Prospect: information for the user

Bortezomib Fresenius Kabi 2.5 mg powder for injection EFG

Bortezomib Fresenius Kabi 3.5 mg powder for injection EFG

bortezomib

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 read it again.
• If you have any questions, consult your doctor or pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

This medication contains the active ingredient bortezomib, a “proteasome inhibitor”.Proteasomes play an important role in controlling the functioning and growth of cells. Bortezomib can destroy cancer cells, interfering with their functioning.

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

• alone or in combination with pegylated liposomal doxorubicin or dexamethasone, for patients whose disease is worsening (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 melphalan and prednisone, for patients whose disease has not been previously treated and is not suitable to receive high doses of chemotherapy prior to a stem cell transplant.
• in combination with dexamethasone or dexamethasone together with thalidomide, in patients whose disease has not been previously treated and who receive high doses of chemotherapy prior to a stem cell transplant (induction treatment).

Bortezomib is used in the treatment of mantle cell lymphoma (a type of cancer that affects lymph nodes) in patients 18 years of age or older in combination with 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.

No use bortezomib

Warnings and precautions

Inform your doctor if you experience the following:

• low red or white blood cell count
• bleeding problems and/or low platelet count in the blood
• diarrhea, constipation, nausea, or vomiting
• history of fainting, dizziness, or drowsiness
• kidney problems
• mild 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 (including around the eyes or spread across the body)
• symptoms of tumor lysis syndrome, such as muscle cramps, muscle weakness, confusion, vision loss or changes, and difficulty breathing
• memory loss, thought changes, difficulty walking, or vision loss. These may be signs of a severe brain infection, and your doctor may recommend further testing and follow-up.

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

Inform your doctor if you have multiple myeloma and are receiving rituximab in combination with bortezomib:

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

Before starting treatment with bortezomib, read the prospectuses of all medications you are taking in combination with bortezomib to consult the information related to these medications.

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

Children and adolescents

Bortezomib should not be used in children and adolescents because its effects on them are unknown.

Use of bortezomib with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take other medications.

Particularly, inform your doctor if you are using medications that contain any of the following active ingredients:

• 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 to treat depression or other conditions
• oral antidiabetic medications

Pregnancy and breastfeeding

You should not use this medication if you are pregnant unless it is clearly necessary.

Women of childbearing age should use effective contraception during treatment and for up to 8 months after completing it. Talk to your doctor if you want to freeze your eggs before starting treatment.

Men should not father a child while using bortezomib and should use effective contraception during treatment and for up to 5 months after completing it. Talk to your doctor if you want to preserve your sperm before starting treatment.

You should not breastfeed while using bortezomib. Consult your doctor when it is safe to resume breastfeeding after completing your treatment.

Thalidomide causes birth defects and fetal death. When bortezomib is administered in combination with thalidomide, follow the thalidomide pregnancy prevention program (see the thalidomide prospectus).

Driving and operating machinery

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 be cautious.

Your doctor will tell you the dose of bortezomib based on your height and weight (body surface area). The usual starting dose of bortezomib is 1.3 mg/m2of 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 appearance 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 (3-week) period corresponds to a treatment cycle. You may receive up to 8 cycles (24 weeks).

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

When bortezomib is given along with pegylated liposomal doxorubicin, you will receive bortezomib by intravenous or subcutaneous injection in a 21-day treatment cycle, and pegylated liposomal doxorubicin 30 mg/m2is administered on day 4 of the bortezomib 21-day treatment cycle by intravenous infusion after the bortezomib injection.

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

When bortezomib is given along with dexamethasone, you will receive bortezomib by intravenous or subcutaneous injection in a 21-day treatment cycle, and dexamethasone 20 mg is administered orally on days 1, 2, 4, 5, 8, 9, 11, and 12 of the bortezomib 21-day treatment cycle.

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

Untreated multiple myeloma

If you have not been treated for multiple myeloma before andare nota candidate to receive a blood stem cell transplant, you will receive bortezomib along with two other medications; melphalan and prednisone.

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

• In cycles 1 to 4, bortezomib is administered twice a week on days 1, 4, 8, 11, 22, 25, 29, and 32.
• In cycles 5 to 9, bortezomib is administered once a week on days 1, 8, 22, and 29.

Melphalan (9 mg/m2) and prednisone (60 mg/m2) are administered orally during days 1, 2, 3, and 4 of the first week of each cycle.

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

When bortezomib is given along with dexamethasone, you will receive bortezomib by intravenous or subcutaneous injection in a 21-day treatment cycle, and dexamethasone is administered orally in doses of 40 mg on days 1, 2, 3, 4, 8, 9, 10, and 11 of the bortezomib 21-day treatment cycle.

You will receive 4 cycles (12 weeks).

When bortezomib is given along 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 bortezomib 28-day treatment cycle, and thalidomide is administered orally once a day in doses of 50 mg until day 14 of the first cycle, and if tolerated, the thalidomide dose is increased to 100 mg on days 15-28, and from the second cycle and onwards, it may be increased further to 200 mg daily. You may receive up to 6 cycles (24 weeks).

Untreated mantle cell lymphoma

If you have not been treated before for mantle cell lymphoma, you will receive bortezomib by intravenous or subcutaneous injection along with the medications rituximab, cyclophosphamide, doxorubicin, and prednisone.

Bortezomib is administered by intravenous or subcutaneous injection 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 medications are administered by intravenous infusion on day 1 of the bortezomib 21-day treatment cycle:

Rituximab in doses of 375 mg/m2, cyclophosphamide in doses of 750 mg/m2, and doxorubicin in doses of 50 mg/m2.

Prednisone is administered orally in doses of 100 mg/m2on days 1, 2, 3, 4, and 5 of the bortezomib treatment cycle.

How bortezomib is administered

This medication is administered by intravenous or subcutaneous injection. You will receive bortezomib from a healthcare professional experienced in the use of cytotoxic medications.

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

If you receive more bortezomib than you should

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

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

If you are given bortezomib for multiple myeloma or mantle cell lymphoma, tell your doctor right away if you notice any of the following symptoms:

Bortezomib treatment can cause a very frequent decrease in the number of red and white blood cells and platelets in the blood. Therefore, regular blood tests will be performed before and during bortezomib treatment to regularly check your blood cell count. You may experience a reduction in the number of:

If you are given bortezomib for multiple myeloma treatment, the side effects you may experience are listed below:

Very common side effects (may affect more than 1 in 10 patients)

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

Common side effects (may affect up to 1 in 10 patients)

• Low blood pressure, sudden drop in blood pressure when standing, which could lead to dizziness
• High blood pressure
• Decreased kidney function
• Headache
• General feeling of discomfort, pain, dizziness, weakness or loss of consciousness
• Chills
• Infections, including pneumonia, respiratory infections, bronchitis, fungal infections, coughs with mucus, flu-like illness
• Herpes zoster (localized including around the eyes or extended over the body)
• Chest pain or difficulty breathing during exercise
• Different types of rashes
• Itching skin, skin lumps or dry skin
• Facial flushing or small blood vessel rupture
• Redness of the skin
• Dehydration
• Heartburn, swelling, belching, flatulence, stomach pain, intestinal or stomach bleeding
• Alteration of liver function
• Mouth or lip sores, dry mouth, mouth ulcers or throat pain
• Weight loss, loss of taste
• Muscle cramps, muscle spasms, muscle weakness, pain in the limbs
• Blurred vision
• Conjunctivitis (infection of the outer layer of the eye and the inner surface of the eyelids)
• Nasal bleeding
• 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

Rare side effects (may affect up to 1 in 100 patients)

• Heart failure, heart attack, chest pain, chest discomfort, increased or decreased heart rate
• Renal failure
• Vein inflammation, blood clots in veins and lungs
• Blood clotting problems
• Poor circulation
• Pericarditis (inflammation of the heart lining) or fluid around the heart
• Infections, including urinary tract infections, flu, herpes virus infection, ear infections, and cellulitis
• Membranous mucosal bleeding or hemorrhages, for example, in the mouth or vagina
• Cerebrovascular disorders
• Paralysis, seizures, falls, movement disorders, changes or decreases in sensitivity (touch, hearing, taste, smell), attention disorders, tremors, twitching
• Arthritis, including inflammation of the joints of the fingers of the hands and feet and jaw
• Lung disorders, preventing the body from receiving a sufficient amount of oxygen. Some of them are difficulty breathing, shortness of breath, shortness of breath without exercise, shallow, difficult or stopping breathing, rapid breathing
• Hypophonia, speech disorders
• Decreased or increased urine production (due to renal damage), pain while urinating or blood/protein in the urine, fluid retention
• Alteration of consciousness, confusion, alteration or loss of memory
• Hypersensitivity
• Loss of hearing, deafness or tinnitus, ear discomfort
• Alterations in hormone levels that may affect salt and water absorption
• Hyperthyroidism
• Inability to produce sufficient insulin or resistance to normal insulin levels
• Irritation or inflammation of the eyes, too moist eyes, eye pain, dry eyes, eye infections, chalazion (cyst on the eyelid), eyelid redness and swelling, watery eyes (lacrimation), abnormal vision, eye hemorrhage
• Swollen lymph nodes
• Joint or muscle stiffness, feeling of heaviness, pain in the groin
• Loss of hair and abnormal hair texture
• Allergic reactions
• Redness or pain at the injection site
• Mouth pain
• Mouth or lip sores, mouth dryness, mouth ulcers, esophageal, stomach, or intestinal ulcers, associated with pain or bleeding, slow intestinal movement (including obstruction), abdominal or esophageal discomfort, difficulty swallowing, vomiting blood
• Skin infections
• Bacterial and viral infections
• Dental infections
• Pancreatitis, bile duct obstruction
• Genital pain, erectile dysfunction
• Weight gain
• Thirst
• Hepatitis
• Disorders at the injection site or related to the injection device
• Severe skin reactions (life-threatening), skin ulcers
• Bruises, falls, and wounds
• Inflammation or bleeding of small blood vessels that may appear as small red or purple spots (usually on the legs) to large patches similar to bruises under the skin or tissue.
• Benign cysts
• A severe and reversible brain disorder that includes seizures, high blood pressure, headaches, fatigue, confusion, blindness, or other vision problems.

Rare side effects (may affect up to 1 in 1,000 patients)

• Heart problems, including heart attack, angina
• Severe nerve inflammation, which can cause paralysis and difficulty breathing (Guillain-Barré syndrome)
• Flushing
• Vein discoloration
• Spinal nerve inflammation
• Ear problems, ear hemorrhage
• Decreased thyroid activity
• Budd-Chiari syndrome (clinical symptoms caused by obstruction of the hepatic veins)
• Changes or abnormalities in intestinal function
• Brain hemorrhage
• Yellow discoloration of the eyes and skin (jaundice)
• Severe allergic reaction (anaphylactic shock), whose signs may be difficulty breathing, chest pain or tightness, and/or dizziness/dizziness, intense itching skin or skin lumps, facial swelling, lips, tongue, and/or throat swelling, which may cause difficulty swallowing, collapse
• Mastitis
• Vaginal rupture
• Genital inflammation
• Inability to tolerate alcohol consumption
• Emaciation or loss of body mass
• Increased appetite
• Fistula
• Joint effusion
• Benign synovial cysts
• Fracture
• Disintegration of muscle fibers that causes other complications
• Swelling of the liver, liver hemorrhage
• Renal cancer
• Skin condition similar to psoriasis
• Skin cancer
• Pale skin
• Increased platelets or plasma cells (a type of white blood cell) in the blood
• Blood clot in small blood vessels (microangiopathy)
• Abnormal reaction to blood transfusions
• Partial or complete loss of vision
• Loss of libido
• Halitosis
• Protruding eyes
• Photophobia
• Accelerated breathing
• Rectal pain
• Bile stones
• Hernia
• Wounds
• Weak or brittle nails
• Anomalous protein deposits in vital organs
• Coma
• Intestinal ulcers
• Multi-organ failure Death

If you are given bortezomib together with other medicines for the treatment of mantle cell lymphoma, the side effects you may experience are listed below:

Very common side 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 the hands or feet due to nerve damage
• Nausea or vomiting
• Diarrhea
• Mouth ulcers
• Constipation
• Muscle pain, bone pain
• Loss of hair and abnormal hair texture
• Exhaustion, feeling weak
• Fever

Common side effects (may affect up to 1 in 10 patients)

• Herpes zoster (localized including around the eyes or extended over the body)
• Herpes virus infection
• Bacterial and viral infections
• Respiratory infections, bronchitis, coughs with mucus, flu-like illness
• Fungal infections
• Hypersensitivity (allergic reaction)
• Inability to produce sufficient insulin or resistance to normal insulin levels
• Fluid retention
• Difficulty or problems sleeping
• Loss of consciousness
• Alteration 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 when standing, which could lead to dizziness
• Difficulty breathing during exercise
• Coughs
• Hypophonia
• Tinnitus, ear discomfort
• Intestinal or stomach bleeding
• Heartburn
• Abdominal or esophageal discomfort
• Difficulty swallowing
• Intestinal or stomach infection or inflammation
• Abdominal pain
• Lip or mouth sores, throat pain
• Alteration of liver function
• Itching skin
• Redness of the skin
• Rashes
• 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
• General feeling of discomfort
• Weight loss
• Weight gain

Rare side effects (may affect up to 1 in 100 patients)

• Hepatitis
• Severe allergic reaction (anaphylactic reaction), whose signs may be difficulty breathing, chest pain or tightness, and/or dizziness/dizziness, intense itching skin or skin lumps, facial swelling, lips, tongue, and/or throat swelling, which may cause difficulty swallowing, collapse
• Movement disorders, paralysis, twitching
• Dizziness
• Loss of hearing, deafness
• Lung disorders, preventing the body from receiving a sufficient amount of oxygen. Some of them are difficulty breathing, shortness of breath, shortness of breath without exercise, shallow, difficult or stopping breathing, rapid breathing
• Blood clots in the lungs
• Yellow discoloration of the eyes and skin (jaundice)
• Chalazion (cyst on the eyelid), eyelid redness and swelling

Rare side effects (may affect up to 1 in 1,000 patients)

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

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through thenational notification system included in theAppendix V.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 vial and on the packaging after CAD.

This medication does not require special storage conditions in terms of temperature. Store the vial in the outer packaging to protect it from light.

The chemical and physical stability of the reconstituted solution has been demonstrated at concentrations of 1 mg/ml and 2.5 mg/ml for 96 hours at 25 °C and 8 days at 2-8 °C, when stored in the original syringe and/or vial.

From a microbiological point of view, the product must be used immediately after preparation. If not used immediately, the storage times under use conditions and the previous use conditions will be the responsibility of the user. The total storage time of the reconstituted medication should not exceed 96 hours (if stored at 25 °C) and 8 days (if stored at 2-8 °C) before administration.

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

Composition of Bortezomib Fresenius Kabi

Bortezomib Fresenius Kabi 2.5 mg powder for injection

Each vial contains 2.5 mg of bortezomib (as mannitol borate ester).

Bortezomib Fresenius Kabi 3.5 mg powder for injection

Each vial contains 3.5 mg of bortezomib (as mannitol borate ester).

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 package

Bortezomib powder for injection is a lyophilized powder or paste of white or off-white color.

Bortezomib Fresenius Kabi 2.5 mg powder for injection

Each package of Bortezomib Fresenius Kabi 2.5 mg powder for injection contains a transparent glass vial of 10 ml with a grey rubber stopper and a yellow aluminum flip-off cap, containing 2.5 mg of bortezomib.

Bortezomib Fresenius Kabi 3.5 mg powder for injection

Each package of Bortezomib Fresenius Kabi 3.5 mg powder for injection contains a transparent glass vial of 10 ml with a grey rubber stopper and a blue aluminum flip-off cap, containing 3.5 mg of bortezomib.

The vial is presented wrapped in a retractable sleeve (without tray) or in a tray with a lid. Each box contains 1 single-use vial.

Marketing Authorization Holder

Fresenius Kabi Deutschland GmbH Else-Kröner-Straße 1,

61352 Bad Homburg v.d.Höhe Germany

ManufacturerFresenius Kabi Deutschland GmbH Pfingstweide 53

61169 Friedberg, Germany

Or

Fresenius Kabi Polska Sp. z.o.o., ul. Sienkiewicza 25, Kutno,

99-300, Poland

For more information about this medication, please contact the Marketing Authorization Holder.

Last review date of this leaflet:

Other sources of information

The detailed information about this medication is available on the European Medicines Agency website:http://www.ema.europa.eu.

This information is intended only for healthcare professionals:

1.RECONSTITUTION FOR INTRAVENOUS INJECTION

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

BORTEZOMIB DOES NOT CONTAIN PRESERVATIVES AND THEREFORE IT IS RECOMMENDED TO FOLLOW STRICT ASPTIC TECHNIQUE DURING ITS HANDLING.

1.1Preparation of a 2.5 mg vial: add carefully 2.5 mlof sterile 0.9% sodium chloride injection solution to the vial containing the bortezomib powder using a suitable syringe without removing the stopper from the vial. The dissolution of the lyophilized powder is completed in less than 2 minutes.

Preparation of a 3.5 mg vial: add carefully 3.5 mlof sterile 0.9% sodium chloride injection solution to the vial containing the bortezomib powder using a suitable syringe without removing the stopper from the vial. The dissolution of the lyophilized powder is completed in less than 2 minutes.

The resulting solution concentration will be 1 mg/ml. The solution must be colorless and transparent, with a final pH of 4 to 7. It is not necessary to check the pH of the solution.

From a microbiological point of view, the reconstituted product must be used immediately after preparation. If not used immediately, the storage times in use conditions and the previous use conditions will be the responsibility of the user. The total storage time of the reconstituted medication should not exceed 96 hours (if stored at 25°C) and 8 days (if stored at 2-8°C) before administration.

No protection of the reconstituted product from light is necessary.

4.ADMINISTRATION

Bortezomib Fresenius Kabi 2.5 mg and 3.5 mg MUST BE ADMINISTERED ONLY BY INTRAVENOUS OR SUBCUTANEOUS ROUTE. Do not administer by other routes. Intrathecal administration has caused cases of death.

1. ELIMINATION

One vial is for single use and the remaining solution must be discarded.

The elimination of unused medication and all materials that have come into contact with it will be carried out in accordance with local regulations.

The following information is intended only for healthcare professionals:

Only the 2.5 mg and 3.5 mg vials can be administered subcutaneously, as described below.

1.RECONSTITUTION FOR SUBCUTANEOUS INJECTION

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

BORTEZOMIB DOES NOT CONTAIN PRESERVATIVES. AND THEREFORE IT IS RECOMMENDED TO FOLLOW STRICT ASPTIC TECHNIQUE DURING ITS HANDLING.

Preparation of a 3.5 mg vial: add carefully 1.4 mlof sterile 0.9% sodium chloride injection solution to the vial containing the bortezomib powder using a suitable syringe without removing the stopper from the vial. The dissolution of the lyophilized powder is completed in less than 2 minutes.

The resulting solution concentration will be 2.5 mg/ml. The solution must be colorless and transparent, with a final pH of 4 to 7. It is not necessary to check the pH of the solution.

From a microbiological point of view, the reconstituted product must be used immediately after preparation. If not used immediately, the storage times in use conditions and the previous use conditions will be the responsibility of the user. The total storage time of the reconstituted medication should not exceed 96 hours (if stored at 25°C) and 8 days (if stored at 2-8°C) before administration.

No protection of the reconstituted product from light is necessary.

2.ADMINISTRATION

• Once dissolved, remove the appropriate amount of the reconstituted solution according to the calculated dose based on the patient's Body Surface Area.
• Confirm the dose and concentration contained in the syringe before use (check that the syringe is marked 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 in the abdomen (right or left side).
• The administration sites should be rotated with each injection.
• If local reactions occur at the injection site after subcutaneous injection of bortezomib, or a less concentrated solution of bortezomib (1 mg/ml instead of 2.5 mg/ml) can be administered subcutaneously, or it is recommended to change to intravenous injection.

Bortezomib Fresenius Kabi 2.5 mg and 3.5 mg MUST BE ADMINISTERED ONLY BY INTRAVENOUS OR SUBCUTANEOUS ROUTE. Do not administer by other routes. Intrathecal administration has caused cases of death.

1. ELIMINATION

One vial is for single use and the remaining solution must be discarded.

The elimination of unused medication and all materials that have come into contact with it will be carried out in accordance with local regulations.