Label: Information for the User

VELCADE 3.5 mg Powder for Injection

bortezomib

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

• Keep this label, as you may need to refer to 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 label. See section 4.

VELCADE 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.

VELCADE is used in the treatment of multiple myeloma (a bone marrow cancer) in patients aged 18 years 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).

VELCADE is used in the treatment of mantle cell lymphoma (a type of cancer that affects lymph nodes) in patients aged 18 years 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 VELCADE

• if you are allergic to bortezomib, boron, or any of the other components of this medication (listed in section 6)
• if you have 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 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 VELCADE to check your blood cell count regularly.

Inform your doctor if you have mantle cell lymphoma and are receiving rituximab in combination with VELCADE:

• if you think you have or have had 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 VELCADE, read the prospectuses of all medications you are taking in combination with VELCADE to consult 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

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

Use of VELCADE 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 VELCADE if you are pregnant unless it is clearly necessary.

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

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

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

Driving and operating machinery

VELCADE 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 VELCADE based on your height and weight (body surface area). The usual starting dose of VELCADE is 1.3 mg/m2of body surface area, given 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 VELCADE is given alone, you will receive 4 doses of VELCADE 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 VELCADE along with the medications doxorubicin liposomal pegylated or dexamethasone.

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

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

When VELCADE is given with dexamethasone, you will receive VELCADE 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 VELCADE 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 and are not a candidate for a stem cell transplant, you will receive VELCADE 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, VELCADE is administered twice a week on days 1, 4, 8, 11, 22, 25, 29, and 32.
• In cycles 5 to 9, VELCADE 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 and are a candidate for a stem cell transplant, you will receive VELCADE by intravenous or subcutaneous injection along with the medications dexamethasone, or dexamethasone and thalidomide, as induction treatment.

When VELCADE is given with dexamethasone, you will receive VELCADE 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 VELCADE 21-day treatment cycle.

You will receive 4 cycles (12 weeks).

When VELCADE is given 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 VELCADE 28-day treatment cycle, and thalidomide is administered orally once daily 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 for mantle cell lymphoma before, you will receive VELCADE by intravenous or subcutaneous injection along with the medications rituximab, cyclophosphamide, doxorubicin, and prednisone.

VELCADE 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 VELCADE 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 VELCADE treatment cycle.

How VELCADE is Administered

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

The VELCADE 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 VELCADE 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 VELCADE 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.

Treatment with VELCADE 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 VELCADE 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 visible injury (for example, intestinal, stomach, mouth and gum bleeding or brain or liver bleeding)
• Red blood cells, which can cause anemia, with symptoms such as fatigue and paleness
• White blood cells, which may make you more prone to infections or symptoms similar to the flu.

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

Very common side effects (can 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 (can 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 weak or loss of consciousness
• Chills
• Infections, including pneumonia, respiratory infections, bronchitis, fungal infections, coughs with phlegm, 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, 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 outermost 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 (can 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, 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 (tactile, auditory, gustatory, olfactory), attention disorders, tremors, spasms
• 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, 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, memory loss or alteration
• 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, excessive eye moisture, eye pain, dry eyes, eye infections, chalazion (cyst on the eyelid), eyelid redness and swelling, watery eyes (lacrimation), abnormal vision, eye hemorrhage
• Lymph node swelling
• Joint or muscle stiffness, feeling heavy, 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
• Weight loss, loss of taste
• Muscle cramps, muscle spasms, muscle weakness, pain in the limbs
• Blurred vision
• Conjunctivitis (infection of the outermost 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 (can 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
• Hypothyroidism
• 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/fainting, intense itching of the 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
• Myopathy leading to 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
• Microangiopathic thrombosis (blood clot in small blood vessels)
• Abnormal reaction to blood transfusions
• Partial or total loss of vision
• Loss of libido
• Halitosis
• Protruding eyes
• Photophobia
• Tachypnea
• Rectal pain
• Biliary calculi
• Hernia
• Wounds
• Brittle or fragile nails
• Anomalous protein deposits in vital organs
• Coma
• Intestinal ulcers
• Multi-organ failure
• Death

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

Very common side effects (can 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
• Diarhea
• Mouth ulcers
• Constipation
• Muscle pain, bone pain
• Loss of hair and abnormal hair texture
• Exhaustion, feeling weak
• Fever

Common side effects (can 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 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, 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
• Coughs
• Hypophonia
• Tinnitus, ear discomfort
• Intestinal or stomach bleeding
• Heartburn
• Stomach pain, swelling
• Difficulty swallowing
• Stomach or intestinal infection or inflammation
• Stomach 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 (can 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/fainting, intense itching of the skin or skin bumps, facial swelling, lip, tongue, and/or throat swelling, which may cause difficulty swallowing, collapse
• Movement disorders, paralysis, spasms
• 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, 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 (can affect up to 1 in 1,000 patients)

• Microangiopathic thrombosis (blood clot in small blood vessels)
• Severe nerve inflammation, 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 or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the national 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 30°C. Store the vial in the outer packaging to protect it from light.

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°C when stored in the original vial and/or syringe, the total storage time of the reconstituted medication must not exceed 8 hours before administration.

VELCADE 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.

VELCADE Composition

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

Product appearance and packaging contents

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

Each VELCADE 3.5 mg lyophilized powder for injection vial contains a 10 ml glass vial with a blue crown capsule, in a transparent blister pack.

Marketing Authorization Holder

JANSSEN-CILAG INTERNATIONAL NV

Turnhoutseweg 30

B-2340 Beerse

Belgium

Manufacturer

Janssen Pharmaceutica NV

Turnhoutseweg 30

B-2340 Beerse

Belgium

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

Last review date of thisleaflet:

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

The following information is only for healthcare professionals:

1. RECONSTITUTION FOR INTRAVENOUS ADMINISTRATION

Nota: VELCADE 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 VELCADE LACKS PRESERVATIVES, IT IS RECOMMENDED TO FOLLOW STRICT ASPTIC TECHNIQUE DURING HANDLING.

1.1. Preparation of a 3.5 milligram vial: add carefully 3.5 millilitersof sterile 0.9% sodium chloride injection solution to the vial containing the VELCADE lyophilized powder using a suitable syringe without removing the vial cap. The dissolution of the lyophilized powder is completed in less than 2 minutes.

The resulting solution concentration will be 1 milligram per milliliter. 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.

1.2. Before 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).

1.3. 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, stored in the original vial and/or syringe. The total conservation time of the reconstituted medication should not exceed 8 hours before administration. If the reconstituted solution is not used immediately, the conservation times after reconstitution and conditions before use are the responsibility of the user.

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

1. 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 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 0.9% sodium chloride injection solution.

VELCADE 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.

1. DISPOSAL

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

The disposal 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 only for healthcare professionals:

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

1. RECONSTITUTION FOR SUBCUTANEOUS ADMINISTRATION

Nota: VELCADE 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 VELCADE LACKS PRESERVATIVES, IT IS RECOMMENDED TO FOLLOW STRICT ASPTIC TECHNIQUE DURING HANDLING.

1.1. Preparation of a 3.5 milligram vial: add carefully 1.4 millilitersof sterile 0.9% sodium chloride injection solution to the vial containing the VELCADE lyophilized powder using a suitable syringe without removing the vial cap. The dissolution of the lyophilized powder is completed in less than 2 minutes.

The resulting solution concentration will be 2.5 milligrams per milliliter. 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.

1.2. Before 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).

1.3. 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, stored in the original vial and/or syringe. The total conservation time of the reconstituted medication should not exceed 8 hours before administration. If the reconstituted solution is not used immediately, the conservation times after reconstitution and conditions before use are the responsibility of the user.

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

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

VELCADE 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.

1. DISPOSAL

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

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