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BORTEZOMIB KOANAA 3.5 MG POWDER FOR SOLUTION FOR INJECTION

Active substance(s): BORTEZOMIB

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Package leaflet: Information for the user

subcutaneously as a 21-day treatment cycle and pegylated liposomal
doxorubicin 30 mg/m² is given on day 4 of the Bortezomib Koanaa 21-day
treatment cycle as an intravenous infusion after the Bortezomib Koanaa
injection.
You might receive up to 8 cycles (24 weeks).

Bortezomib Koanaa 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.

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

When Bortezomib Koanaa is given together with dexamethasone, you will
receive Bortezomib Koanaa intravenously and 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 Koanaa , 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 Koanaa
together with two other medicines; melphalan and prednisone.

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

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

Bortezomib Koanaa 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.

If you have not been treated before for multiple myeloma, and you are suitable for
blood stem cell transplantation you will receive Bortezomib Koanaa
intravenously or subcutaneously together with the medicines dexamethasone,
or dexamethasone and thalidomide, as induction treatment.

Bortezomib Koanaa is used for the treatment of multiple myeloma (a cancer of
the bone marrow) in patients older than 18 years:

When Bortezomib Koanaa is given together with dexamethasone, you will
receive Bortezomib Koanaa 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 Koanaa 21-day treatment cycle.
You will receive 4 cycles (12 weeks).

-

-

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 highdose 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 Koanaa 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 Koanaa
Do not use Bortezomib Koanaa
-

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

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.

When Bortezomib Koanaa 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 Koanaa 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 Koanaa intravenously or subcutaneously together with the
medicines rituximab, cyclophosphamide, doxorubicin and prednisone.
Bortezomib Koanaa 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 Koanaa
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
Koanaa treatment cycle.
How Bortezomib Koanaa is given
This medicine is for intravenous or subcutaneous use. Bortezomib Koanaa will
be administered by a healthcare professional experienced in the use of cytotoxic
medicines.
Bortezomib Koanaa 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 Koanaa
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

You will have to take regular blood tests before and during your treatment with
Bortezomib Koanaa, to check your blood cell counts regularly.

Like all medicines, this medicine can cause side effects, although not everybody
gets them. Some of these effects may be serious.

If you have mantle cell lymphoma and are given the medicine rituximab with
Bortezomib Koanaa 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.

If you are given Bortezomib Koanaa 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.

You must read the package leaflets of all medicinal products to be taken in
combination with Bortezomib Koanaa for information related to these medicines
before starting treatment with Bortezomib Koanaa. 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 Koanaa should not be used in children and adolescents because it is
not known how the medicine will affect them.
Other medicines and Bortezomib Koanaa
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 Koanaa if you are pregnant, unless clearly
necessary.
Both men and women receiving Bortezomib Koanaa must use effective
contraception during and for up to 3 months after treatment. If, despite these
measures, pregnancy occurs, tell your doctor immediately.

Treatment with Bortezomib Koanaa 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 Koanaa, 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 Koanaa 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)









Common side effects (may affect up to 1 in 10 people)

You should not breast-feed while using Bortezomib Koanaa. 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 Koanaa 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 Koanaa 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 Koanaa
Your doctor will work out your dose of Bortezomib Koanaa according to your
height and weight (body surface area). The usual starting dose of Bortezomib
Koanaa 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 Koanaa is given alone, you will receive 4 doses of Bortezomib
Koanaa 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 Koanaa together with the medicines
pegylated liposomal doxorubicin or dexamethasone.
When Bortezomib Koanaa is given together with pegylated liposomal
doxorubicin, you will receive Bortezomib Koanaa intravenously or

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





















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

Bortezomib

Bortezomib Koanaa 3.5 mg
powder for solution for injection

The following information is intended for healthcare professionals
only:

1. RECONSTITUTION FOR INTRAVENOUS INJECTION

Note: Bortezomib Koanaa 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 KOANAA
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 Koanaa 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).

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 20°C-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.

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.

2. ADMINISTRATION









Bortezomib Koanaa 3.5 mg powder for solution for injection
IS FOR SUBCUTANEOUS OR INTRAVENOUS USE. Do not
give by other routes. Intrathecal administra-tion 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.

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













































Heart failure, heart attack, chest pain, chest discomfort, increased or
reduced heart rate
Failing of your kidneys
Inflammation of a vein, blood clots in your veins and lungs
Problems with blood clotting
Insufficient circulation
Inflammation of the lining around your heart or fluid around your heart
Infections including urinary tract infections, the flu, herpes virus
infections, ear infection and cellulitis
Bloody stools, or bleeding from mucosal membranes, e.g., mouth, vagina
Cerebrovascular disorders
Paralysis, seizures, falling, movement disorders, abnormal or change in,
or reduced sensation (feeling, hearing, tasting, smelling), attention
disturbance, trembling, twitching
Arthritis, including inflammation of the joints in the fingers, toes, and the
jaw
Disorders that affect your lungs, preventing your body from getting
enough oxygen. Some of these include difficulty breathing, shortness of
breath, shortness of breath without exercise, breathing that becomes
shallow, difficult or stops, wheezing
Hiccups, speech disorders
Increased or decreased urine production (due to kidney damage), painful
passing of urine or blood/proteins in the urine, fluid retention
Altered levels of consciousness, confusion, memory impairment or loss
Hypersensitivity
Hearing loss, deafness or ringing in the ears, ear discomfort
Hormone abnormality which may affect salt and water absorption
Overactive thyroid gland
Inability to produce enough insulin or resistance to normal levels of insulin
Irritated or inflamed eyes, excessively wet eyes, painful eyes, dry eyes,
eye infections, discharge from the eyes, abnormal vision, bleeding of the
eye
Swelling of your lymph glands
Joint or muscle stiffness, sense of heaviness, pain in your groin
Hair loss and abnormal hair texture
Allergic reactions
Redness or pain at the injection site
Mouth pain
Infections or inflammation of the mouth, mouth ulcers, oesophagus,
stomach and intestines, sometimes associated with pain or bleeding,
poor movement of the intestines (including blockage), abdominal or
oesophageal discomfort, difficulty swallowing, vomiting of blood
Skin infections
Bacterial and viral infections
Tooth infection
Inflammation of the pancreas, obstruction of the bile duct
Genital pain, problem having an erection
Weight increase
Thirst
Hepatitis
Injection site or injection device related disorders
Skin reactions and disorders (which may be severe and life threatening),
skin ulcers
Bruises, falls and injuries
Inflammation or haemorrhage of the blood vessels that can appear as
small red or purple dots (usually on the legs) to large bruise-like patches
under the skin or tissue
Benign cysts
A severe reversible brain condition which includes seizures, high blood
pressure, headaches, tiredness, confusion, blindness or other vision
problems.

Rare side effects (may affect up to 1 in 1,000 people)








Heart problems to include heart attack, angina
Flushing
Discoloration of the veins
Inflammation of the spinal nerve
Problems with your ear, bleeding from your ear
Underactivity of your thyroid gland
Budd–Chiari syndrome (the clinical symptoms caused by blockage of the
hepatic veins)
• Changes in or abnormal bowel function
• Bleeding in the brain
• Yellow discolouration of eyes and skin (jaundice)
• Serious allergic reaction (anaphylactic shock) signs of which may include
difficulty breathing, chest pain or chest tightness, and/or feeling
dizzy/faint, severe itching of the skin or raised lumps on the skin, swelling
of the face, lips, tongue and /or throat, which may cause difficulty in
swallowing, collapse
• Breast disorders
• Vaginal tears
• Genital swelling
• Inability to tolerate alcohol consumption
• Wasting, or loss of body mass
• Increased appetite
• Fistula
• Joint effusion
• Cysts in the lining of joints (synovial cysts)
• Fracture
• Breakdown of muscle 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 Koanaa together with other medicines for the
treatment of mantle cell lymphoma the side effects you may get are listed below:

























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 intentines
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 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 Koanaa
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.
This medicine does not require any special storage conditions. Keep the vial in
the outer carton in order to protect from light.
Intravenous administration
The chemical and physical in-use stability of the reconstituted solution at a
concentration of 1 mg/ml has been demonstrated for 8 hours at 20°C-25°C
stored in the original vial and/or a syringe. From a microbiological point of view,
unless the method of opening/reconstitution/dilution precludes the risk of
microbial contamination, the reconstituted solution should be used immediately
after preparation. If not used immediately, in-use storage times and conditions
prior to use are the responsibility of the user.
Subcutaneous administration
The chemical and physical in -use stability of the reconstituted solution of 2.5
mg/ml has been demonstrated for 8 hours at 20°C-25°C stored in the original vial
and/or a syringe. From a microbiological point of view, unless the method of
opening/reconstitution/dilution precludes the risk of microbial contamination, the
reconstituted solution should be used immediately after preparation. If not used
immediately, in-use storage times and conditions prior to use are the
responsibility of the user.
Bortezomib Koanaa 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 Koanaa 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 Koanaa looks like and contents of the pack
Bortezomib Koanaa is a white to off white lyophilized powder or plug.
Each carton of Bortezomib Koanaa contains 10 mL glass vial, dark grey bromo
butyl rubber stopper with light blue colour aluminium seal.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Koanaa Healthcare Limited
4th Floor Cavendish House,
369 Burnt Oak Broadway,
Edgware, HA8 5AW Middlesex
United Kingdom.
Manufacturer:
Wave Pharma Limited.
4th Floor Cavendish House,
369 Burnt Oak Broadway,
Edgware, HA8 5AW Middlesex
United Kingdom.

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

This medicinal product is authorised in the Member States of the EEA
under the following names:
France

BORTEZOMIB KOANAA 3,5 mg, poudre pour solution
injectable
Germany
Bortezomib Koanaa 3.5 mg pulver zur Herstellung einer
Injektionslösung
Ireland
Bortezomib Koanaa 3.5 mg powder for solution for injection
Italy
Bortezomib Koanaa 3.5 mg polvere per soluzione iniettabile
Malta
Bortezomib Koanaa 3.5 mg powder for solution for injection
Netherlands
Bortezomib Koanaa 3.5 mg poeder voor oplossing voor
injectie
Romania
Bortezomib Koanaa 3.5 mg pulbere pentru soluție injectabilă
United Kingdom Bortezomib Koanaa 3.5 mg powder for solution for injection

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 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

This leaflet was last revised in 11/2016.

The following information is intended for healthcare
professionals only:

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

1. RECONSTITUTION FOR SUBCUTANEOUS INJECTION

Note: Bortezomib Koanaa 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 KOANAA
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 Koanaa 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).

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 20°C-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. ADMINISTRATION

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.

Bortezomib Koanaa 3.5 mg powder for solution for injection
IS FOR SUBCUTANEOUS OR INTRAVENOUS USE. Do not
give by other routes. Intrathecal administra-tion 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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