Label: information for the user

Bortezomib Dr. Reddys 3.5 mg powder for injectable solution EFG

Read this label carefully before starting to use this medication, becauseit contains important information for you.

• Keep this label, 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 arenot listed in this label. 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 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 Dr. Reddys

• 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 disorientation

•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 (localized, including around the eyes, or widespread)

•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 mantle cell lymphoma 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 episodes of hepatitis, 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 preventive 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 Dr. Reddys

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.

Talidomide 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/m2 of 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 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/m2 is administered on day 4 of the bortezomib 21-day treatment cycle by 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 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 bortezomiv 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 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 stem cell transplant, you will receive bortezomiv by intravenous or subcutaneous injection along with the medications dexamethasone, or dexamethasone and thalidomide, as induction treatment.

When bortezomiv is given along with dexamethasone, you will receive bortezomiv 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 bortezomiv 21-day 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 bortezomiv 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 bortezomiv by intravenous or subcutaneous injection along with the medications rituximab, cyclophosphamide, doxorubicin, and prednisone. Bortezomiv 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 bortezomiv 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/m2 on days 1, 2, 3, 4, and 5 of the bortezomiv treatment cycle.

How Bortezomiv Dr. Reddys is administered

This medication is administered by intravenous or subcutaneous injection. You will receive Bortezomiv by 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 into a vein or under the skin. The injection into the vein is rapid, lasting between 3 and 5 seconds. The injection under the skin is administered in the thighs or abdomen.

If you receive more Bortezomiv Dr. Reddys 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, fainting

-Coughs and difficulty breathing or chest tightness.

The treatment with bortezomib can cause very frequently a 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 bruising (bruises), or bleeding without apparent injury (for example, intestinal, stomach, mouth and gum bleeding or bleeding in the brain or liver)

-Red blood cells, which can 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 multiple myeloma treatment, the side effects you may experience are listed below:

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

•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/or white blood cells (see above)

•Fever

•Feeling unwell (nausea) or vomiting, loss of appetite

•Constipation with or without swelling (may be severe)

•Dyspepsia: 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 people)

•Low blood pressure, sudden drop in blood pressure when standing, which could lead to fainting

•High blood pressure

•Renal dysfunction

•Headache

•General feeling of being unwell, pain, dizziness, disorientation, feeling weak or loss of consciousness

•Chills

•Infections, including pneumonia, respiratory infections, bronchitis, 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

•Redness of the skin

•Dehydration

•Heartburn, swelling, belching, stomach pain

•Liver function alteration

•Mouth or lip sores, sore throat

•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 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 people)

•Heart failure, heart attack, chest pain, chest discomfort, increase or decrease in 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, viral infections, ear infections, and cellulitis

•Mucous membrane hemorrhages or bleeding in the mouth or vagina

•Cerebrovascular disorders

•Paralysis, seizures, falls, movement disorders, changes or decreases in sensitivity (tactile, auditory, gustatory, olfactory), attention disorders, tremors, shakiness

•Arthritis, including inflammation of the joints of the fingers of the hands and feet and jaw

•Respiratory 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, labored breathing

•Hypophonia, speech disorders

•Alteration of urine production (due to renal damage), pain while urinating or blood/protein in the urine, fluid retention

•Alteration of consciousness, confusion, memory loss or alteration

•Hypersensitivity

•Loss of hearing, deafness or tinnitus, ear discomfort

•Alterations in hormone levels that may affect sodium and water absorption

•Hyperthyroidism

•Inability to produce sufficient insulin or resistance to normal insulin levels

•Eye irritation or inflammation, excessively watery eyes, eye pain, dry eyes, eye infections, chalazion, red and swollen eyelids, watery eyes (lacrimation), abnormal vision, eye hemorrhage

•Lymph node swelling

•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

•Infections or inflammation of the mouth, ulcers in the mouth, esophagus, stomach, and intestines, sometimes associated with pain or bleeding, slow movement of the intestines (including obstruction), abdominal or esophageal discomfort, difficulty swallowing, vomiting blood

•Skin infections

•Bacterial and viral infections

•Dental infections

•Pancreatitis, bile duct obstruction

•Pain in the genitals, erectile dysfunction

•Weight gain

•Thirst

•Hepatitis

•Device-related or injection-site reactions

•Severe skin reactions (life-threatening), skin ulcers

•Bruises, falls, and injuries

•Small blood vessel inflammation or hemorrhage 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 people)

•Heart problems, including heart attack, angina

•Severe nerve inflammation, which can cause paralysis and difficulty breathing (Guillain-Barré syndrome)

•Flushing

•Change in vein color

•Spinal cord nerve inflammation

•Ear problems, ear hemorrhage

•Hypothyroidism

•Budd-Chiari syndrome (clinical symptoms caused by hepatic vein obstruction)

•Intestinal function changes or abnormalities

•Brain hemorrhage

•Jaundice (yellowing of the eyes and skin)

•Severe allergic reaction (anaphylactic shock), whose signs may be difficulty breathing, chest pain or tightness, and/or dizziness/fainting, intense itching skin or skin bumps, facial swelling, lip, tongue, and/or throat swelling, which may cause difficulty swallowing, collapse

•Breast disorders

•Vaginal rupture

•Genital inflammation

•Inability to tolerate alcohol consumption

•Emaciation or weight loss

•Increased appetite

•Fistula

•Joint effusion

•Joint cysts (synovial cysts)

•Fracture

•Muscle fiber breakdown leading to other complications

•Swelling of the liver, liver hemorrhage

•Renal cancer

•Porphyria cutanea tarda-like skin disease

•Skin cancer

•Pale skin

•Increased platelets or plasma cells (a type of white blood cell) in the blood

•Microangiopathic thrombosis (blood clots in small blood vessels)

•Abnormal reaction to blood transfusions

•Partial or complete loss of vision

•Loss of libido

•Halitosis

•Proptosis

•Photophobia

•Accelerated breathing

•Rectal pain

•Bile stones

•Hernia

•Wounds

•Weak or brittle nails

•Abnormal protein deposits in vital organs

•Coma

•Ulcers in the intestines

•Multi-organ failure

•Death

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

Very common side 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 the hands or feet due to nerve damage

•Nausea or vomiting

•Dyspepsia

•Ulcers in the mouth

•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 people)

•Herpes zoster (localized including around the eyes or extended over the body)

•Viral infections

•Bacterial and viral infections

•Respiratory infections, bronchitis, coughs with phlegm, 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, increase or decrease in heart rate

•High or low blood pressure

•Sudden drop in blood pressure when standing, which could lead to fainting

•Difficulty breathing while exercising

•Coughs

•Hypophonia

•Ear discomfort

•Intestinal or stomach hemorrhage

•Heartburn

•Stomach pain, swelling

•Difficulty swallowing

•Infection or inflammation of the stomach and intestines

•Stomach pain

•Mouth or lip sores, sore throat

•Liver function alteration

•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 being unwell

•Weight loss

•Weight gain

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

•Hepatitis

•Severe allergic reaction (anaphylactic reaction), whose signs may be difficulty breathing, chest pain or tightness, and/or dizziness/fainting, intense itching skin or skin bumps, facial swelling, lip, tongue, and/or throat swelling, which may cause difficulty swallowing, collapse

•Movement disorders, paralysis, shakiness

•Dizziness

•Loss of hearing, deafness

•Respiratory 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, labored breathing

•Blood clots in the lungs

•Jaundice (yellowing of the eyes and skin)

•Chalazion, red and swollen eyelids

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

•Blood clots in small blood vessels (microangiopathic thrombosis)

• Inflammation of the nerves, which can cause paralysis and difficulty breathing (Guillain-Barré syndrome)

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, 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:https://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.

Do not store above 25°C. Store the vial in the outer packaging to protect it from light.

After reconstitution:

Chemical and physical stability has been demonstrated for 8 hours at 25°C and 15 days at 2°C-8°C.

From a microbiological standpoint, unless the reconstitution method excludes the risk of microbial contamination, the product should be used immediately.

The vial is for single use only. 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 Dr. Reddys

• The active ingredient is bortezomib. Each vial contains 3.5 milligrams of bortezomib (as boric acid mannitol ester).
• The other components are mannitol (Ph. Eur.), nitrogen.

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

The medicine is a white or off-white powder.

Each package contains a 10 ml glass vial with a stopper and a flip-off closure.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Reddy Pharma Iberia, S.A.

Avenida Josep Tarradellas, nº 38

08029 Barcelona (Spain)

Phone: 93.355.49.16

Fax: 93.355.49.61

Responsible for manufacturing

Betapharm Arzneimittel GmbH,

Kobelweg 95,

Augsburg, 86156

Germany

or

SC Rual Laboratories SRL

313, Splaiul Unirii, Building H, 1st floor, sector 3,

Bucharest, 030138

Romania

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Last review date of this leaflet:February 2024

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es)

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The following information is intended only for healthcare professionals:

1. RECONSTITUTION FOR INTRAVENOUS ADMINISTRATION

Nota: bortezomib is a cytotoxic agent. Therefore, caution should be exercised during manipulation and preparation. The use of gloves and other protective clothing is recommended to prevent skin contact.

AS BORTEZOMIB LACKS PRESERVATIVES, STRICT ASPTIC TECHNIQUE SHOULD BE FOLLOWED DURING ITS HANDLING.

1.1.Preparation of a 3.5 milligram vial: add carefully 3.5 millilitersof sterile sodium chloride 9 mg/ml (0.9%) 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 milligram/milliliter. The solution must be colorless and transparent, with a final pH of 4 to 7. No pH check of the solution is required.

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

1.3.The reconstituted solution lacks preservatives and must be used immediately after preparation. However, the chemical and physical stability during use has been demonstrated for 8 hours at 25°C in the original vial and/or syringe. The total conservation time of the reconstituted medicine should not exceed 8 hours before administration. If the reconstituted solution is not used immediately, the conservation times after reconstitution and the conditions before use are the responsibility of the user.

No protection from light is required for the reconstituted medicine.

2. ADMINISTRATION

• Once dissolved, remove the appropriate amount of the 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 (check that the syringe is marked for intravenous administration).
• Inject the solution through a 3-5 second intravenous bolus, through a peripheral or central intravenous catheter in a vein.
• Wash the peripheral or intravenous catheter with sterile sodium chloride 9 mg/ml (0.9%) solution.

THIS MEDICINE MUST BE ADMINISTERED ONLY BY INTRAVENOUS OR SUBCUTANEOUS ROUTE. Do not administer by other routes. Intrathecal administration has caused cases of death.

3. DISPOSAL

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

The disposal of unused medicine 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 3.5 mg vial can be administered subcutaneously, as described below.

1. RECONSTITUTION FOR SUBCUTANEOUS ADMINISTRATION

Nota: bortezomib is a cytotoxic agent. Therefore, caution should be exercised during manipulation and preparation. The use of gloves and other protective clothing is recommended to prevent skin contact.

AS BORTEZOMIB LACKS PRESERVATIVES, IT IS RECOMMENDED TO FOLLOW STRICT ASPTIC TECHNIQUE DURING ITS HANDLING.

1.1Preparation of a 3.5 milligram vial: add carefully 1.4 millilitersof sterile sodium chloride 9 mg/ml (0.9%) 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 milligrams/milliliter. The solution must be colorless and transparent, with a final pH of 4 to 7. No pH check of the solution is required.

1.2Before administration, visually inspect the solution to discard the presenceof particles and color changes. If any color change or particle is observed, the solutionmust be discarded. Check that the correct dose is being used for subcutaneous administration(2.5 mg/ml).

1.3La solución reconstituida carece de conservantes y se debe utilizar inmediatamente después de su preparación. Sin embargo, la estabilidad química y física durante la utilización ha sido demostrada durante 8 horas a 25°C conservado en el vial original y/o jeringa. El tiempo total de conservación del medicamento reconstituido no debe superar las 8 horas antes de la administración. Si la solución reconstituida no se usa inmediatamente, los tiempos de conservación tras la reconstitución y las condiciones antes del uso son responsabilidad del usuario.

No es necesario proteger de la luz el medicamento reconstituido.

2. ADMINISTRATION

• Once dissolved, remove the appropriate amount of the 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 (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, or a less concentrated bortezomib solution (1 mg/ml instead of 2.5 mg/ml) can be administered subcutaneously, or it is recommended to change to intravenous injection.

THIS MEDICINE MUST BE ADMINISTERED ONLY BY INTRAVENOUS OR SUBCUTANEOUS ROUTE. Do not administer by other routes. Intrathecal administration has caused cases of death.

3. DISPOSAL

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

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