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BORTEZOMIB EBEWE 3.5 MG POWDER FOR SOLUTION FOR INJECTION

Active substance(s): BORTEZOMIB

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Sandoz Ltd
Bortezomib 3.5 mg powder for solution for injection

Patient Information Leaflet
PL 04416/1511

Page 1
11/07/17

Package leaflet: Information for the user
Bortezomib 3.5 mg 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. What 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
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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. What 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, pharmacist or nurse before using Bortezomib.
You should tell your doctor 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.

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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
Please tell your doctor, or pharmacist if you are taking, have recently taken or might take any
other medicines.
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.

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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 1.3 mg/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 30 mg/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 20 mg 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

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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 or subcutaneously
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 (9 mg/m2) and prednisone (60 mg/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 40 mg 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 40 mg is given orally on days 1, 2, 3, 4, 8, 9, 10 and 11 of the Bortezomib 28day treatment cycle and thalidomide is given orally daily at 50 mg up to day 14 of the first
cycle, and if tolerated the thalidomide dose is increased to 100 mg on days 15-28 and may be
further increased to 200 mg 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 or subcutaneously 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 375 mg/m2, cyclophosphamide at 750 mg/m2 and doxorubicin at 50 mg/m2.
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Prednisone is given orally at 100 mg/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 heart beat, 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.
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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, light-headedness, 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
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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

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
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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 (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
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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 fibers 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)
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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 (localized 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
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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
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. You can also report side effects directly via
the Yellow Card Scheme: www.mhra.gov.uk/yellowcard. By reporting side effects you can
help provide more information on the safety of this medicine.

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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.
The expiry date refers to the last day of that month.
This medicine does not require any special temperature storage conditions.
Keep the vial in the outer carton in order to protect from light.
Intravenous administration:
The reconstituted solution is stable for 7 days at 20°C-25°C and for 7 days at 2°C-8°C stored
in the original vial and/or a syringe. From a microbiological point of view, the product should
be used immediately. If not used immediately, in-use storage times and conditions prior to
use are the responsibility of the user and would normally not be longer than 24 hours at 2-8°C,
unless reconstitution/dilution has taken place in controlled and validated aseptic conditions.
Subcutaneous administration:
The reconstituted solution is stable for 7 days at 20°C-25°C stored in the original vial and/or a
syringe. From a microbiological point of view, the product should be used immediately. If not
used immediately, in-use storage times and conditions prior to use are the responsibility of the
user and would normally not be longer than 24 hours at 2-8°C, unless reconstitution/dilution
has taken place in controlled and validated aseptic conditions.
Bortezomib 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.
6. Contents of the pack and other information
What Bortezomib contains
The active substance is bortezomib.
The other ingredient is mannitol (E421).
Each vial contains 3.5 mg of bortezomib (as a mannitol boronic ester).
Intravenous reconstitution:
After reconstitution with 3.5 ml, 1 ml of solution for intravenous injection contains 1 mg
bortezomib.
Subcutaneous reconstitution:
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After reconstitution with 1.4 ml, 1 ml of solution for subcutaneous injection contains 2.5 mg
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.
Pack sizes: 1, 3, 5 or 10 vials with or without a protective plastic overwrap.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sandoz Limited
Frimley Business Park,
Frimley,
Camberley,
Surrey,
GU16 7SR
United Kingdom

Manufacturer

Lek Pharmaceuticals d.d.,
Verovškova ulica 57,
1526 Ljubljana,
Slovenia
Or
EBEWE Pharma Ges.m.b.H. Nfg. KG,
Mondseestraße 11,
Unterach, 4866,
Austria

This leaflet was last revised in 07/2017
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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 and other protective clothing to prevent skin contact is
recommended.
ASEPTIC TECHNIQUE MUST BE STRICTLY OBSERVED THROUGHOUT HANDLING
OF Bortezomib SINCE NO PRESERVATIVE IS PRESENT.
1.1 Preparation of the 3.5 mg vial: add 3.5 ml of sterile, 9 mg/ml (0.9%) sodium chloride
solution for injection to the vial containing the Bortezomib powder. Dissolution of the
lyophilized powder is completed in less than 2 minutes.
The concentration of the resulting solution will be 1 mg/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 (1 mg/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 7 days at 20°C-25°C and for 7 days at 2°C-8°C stored in the original
vial and/or a syringe. From a microbiological point of view, the product should be
used immediately. If not used immediately, in-use storage times and conditions prior
to use are the responsibility of the user and would normally not be longer than 24
hours at 2-8°C, unless reconstitution/dilution has taken place in controlled and
validated aseptic conditions.
It is not necessary to protect the reconstituted medicinal product from light.
2. ADMINISTRATION

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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 3-5 second bolus intravenous injection through a peripheral or
central intravenous catheter into a vein.
Flush the peripheral or intravenous catheter with sterile, 9 mg/ml (0.9%) sodium
chloride solution.

{Bortezomib 3.5 mg powder for solution for injection} IS ONLY FOR
SUBCUTANEOUS OR INTRAVENOUS USE. Do not give by other routes. Intrathecal
administration of bortezomib has resulted in death.
3. DISPOSAL
Bortezomib 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 for
cytotoxic agents.

RECONSTITUTION FOR SUBCUTANEOUS INJECTION
Note: Bortezomib is a cytotoxic agent. Therefore, caution should be used during handling and
preparation. Use of gloves and other protective clothing to prevent skin contact is
recommended.
ASEPTIC TECHNIQUE MUST BE STRICTLY OBSERVED THROUGHOUT HANDLING
OF Bortezomib SINCE NO PRESERVATIVE IS PRESENT.
1.1 Preparation of the 3.5 mg vial: add 1.4 ml of sterile, 9 mg/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 2.5 mg/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
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Bortezomib 3.5 mg powder for solution for injection

Patient Information Leaflet
PL 04416/1511

Page 17
11/07/17

should be discarded. Be sure that the correct dose is being given for the subcutaneous
route of administration (2.5 mg/ml).
2. 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 7 days at 20°C -25°C stored in the original vial and/or a syringe.
From a microbiological point of view, the product should be used immediately. If not
used immediately, in-use storage times and conditions prior to use are the
responsibility of the user and would normally not be longer than 24 hours at 2-8°C,
unless reconstitution/dilution has taken place in controlled and validated aseptic
conditions.
It is not necessary to protect the reconstituted medicinal product from light.
3.

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 (1 mg/ml instead of 2.5 mg/ml) may be
administered subcutaneously or a switch to intravenous injection is recommended.

{Bortezomib 3.5 mg powder for solution for injection} IS ONLY FOR
SUBCUTANEOUS OR INTRAVENOUS USE. Do not give by other routes. Intrathecal
administration of Bortezomib has resulted in death.
3. DISPOSAL
Bortezomib 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 for
cytotoxic agents.

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