Bortezomib sun 3,5 mg polvo para solucion inyectable efg

Prospect: Information for the User

Bortezomib SUN 3.5 mg Powder for Injection EFG

bortezomib

Read this prospect carefully before starting to use this medication, because it contains important information for you.

• Keep this prospect. 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.

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

Bortezomib SUN is used for 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 who are 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 are receiving high doses of chemotherapy prior to a stem cell transplant (induction treatment).
• mantle cell lymphoma(a type of cancer that affects lymph nodes) inpatients 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.

Do not use Bortezomib SUN

• 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

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 over 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 advise further tests and follow-up.

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

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

• if you think you have or have had hepatitis in the past. 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 you will be closely monitored by your doctor to detect any signs of active hepatitis B.

Before starting treatment with Bortezomib SUN, read the leaflets of all the medicines you are taking in combination with Bortezomib SUN to consult the information related to these medicines. When taking thalidomide, special attention should be paid to pregnancy testing and preventive measures (see Pregnancy and Breastfeeding in this section).

Children and adolescents

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

Other medicines and Bortezomib SUN

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

Particularly, inform your doctor if you are using medicines 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)(Hypericum perforatum), used for depression or other conditions
• oral antidiabetic medicines.

Pregnancy and breastfeeding

You should not use Bortezomib SUN if you are pregnant unless it is clearly necessary.

You should not breastfeed while using Bortezomib SUN. Consult your doctor when it is safe to restart breastfeeding after completing your treatment.

Talidomide causes birth defects and fetal death. When Bortezomib SUN is administered in combination with thalidomide, follow the thalidomide pregnancy prevention program (see the thalidomide leaflet).

Contraception

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

Driving and operating machinery

Bortezomib SUN 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 careful.

Your doctor will tell you the dose of Bortezomib SUN based on your height and weight (body surface area). The usual starting dose of Bortezomib SUN 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).

Multiple Myeloma in Progression

• When Bortezomib SUN is administered alone, you will receive 4 doses of Bortezomib SUN 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 SUN along with the medications doxorubicin liposomal pegylated or dexamethasone.

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

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

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

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 Bortezomib SUN 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 SUN is administered twice a week on days 1, 4, 8, 11, 22, 25, 29, and 32.
• In cycles 5 to 9, Bortezomib SUN 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 the first week of each cycle.

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

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

You will receive 4 cycles (12 weeks).

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

Dexamethasone is administered orally at a dose of 40 mg on days 1, 2, 3, 4, 8, 9, 10, and 11 of the 28-day treatment cycle of Bortezomib SUN. Thalidomide is administered orally once a day at a dose of 50 mg until day 14 of the first cycle, and if tolerated, the dose of thalidomide 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 for mantle cell lymphoma before, you will receive Bortezomib SUN by intravenous or subcutaneous injection along with the medications rituximab, cyclophosphamide, doxorubicin, and prednisone.

Bortezomib SUN 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 21-day treatment cycle of Bortezomib SUN:

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

Prednisone is administered orally at a dose of 100 mg/m2on days 1, 2, 3, 4, and 5 of the 21-day treatment cycle of Bortezomib SUN.

How Bortezomib SUN is Administered

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

Bortezomib SUN 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 Bortezomib SUN 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.

Consult your doctor immediately if you experience any of the following symptoms:

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

This Bortezomib SUN treatment may cause a very frequent decrease in the number of red and white blood cells and platelets in the blood. Therefore, you will need to have regular blood tests before and during treatment with Bortezomib SUN to check your blood cell count regularly. You may experience a reduction in the number of:

• • Platelets, which may make you more prone to bruising (bruises), or bleeding without visible 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.

Multiple Myeloma

If you are administered Bortezomib SUN 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
• 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
• Fatigue (tiredness), 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 fainting
• High blood pressure
• Decreased kidney function
• Headache
• General feeling of discomfort, pain, dizziness, disorientation, feeling of weakness or loss of consciousness
• Chills
• Infections, including pneumonia, respiratory infections, bronchitis, fungal infections, cough 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
• Skin 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, pain in the limbs
• Blurred vision
• Conjunctivitis (infection of the outer layer of the eye and the inner surface of the eyelids)
• Nasal hemorrhage
• 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 infection, cellulitis
• Bleeding from mucous membranes, for example, from 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
• Respiratory disorders, preventing the body from receiving a sufficient amount of oxygen. Some of them include difficulty breathing, shortness of breath, shortness of breath without exercise, shallow, difficult or stopping breathing, rapid breathing
• Hoarseness
• 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
• Eye irritation or inflammation, 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
• Oral, esophageal, stomach, and intestinal infections, 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 infection
• Pancreatitis, bile duct obstruction
• Genital pain, erectile dysfunction
• Weight gain
• Thirst
• Heptatitis
• 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
• Palpitations
• Vein discoloration
• Spinal cord nerve inflammation
• Ear problems, ear hemorrhage
• Hyperthyroidism
• 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 include 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
• 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 leading to other complications
• Swelling of the liver, liver hemorrhage
• Kidney 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 clot in small blood vessels (microangiopathy)
• Abnormal reaction to blood transfusions
• Partial or complete loss of vision
• Loss of libido
• Halitosis
• Bulging 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.

Castleman's disease

If you are administered Bortezomib SUN along with other medications for the treatment of Castleman's disease, 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
• Fatigue, 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, cough 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 fainting
• Difficulty breathing with exercise
• Cough
• Hoarseness
• Ear hemorrhage
• Heartburn
• Stomach pain, swelling
• Difficulty swallowing
• Stomach or intestinal infection or inflammation
• Stomach pain
• Mouth or lip sores, throat pain
• Liver function alteration
• Itching skin
• Skin redness
• Rash
• Muscle spasms
• Urinary tract infection
• 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)

• Heptatitis
• Severe allergic reaction (anaphylactic reaction), whose signs may include 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 include 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)

Reporting of 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.

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

From a microbiological standpoint, the reconstituted solution must be used immediately after preparation. If the reconstituted solution is not used immediately, the storage times after reconstitution and conditions before use are the responsibility of the user. However, the reconstituted solution is stable for 8 hours at 25 ºC when stored in the original vial and/or syringe, the total storage time of the reconstituted medication must not exceed 8 hours before administration.

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

Composition of Bortezomib SUN

• The active ingredient is bortezomib. Each vial contains 3.5 mg 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 Bortezomib SUN and contents of the package

Bortezomib SUN 3.5 mg powder for injection EFG is a white or off-white lyophilized powder or a lyophilized powder.

Each package of Bortezomib SUN contains a 10 ml glass vial with a greenish aluminum cap, in a transparent blister.

Marketing authorization holder and responsible manufacturer

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132 JH Hoofddorp

Netherlands

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

België/Belgique/Belgien/????????/Ceská republika/

Danmark/Eesti/Ελλ?δα/Hrvatska/Ireland/Ísland/Κ?προς/

Latvija/Lietuva/Luxembourg/Luxemburg/Magyarország/

Malta/Nederland/Norge/Österreich/Portugal/

Slovenija/Slovenská republika/Suomi/Finland/Sverige

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132 JH Hoofddorp

Netherlands

Phone: +31 (0)23 568 5501

Deutschland

Sun Pharmaceuticals Germany GmbH

Hemmelrather Weg 201

51377 Leverkusen

Germany

Phone: +49 (0) 214 403 99 192

España

Sun Pharma Laboratorios, S.L.

Rambla de Catalunya 53-55

08007 Barcelona

Spain

Phone: +34 93 342 78 90

France

Sun Pharma France

11-15, Quai de Dion Bouton

92800 Puteaux

France

Phone: +33 1 41 44 44 50

Italia

Sun Pharma Italia Srl

Viale Giulio Richard, 1

20143 Milano

Italy

Phone: +39 02 33 49 07 93

Polska

Ranbaxy (Poland) Sp. Z o. o.

ul. Kubickiego 11

02-954 Warszawa

Poland

Phone: +48 22 642 07 75

România

Terapia S.A.

Str. Fabricii nr 124

Cluj-Napoca, Judetul Cluj

Romania

Phone: +40 (264) 501 500

United Kingdom (Northern Ireland)

Ranbaxy UK Ltd

a Sun Pharma Company

Millington Road 11

Hyde Park, Hayes 3

5th Floor

Hayes

UB3 4AZ HAYES

United Kingdom

Phone: +44 (0) 208 848 8688

Last review date of this leaflet:

Other sources of information

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

This information is intended solely for healthcare professionals:

1. RECONSTITUTION FOR INTRAVENOUS ADMINISTRATION

Nota: Bortezomib SUN 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 SUN DOES NOT CONTAIN PRESERVATIVES, IT IS RECOMMENDED TO FOLLOW STRICT ASPTIC TECHNIQUE DURING ITS HANDLING.

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

The reconstituted product does not need to be protected from light.

1. ADMINISTRATION FORM

• 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 by intravenous bolus over 3-5 seconds, through a peripheral or central intravenous catheter in a vein.
• Clean the peripheral or intravenous catheter with sterile sodium chloride 9 mg/ml (0.9%) solution.

Bortezomib SUN 3.5 mg powder for injection EFG MUST BE ADMINISTERED ONLY BY INTRAVENOUS OR SUBCUTANEOUS ROUTE. Do not administer by other routes. Administration by intrathecal route 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.

This information is intended solely for healthcare professionals:

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

1. RECONSTITUTION FOR SUBCUTANEOUS ADMINISTRATION

Nota: Bortezomib SUN 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 SUN DOES NOT CONTAIN PRESERVATIVES, IT IS RECOMMENDED TO FOLLOW STRICT ASPTIC TECHNIQUE DURING ITS HANDLING.

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. The pH of the solution does not need to be checked.

The reconstituted product does not need to be protected from light.

1. ADMINISTRATION FORM

• 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 abdomen (right or left side).
• The administration sites should be rotated with each injection.
• If local reactions occur at the administration site after subcutaneous injection of Bortezomib SUN, or if it can be administered subcutaneously with a less concentrated solution of Bortezomib SUN (1 mg/ml instead of 2.5 mg/ml), or if it is recommended to change to intravenous injection.

Bortezomib SUN 3.5 mg powder for injection EFG MUST BE ADMINISTERED ONLY BY INTRAVENOUS OR SUBCUTANEOUS ROUTE. Do not administer by other routes. Administration by intrathecal route 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.