BEKEMV 300 mg Koncentrat Do Sporządzania Roztworu Do Infuzji

Treść ulotki

1. BEKEMV 300 mg concentrate for solution for infusion
   1. What is BEKEMV and what is it used for
   2. What you need to know before you use BEKEMV
   3. How to use BEKEMV
   4. Possible side effects
   5. How to store BEKEMV
   6. Contents of the pack and other information
   7. How is BEKEMV supplied?
   8. Before administration
   9. Administration
   10. Special precautions for handling and storage

BEKEMV 300 mg concentrate for solution for infusion

eculizumab

Medicinal product subject to additional monitoring. This will allow the rapid identification of
new safety information. You can contribute by reporting any adverse effects
experienced during the use of this medicine. See the end of section 4 for
information on how to report adverse effects.

Read this leaflet carefully before using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

• 1. What BEKEMV is and what it is used for
• 2. What you need to know before you use BEKEMV
• 3. How to use BEKEMV
• 4. Possible side effects
• 5. How to store BEKEMV
• 6. Contents of the pack and other information

1. What is BEKEMV and what is it used for

What is BEKEMV
BEKEMV contains the active ingredient eculizumab and belongs to a class of medicines called
monoclonal antibodies. Eculizumab binds to a specific protein present in the body, which causes
inflammation, and inhibits its action, thus preventing specific systems of the body
from attacking and destroying vulnerable blood cells or kidneys.

What is BEKEMV used for
Paroxysmal nocturnal hemoglobinuria
BEKEMV is used to treat adults and children affected by a disease that affects the blood,
called paroxysmal nocturnal hemoglobinuria (PNH). In patients with PNH, red blood cells
can be destroyed; this causes a decrease in the number of red blood cells (anemia),
fatigue, functional limitations, pain, dark urine, dyspnea (difficulty breathing) and blood
clots. Eculizumab can block the body's inflammatory response and its ability to
attack and destroy its own vulnerable PNH red blood cells.

Atypical hemolytic uremic syndrome
BEKEMV is also used for the treatment of adult and pediatric patients affected by a disease that
affects the blood and the renal system called atypical hemolytic uremic syndrome (aHUS). In
patients with aHUS, the kidneys, red blood cells and platelets can become inflamed; this causes
a decrease in platelets and red blood cells (thrombocytopenia and anemia), reduction or loss of
renal function, blood clots, fatigue and functional limitations. Eculizumab is able to
block the body's inflammatory response and its ability to attack and destroy its own
vulnerable blood and kidney cells.

2. What you need to know before you use BEKEMV

Do not use BEKEMV

• if you are allergic to eculizumab or any of the other ingredients of this medicine (listed in section 6);
• if you have fructose intolerance, a rare genetic disease in which the enzyme responsible for the transformation of fructose is not produced;
• this medicine should not be administered to children under 2 years of age. This medicine contains sorbitol and sorbitol can be fatal in case of hereditary fructose intolerance (HFI). In children under 2 years of age, HFI may not yet have been diagnosed. (See special warnings at the end of this paragraph under “BEKEMV contains sorbitol”);
• if you have not been vaccinated against meningococcal infection or if you are not taking antibiotics to reduce the risk of infection for two weeks after being vaccinated;
• if you have meningococcal infection.

Warnings and precautions
Alert regarding meningococcal infection and other infections caused by Neisseria
Therapy with BEKEMV may reduce natural resistance to infections, especially against
some microorganisms that cause meningococcal infection (serious infection of the lining of the
brain and sepsis) and other infections caused by Neisseria,including disseminated gonorrhea.
Consult your doctor before taking BEKEMV to make sure you get vaccinated against

Neisseria meningitidis, an organism that causes meningococcal infection, at least 2 weeks before
starting treatment or taking antibiotics to reduce the risk of infection for two weeks
after being vaccinated.
Make sure your vaccination against meningococcal infection is not expired. You should know,
however, that vaccination may not prevent this type of infection. In accordance with
national recommendations, your doctor may consider it necessary to take additional measures to prevent
infection.
If you are at risk of gonorrhea, ask your doctor or pharmacist for advice before using this medicine.
Symptoms of meningococcal infection
Given the importance of identifying and treating certain types of infection quickly in patients treated with
BEKEMV, you will be given a card to carry with you listing specific symptoms to watch out for.
This card is called: “Patient Safety Card”.
If you suffer from any of the following symptoms, you should immediately call your doctor:

• headache with nausea or vomiting;
• headache with stiffness of the neck or back;
• fever;
• rash;
• confusion;
• severe muscle pain with flu-like symptoms;
• sensitivity to light.

Treatment of meningococcal infection while traveling
If you think you are going to a distant country where you will not be able to contact your doctor or where
you will temporarily not be able to receive medical treatment, your doctor may, as a precaution, prescribe
an antibiotic active against Neisseria meningitidisthat you should carry with
you. If you suffer from any of the symptoms listed above, you should take the antibiotics as prescribed.
Remember to consult a doctor as soon as possible, even if you feel better after taking the
antibiotics.

Infections
Before starting treatment with BEKEMV, tell your doctor if you have any ongoing infections.

Allergic reactions
BEKEMV contains a protein and proteins can cause allergic reactions in some people.

Children and adolescents
Patients under the age of 18 years must be vaccinated against infections caused by Haemophilus

influenzaeand pneumococcus.

Elderly people
No special precautions are necessary to treat patients over 65 years of age.

Other medicines and BEKEMV
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding,
ask your doctor or pharmacist for advice before using this medicine.
Women of childbearing potential
The use of effective contraceptive methods during therapy and for up to 5 months after the end of therapy
should be considered in women of childbearing potential.

Driving and using machines
BEKEMV does not or negligibly alters the ability to drive and use machines.

BEKEMV contains sorbitol
This medicine contains 50 mg of sorbitol per mL.
Sorbitol is a source of fructose. If your doctor has diagnosed you (or your child) with hereditary fructose
intolerance, a rare genetic disease, you (or your child) should not take this
medicine. Patients with hereditary fructose intolerance are unable to metabolize fructose, the
accumulation of which can cause serious side effects.
Before taking this medicine, tell your doctor if you (or your child) suffer from hereditary
fructose intolerance or if the child feels unwell, vomits or has unpleasant reactions such as bloating and
stomach cramps or diarrhea when taking sweet foods or drinks.

Sodium
BEKEMV contains sodium when diluted with sodium chloride.
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially “sodium-free”.
Once diluted with sodium chloride 9 mg/mL (0.9%) injectable solution, this medicine
contains 0.34 g of sodium (the main component of table salt) per 180 mL at the maximum dose.
This is equivalent to 17.0% of the maximum recommended daily intake with the diet of an adult.
This should be taken into consideration if you are following a low-sodium diet.
Once diluted with sodium chloride 4.5 mg/mL (0.45%) injectable solution, this medicine
contains 0.18 g of sodium (the main component of table salt) per 180 mL at the maximum dose.
This is equivalent to 9.0% of the maximum recommended daily intake with the diet of an adult.
This should be taken into consideration if you are following a low-sodium diet.
If the healthcare professional dilutes the vials of BEKEMV with 5% glucose solution, the
medicine is essentially “sodium-free”.

3. How to use BEKEMV

At least two weeks before starting treatment with BEKEMV, your doctor will administer a
vaccine against meningococcal infection, if the vaccine had not already been administered
previously or if your vaccination has expired. If your child is not yet of vaccination age or if you
have not been vaccinated at least two weeks before starting treatment with BEKEMV, your doctor
will prescribe antibiotics to reduce the risk of infection for up to two weeks after vaccination.
The doctor will administer a vaccine to your child, under the age of 18, against infections from

Haemophilus influenzaeand pneumococcus according to national vaccination recommendations for
each age group.

Instructions for correct use
The therapy will be administered by the doctor or another healthcare professional via the infusion of a
diluted solution of a vial of BEKEMV through an intravenous line directly into a vein. It is
recommended that the start of therapy, the so-called "initial phase", continue for 4 weeks and be
followed by a maintenance phase:
If you are using this medicine for the treatment of EPN:
For adults:

• Initial phase

Each week for the first four weeks, your doctor will administer an intravenous infusion of
a diluted solution of BEKEMV. Each infusion will consist of a dose of 600 mg (2 vials
of 30 mL) and will last 25-45 minutes (35 minutes ± 10 minutes).

• Maintenance phase
• In the fifth week, your doctor will administer an intravenous infusion of a diluted solution of BEKEMV at a dose of 900 mg (3 vials of 30 mL) over a period of 25-45 minutes (35 minutes ± 10 minutes).
• After the fifth week, your doctor will administer 900 mg of diluted BEKEMV solution every two weeks as long-term therapy.

If you are using this medicine for the treatment of SEUa:
For adults:

• Initial phase

Each week for the first four weeks, your doctor will administer an intravenous infusion of
a diluted solution of BEKEMV. Each infusion will consist of a dose of 900 mg (3 vials
of 30 mL) and will last 25-45 minutes (35 minutes ± 10 minutes).

• Maintenance phase
• In the fifth week, your doctor will administer an intravenous infusion of a diluted solution of BEKEMV with a dose of 1,200 mg (4 vials of 30 mL) over a period of 25-45 minutes (35 minutes ± 10 minutes).
• After the fifth week, your doctor will administer 1,200 mg of diluted BEKEMV solution every two weeks as long-term therapy.

For children and adolescents:

• Children and adolescents with EPN or SEUa with a body weight equal to or greater than 40 kg receive the same dosage as adults.
• Children and adolescents with EPN or SEUa with a body weight less than 40 kg require a lower dose based on their weight. Your doctor will calculate this.

For children and adolescents with EPN or SEUa over 2 years of age and weighing less than
40 kg:

Patients undergoing plasma exchange may receive a supplemental dose of
BEKEMV.
After each infusion, you will remain under observation for about an hour. The doctor's instructions must
be followed carefully.

If you receive more BEKEMV than you should
If you suspect you have received a dose of BEKEMV higher than prescribed, ask your
doctor for advice.

If you forget to attend an appointment for BEKEMV administration
If you should forget an appointment, contact your doctor immediately and refer to the following paragraph “If you stop treatment with BEKEMV”.

If you stop treatment with BEKEMV for EPN
Discontinuation or suspension of therapy with BEKEMV can quickly cause the reappearance
of EPN symptoms in a more severe form. The doctor will discuss with you the possible side effects and
explain the risks. The doctor will keep you under close observation for at least 8 weeks.
The risks of stopping BEKEMV include increased destruction of red blood cells, which
can cause:

• a significant reduction in the number of red blood cells (anemia);
• confusion or alteration of your state of alertness;
• chest pain or angina pectoris;
• increased creatinine levels in the blood (kidney problems);
• thrombosis (blood clots). If you experience any of these symptoms, contact your doctor.

If you stop treatment with BEKEMV for SEUa
Discontinuation or suspension of therapy with BEKEMV can cause the reappearance of SEUa symptoms.
The doctor will discuss with you the possible side effects and explain the risks. The doctor will
keep you under close observation.
The risks of stopping BEKEMV include an increase in platelet inflammation,
which can cause:

• a significant reduction in the number of platelets (thrombocytopenia);
• a significant increase in the destruction of red blood cells;
• decreased urine output (kidney problems);
• increased creatinine levels in the blood (kidney problems);
• symptoms of confusion or alteration of your state of alertness;
• chest pain or angina pectoris;
• shortness of breath;
• thrombosis (blood clots).

If you experience any of these symptoms, contact your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Before treatment, your doctor will discuss possible side effects with you and explain the benefits and risks of BEKEMV.
The most serious side effect was meningococcal sepsis.
If you develop symptoms of meningococcal infection (see section 2 Warning about meningococcal infection and other infections caused by Neisseria), you should tell your doctor immediately.
If you are not sure about any of the side effects listed below, ask your doctor for explanation.

Very common(may affect more than 1 in 10 people)

• headache

Common(may affect up to 1 in 10 people)

• lung infection (pneumonia), common cold (nasopharyngitis), urinary tract infections (urinary tract infection)
• low white blood cell count (leukopenia), reduced red blood cells which can make the skin pale and cause weakness or shortness of breath
• inability to sleep
• dizziness, high blood pressure
• upper respiratory tract infections, cough, sore throat (oropharyngeal pain), bronchitis, cold sores (herpes simplex)
• diarrhea, vomiting, nausea, abdominal pain, rash, hair loss (alopecia), itching
• joint pain (arms and legs), limb pain (arms and legs)
• fever (pyrexia), feeling tired (fatigue), flu-like illness
• infusion reaction

Uncommon(may affect up to 1 in 100 people)

• serious infection (meningococcal infection), sepsis, septic shock, viral infection, lower respiratory tract infection, gastrointestinal influenza (gastrointestinal infection), cystitis
• infection, fungal infection, pus collection (abscess), a type of skin infection (cellulitis), influenza, sinusitis, dental infection (abscess), gum infection
• relatively few platelets in the blood (thrombocytopenia), low level of lymphocytes, a particular type of white blood cells (lymphopenia), awareness of heartbeat
• severe allergic reaction causing difficulty breathing or dizziness (anaphylactic reaction), hypersensitivity
• loss of appetite
• depression, anxiety, mood swings, sleep disorder
• tingling of a body part (paresthesia), tremor, altered taste (dysgeusia), fainting
• blurred vision
• ringing in the ears, vertigo
• sudden and rapid onset of extremely high blood pressure, low blood pressure, hot flushes, venous disorder
• dyspnea (difficulty breathing), nosebleed, blocked nose (nasal congestion), throat irritation, runny nose (rhinorrhea)
• inflammation of the peritoneum (the tissue lining most of the abdominal organs), constipation, discomfort in the stomach after meals (dyspepsia), abdominal distension
• urticaria, skin redness, dry skin, red or purple spots on the skin, increased sweating, skin inflammation
• muscle cramps, muscle pain, back and neck pain, bone pain
• kidney disease, difficulty or pain when urinating (dysuria), blood in the urine
• spontaneous erection of the penis
• swelling (edema), chest discomfort, feeling weak (asthenia), chest pain, pain at the infusion site, chills
• increased liver enzymes, decrease in the proportion of blood volume occupied by red blood cells, decrease in the protein present in red blood cells that carries oxygen

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

• fungal infection (Aspergillusinfection), joint infection (bacterial arthritis), infection by Haemophilus influenzae, impetigo, sexually transmitted bacterial disease (gonorrhea)
• skin tumor (melanoma), bone marrow disease
• destruction of red blood cells (hemolysis), aggregation of cells, abnormal coagulation factor, abnormal blood coagulation
• hyperactivity of the thyroid gland (Basedow's disease)
• abnormal dreams
• eye irritation
• bruising
• unusual backflow of food from the stomach, gum pain
• yellowing of the skin and/or eyes (jaundice)
• alteration of skin color
• spasm of the mouth muscles, swollen joints
• menstrual disorders
• abnormal leakage of the infused drug outside the vein, abnormal sensation at the infusion site, feeling of warmth

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store BEKEMV

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package and on the label of the
vial after “Exp.”. The expiry date refers to the last day of that month.
Store in a refrigerator (2°C – 8°C). Do not freeze.
The vials of BEKEMV in the original package can be removed from the refrigerator once for a maximum of 7 days. At the end of this period the product can be returned to the
refrigerator.
Store in the original package to protect the medicine from light. After dilution,
use the medicine within 24 hours.
Do not dispose of any medicine in wastewater. Ask your pharmacist how to dispose of medicines that
you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What BEKEMV contains

• The active substance is eculizumab (300 mg/30 mL in a vial of 10 mg/mL).
• The other ingredients are:
• acetic acid
• sodium hydroxide
• disodium edetate (EDTA)
• sorbitol (E420, see section 2 “BEKEMV contains sorbitol”)
• polysorbate 80
• water for injections

Description of the appearance of BEKEMV and contents of the pack
BEKEMV is presented as a concentrate for solution for infusion (30 mL in a vial –
pack of 1 vial).
BEKEMV is a solution from clear to opalescent and from colourless to slightly yellow.

Marketing authorisation holder and manufacturer
Amgen Technology (Ireland) UC
Pottery Road, Dun Laoghaire
Co. Dublin,
A96 F2A8 Ireland

Marketing authorisation holder
Amgen Technology (Ireland) UC
Pottery Road, Dun Laoghaire
Co. Dublin,
A96 F2A8 Ireland

Manufacturer
Amgen NV
Telecomlaan 5-7
1831 Diegem
Belgium
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
s.a. Amgen n.v.
Tél/Tel: +32 (0)2 7752711

Lietuva
Amgen Switzerland AG Vilniaus filialas
Tel: +370 5 219 7474

България
Амджен България ЕООД
Тел.: +359 (0)2 424 7440

Luxembourg/Luxemburg
s.a. Amgen
Belgique/Belgien
Tél/Tel: +32 (0)2 7752711

Česká republika
Amgen s.r.o.
Tel: +420 221 773 500

Magyarország
Amgen Kft.
Tel.: +36 1 35 44 700

Danmark
Amgen, filial af Amgen AB, Sverige
Tlf: +45 39617500

Malta
Amgen S.r.l.
Italy
Tel: +39 02 6241121

Deutschland
Amgen GmbH
Tel: +49 89 1490960

Nederland
Amgen B.V.
Tel: +31 (0)76 5732500

Eesti
Amgen Switzerland AG Vilniaus filialas
Tel: +372 586 09553

Norge
Amgen AB
Tlf: +47 23308000

Ελλάδα
Amgen Ελλάς Φαρμακευτικά Ε.Π.Ε.
Τηλ: +30 210 3447000

Österreich
Amgen GmbH
Tel: +43 (0)1 50 217

España
Amgen S.A.
Tel: +34 93 600 18 60

Polska
Amgen Biotechnologia Sp. z o.o.
Tel.: +48 22 581 3000

France
Amgen S.A.S.
Tél: +33 (0)9 69 363 363

Portugal
Amgen Biofarmacêutica, Lda.
Tel: +351 21 422 06 06

Hrvatska
Amgen d.o.o.
Tel: +385 (0)1 562 57 20

România
Amgen România SRL
Tel: +4021 527 3000

Ireland
Amgen Ireland Limited
Tel: +353 1 8527400

Slovenija
AMGEN zdravila d.o.o.
Tel: +386 (0)1 585 1767

Ísland
Vistor hf.
Sími: +354 535 7000

Slovenská republika
Amgen Slovakia s.r.o.
Tel: +421 2 321 114 49

Italia
Amgen S.r.l.
Tel: +39 02 6241121

Suomi/Finland
Amgen AB, sivuliike Suomessa/Amgen AB, filial
i Finland
Puh/Tel: +358 (0)9 54900500

Kύπρος
C.A. Papaellinas Ltd
Τηλ: +357 22741 741

Sverige
Amgen AB
Tel: +46 (0)8 6951100

Latvija
Amgen Switzerland AG Rīgas filiāle
Tel: +371 257 25888

United Kingdom (Northern Ireland)
Amgen Limited
Tel: +44 (0)1223 420305

Other sources of information
More detailed information on this medicinal product is available on the website of the European
Medicines Agency, http://www.ema.europa.eu/ .

Instructions for use for healthcare professionals - Handling of BEKEMV
In order to improve the traceability of biological medicinal products, the name and batch number of the
medicinal product administered must be clearly recorded.
The following information is intended exclusively for healthcare professionals:

1. How is BEKEMV supplied?

Each vial of BEKEMV contains 300 mg of active substance in 30 mL of solution.

2. Before administration

Dilution must be performed in accordance with good preparation practices, in particular with respect to aseptic technique.
BEKEMV must be prepared for administration by a qualified healthcare professional,
using aseptic technique.

• Visually inspect the BEKEMV solution to ensure the absence of particles or changes in color.
• Withdraw the required amount of BEKEMV from the vial(s) using a sterile syringe.
• Transfer the recommended dose into an infusion bag.
• Dilute BEKEMV to a final concentration of 5 mg/mL (initial concentration divided by 2) by adding the correct amount of diluent to the infusion bag.
• For 300 mg doses, use 30 mL of BEKEMV (10 mg/mL) and add 30 mL of diluent.
• For 600 mg doses, use 60 mL of BEKEMV and add 60 mL of diluent.
• For 900 mg doses, use 90 mL of BEKEMV and add 90 mL of diluent.
• For 1,200 mg doses, use 120 mL of BEKEMV and add 120 mL of diluent. The final volume of the diluted solution of 5 mg/mL of BEKEMV is 60 mL for 300 mg doses, 120 mL for 600 mg doses, 180 mL for 900 mg doses, or 240 mL for 1,200 mg doses.
• Diluents are sodium chloride 9 mg/mL (0.9%) injectable solution, sodium chloride 4.5 mg/mL (0.45%) injectable solution, or glucose in water (5%).
• Gently shake the infusion bag containing the diluted BEKEMV solution to allow thorough mixing of the medicine and diluent.
• The diluted solution must be allowed to warm to room temperature (18°C - 25°C) before administration by exposing it to the ambient temperature.
• The diluted solution must not be heated in the microwave or by any other heat source other than room temperature.
• Discard any unused portion remaining in the vial.
• Diluted solutions of BEKEMV can be stored at a temperature of 2°C - 8°C for up to 24 hours before administration.

3. Administration

• Do not administer BEKEMV with rapid intravenous injections or bolus.
• BEKEMV must be administered only by intravenous infusion.
• The diluted solution of BEKEMV should be administered with an intravenous infusion lasting 25-45 minutes (35 minutes ± 10 minutes) in adult patients and an infusion lasting 1-4 hours in pediatric patients under 18 years of age via gravity drip, syringe pump, or infusion pump. During administration, it is not necessary to protect the diluted solution of BEKEMV from light.

The patient must be monitored for one hour after the infusion. If an adverse event occurs
during the administration of BEKEMV, the infusion may be slowed down or interrupted at the physician's discretion.
If the infusion rate is reduced, the total infusion time should not exceed two hours in adults and four hours in pediatric patients under 18 years of age.

4. Special precautions for handling and storage

Store in a refrigerator (2°C – 8°C). Do not freeze. Store in the original package to
protect the medicine from light. The vials of BEKEMV in the original package can
be removed from the refrigerator for one time only for a maximum of 7 days. At the end of this period
the product can be returned to the refrigerator.
Do not use this medicine after the expiry date which is stated on the box and on the vial label after “Exp.”. The expiry date refers to the last day of that month.