe without removing the vial stopper. The lyophilised powder dissolves completely within less than 2 minutes.

The resulting solution concentration will be 1 mg/ml. The solution should be colourless and clear, with a final pH of 4 to 7. The pH of the solution does not need to be checked.

1.2 Before administration, inspect the solution visually for the presence of particles and discoloration. If discoloration or particles are observed, the solution must be discarded. Confirm that the correct dose for intravenous administration (1 mg/ml) is being used.

1.3 The reconstituted solution contains no preservatives and should be used immediately after preparation. However, chemical and physical in-use stability has been demonstrated for up to 7 days at 25°C when stored in the original vial and/or syringe. The total storage time of the reconstituted medicinal product must not exceed 7 days before administration. If the reconstituted solution is not used immediately, the storage times and conditions prior to use are the responsibility of the user.

There is no need to protect the reconstituted product from light.

2. ADMINISTRATION

• After dissolution, withdraw the appropriate amount of reconstituted solution according to the dose calculated based on the patient's Body Surface Area.
• Confirm the dose and concentration contained in the syringe before use (ensure the syringe is labelled for intravenous administration).
• Inject the solution as an intravenous bolus over 3-5 seconds through a peripheral or central intravenous catheter into a vein.
• Flush the peripheral or intravenous catheter with sterile 9 mg/ml (0.9%) sodium chloride solution.

Bortezomib 3.5 mg powder for injectable solution MUST BE ADMINISTERED ONLY BY INTRAVENOUS OR SUBCUTANEOUS ROUTE. Do not administer by other routes. Intrathecal administration has resulted in fatal cases.

3. DISPOSAL

The vial is for single use only; any remaining solution must be discarded.

Disposal of unused medicinal product and all materials that have come into contact with it must be carried out in accordance with local regulations.

This information is intended for healthcare professionals only:

Only the 3.5 mg vial may be administered subcutaneously, as described below.

1. RECONSTITUTION FOR SUBCUTANEOUS INJECTION

Note: Bortezomib Aurovitas is a cytotoxic agent. Therefore, caution should be exercised during handling and preparation. The use of gloves and other protective clothing is recommended to prevent skin contact.

SINCE BORTEZOMIB DOES NOT CONTAIN PRESERVATIVES, STRICT ASEPTIC TECHNIQUE SHOULD BE FOLLOWED DURING HANDLING.

1.1 Preparation of a 3.5 mg vial: carefully add 1.4 ml of sterile 9 mg/ml (0.9%) sodium chloride injection solution to the vial containing Bortezomib Aurovitas powder, using an appropriately sized syringe without removing the vial stopper. The lyophilised powder dissolves completely within less than 2 minutes.

The resulting solution concentration will be 2.5 mg/ml. The solution should be colourless and clear, with a final pH of 4 to 7. The pH of the solution does not need to be checked.

1.2 Before administration, inspect the solution visually for the presence of particles and discoloration. If discoloration or particles are observed, the solution must be discarded. Confirm that the correct dose for subcutaneous administration (2.5 mg/ml) is being used.

1.3 The reconstituted solution contains no preservatives and should be used immediately after preparation. However, chemical and physical in-use stability has been demonstrated for up to 7 days at 25°C when stored in the original vial and/or syringe. The total storage time of the reconstituted medicinal product must not exceed 7 days before administration. If the reconstituted solution is not used immediately, the storage times and conditions prior to use are the responsibility of the user.

There is no need to protect the reconstituted product from light.

2. ADMINISTRATION

• After dissolution, withdraw the appropriate amount of reconstituted solution according to the dose calculated based on the patient's Body Surface Area.
• Confirm the dose and concentration contained in the syringe before use (ensure the syringe is labelled for subcutaneous administration).
• Inject the solution subcutaneously at an angle of 45–90°.
• The reconstituted solution is administered subcutaneously in the thigh (right or left) or abdomen (right or left side).
• Injection sites should be rotated with each administration.
• If local reactions occur at the injection site following subcutaneous administration of bortezomib, a less concentrated subcutaneous solution of bortezomib (1 mg/ml instead of 2.5 mg/ml) may be administered, or switching to intravenous injection is recommended.

Bortezomib 3.5 mg powder for injectable solution MUST BE ADMINISTERED ONLY BY INTRAVENOUS OR SUBCUTANEOUS ROUTE. Do not administer by other routes. Intrathecal administration has resulted in fatal cases.

3. DISPOSAL

The vial is for single use only; any remaining solution must be discarded.

Disposal of unused medicinal product and all materials that have come into contact with it must be carried out in accordance with local regulations.