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BORTEZOMIB DR. REDDYS 3.5 MG POWDER FOR SOLUTION FOR INJECTION

Active substance(s): BORTEZOMIB

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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 side effects not listed in this leaflet. See section 4.

What is in this leaflet:
1.
2.
3.
4.
5.
6.

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).

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

Previously untreated multiple myeloma

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



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 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

Do not use Bortezomib


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 mantle cell lymphoma you will
receive bortezomib intravenously or subcutaneously together with the
medicines rituximab, cyclophosphamide, doxorubicin and prednisone.

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

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.
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

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 is given

This medicine is for intravenous or subcutaneous use. Bortezomib will be
administered by a healthcare 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.
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)

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



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)

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).





















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

RECONSTITUTION FOR INTRAVENOUS INJECTION

The following information is intended for healthcare professionals only:

1.
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
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).

ADMINISTRATION

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 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.

2.
It is not necessary to protect the reconstituted medicinal product from light.







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.



DISPOSAL

Bortezomib 3.5 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.

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.

Uncommon side effects (may affect up to 1 in 100 people)

Common side effects (may affect up to 1 in 10 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 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









































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 conciousness
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 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, website
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.
Do not store above 25°C. Keep the vial in the outer carton in order to
protect from light.
The reconstituted solution should be used immediately after preparation.
If the reconstituted solution is not used immediately, in-use storage times
and conditions prior to use are the responsibility of the user. However,
the reconstituted solution is stable for 8 hours at 25°C stored in the
original vial and/or a syringe, with a total storage time for the
reconstituted medicine not exceeding 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. Contents of the pack and other information
What Bortezomib powder contains



The active substance is bortezomib. Each vial contains 3.5 mg of
bortezomib (as a mannitol boronic ester).
The other ingredients are mannitol (E421) and nitrogen.

Intravenous reconstitution:
After reconstitution, 1 ml of solution for intravenous injection contains
1 mg bortezomib.
Subcutaneous reconstitution:
After reconstitution, 1 ml of solution for subcutaneous injection contains
2.5 mg bortezomib.
What Bortezomib powder 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 3.5 mg powder for solution for injection
contains a glass 10 ml vial with a stopper and a flip-off seal.
Marketing Authorisation Holder and Manufacturer
Dr. Reddy’s Laboratories (UK) Ltd., 6 Riverview Road, Beverley,
East Yorkshire, HU17 0LD, United Kingdom
This leaflet was last revised in 05/2016

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

The following information is intended for healthcare professionals only:

RECONSTITUTION FOR SUBCUTANEOUS INJECTION

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

1.

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 should be discarded. Be
sure that the correct dose is being given for the subcutaneous route of administration
(2.5 mg/ml).

ADMINISTRATION

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 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.

2.

It is not necessary to protect the reconstituted medicinal product from light.











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.

DISPOSAL

Bortezomib 3.5 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.

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

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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