BORTEZOMIB QILU 2.5 mg/mL Injectable Solution

Introduction

Package Leaflet: Information for the Patient

Bortezomib Qilu 2.5 mg/ml Solution for Injection

bortezomib

Read all of this leaflet carefully before you start receiving this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Bortezomib Qilu and what is it used for
2. What you need to know before you receive Bortezomib Qilu
3. How Bortezomib Qilu is administered
4. Possible side effects
5. Storage of Bortezomib Qilu
6. Contents of the pack and further information

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

Bortezomib Qilu contains the active substance bortezomib, a “proteasome inhibitor”. Proteasomes play an important role in controlling cell function and growth. Bortezomib can destroy cancer cells by interfering with their function.

Bortezomib is used to treat multiple myeloma (a type of bone marrow cancer) in patients over 18 years of age:

• alone or with the medicines doxorubicin liposomal pegylated or dexamethasone, for patients whose disease is getting worse (in progression) after receiving at least one previous treatment and for those patients whose stem cell transplant did not work or is not suitable

• in combination with the medicines melphalan and prednisone, for patients whose disease has not been previously treated and who are not suitable for high-dose chemotherapy before a stem cell transplant.
• in combination with the medicines dexamethasone or dexamethasone and thalidomide, in patients whose disease has not been previously treated and who receive high-dose chemotherapy before a stem cell transplant (induction treatment).

Bortezomib is used to treat mantle cell lymphoma (a type of cancer that affects the lymph nodes) in patients over 18 years of age in combination with the medicines rituximab, cyclophosphamide, doxorubicin, and prednisone, in patients whose disease has not been previously treated and for those patients who are not considered suitable for a stem cell transplant.

2. What you need to know before you receive Bortezomib Qilu

Do not receive Bortezomib Qilu

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

Warnings and precautions

Talk to your doctor before receiving Bortezomib Qilu

Tell your doctor if you have:

• low number of red or white blood cells
• 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
• numbness, tingling, or pain in the hands or feet (neuropathy) in the past
• heart problems or high blood pressure
• difficulty breathing or coughing
• seizures
• shingles (localized, including around the eyes, or widespread)
• symptoms of tumor lysis syndrome, such as muscle cramps, muscle weakness, confusion, vision loss, or 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 advise further tests and monitoring.

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

You must tell your doctor if you have mantle cell lymphoma and are receiving rituximab in combination with bortezomib:

• if you think you currently have or have had in the past hepatitis infection. In a few cases, patients who have had hepatitis B may have repeated attacks of hepatitis, which can be fatal. If you have a history of hepatitis B infection, you will be closely monitored by your doctor for signs of active hepatitis B.

Before starting treatment with bortezomib, you should read the package leaflets of all the medicines you need to take in combination with bortezomib to find out about the information related to these medicines.

When using thalidomide, special attention should be paid to pregnancy testing and prevention measures (see Pregnancy and Breastfeeding).

Children and adolescents

Bortezomib should not be used in children and adolescents because it is not known how it will affect them.

Other medicines and Bortezomib Qilu

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

In particular, tell your doctor if you are using medicines that contain any of the following active substances:

• ketoconazole, to treat fungal infections
• ritonavir, to treat HIV infection
• rifampicin, an antibiotic 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 antidiabetics

Pregnancy and breastfeeding

You should not receive bortezomib if you are pregnant unless it is clearly necessary.

Both men and women using bortezomib must use effective contraception during and up to 3 months after treatment. If, despite these measures, you become pregnant, inform your doctor immediately.

You should not breastfeed while using bortezomib. Ask your doctor when it is safe to restart breastfeeding after finishing your treatment.

Thalidomide causes birth defects and fetal death. When bortezomib is given in combination with thalidomide, you should follow the thalidomide pregnancy prevention program (see the thalidomide package leaflet).

Driving and using machines

Bortezomib may cause fatigue, dizziness, fainting, or blurred vision. Do not drive or use tools or machines if you experience these side effects; even if you do not experience them, you should be cautious.

Bortezomib Qilu contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per vial; this is essentially “sodium-free”.

3. How Bortezomib Qilu is administered

Your doctor will tell you the dose of bortezomib based on your size and weight (body surface area). The usual starting dose of bortezomib is 1.3 mg/m2 of body surface area twice a week.

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

Progressive multiple myeloma

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

You may also receive bortezomib with the medicines doxorubicin liposomal pegylated or dexamethasone.

When bortezomib is given with doxorubicin liposomal pegylated, you will receive bortezomib by intravenous or subcutaneous injection in a 21-day treatment cycle and doxorubicin liposomal pegylated 30 mg/m2 will be administered on day 4 of the 21-day bortezomib treatment cycle, by intravenous infusion after the bortezomib injection.

You may receive up to 8 cycles (24 weeks).

When bortezomib is given with dexamethasone, you will receive bortezomib by intravenous or subcutaneous injection in a 21-day treatment cycle and dexamethasone 20 mg will be 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 been previously treated for multiple myeloma and are nota candidate for a stem cell transplant, you will receive bortezomib with the 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 will be administered twice a week on days 1, 4, 8, 11, 22, 25, 29, and 32.
• In cycles 5 to 9, bortezomib will be administered once a week on days 1, 8, 22, and 29. Melphalan (9 mg/m2) and prednisone (60 mg/m2) will be administered orally during days 1, 2, 3, and 4 of the first week of each cycle.

If you have not received previous treatment for multiple myeloma and area candidate for a stem cell transplant, you will receive bortezomib by intravenous or subcutaneous injection with the medicines dexamethasone, or dexamethasone and thalidomide, as induction treatment.

When bortezomib is given with dexamethasone, you will receive bortezomib by intravenous or subcutaneous injection in a 21-day treatment cycle and dexamethasone will be 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 given with thalidomide and dexamethasone, the duration of one treatment cycle is 28 days (4 weeks).

Dexamethasone 40 mg will be administered orally on days 1, 2, 3, 4, 8, 9, 10, and 11 of the 28-day bortezomib treatment cycle, and thalidomide will be administered orally once daily at a dose of 50 mg up to day 14 of the first cycle, and if tolerated, the thalidomide dose will be increased to 100 mg from days 15-28, and from the second cycle onwards, 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 been previously treated for mantle cell lymphoma, you will receive bortezomib by intravenous or subcutaneous injection with the medicines rituximab, cyclophosphamide, doxorubicin, and prednisone.

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

The following medicines will be 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 will be administered orally at a dose of 100 mg/m2 on days 1, 2, 3, 4, and 5 of the 21-day bortezomib treatment cycle.

How Bortezomib Qilu is administered

This medicine should be administered by a healthcare professional experienced in the use of cytotoxic medicines.

This medicine is for subcutaneous use (injection under the skin), and after dilution, also for intravenous use (injection into a vein). The injection into a vein is rapid and lasts between 3 and 5 seconds. The injection under the skin is administered into the thighs or abdomen.

If you receive more Bortezomib Qilu 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 side effects.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them. Some of these effects can be serious.

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

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

Treatment with bortezomib can very frequently cause a decrease in the number of red and white blood cells and platelets in the blood. Therefore, you will need to undergo regular blood tests before and during treatment with this medicine to regularly check your blood cell count. You may experience a reduction in the number of:

• Platelets, which can make you more prone to bruising (bruises) or bleeding without apparent injury (e.g., intestinal, stomach, mouth, and gum bleeding or brain or liver bleeding)
• Red blood cells, which can cause anemia, with symptoms such as fatigue and paleness
• White blood cells, which can make you more prone to infections or symptoms similar to those of the flu.

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

Very Common Adverse Effects (may affect more than 1 in 10 patients)

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

Common Adverse Effects (may affect up to 1 in 10 patients)

• Low blood pressure, sudden drop in blood pressure when standing, which could lead to fainting
• High blood pressure
• Decreased kidney function
• Headache
• Feeling of general discomfort, pain, dizziness, drowsiness, 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 spread throughout the body)
• Chest pain or difficulty breathing when exercising
• Various types of rashes
• Itching of the skin, skin bumps, or dry skin
• Facial flushing or rupture of small blood vessels
• Redness of the skin
• Dehydration
• Heartburn, bloating, belching, flatulence, stomach pain, intestinal or stomach bleeding
• Alteration of liver function
• Sores in the mouth or lip, dry mouth, mouth ulcers, or sore throat
• Weight loss, loss of taste
• Muscle cramps, muscle spasms, muscle weakness, pain in the limbs
• 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 in other parts of the body

Uncommon Adverse Effects (may affect up to 1 in 100 patients)

• Heart problems, including heart attack, angina pectoris
• Severe nerve inflammation, which can cause paralysis and breathing difficulties (Guillain-Barré syndrome)
• Flushing
• Discoloration of the veins
• Inflammation of the spinal nerves
• Ear problems, ear bleeding
• Underactive thyroid gland
• Budd-Chiari syndrome (clinical symptoms caused by obstruction of the hepatic veins)
• Changes or anomalies in intestinal function
• Cerebral hemorrhage
• Yellowing of the eyes and skin (jaundice)
• Severe allergic reaction (anaphylactic shock), whose signs can be difficulty breathing, pain or oppression in the chest and/or feeling of dizziness/fainting, intense itching of the skin or skin bumps, swelling of the face, lips, tongue, and/or throat, which can cause difficulty swallowing, collapse
• Breast disorders
• Vaginal tear
• Inflammation of the genitals
• Inability to tolerate alcohol consumption
• Emaciation or loss of body mass
• Increased appetite
• Fistula
• Joint effusion (fluid accumulation in a joint)
• Cysts in the joint lining (synovial cysts)
• Fracture
• Breakdown of muscle fibers that can cause other complications
• Liver swelling, liver bleeding
• Kidney cancer
• Skin disease similar to psoriasis
• Skin cancer
• Pallor of the skin
• Increased 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 total loss of vision
• Loss of libido
• Drooling
• Bulging eyes
• Sensitivity to light
• Rapid breathing
• Rectal pain
• Gallstones
• Hernia
• Wounds
• Weak or brittle nails
• Abnormal protein deposits in vital organs
• Coma
• Intestinal ulcers
• Multi-organ failure
• Death

Rare Adverse Effects (may affect up to 1 in 1,000 patients)

• Heart problems, including heart attack, angina pectoris
• Severe nerve inflammation, which can cause paralysis and breathing difficulties (Guillain-Barré syndrome)
• Flushing
• Discoloration of the veins
• Inflammation of the spinal nerves
• Ear problems, ear bleeding
• Underactive thyroid gland
• Budd-Chiari syndrome (clinical symptoms caused by obstruction of the hepatic veins)
• Changes or anomalies in intestinal function
• Cerebral hemorrhage
• Yellowing of the eyes and skin (jaundice)
• Severe allergic reaction (anaphylactic shock), whose signs can be difficulty breathing, pain or oppression in the chest and/or feeling of dizziness/fainting, intense itching of the skin or skin bumps, swelling of the face, lips, tongue, and/or throat, which can cause difficulty swallowing, collapse
• Breast disorders
• Vaginal tear
• Inflammation of the genitals
• Inability to tolerate alcohol consumption
• Emaciation or loss of body mass
• Increased appetite
• Fistula
• Joint effusion (fluid accumulation in a joint)
• Cysts in the joint lining (synovial cysts)
• Fracture
• Breakdown of muscle fibers that can cause other complications
• Liver swelling, liver bleeding
• Kidney cancer
• Skin disease similar to psoriasis
• Skin cancer
• Pallor of the skin
• Increased 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 total loss of vision
• Loss of libido
• Drooling
• Bulging eyes
• Sensitivity to light
• Rapid breathing
• Rectal pain
• Gallstones
• Hernia
• Wounds
• Weak or brittle nails
• Abnormal protein deposits in vital organs
• Coma
• Intestinal ulcers
• Multi-organ failure
• Death

If you are administered bortezomib along with other medicines for the treatment of mantle cell lymphoma, the adverse effects you may experience are included below:

Very Common Adverse Effects (may affect more than 1 in 10 patients)

• 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
• Sores in the mouth
• 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 patients)

• Herpes zoster (localized, including around the eyes or spread throughout the body)
• Herpes virus infection
• Bacterial and viral infections
• Respiratory infections, bronchitis, cough with phlegm, flu-like illness
• Fungal infections
• Allergic reaction (hypersensitivity)
• Inability to produce sufficient insulin or resistance to normal insulin levels
• Fluid retention
• Difficulty or problems sleeping
• Loss of consciousness
• Alteration of consciousness level, 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 when standing, which could lead to fainting
• Difficulty breathing when exercising
• Cough
• Hiccup
• Ringing in the ears, ear discomfort
• Intestinal or stomach bleeding
• Heartburn
• Stomach pain, bloating
• Difficulty swallowing
• Infection or inflammation of the stomach and intestines
• Stomach pain
• Sores in the mouth or lip, sore throat
• Alteration of liver function
• Itching of the skin
• Redness of the skin
• Rash
• Muscle spasms
• Urinary tract infections
• Pain in the limbs
• Swelling of the body, including around the eyes and in other parts of the body
• Chills
• Redness and pain at the injection site
• Feeling of general discomfort
• Weight loss
• Weight gain

Uncommon Adverse Effects (may affect up to 1 in 100 patients)

• Hepatitis
• Severe allergic reaction (anaphylactic reaction), whose signs can be difficulty breathing, pain or oppression in the chest and/or feeling of dizziness/fainting, intense itching of the skin or skin bumps, swelling of the face, lips, tongue, and/or throat, which can cause difficulty swallowing, collapse
• Movement disorders, paralysis, tremors
• Dizziness
• Hearing loss, deafness
• Disorders affecting the lungs, preventing the body from receiving sufficient oxygen. Some of these are difficulty breathing, shortness of breath, shortness of breath without exercise, breathing that can become shallow, difficult, or stop, rapid breathing
• Blood clots in the lungs
• Yellowing of the eyes and skin (jaundice)
• Cyst in the eyelid (chalazion), eyelids reddened and swollen

Rare Adverse Effects (may affect up to 1 in 1,000 patients)

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

Reporting of Adverse Effects

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

5. Storage of Bortezomib Qilu

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

Do not use this medicine after the expiration date that appears on the vial and on the box after CAD. The expiration date is the last day of the month indicated.

Store in the refrigerator (between 2°C and 8°C). Keep the vial in the outer packaging to protect it from light.

The diluted solution should be used immediately after preparation. If the diluted solution is not used immediately, the storage times and conditions before use are the responsibility of the user. In any case, the diluted solution is physically and chemically stable for 28 days when stored between 2 and 8°C protected from light, 7 days when stored at 25°C protected from light, or 24 hours when stored at 25°C (in normal indoor lighting conditions) in the original vial or in a polypropylene syringe.

Regarding stability within the vial or syringe, the same storage times apply to the diluted solution and the undiluted solution.

This medicine is for single use. The disposal of unused medicine and all materials that have come into contact with it will be carried out in accordance with local regulations.

6. Container Contents and Additional Information

Composition of Bortezomib Qilu

• The active ingredient is bortezomib. Each vial contains 3.5 mg of bortezomib (as boronic acid ester of mannitol).
• The other components (excipients) are: mannitol (E421), sodium chloride, and water for injectable preparations.

Appearance of Bortezomib Qilu and Container Contents

Bortezomib Qilu injectable solution is a clear, colorless to pale yellow solution.

A 10 ml glass vial closed with a gray rubber stopper and an aluminum and blue plastic cap containing 1.4 ml of solution.

Container Sizes

1 vial of 1.4 ml

4 vials of 1.4 ml

Only some container sizes may be marketed.

Marketing Authorization Holder

Qilu Pharma Spain S.L.

Paseo Castellana 40, 8th floor

Madrid

Spain

Manufacturer

KYMOS, S.L.

Ronda de Can Fatjó, 7B (Parque Tecnológico del Vallès)

Cerdanyola del Vallès, 08290 Barcelona

Spain

or

Eurofins Analytical Services Hungary Kft.

1045 Budapest, Anonymus u. 6.

Hungary

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Germany: Bortezomib Qilu 2.5 mg/ml Injektionslösung

Spain: Bortezomib Qilu 2.5 mg/ml solution for injection

France: BORTEZOMIB QILU 2.5 mg/ml solution injectable

Italy: Bortezomib Qilu

Date of revision of this leaflet:09/2023

Other sources of information

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

The following information is intended for healthcare professionals only:

Note: Bortezomib Qilu 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. Pregnant women who are part of the staff should not handle this medicinal product.

AS BORTEZOMIB QILU DOES NOT CONTAIN PRESERVATIVES, IT IS RECOMMENDED TO STRICTLY FOLLOW ASEPTIC TECHNIQUE DURING ITS HANDLING.

Bortezomib Qilu 2.5 mg/ml solution for injection IS FOR SUBCUTANEOUS OR INTRAVENOUS ADMINISTRATION. It should not be administered by other routes. Administration by the intrathecal route has resulted in death.

1. PREPARATION FOR INTRAVENOUS INJECTION

1.1 Preparation of a 3.5 mg/1.4 ml vial: add 2.3 mlof sodium chloride 9 mg/ml (0.9%) injectable solution to the vial containing bortezomib.

Each vial contains an additional excess of 0.15 ml. Consequently, each 1.4 ml vial contains 3.875 mg of bortezomib, respectively.

The concentration of the resulting solution will be 1 mg/ml. The solution should be clear and colorless.

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

The diluted solution does not contain preservatives and should be used immediately after preparation. In any case, its chemical and physical stability has been demonstrated after the first opening and/or dilution, for 28 days between 2 and 8 °C protected from light, 7 days at 25 °C protected from light, or 24 hours at 25 °C under normal indoor lighting conditions when stored in the original vial or in a polypropylene syringe.

From a microbiological point of view, unless the opening and/or dilution method excludes the risk of microbial contamination, the product should be used immediately. If it is not used immediately, the in-use storage times and conditions are the responsibility of the user.

During preparation for administration and during administration itself, it is not necessary to protect the medicinal product from light.

1. ADMINISTRATION OF INTRAVENOUS INJECTION

1. After dilution, extract the appropriate amount of diluted solution according to the calculated dose based on the patient's body surface area.

1. Confirm the dose and concentration contained in the syringe before use (verify that the syringe is marked for intravenous use).

1. Inject the solution through a peripheral or central intravenous catheter in a vein using a bolus injection of 3 to 5 seconds.

1. Flush the peripheral or intravenous catheter with sodium chloride 9 mg/ml (0.9%) solution.

1. PREPARATION FOR SUBCUTANEOUS INJECTION

1. Bortezomib injectable solution is ready for use by the subcutaneous route.

The concentration of the solution is 2.5 mg/ml. The solution is clear and colorless to pale yellow.

1. Before administration, visually inspect the solution to rule out the presence of particles and discoloration. If any discoloration or particles are observed, the solution should be discarded. Check that the correct dose is being used for subcutaneous administration (2.5 mg/ml).

1. The product does not contain preservatives and should be used immediately after extracting the appropriate amount of solution from the vial.

1. During preparation for administration or during administration itself, it is not necessary to protect the medicinal product from light.

1. ADMINISTRATION OF SUBCUTANEOUS INJECTION

1. Extract the appropriate amount of solution according to the calculated dose based on the patient's body surface area.

1. Confirm the dose and concentration contained in the syringe before use (verify that the syringe is marked for subcutaneous use).

1. Inject the solution subcutaneously at an angle of 45°-90°.

1. The solution is administered subcutaneously in the thighs (right or left) or in the abdomen (right or left).

1. The injection sites should be rotated for subsequent injections.

1. In the event of a reaction at the injection site after subcutaneous administration of bortezomib injectable, a solution of bortezomib with a lower concentration (1 mg/ml instead of 2.5 mg/ml) may be administered subcutaneously, or alternatively, it is recommended to switch to intravenous injection.

1. DISPOSAL

A vial is for single use and the remaining solution should be discarded.

Disposal of unused medicinal products or all residual materials should be carried out in accordance with local regulations.