Bortezomib Sun 3.5 mg powder for solution for injection EFG: detailed information

Brand name Bortezomib Sun 3.5 mg powder for solution for injection EFG

Form powder for solution for injection

Active substance / Dosage

BORTEZOMIB · 3,5 mg

Prescription type Hospital Use Only

ATC code

L01X L01XG L01XG01

Registration number 1161102001

Manufacturer Sun Pharmaceutical Industries (Europe) B.V.

Bortezomib Sun 3.5 mg powder for solution for injection EFG powder for solution for injection

Table of Contents

Package leaflet: Information for the user
Introduction
1. What Bortezomib SUN is and what it is used for
2. What you need to know before using Bortezomib SUN
3. How to use Bortezomib SUN
4. Possible adverse effects
5. Storage of Bortezomib SUN
6. Package contents and other information

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Bortezomib SUN 3.5 mg powder for solution for injection EFG

bortezomib

Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
If you experience any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. See section 4.

Contents of the leaflet

What Bortezomib SUN is and what it is used for
What you need to know before using Bortezomib SUN
How to use Bortezomib SUN
Possible side effects
How to store Bortezomib SUN
Contents of the pack and other information

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

Bortezomib SUN contains the active substance bortezomib, a "proteasome inhibitor". Proteasomes play an important role in regulating cell function and growth. Bortezomib can destroy cancer cells by interfering with their normal functioning.

Bortezomib SUN is used for the treatment of:

Multiple myeloma (a cancer of the bone marrow) in patients over 18 years of age:
alone or in combination with pegylated liposomal doxorubicin or dexamethasone, for patients whose disease is progressing after having received at least one prior therapy, and for those patients for whom stem cell transplantation has not been successful or is not suitable.
in combination with melphalan and prednisone, for patients who have not previously been treated and for whom high-dose chemotherapy followed by stem cell transplantation is not considered appropriate.
in combination with dexamethasone or dexamethasone plus thalidomide, for patients who have not previously been treated and who are undergoing high-dose chemotherapy prior to stem cell transplantation (induction treatment).
Mantle cell lymphoma (a type of cancer affecting the lymph nodes) in patients aged 18 years or older, in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone, for patients who have not previously been treated and for whom stem cell transplantation is not considered appropriate.

2. What you need to know before using Bortezomib SUN

DO NOT use Bortezomib SUN

if you are allergic to bortezomib, to boron, or to any of the other ingredients of this medicine (listed in section 6)
if you have certain severe lung or heart problems.

Warnings and precautions

Tell your doctor if you have any of the following:

low red or white blood cell counts
bleeding problems and/or low platelet count in the blood
diarrhoea, constipation, nausea, or vomiting
history of fainting, dizziness, or lightheadedness
kidney problems
moderate to severe liver problems
previous numbness, tingling, or pain in hands or feet (neuropathy)
heart problems or blood pressure issues
difficulty breathing or cough
seizures
shingles (localized, including around the eyes, or widespread)
symptoms of tumour lysis syndrome, such as muscle cramps, muscle weakness, confusion, vision loss or changes, and difficulty breathing
memory loss, mental changes, difficulty walking, or vision loss. These may be signs of a serious brain infection, and your doctor may recommend further tests and monitoring.

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

You must inform your doctor if you have mantle cell lymphoma and are receiving rituximab together with Bortezomib SUN:

if you think you currently have or have had hepatitis infection in the past. In a few cases, patients who have had hepatitis B may experience recurrent hepatitis episodes, which can be fatal. If you have a history of hepatitis B infection, your doctor will closely monitor you for signs of active hepatitis B.

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

Children and adolescents

Bortezomib SUN must not be used in children and adolescents, as the effect of the medicine on them is unknown.

Other medicines and Bortezomib SUN

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

In particular, inform your doctor if you are taking medicines containing any of the following active substances:

ketoconazole, used to treat fungal infections
ritonavir, used to treat HIV infection
rifampicin, an antibiotic used to treat bacterial infections
carbamazepine, phenytoin, or phenobarbital, used to treat epilepsy
St. John’s wort (Hypericum perforatum), used for depression or other conditions
oral antidiabetic medicines.

Pregnancy and breastfeeding

You must not use Bortezomib SUN if you are pregnant unless clearly necessary.

Women of childbearing age must use effective contraception during treatment and for 8 months after treatment ends. Talk to your doctor if you wish to freeze your eggs before starting treatment.

Men must not father a child while using Bortezomib SUN and must use effective contraception during treatment and for 5 months after treatment ends. Talk to your doctor if you wish to preserve your sperm before starting treatment.

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

Thalidomide causes birth defects and fetal death. When Bortezomib SUN is administered in combination with thalidomide, the thalidomide pregnancy prevention programme must be followed (refer to the thalidomide package leaflet).

Driving and use of machines

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 exercise caution.

3. How to use Bortezomib SUN

Your doctor will determine 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/m² of body surface area, administered twice weekly.

Your doctor may adjust the dose and the total number of treatment cycles depending on your response to treatment, the occurrence of certain adverse effects, and your baseline condition (e.g., liver problems).

Relapsed multiple myeloma

When Bortezomib SUN is given alone, you will receive 4 doses of Bortezomib SUN intravenously or subcutaneously on days 1, 4, 8, and 11, followed by a 10-day “rest” period without treatment. This 21-day period (3 weeks) constitutes one treatment cycle. You may receive up to 8 cycles (24 weeks).

You may also receive Bortezomib SUN in combination with pegylated liposomal doxorubicin or dexamethasone.

When Bortezomib SUN is administered together with pegylated liposomal doxorubicin, you will receive Bortezomib SUN intravenously or subcutaneously in a 21-day treatment cycle. Pegylated liposomal doxorubicin 30 mg/m² is administered on day 4 of the 21-day Bortezomib SUN treatment cycle, by intravenous infusion after the Bortezomib SUN injection.

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

When Bortezomib SUN is administered together with dexamethasone, you will receive Bortezomib SUN intravenously or subcutaneously 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 Bortezomib SUN treatment cycle.

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

Previously untreated multiple myeloma

If you have not been previously treated for multiple myeloma and are not eligible for blood stem cell transplantation, you will receive Bortezomib SUN in combination with two other drugs: melphalan and prednisone.

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

In cycles 1 to 4, Bortezomib SUN is administered twice weekly on days 1, 4, 8, 11, 22, 25, 29, and 32.
In cycles 5 to 9, Bortezomib SUN is administered once weekly on days 1, 8, 22, and 29.

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

If you have not previously received treatment for multiple myeloma and are eligible for blood stem cell transplantation, you will receive Bortezomib SUN intravenously or subcutaneously in combination with dexamethasone, or with dexamethasone and thalidomide, as induction therapy.

When Bortezomib SUN is administered together with dexamethasone, you will receive Bortezomib SUN intravenously or subcutaneously 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 Bortezomib SUN treatment cycle.

You will receive 4 cycles (12 weeks).

When Bortezomib SUN is administered together 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 Bortezomib SUN treatment cycle. Thalidomide is administered orally once daily at a dose of 50 mg up to day 14 of the first cycle; if tolerated, the thalidomide dose is increased to 100 mg on days 15–28, and from the second cycle onwards, it may be further increased to 200 mg daily.

You may receive up to 6 cycles (24 weeks).

Previously untreated mantle cell lymphoma

If you have not been previously treated for mantle cell lymphoma, you will receive Bortezomib SUN intravenously or subcutaneously in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone.

Bortezomib SUN is administered intravenously or subcutaneously on days 1, 4, 8, and 11, followed by a “rest period” without treatment. The duration of one 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 Bortezomib SUN treatment cycle:

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/m² on days 1, 2, 3, 4, and 5 of the Bortezomib SUN treatment cycle.

How Bortezomib SUN is administered

This medicine is administered intravenously or subcutaneously. Bortezomib SUN will be given to you by a healthcare professional experienced in the use of cytotoxic drugs.

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

If you receive more Bortezomib SUN than you should

This medicine will be administered by your doctor or nurse, so it is unlikely that you will receive too much.

In the unlikely event of an overdose, your doctor will monitor you for any adverse effects.

4. Possible adverse effects

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

Contact your doctor immediately if any of the following symptoms occur:

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 breathing difficulties or chest tightness.

Treatment with Bortezomib SUN may very commonly cause a decrease in the number of red blood cells, 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 monitor your blood cell counts regularly. You may experience a reduction in the number of:

- platelets, which may make you more prone to bruising (contusions) or bleeding without obvious injury (for example, intestinal, stomach, mouth, and gum bleeding, or bleeding in the brain or liver)
red blood cells, which may cause anemia, with symptoms such as fatigue and paleness
white blood cells, which may make you more susceptible to infections or flu-like symptoms.

Multiple myeloma

If you are receiving Bortezomib SUN for the treatment of multiple myeloma, the adverse effects you may experience include the following:

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

tenderness, numbness, tingling, or burning sensation in the skin, or pain in hands or feet due to nerve damage
reduction in the number of red and/or white blood cells (see above)
fever
nausea or vomiting, loss of appetite
constipation with or without swelling (may be severe)
diarrhea: if this occurs, it is important to drink more fluids than usual. Your doctor may prescribe another medicine to control the diarrhea
exhaustion (fatigue), feeling weak
muscle pain, bone pain.

Common adverse 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
reduced kidney function
headache
general malaise, pain, dizziness, lightheadedness, feeling weak, or loss of consciousness
chills
infections, including pneumonia, respiratory infections, bronchitis, fungal infections, cough with phlegm, flu-like illness
herpes zoster (localized, including around the eyes, or widespread over the body)
chest pain or difficulty breathing during exercise
various types of skin rashes
itchy skin, skin lumps, or dry skin
facial flushing or small capillary rupture
redness of the skin
dehydration
stomach burning, bloating, burping, flatulence, stomach pain, intestinal or stomach bleeding
altered liver function
mouth or lip sores, dry mouth, mouth ulcers, or sore throat
weight loss, loss of taste
muscle cramps, muscle spasms, muscle weakness, limb pain
blurred vision
infection of the outer layer of the eye and inner eyelid surface (conjunctivitis)
nosebleeds
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 other body parts.

Uncommon adverse 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
inflammation of the heart lining or fluid around the heart
infections, including urinary tract infections, flu, herpes virus infection, ear infection, and cellulitis
bloody stools or bleeding from mucous membranes, for example, mouth or vagina
cerebrovascular disorders
paralysis, seizures, falls, movement disorders, altered or changed sensation (touch, hearing, taste, smell), attention disorders, tremors, jerking
arthritis, including inflammation of joints in fingers, toes, and jaw
lung disorders that prevent the body from receiving enough oxygen. These may include difficulty breathing, shortness of breath, breathlessness without exertion, shallow, difficult, or stopped breathing, wheezing
hiccups, speech disorders
increased or decreased urine production (due to kidney injury), painful urination, blood/protein in urine, fluid retention
altered level of consciousness, confusion, memory changes or loss
hypersensitivity
hearing loss, deafness, or ringing in the ears, ear discomfort
hormonal disorders that may affect salt and water absorption
overactivity of the thyroid gland
inability to produce enough insulin or resistance to normal insulin levels
eye irritation or inflammation, excessively watery eyes, eye pain, dry eyes, eye infections, eyelid cyst (chalazion), red and swollen eyelids, watery eyes (lacrimation), abnormal vision, eye bleeding
swollen lymph nodes
joint or muscle stiffness, feeling of heaviness, groin pain
hair loss 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 intestine, sometimes associated with pain or bleeding, reduced 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, difficulty achieving an erection
weight gain
thirst
hepatitis
injection site or injection device-related disorders
skin reactions and skin disorders (which may be severe and life-threatening), skin ulcers
bruising, falls, and injuries
inflammation or bleeding of blood vessels, appearing as small red or purple spots (usually on the legs) up to large bruise-like areas under the skin or tissue
benign cysts
a serious and reversible brain disorder including seizures, high blood pressure, headaches, fatigue, confusion, blindness, or other vision problems.

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

heart problems, including heart attack, angina
- severe nerve inflammation, which may cause paralysis and breathing difficulties (Guillain–Barré syndrome)
hot flushes
discoloration of veins
spinal nerve inflammation
ear problems, ear bleeding
underactivity of the thyroid gland
Budd–Chiari syndrome (clinical symptoms caused by obstruction of the hepatic veins)
changes or abnormalities in intestinal function
cerebral hemorrhage
yellowing 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 skin itching or skin lumps, swelling of the face, lips, tongue, and/or throat, which may cause difficulty swallowing, collapse
breast disorders
vaginal tear
genital inflammation
inability to tolerate alcohol consumption
emaciation or loss of body mass
increased appetite
fistula
joint effusion
cysts in the joint lining (synovial cysts)
fracture
breakdown of muscle fibers causing other complications
liver swelling, liver bleeding
kidney cancer
skin disease resembling psoriasis
skin cancer
paleness of the skin
increased platelets or plasma cells (a type of white blood cell) in the blood
blood clot in small blood vessels (thrombotic microangiopathy)
abnormal reaction to blood transfusions
partial or complete loss of vision
loss of libido
drooling
protruding eyes
light sensitivity
rapid breathing
rectal pain
gallstones
hernia
wounds
weak or brittle nails
abnormal protein deposits in vital organs
coma
intestinal ulcers
multi-organ failure
death.

Mantle cell lymphoma

If you are receiving Bortezomib SUN in combination with other medicines for the treatment of mantle cell lymphoma, the adverse effects you may experience include the following:

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

pneumonia
loss of appetite
tenderness, numbness, tingling, or burning sensation in the skin, or pain in hands or feet due to nerve damage
nausea or vomiting
diarrhea
mouth ulcers
constipation
muscle pain, bone pain
hair loss and abnormal hair texture
exhaustion, feeling weak
fever.

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

Herpes zoster (localized, including around the eyes, or widespread over the body)
herpes virus infection
bacterial and viral infections
respiratory infections, bronchitis, cough with phlegm, flu-like illness
fungal infections
hypersensitivity (allergic reaction)
inability to produce enough insulin or resistance to normal insulin levels
fluid retention
difficulty or problems sleeping
loss of consciousness
altered 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 during exercise
cough
hiccups
ringing in the ears, ear discomfort
intestinal or stomach bleeding
stomach burning
stomach pain, bloating
difficulty swallowing
infection or inflammation of stomach and intestine
stomach pain
mouth or lip sores, sore throat
altered liver function
itchy skin
redness of the skin
rash
muscle spasms
urinary tract infection
limb pain
body swelling, including around the eyes and other body parts
chills
redness and pain at the injection site
general malaise
weight loss
weight gain.

Uncommon adverse effects (may affect up to 1 in 100 patients)

hepatitis
severe allergic reaction (anaphylactic reaction), whose signs may include difficulty breathing, chest pain or tightness and/or dizziness/fainting, intense skin itching or skin lumps, swelling of the face, lips, tongue, and/or throat, which may cause difficulty swallowing, collapse
movement disorders, paralysis, jerking
dizziness
hearing loss, deafness
lung disorders that prevent the body from receiving enough oxygen. These may include difficulty breathing, shortness of breath, breathlessness without exertion, shallow, difficult, or stopped breathing, wheezing
blood clots in the lungs
yellowing of the eyes and skin (jaundice)
eyelid cyst (chalazion), red and swollen eyelids.

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

blood clot in small blood vessels (thrombotic microangiopathy)
severe nerve inflammation, which may cause paralysis and breathing difficulties (Guillain–Barré syndrome).

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system detailed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Bortezomib SUN

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the vial and packaging following EXP.

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

From a microbiological standpoint, the reconstituted solution should be used immediately after preparation. If the reconstituted solution is not used immediately, the storage times after reconstitution and the conditions prior to 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 a syringe; the total storage time of the reconstituted medicine must not exceed 8 hours before administration.

Bortezomib SUN is for single use only. Any unused medicine and all materials that have come into contact with it must be disposed of in accordance with local regulations.

6. Package contents and other information

Composition of Bortezomib SUN

The active substance is bortezomib. Each vial contains 3.5 mg of bortezomib (as manitol boronic ester).
The other component is mannitol (E421).

Reconstitution for intravenous administration:

After reconstitution, 1 ml of intravenous injection solution contains 1 mg of bortezomib.

Reconstitution for subcutaneous administration:

After reconstitution, 1 ml of subcutaneous injection solution contains 2.5 mg of bortezomib.

Appearance of Bortezomib SUN and contents of the pack

Bortezomib SUN 3.5 mg powder for injectable solution EFG is a lyophilised tablet or a white or almost white lyophilised powder.

Each pack of Bortezomib SUN contains a 10 ml glass vial with a light green aluminium cap, in a transparent blister. The vials are supplied with or without plastic protection (overwrap).

Marketing Authorisation Holder and Manufacturer

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132 JH Hoofddorp

The Netherlands

Further information on this medicinal product is available from the local representative of the Marketing Authorisation Holder:

List of various European countries in different languages followed by

Deutschland

Sun Pharmaceuticals Germany GmbH

Hemmelrather Weg 201

51377 Leverkusen

Germany

tel. +49 (0) 214 403 99 0

España

Sun Pharma Laboratorios, S.L.

Rambla de Catalunya 53-55

08007 Barcelona

Spain

tel. +34 93 342 78 90

France

Sun Pharma France

31 Rue des Poissonniers

92200 Neuilly-sur-Seine

France

tel. +33 1 41 44 44 50

Italia

Sun Pharma Italia Srl

Viale Giulio Richard, 1

20143 Milano

Italy

tel. +39 02 33 49 07 93

Polska

Ranbaxy (Poland) Sp. z o.o.

ul. Idzikowskiego 16

00-710 Warszawa

Poland

Tel. +48 22 642 07 75

România

Terapia S.A.

Str. Fabricii nr 124

Cluj-Napoca, Judetul Cluj

Romania

Tel. +40 (264) 501 500

Date of the most recent review of this leaflet:

Other sources of information

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

This information is intended for healthcare professionals only:

RECONSTITUTION FOR INTRAVENOUS INJECTION

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

SINCE BORTEZOMIB SUN DOES NOT CONTAIN PRESERVATIVES, STRICT ASEPTIC TECHNIQUE SHOULD BE FOLLOWED DURING HANDLING.

1.1 Preparation of a 3.5 mg vial: carefully add 3.5 ml of sterile 0.9% sodium chloride injection solution (9 mg/ml) to the vial containing Bortezomib SUN powder using an appropriately sized syringe without removing the vial stopper. Dissolution of the lyophilised powder is complete within less than 2 minutes.

The resulting solution concentration will be 1 mg/ml. The solution should be colourless and clear, with a final pH of 4 to 7. There is no need to check the pH of the solution.

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

1.3 The reconstituted solution contains no preservatives and should be used immediately after preparation. However, chemical and physical in-use stability has been demonstrated for 8 hours at 25 °C when stored in the original vial and/or syringe. The total storage time of the reconstituted medicinal product must not exceed 8 hours before administration. If the reconstituted solution is not used immediately, the storage times after reconstitution and the conditions prior to use are the responsibility of the user.

There is no need to protect the reconstituted product from light.

METHOD OF ADMINISTRATION

After dissolution, withdraw the appropriate amount of reconstituted solution according to the dose calculated based on the patient's Body Surface Area.
Confirm the dose and concentration in the syringe before use (check that the syringe is labelled for intravenous administration).
Inject the solution as an intravenous bolus over 3-5 seconds through a peripheral or central intravenous catheter into a vein.
Flush the peripheral or intravenous catheter with sterile 0.9% sodium chloride solution (9 mg/ml).

Bortezomib SUN 3.5 mg powder for injectable solution EFG MUST BE ADMINISTERED ONLY BY INTRAVENOUS OR SUBCUTANEOUS ROUTE. Do not administer by other routes. Intrathecal administration has resulted in fatal cases.

DISPOSAL

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

Disposal of unused medicinal product and all materials that have come into contact with it must be carried out in accordance with local regulations.