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BORTEZOMIB TEVA 2.5 MG POWDER FOR SOLUTION FOR INJECTION

Active substance(s): BORTEZOMIB / BORTEZOMIB

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Package leaflet: Information for the user
Bortezomib 2.5 mg Powder for Solution for Injection

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, pharmacist or nurse.

If you get any side effects, talk to your doctor, pharmacist or nurse. 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 Powder for Solution for Injection 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.

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 if you have any of the following:

low numbers of red or white blood cells
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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 tumour 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, breast-feeding and fertility 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, pharmacist or nurse 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, breast-feeding and fertility
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
If you have not been treated before for multiple myeloma, and you are not suitable for blood stem cell
transplantation you will receive Bortezomib 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).
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Dexamethasone 40 mg 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 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.
Prednisone is given orally at 100 mg/m2 on days 1, 2, 3, 4 and 5 of the Bortezomib treatment cycle.
How Bortezomib Powder for Solution for Injection 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.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
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: may affect more than 1 in 10 peoplesensitivity, 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 being sick (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: 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
 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: 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
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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 disordersincreased 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 insulinirritated 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: 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)
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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: 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
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fever.

Common: 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
 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: 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
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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 discolouration of the eyes and skin (jaundice).

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects
not listed in this leaflet.
You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. 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. The expiry date
refers to the last day of that month.
This medicinal product does not require any special temperature storage conditions. Keep the vial in the
outer carton in order to protect from light.
Chemical and physical in-use stability of the reconstituted solution has been demonstrated for 8 hours at
25°C (stored in the original vial and/or a syringe). From a microbiological point of view, unless the method
of opening/reconstitution precludes the risk of microbial contamination, the product should be used
immediately.
If not used immediately, in-use storage times and conditions are the responsibility of the user.
Bortezomib is for single use only.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures will help protect the environment.
6.

Contents of the pack and other information

What Bortezomib Powder for Solution for Injection contains
 The active substance is bortezomib. Each vial contains 2.5 mg of bortezomib (as a mannitol boronic
ester).
 The other ingredients are mannitol (E421).
Intravenous reconstitution:
After reconstitution with 2.5 ml, 1 ml of solution for intravenous injection contains 1 mg bortezomib.
Subcutaneous reconstitution:
After reconstitution with 1 ml, 1 ml of solution for subcutaneous injection contains 2.5 mg bortezomib.
What Bortezomib Powder for Solution for Injection looks like and contents of the pack
Bortezomib powder for solution for injection is a white to off-white cake or powder.
Each carton of Bortezomib 2.5 mg powder for solution for injection contains a glass vial with a grey stopper,
and grey aluminium cap with an orange flip-off disc. The vials are sleeved (provided with a protective
transparent cover).

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Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: TEVA UK Limited, Eastbourne, BN22 9AG, United Kingdom
Manufacturer:
TEVA Gyógyszergyár Zrt., Táncsics Mihály út 82., Gödöllő, H-2100, Hungary
OR*
Teva Operations Poland Sp. z.o.o, ul. Mogilska 80, Kraków, 31-546, Poland
OR*
PLIVA Hrvatska d.o.o. (PLIVA Croatia Ltd.), Prilaz baruna Filipovića 25, Zagreb, 10000, Croatia
This leaflet was last revised in 06/2017
PL 00289/2104
*Only

the actual site of batch release will appear on the printed version of the leaflet
----------------------------------------------------------------------------------------------------------------------------------------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 and protect the user is recommended.
ASEPTIC TECHNIQUE MUST BE STRICTLY OBSERVED THROUGHOUT HANDLING OF
BORTEZOMIB SINCE NO PRESERVATIVE IS PRESENT.
1.1.

Preparation of the 2.5 mg vial: add 2.5 ml of sterile, 9 mg/ml (0.9%) sodium chloride solution for
injection to the vial containing the Bortezomib powder without removing the stopper. Dissolution of
the lyophilised 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 of the reconstituted solution when prepared as
described above has been demonstrated for 8 hours at 25°C 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.

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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 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 2.5 mg 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.
----------------------------------------------------------------------------------------------------------------------------------------The following information is intended for healthcare professionals only:
Only the 2.5 mg and 3.5 mg vials 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 and other protective clothing to prevent skin contact and protect the user is recommended.
ASEPTIC TECHNIQUE MUST BE STRICTLY OBSERVED THROUGHOUT HANDLING OF
BORTEZOMIB SINCE NO PRESERVATIVE IS PRESENT.
1.1

Preparation of the 2.5 mg vial: add 1 ml of sterile, 9 mg/ml (0.9%) sodium chloride solution for
injection to the vial containing the Bortezomib powder without removing the stopper. 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.

1.1

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 (2.5 mg/ml).

1.3

The reconstituted product is preservative free and should be used immediately after preparation.
However, the chemical and physical in-use stability of the reconstituted solution when prepared as
described above has been demonstrated for 8 hours at 25°C 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
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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
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 2.5 mg 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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REG0214674

Version 0.10

Approved

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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