Prospecto: information for the user

Bortezomib Baxter 3.5 mg powder for injectable solution EFG

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 doubts, consult your doctor or pharmacist.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

Content of the prospect:

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

2.What you need to know before starting to use Bortezomib Baxter

3.How to use Bortezomib Baxter

4.Possible adverse effects

5.Storage of Bortezomib Baxter

6.Contents of the package and additional information

Bortezomib Baxter 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 in whom a stem cell transplant is not considered suitable.

No use Bortezomib Baxter

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

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
• 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
• Herpes zoster (including around the eyes or spread across the body)
• Symptoms of tumor lysis syndrome, such as muscle cramps, muscle weakness, confusion, loss or changes in vision, and difficulty breathing
• Memory loss, changes in thought, difficulty walking, or loss of vision. 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 hepatitis in the past. 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 any 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 given 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.

Other Medications and Bortezomib Baxter

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 bortezomib if you are pregnant unless it is clearly necessary.

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

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 Machines

Bortezomib may cause fatigue, dizziness, fainting, or blurred vision. Do not drive or operate tools or machines 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 bortezomiv is 1.3 mg/m2of body surface area twice a week.

Your doctor may change the dose and the total number of treatment cycles based 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 Bortezomiv intravenously or subcutaneously 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 bortezomiv along with the medications doxorubicin liposomal pegylated or dexamethasone.

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

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

When bortezomiv is given along with dexamethasone, you will receive bortezomiv intravenously or subcutaneously 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 21-day bortezomiv 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 bortezomiv 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, bortezomiv is administered twice a week on days 1, 4, 8, 11, 22, 25, 29, and 32.
• In cycles 5 to 9, bortezomiv 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 bortezomiv intravenously or subcutaneously along with the medications dexamethasone, or dexamethasone and thalidomide, as induction treatment.

When bortezomiv is given along with dexamethasone, you will receive bortezomiv intravenously or subcutaneously 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 21-day bortezomiv treatment cycle.

You will receive 4 cycles (12 weeks).

When bortezomiv 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 28-day bortezomiv 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 bortezomiv intravenously or subcutaneously along with the medications rituximab, cyclophosphamide, doxorubicin, and prednisone.

Bortezomiv 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 medications are administered via intravenous infusion on day 1 of the 21-day bortezomiv 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 21-day bortezomiv treatment cycle.

How Bortezomiv Baxter is administered

This medication is administered intravenously or subcutaneously. You will receive bortezomiv from a healthcare professional experienced in the use of cytotoxic medications.

The bortezomiv powder must be dissolved before administration. This will be done by a healthcare professional. The reconstituted solution is injected afterwards 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 Bortezomiv Baxter 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:

• 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, dizziness
• Coughs and difficulty breathing or chest tightness.

Treatment with bortezomib 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 treatment with bortezomib to regularly check your blood cell count. You may experience a reduction in the number of:

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

If you are given bortezomib for the treatment of multiple myeloma, 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
• Reduction in the number of red and/or 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 of weakness
• 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, feeling of 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 while exercising
• Different types of rashes
• Itching skin, skin lumps or dry skin
• Facial flushing or small blood vessel rupture
• Facial redness
• Dehydration
• Heartburn, swelling, belching, flatulence, stomach pain, intestinal or stomach bleeding
• Liver function alteration
• Mouth or lip sores, dry mouth, mouth ulcers or throat pain
• Weight loss, loss of taste
• Muscle cramps, muscle spasms, muscle weakness, limb pain
• Blurred vision
• Conjunctivitis (infection of the outermost layer of the eye and the inner surface of the eyelids)
• Nasal hemorrhages
• 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
• Kidney 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
• Mucous membrane 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, shakiness
• 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 kidney damage), pain while urinating or blood/protein in the urine, fluid retention
• Alteration of the level of consciousness, confusion, alteration or loss of memory
• Hypersensitivity
• Loss of hearing, deafness or ringing in the ears, ear discomfort
• Hormonal alterations 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), red and swollen eyelids, 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 or throat pain
• Infections or inflammation of the mouth, ulcers in the mouth, esophagus, stomach, and intestines, sometimes 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 hematomas 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 bumps, 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
• Myopathy, which causes other complications
• Swelling of the liver, liver hemorrhage
• Renal cancer
• Dermatological condition similar to psoriasis
• Skin cancer
• Pale skin
• Increased platelets or plasma cells (a type of white blood cell) in the blood
• Blood clots in small blood vessels (microangiopathy)
• Abnormal reaction to blood transfusions
• Partial or total loss of vision
• Loss of libido
• Exophthalmos
• Photophobia
• Accelerated breathing
• Rectal pain
• Biliary calculi
• Hernia
• Wounds
• Weak or brittle nails
• Anomalous protein deposits in vital organs
• Coma
• Intestinal ulcers
• Multi-organ failure
• Death

If you are given bortezomib along 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 of weakness
• 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 the 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 when standing, which could lead to dizziness
• Difficulty breathing while exercising
• Coughs
• Hypophonia
• Ringing in the ears, ear discomfort
• Intestinal or stomach bleeding
• Heartburn
• Abdominal or esophageal discomfort
• Difficulty swallowing
• Infection or inflammation of the stomach and intestines
• Abdominal pain
• Lip or mouth sores, throat pain
• Liver function alteration
• Itching skin
• Facial redness
• Rash
• Muscle spasms
• Urinary tract infections
• Limb pain
• 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 bumps, facial swelling, lips, tongue, and/or throat swelling, which may cause difficulty swallowing, collapse
• Movement disorders, paralysis, shakiness
• 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), red and swollen eyelids

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

• Blood clots 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 the Spanish System for the 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 vial and on the packaging after CAD.

This medication does not requireanyspecialtemperatureconservation.

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

Reconstituted solution

Do not refrigerate.

Chemical and physical stability has been demonstrated for use during 8 hours at 25°C.

From a microbiological standpoint, unless the opening method avoids the risk of microbial contamination, the reconstituted product should be used immediately. If not used immediately, the storage times and conditions after reconstitution are the responsibility of the user.

Bortezomib Baxter 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 Baxter

• The active ingredient is bortezomib. Each vial contains 3.5 milligrams of bortezomib (as boric acid mannitol ester).
• The other component is mannitol (E421).

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 Baxter lyophilized powder for injection is a white or off-white paste or powder.

Each package of Bortezomib Baxter 3.5 mg lyophilized powder for injection EFG contains a 10 ml glass vial with a grey rubber stopper and aluminum seal, with a removable orange cap and a silver pressure stopper. The vial contains 3.5 mg of bortezomib. Each package contains a single-use vial.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Baxter Holding B.V.

Kobaltweg 49, 3542 CE

Utrecht, Netherlands

Responsible for manufacturing

Baxter Oncology GmbH

Kantstraße 2

33790 Halle/Westfalen

Germany

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

Baxter, S.L.

Polígono Industrial Sector 14

C/Pouet de Camilo, 2

46394 Ribarroja del Turia (Valencia)

Spain

This medicine is authorized in the member states of the European Economic Area and in the United Kingdom (Northern Ireland) with the following names:

Germany: Bortezomib Baxter 3.5 mg, Pulver zur Herstellung einer Injektionslösung

Netherlands: Bortezomib Baxter 3.5 mg poeder voor oplossing voor injectie

United Kingdom (Northern Ireland): Bortezomib 3.5 mg powder for solution for injection

France: Bortezomib Baxter 3.5 mg, poudre pour solution injectable

Spain: Bortezomib Baxter 3.5 mg polvo para solución inyectable EFG

Italy: Bortezomib Baxter

Sweden: Bortezomib Baxter

Norway: Bortezomib Baxter

Finland: Bortezomib Baxter

Denmark: Bortezomib Baxter

Ireland: Bortezomib 3.5 mg powder for solution for injection

Belgium: Bortezomib Baxter 3.5 mg poudre pour solution injectable

Portugal: Bortezomib Baxter

Greece: Bortezomib/Baxter 3.5 mgκ?νιςγιαεν?σιμοδι?λυμα

Luxembourg: Bortezomib Baxter 3.5 mg poudre pour solution injectable

Austria: Bortezomib Baxter 3.5 mg Pulver zur Herstellung einer Injektionslösung

Cyprus: Bortezomib/Baxter 3.5 mgκ?νιςγιαεν?σιμοδι?λυμα

Malta: Bortezomib 3.5mg powder for solution for injection

Last review date of this leaflet::October 2021

For detailed and updated information about this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.es/.

The following information is intended only for healthcare professionals:

1.RECONSTITUTION FOR INTRAVENOUS INJECTION

Nota: Bortezomib is a cytotoxic agent. Therefore, it should be handled and prepared with caution. It is recommended to use gloves and protective clothing to avoid skin contact.

IT IS RECOMMENDED TO FOLLOW A STRICT ASPTIC TECHNIQUE DURING THE HANDLING OF BORTEZOMIB BAXTER, AS IT DOES NOT CONTAIN PRESERVATIVES.

1.1Preparation of a 3.5 milligram vial: add 3.5 ml of 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.

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

1.3Do not refrigerate. Chemical and physical stability has been demonstrated during use for 8 hours at 25°C. From a microbiological point of view, unless the opening method avoids the risk of microbial contamination, the reconstituted product (without preservative) must be used immediately. If not used immediately, the storage times and conditions after reconstitution are the responsibility of the user.

No protection from light is required for the reconstituted product.

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 intravenous administration).
• Inject the solution via a 3‑5 second intravenous bolus, through a peripheral or central intravenous catheter in a vein.
• Wash the peripheral or intravenous catheter with sterile 0.9% sodium chloride injection solution.

Bortezomib Baxter 3.5 mg lyophilized powder for injection MUST BE ADMINISTERED ONLY BY INTRAVENOUS OR SUBCUTANEOUS ROUTE. Do not administer by other routes. Intrathecal administration has caused cases of death.

3.ELIMINATION

A 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:

1.RECONSTITUTION FOR SUBCUTANEOUS INJECTION

Nota: Bortezomib is a cytotoxic agent. Therefore, it should be handled and prepared with caution. It is recommended to use gloves and protective clothing to avoid skin contact.

AS BORTEZOMIB BAXTER DOES NOT CONTAIN PRESERVATIVES, IT IS RECOMMENDED TO FOLLOW A STRICT ASPTIC TECHNIQUE DURING ITS HANDLING.

1.1Preparation of a 3.5 milligram vial: add 1.4 ml of sterile 0.9% sodium chloride injection solution to the vial containing the Bortezomib Baxter 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.

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

1.3Do not refrigerate. Chemical and physical stability has been demonstrated during use for 8 hours at 25°C. From a microbiological point of view, unless the opening method avoids the risk of microbial contamination, the reconstituted product (without preservative) must be used immediately. If not used immediately, the storage times and conditions after reconstitution are the responsibility of the user.

No protection from light is required for the reconstituted product.

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).
• Rotate the administration sites with each injection.
• If local reactions occur at the administration site after subcutaneous injection of Bortezomib Baxter, either administer a less concentrated bortezomib solution (1 mg/ml instead of 2.5 mg/ml) or recommend switching to intravenous injection.

Bortezomib Baxter 3.5 mg lyophilized powder for injection MUST BE ADMINISTERED ONLY BY INTRAVENOUS OR SUBCUTANEOUS ROUTE. Do not administer by other routes. Intrathecal administration has caused cases of death.

3.ELIMINATION

A 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.