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BORTEZOMIB 3.5 MG POWDER FOR SOLUTION FOR INJECTION

Active substance(s): BORTEZOMIB / BORTEZOMIB

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Bortezomib 3.5mg powder for solution for injection
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 further questions, ask your doctor or pharmacist.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Bortezomib is and what it is used for
2. What you need to know before you use
Bortezomib
3. How to use Bortezomib
4. Possible side effects
5. How to store Bortezomib
6. Contents of the pack and other information

1. W
 HAT BORTEZOMIB IS AND
WHAT IT IS USED FOR

Bortezomib contains the active substance
bortezomib, a so-called ‘proteasome inhibitor’.
Proteasomes play an important role in
controlling cell function and growth. By
interfering with their function, bortezomib can
kill cancer cells.
Bortezomib is used for the treatment of multiple
myeloma (a cancer of the bone marrow) in
patients older than 18 years:
• alone or together with the medicines
pegylated liposomal doxorubicin or
dexamethasone, for patients whose disease is
worsening (progressive) after receiving at least
one prior treatment and for whom blood
stem cell transplantation was not successful
or is unsuitable.
• in combination with the medicines melphalan
and prednisone, for patients whose disease
has not been previously treated and are
unsuitable for high-dose chemotherapy with
blood stem cell transplantation.
• in combination with the medicines
dexamethasone or dexamethasone together
with thalidomide, for patients whose disease
has not been previously treated and before
receiving high-dose chemotherapy with blood
stem cell transplantation (induction treatment).
Bortezomib is used for the treatment of mantle
cell lymphoma (a type of cancer affecting the
lymph nodes) in patients 18 years or older in
combination with the medicines rituximab,
cyclophosphamide, doxorubicin and prednisone,
for patients whose disease has not been
previously treated and for whom blood stem cell
transplantation is unsuitable.

2. W
 HAT YOU NEED TO KNOW BEFORE
YOU USE BORTEZOMIB
Do not use Bortezomib
• if you are allergic to bortezomib, 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
Talk to your doctor or pharmacist before using
Bortezomib, if you have any of the following:
• low numbers of red or white blood cells
• bleeding problems and/or low number of
platelets in your blood
• diarrhoea, constipation, nausea or vomiting
• fainting, dizziness or light-headedness in
the past
• kidney problems
• moderate to severe liver problems
• numbness, tingling, or pain in the hands or
feet (neuropathy) in the past
• heart or blood pressure problems
• shortness of breath or cough
• seizures
• shingles (localised including around the eyes
or spread across the body)
• symptoms of tumor lysis syndrome such as
muscle cramping, muscle weakness,
confusion, visual loss or disturbances and
shortness of breath
• memory loss, trouble thinking, difficulty with
walking or loss of vision. These may be signs
of a serious brain infection and your doctor
may suggest further testing and follow-up.
You will have to take regular blood tests before
and during your treatment with Bortezomib, to
check your blood cell counts regularly.
If you have mantle cell lymphoma and are given
the medicine rituximab with Bortezomib you
should tell your doctor:
• if you think you have hepatitis infection now or
have had it in the past. In a few cases, patients
who have had hepatitis B might have a
repeated attack of hepatitis, which can be fatal.
If you have a history of hepatitis B infection
you will be carefully checked by your doctor
for signs of active hepatitis B.
You must read the package leaflets of all
medicinal products to be taken in combination
with Bortezomib for information related to these
medicines before starting treatment with
Bortezomib. When thalidomide is used,
particular attention to pregnancy testing and
prevention requirements is needed (see
Pregnancy and breast-feeding in this section).
Children and adolescents
Bortezomib should not be used in children and
adolescents because it is not known how the
medicine will affect them.
Other medicines and Bortezomib
Tell your doctor or pharmacist if you are using,
have recently used or might use any other
medicines, including medicines obtained without
a prescription.
In particular, tell your doctor if you are using
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 antidiabetics
Pregnancy and breast-feeding
You should not use Bortezomib if you are
pregnant, unless clearly necessary.
Both men and women receiving Bortezomib
must use effective contraception during and for
up to 3 months after treatment. If, despite these
measures, pregnancy occurs, tell your doctor
immediately.
You should not breast-feed while using Bortezomib.
Discuss with your doctor when it is safe to
restart breast-feeding after finishing your
treatment.
Thalidomide causes birth defects and foetal
death. When Bortezomib is given in combination
with thalidomide you must follow the pregnancy
prevention programme for thalidomide (see
package leaflet for thalidomide).
Driving and using machines
Bortezomib might cause tiredness, dizziness,
fainting, or blurred vision. Do not drive or
operate tools or machines if you experience such
side effects; even if you do not, you should still
be cautious.

3. HOW TO USE BORTEZOMIB

Your doctor will work out your dose of
Bortezomib according to your height and weight
(body surface area). The usual starting dose of
Bortezomib is 1.3mg/m2 body surface area twice
a week. Your doctor may change the dose and
total number of treatment cycles, depending on
your response to the treatment on the
occurrence of certain side effects and on your
underlying conditions (e.g. liver problems).
Progressive multiple myeloma
When Bortezomib is given alone, you will receive
4 doses of Bortezomib 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) corresponds to one
treatment cycle. You might receive up to 8 cycles
(24 weeks).
You may also be given Bortezomib together with
the medicines pegylated liposomal doxorubicin
or dexamethasone.
When Bortezomib is given together with
pegylated liposomal doxorubicin, you will
receive Bortezomib intravenously or
subcutaneously as a 21-day treatment cycle and
pegylated liposomal doxorubicin 30mg/m2 is
given on day 4 of the Bortezomib 21-day
treatment cycle as an intravenous infusion after
the Bortezomib injection.
You might receive up to 8 cycles (24 weeks).
When Bortezomib is given together with
dexamethasone, you will receive Bortezomib
intravenously or subcutaneously as a 21-day
treatment cycle and dexamethasone 20mg is

given orally on days 1, 2, 4, 5, 8, 9, 11, and 12,
of the Bortezomib, 21-day treatment cycle.
You might receive up to 8 cycles (24 weeks).
Previously untreated multiple myeloma
If you have not been treated before for multiple
myeloma, and you are not suitable for blood
stem cell transplantation you will receive
Bortezomib intravenously together with two
other medicines, 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 is administered
twice weekly on days 1, 4, 8, 11, 22, 25, 29
and 32.
• In cycles 5 to 9, Bortezomib is administered
once weekly on days 1, 8, 22 and 29.
Melphalan (9mg/m2) and prednisone (60mg/m2)
are both given orally on days 1, 2, 3 and 4 of the
first week of each cycle.
If you have not been treated before for multiple
myeloma, and you are suitable for blood stem
cell transplantation you will receive
Bortezomib intravenously or subcutaneously
together with the medicines dexamethasone,
or dexamethasone and thalidomide, as
induction treatment.
When Bortezomib is given together with
dexamethasone, you will receive Bortezomib
intravenously or subcutaneously as a 21-day
treatment cycle and dexamethasone 40mg is
given orally on days 1, 2, 3, 4, 8, 9, 10 and 11 of
the Bortezomib 21-day treatment cycle.
You will receive 4 cycles (12 weeks).
When Bortezomib is given together with
thalidomide and dexamethasone, the duration of
a treatment cycle is 28 days (4 weeks).
Dexamethasone 40mg is given orally on days 1,
2, 3, 4, 8, 9, 10 and 11 of the Bortezomib 28-day
treatment cycle and thalidomide is given orally
daily at 50mg up to day 14 of the first cycle, and
if tolerated the thalidomide dose is increased to
100mg on days 15-28 and may be further
increased to 200mg daily from the second
cycle onwards.
You might receive up to 6 cycles (24 weeks).
Previously untreated mantle cell lymphoma
If you have not been treated before for mantle
cell lymphoma you will receive Bortezomib
intravenously or subcutaneously together with
the medicines rituximab, cyclophosphamide,
doxorubicin and prednisone.
Bortezomib is given intravenously 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 might receive up to 8
cycles (24 weeks).
The following medicinal products are given on
day 1 of each Bortezomib 21-day treatment cycle
as intravenous infusions:
Rituximab at 375mg/m2, cyclophosphamide at
750mg/m2 and doxorubicin at 50mg/m2.
Prednisone is given orally at 100mg/m2 on
days 1, 2, 3, 4 and 5 of the Bortezomib
treatment cycle.
How Bortezomib is given
This medicine is for intravenous or
subcutaneous use. Bortezomib will be
administered by a health care professional
experienced in the use of cytotoxic medicines.
Bortezomib powder has to be dissolved before
administration. This will be done by a healthcare
professional. The resulting solution is then either
injected into a vein or under the skin. Injection
into a vein is rapid, taking 3 to 5 seconds.
Injection under the skin is in either the thighs or
the abdomen.
If you are given too much Bortezomib
As this medicine is being given by your doctor or
nurse, it is unlikely that you will be given too
much. In the unlikely event of an overdose, your
doctor will monitor you for side effects.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side
effects, although not everybody gets them. Some
of these effects may be serious.
If you are given Bortezomib for multiple
myeloma or mantle cell lymphoma, tell your
doctor straight away if you notice any of the
following symptoms:
• muscle cramping, muscle weakness
• confusion, visual loss or disturbances,
blindness, seizures, headaches
• shortness of breath, swelling of your feet or
changes in your heartbeat, high blood
pressure, tiredness, fainting
• coughing and breathing difficulties or
tightness in the chest.
Treatment with Bortezomib can very commonly
cause a decrease in the numbers of red and
white blood cells and platelets in your blood.
Therefore, you will have to take regular blood
tests before and during your treatment with
Bortezomib, to check your blood cell counts
regularly. You may experience a reduction in the
number of:
• platelets, which may make you be more prone
to bruising, or to bleeding without obvious
injury (e.g. bleeding from your bowels,
stomach, mouth and gum or bleeding in the
brain or bleeding from the liver)
• red blood cells, which can cause anaemia, with
symptoms such as tiredness and paleness
• white blood cells may make you more prone
to infections or flu-like symptoms
If you are given Bortezomib for the treatment of
multiple myeloma the side effects you may get
are listed below:
Very common side effects
(may affect more than 1 in 10 people)
• Sensitivity, numbness, tingling or burning
sensation of the skin, or pain in the hands or
feet, due to nerve damage
• Reduction in the number of red blood cells
and or white blood cells (see above)
• Fever
• Feeling sick (nausea) or vomiting, loss of
appetite
• Constipation with or without bloating
(can be severe)
• Diarrhoea: if this happens, it is important that
you drink more water than usual. Your doctor
may give you another medicine to control
diarrhoea
• Tiredness (fatigue), feeling weak
• Muscle pain, bone pain
Common side effects
(may affect up to 1 in 10 people)
• Low blood pressure, sudden fall of blood
pressure on standing which may lead to
fainting
• High blood pressure
• Reduced functioning of your kidneys
• Headache
• General ill feeling, pain, vertigo, lightheadedness, a feeling of weakness or loss of
consciousness
• Shivering
• Infections, including pneumonia, respiratory
infections, bronchitis, fungal infections,
coughing with phlegm, flu-like illness
• Shingles (localised including around the eyes
or spread across the body)
• Chest pains or shortness of breath with
exercise
• Different types of rash
• Itching of the skin, lumps on the skin or
dry skin
• Facial blushing or tiny broken capillaries
• Redness of the skin
• Dehydration
• Heartburn, bloating, belching, wind, stomach
pain, bleeding from your bowels or stomach
• Alteration of liver functioning
• A sore mouth or lip, dry mouth, mouth ulcers
or throat pain
• Weight loss, loss of taste
• Muscle cramps, muscle spasms, muscle
weakness, pain in your limbs
• Blurred vision
• Infection of the outermost layer of the eye and
the inner surface of the eyelids (conjunctivitis)
• Nose bleeds
• Difficulty or problems in sleeping, sweating,
anxiety, mood swings, depressed mood,
restlessness or agitation, changes in your
mental status, disorientation
• Swelling of body, to include around eyes and
other parts of the body

The following information is intended for healthcare professionals only:
1 RECONSTITUTION FOR INTRAVENOUS INJECTION
Note: Bortezomib is a cytotoxic agent. Therefore, caution should be used during handling and
preparation. Use of gloves, eye protection and other protective clothing to prevent skin contact
is recommended.
Pregnant personnel should not handle this medicine.
ASEPTIC TECHNIQUE MUST BE STRICTLY OBSERVED THROUGHOUT HANDLING OF BORTEZOMIB
SINCE NO PRESERVATIVE IS PRESENT.
1.1 
Preparation of the 3.5mg vial: add 3.5ml of sterile, 9mg/ml (0.9%) sodium chloride solution
for injection to the vial containing the Bortezomib powder. Dissolution of the lyophilised powder
is completed in less than 2 minutes.
The concentration of the resulting solution will be 1mg/ml. The solution will be clear and
colourless, with a final pH of 4 to 7. You do not need to check the pH of the solution.
1.2 Before administration, visually inspect the solution for particulate matter and discolouration.
If any discolouration or particulate matter is observed, the solution should be discarded.
Be sure that the correct dose is being given for the intravenous route of administration
(1mg/ml).
1.3 The reconstituted solution is preservative free and should be used immediately after
preparation. However, the chemical and physical in-use stability has been demonstrated for 8
hours at 25°C in the dark stored in the original vial and/or a syringe. The total storage time for
the reconstituted medicinal product should not exceed 8 hours prior to administration. If the
reconstituted solution is not used immediately, in-use storage times and conditions prior to use
are the responsibility of the user.
It is not necessary to protect the reconstituted medicinal product from light.
2 ADMINISTRATION
• Once dissolved, withdraw the appropriate amount of the reconstituted solution according to
calculated dose based upon the patient´s Body Surface Area.
• Confirm the dose and concentration in the syringe prior to use (check that the syringe is marked
as intravenous administration).
• Inject the solution as a three to five second bolus intravenous injection through a peripheral or
central intravenous catheter into a vein.
• Flush the peripheral or intravenous catheter with sterile, 9mg/ml (0.9%) sodium chloride solution.
Bortezomib 3.5mg powder for solution for injection IS FOR SUBCUTANEOUS OR INTRAVENOUS
USE ONLY. Do not give by other routes. Intrathecal administration has resulted in death.
3 DISPOSAL
A vial is for single use only and the remaining solution must be discarded.
Any unused product or waste material should be disposed of in accordance with local requirements.
(continued overleaf)

Uncommon side effects
(may affect up to 1 in 100 people)
• Heart failure, heart attack, chest pain, chest
discomfort, increased or reduced heart rate
• Failing of your kidneys
• Inflammation of a vein, blood clots in your
veins and lungs
• Problems with blood clotting
• Insufficient circulation
• Inflammation of the lining around your heart
or fluid around your heart
• Infections including urinary tract infections,
the flu, herpes virus infections, ear infection
and cellulitis
• Bloody stools, or bleeding from mucosal
membranes, e.g. mouth, vagina
• Cerebrovascular disorders
• Paralysis, seizures, falling, movement
disorders, abnormal or change in, or reduced
sensation (feeling, hearing, tasting, smelling),
attention disturbance, trembling, twitching
• Arthritis, including inflammation of the joints
in the fingers, toes, and the jaw
• Disorders that affect your lungs, preventing
your body from getting enough oxygen. Some
of these include difficulty breathing, shortness
of breath, shortness of breath without
exercise, breathing that becomes shallow,
difficult or stops, wheezing
• Hiccups, speech disorders
• Increased or decreased urine production (due
to kidney damage), painful passing of urine or
blood/proteins in the urine, fluid retention
• Altered levels of consciousness, confusion,
memory impairment or loss
• Hypersensitivity
• Hearing loss, deafness or ringing in the ears,
ear discomfort
• Hormone abnormality which may affect salt
and water absorption
• Overactive thyroid gland
• Inability to produce enough insulin or
resistance to normal levels of insulin
• Irritated or inflamed eyes, excessively wet
eyes, painful eyes, dry eyes, eye infections,
discharge from the eyes, abnormal vision,
bleeding of the eye
• Swelling of your lymph glands
• Joint or muscle stiffness, sense of heaviness,
pain in your groin
• Hair loss and abnormal hair texture
• Allergic reactions
• Redness or pain at the injection site
• Mouth pain
• Infections or inflammation of the mouth,
mouth ulcers, oesophagus, stomach and
intestines, sometimes associated with pain or
bleeding, poor movement of the intestines
(including blockage), abdominal or
oesophageal discomfort, difficulty swallowing,
vomiting of blood
• Skin infections
• Bacterial and viral infections
• Tooth infection
• Inflammation of the pancreas, obstruction of
the bile duct
• Genital pain, problem having an erection
• Weight increase
• Thirst
• Hepatitis
• Injection site or injection device related
disorders
• Skin reactions and disorders (which may be
severe and life threatening), skin ulcers
• Bruises, falls and injuries
• Inflammation or haemorrhage of the blood
vessels that can appear as small red or purple
dots (usually on the legs) to large bruise-like
patches under the skin or tissue
• Benign cysts
• A severe reversible brain condition which
includes seizures, high blood pressure,
headaches, tiredness, confusion, blindness or
other vision problems.
Rare side effects
(may affect up to 1 in 1,000 people)
• Heart problems to include heart attack, angina
• Flushing
• Discoloration of the veins
• Inflammation of the spinal nerve
• Problems with your ear, bleeding from your ear
• Underactivity of your thyroid gland
• Budd-Chiari syndrome (the clinical symptoms
caused by blockage of the hepatic veins)
• Changes in or abnormal bowel function
• Bleeding in the brain
• Yellow discolouration of eyes and skin
(jaundice)
• Serious allergic reaction (anaphylactic shock)
signs of which may include difficulty
breathing, chest pain or chest tightness, and/
or feeling dizzy/faint, severe itching of the skin
or raised lumps on the skin, swelling of the
face, lips, tongue and /or throat, which may
cause difficulty in swallowing, collapse
• Breast disorders
• Vaginal tears
• Genital swelling
• Inability to tolerate alcohol consumption
• Wasting, or loss of body mass
• Increased appetite
• Fistula
• Joint effusion
• Cysts in the lining of joints (synovial cysts)
• Fracture
• Breakdown of muscle fibres leading to other
complications
• Swelling of the liver, bleeding from the liver
• Cancer of the kidney
• Psoriasis-like skin condition
• Cancer of the skin
• Paleness of the skin
• Increase of platelets or plasma cells (a type of
white cell) in the blood
• Abnormal reaction to blood transfusions
• Partial or total loss of vision
• Decreased sex drive
• Drooling
• Bulging eyes
• Sensitivity to light
• Rapid breathing
• Rectal pain
• Gallstones
• Hernia
• Injuries
• Brittle or weak nails
• Abnormal protein deposits in your vital organs
• Coma
• Intestinal ulcers
• Multi-organ failure
• Death
If you are given Bortezomib together with other
medicines for the treatment of mantle cell
lymphoma the side effects you may get 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 of the skin, or pain in the hands or
feet, due to nerve damage
• Nausea and vomiting
• Diarrhoea
• Mouth ulcers
• Constipation
• Muscle pain, bone pain
• Hair loss and abnormal hair texture
• Tiredness, feeling weak
• Fever
Common side effects
(may affect up to 1 in 10 people)
• Shingles (localised including around the eyes
or spread across the body)
• Herpes virus infections
• Bacterial and viral infections
• Respiratory infections, bronchitis, coughing
with phlegm, flu-like illness
• Fungal infections
• Hypersensitivity (allergic reaction)
• Inability to produce enough insulin or
resistance to normal levels of insulin
• Fluid retention
• Difficulty or problems in sleeping
• Loss of consciousness
• Altered level of consciousness, confusion
• Feeling dizzy
• Increased heartbeat, high blood pressure,
sweating
• Abnormal vision, blurred vision
• Heart failure, heart attack, chest pain, chest
discomfort, increased or reduced heart rate
• High or low blood pressure
• Sudden fall of blood pressure upon standing
which may lead to fainting
• Shortness of breath with exercise
• Cough
• Hiccups
• Ringing in the ears, ear discomfort
• Bleeding from your bowels or stomach
• Heartburn
• Stomach pain, bloating

• Difficulty swallowing
• Infection or inflammation of the stomach and
intestines
• Stomach pain
• Sore mouth or lip, throat pain
• Alteration of liver function
• Itching of skin
• Redness of skin
• Rash
• Muscle spasms
• Muscle pain, bone pain
• Infection of the urinary tract
• Pain in limbs
• Swelling of body, to include eyes and other
parts of the body
• Shivering
• Redness and pain at injection site
• General ill feeling
• Weight loss
• Weight increase
Uncommon side effects
(may affect up to 1 in 100 people)
• Hepatitis
• Severe allergic reaction (anaphylactic reaction)
signs of which may include difficulty
breathing, chest pain or chest tightness, and/
or feeling dizzy/faint, severe itching of the skin
or raised lumps on the skin, swelling of the
face, lips, tongue and /or throat, which may
cause difficulty in swallowing, collapse
• Movement disorders, paralysis, twitching
• Vertigo
• Hearing loss, deafness
• Disorders that affect your lungs, preventing
your body from getting enough oxygen. Some of
these include difficulty breathing, shortness of
breath, shortness of breath without exercise,
breathing that becomes shallow, difficult or
stops, wheezing
• Blood clots in your lungs
• Yellow discoloration of the eyes and skin
(jaundice)
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side
effects not listed in this leaflet.
United Kingdom: You can also report side
effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.
Ireland: You can also report side effects directly
via: HPRA Pharmacovigilance, Earlsfont Terrace,
IRL - Dublin 2. Tel: +352 1 6764971.
Fax +353 1 6762517, Website: www.hpra.ie,
email: medsafety@hpra.ie.
By reporting side effects you can help provide
more information on the safety of this medicine.

5. HOW TO STORE BORTEZOMIB

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 the carton after EXP.
Keep the vial in the outer carton in order to
protect from light.
This medicine does not require any special
temperature storage conditions.
Reconstituted solution
The reconstituted solution should be used
immediately after preparation. If not used
immediately, in-use storage times and conditions
prior to use are the responsibility of the user.
However, the chemical and physical stability of the
reconstituted solution has been demonstrated
for 8 hours at 25°C in the dark when stored in a
vial and in a polypropylene syringe.
The total storage time for the reconstituted
medicinal product should not exceed 8 hours
prior to administration.
Bortezomib is for single use only. Any unused
product or waste material should be disposed of
in accordance with local requirements.

6. C
 ONTENTS OF THE PACK AND
OTHER INFORMATION
What Bortezomib contains
• The active substance is bortezomib. Each vial
contains 3.5mg of bortezomib (as a mannitol
boronic ester).
• The other ingredient is mannitol (E421).
Intravenous reconstitution:
After reconstitution, 1ml of solution for
intravenous injection contains 1mg bortezomib.
Subcutaneous reconstitution:
After reconstitution, 1ml of solution for
subcutaneous injection contains 2.5mg
bortezomib.
What Bortezomib looks like and
contents of the pack
Bortezomib powder for solution for injection is a
white to off-white cake or powder.
Bortezomib is packed in a glass vial with rubber
stopper and a blue flip-off cap.
Each pack contains 1 single-use vial.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
Aspire Pharma Limited
Unit 4, Rotherbrook Court
Bedford Road
Petersfield
Hampshire
GU32 3QG
UK
Manufacturer(s)
Synthon Hispania SL
C/Castelló no1
Pol. Las Salinas
Sant Boi de Llobregat
Barcelona,
08830
Spain
or
Synthon s.r.o.
Brnĕnská 32/čp. 597,
Blansko
678 01
Czech Republic
This leaflet was last revised
03/2017

0000000-P1.7

The following information is intended for healthcare professionals only:
Only the 3.5mg vial can be administered subcutaneously, as described below.
1 RECONSTITUTION FOR SUBCUTANEOUS INJECTION
Note: Bortezomib is a cytotoxic agent. Therefore, caution should be used during handling and
preparation. Use of gloves, eye protection and other protective clothing to prevent skin contact
is recommended.
Pregnant personnel should not handle this medicine.
ASEPTIC TECHNIQUE MUST BE STRICTLY OBSERVED THROUGHOUT HANDLING OF BORTEZOMIB
SINCE NO PRESERVATIVE IS PRESENT.
1.1 Preparation of the 3.5mg vial: add 1.4ml of sterile, 9mg/ml (0.9%) sodium chloride solution for
injection to the vial containing the Bortezomib powder. Dissolution of the lyophilised powder is
completed in less than 2 minutes.
The concentration of the resulting solution will be 2.5mg/ml. The solution will be clear and
colourless, with a final pH of 4 to 7. You do not need to check the pH of the solution.
1.2 Before administration, visually inspect the solution for particulate matter and discolouration. If
any discolouration or particulate matter is observed, the solution should be discarded. Be sure
that the correct dose is being given for the subcutaneous route of administration (2.5mg/ml).
1.3 The reconstituted product is preservative free and should be used immediately after
preparation. However, the chemical and physical in-use stability has been demonstrated for 8
hours at 25°C in the dark stored in the original vial and/or a syringe. The total storage time for
the reconstituted medicinal product should not exceed 8 hours prior to administration. If the
reconstituted solution is not used immediately, in-use storage times and conditions prior to use
are the responsibility of the user.
It is not necessary to protect the reconstituted medicinal product from light.
2. ADMINISTRATION
• Once dissolved, withdraw the appropriate amount of the reconstituted solution according to
calculated dose based upon the patient´s Body Surface Area.
• Confirm the dose and concentration in the syringe prior to use. (check that the syringe is
marked as subcutaneous administration).
• Inject the solution subcutaneously, under a 45-90°angle.
• The reconstituted solution is administered subcutaneously through the thighs (right or left) or
abdomen (right or left).
• Injection sites should be rotated for successive injections.
• If local injection site reactions occur following Bortezomib injection subcutaneously, either a
less concentrated Bortezomib solution (1mg/ml instead of 2.5mg/ml) may be administered
subcutaneously or a switch to intravenous injection is recommended.
Bortezomib 3.5mg powder for solution for injection IS FOR SUBCUTANEOUS OR INTRAVENOUS
USE. Do not give by other routes. Intrathecal administration has resulted in death.
3. DISPOSAL
A vial is for single use only and the remaining solution must be discarded.
Any unused product or waste material should be disposed of in accordance with local requirements.

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Source: Medicines and Healthcare Products Regulatory Agency

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