SOLIRIS 300 mg Koncentrat Do Sporządzania Roztworu Do Infuzji

Treść ulotki

1. Soliris 300 mg concentrate for solution for infusion
   1. What is Soliris and what is it used for
   2. What you need to know before you use Soliris
   3. How to use Soliris
   4. Possible side effects
   5. How to store Soliris
   6. Contents of the pack and other information

Soliris 300 mg concentrate for solution for infusion

Eculizumab

Read this leaflet carefully before you start 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 you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

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

1. What is Soliris and what is it used for

What is Soliris
Soliris 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, thereby preventing specific systems of the body
from attacking and destroying vulnerable blood cells, kidneys, muscles or optic nerves and the
spinal cord.

What is Soliris used for
Paroxysmal nocturnal hemoglobinuria
Soliris is used to treat adult and pediatric patients 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
Soliris 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), reduced 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.

Refractory generalized myasthenia gravis
Soliris is also used for the treatment of adult and pediatric patients starting from 6 years of age
affected by a type of disease that affects the muscles, called generalized Myasthenia Gravis (gMG).
In patients with gMG, muscles can be attacked and damaged by the immune system and this
can lead to profound muscle weakness, impaired mobility, shortness of breath, extreme fatigue,
risk of aspiration and significant impairment of daily life activities. Soliris is
able to block the body's inflammatory response and its ability to attack and
destroy muscles, to improve muscle contraction, thus reducing the symptoms of the disease
and its impact on daily life activities. Soliris is specifically indicated for patients who
remain symptomatic despite treatment with other existing therapies for gMG.

Neuromyelitis optica spectrum disorders
Soliris is also used for the treatment of adult patients affected by a type of disease that affects
predominantly the optic nerves and the spinal cord, called neuromyelitis optica spectrum disorder
(NMOSD). In patients with NMOSD, the optic nerve and the spinal cord are
attacked and damaged by the immune system and this can lead to blindness in one or both eyes,
weakness or paralysis of the legs or arms, painful spasms, loss of sensation and significant
impairment of daily life activities. Soliris is able to block the response
inflammatory of the body and its ability to attack and destroy its own optic nerves and
own spinal cord, thus reducing the symptoms of the disease and its impact on daily life
activities.

2. What you need to know before you use Soliris

Do not use Soliris

• if you are allergic to eculizumab, to proteins derived from mouse products, to other monoclonal antibodies or to any of the other ingredients of this medicine (listed in section 6);
• 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 a meningococcal infection.

Warnings and precautions
Alert regarding meningococcal infection and other infections caused byNeisseria
Therapy with Soliris 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.
Talk to your doctor before taking Soliris to make sure you have been 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 meningococcal vaccination 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 taking this
medicine.
Symptoms of meningococcal infection
Given the importance of identifying and treating certain types of infection quickly in patients treated with
Soliris, you will be given a card to carry with you listing specific symptoms to watch for.
This card is called: “Patient Safety Card”.
If you experience 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 plan to travel to a country far away where you will not be able to contact your doctor or where
you will temporarily not have the opportunity to receive medical treatment, your doctor may, as a
precaution, prescribe you an antibiotic active against Neisseria meningitidisthat you should carry with
you. If you experience 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 Soliris, tell your doctor if you have any ongoing infections.

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

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

influenzaeand pneumococcus.

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

Other medicines and Soliris
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 are pregnant or are planning to become pregnant, or if you are breastfeeding
ask your doctor or pharmacist for advice before taking 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.

Pregnancy/breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding
ask your doctor or pharmacist for advice before using this medicine.

Driving and using machines
Soliris does not impair or negligibly impairs the ability to drive and operate machines.

Soliris contains sodium
When diluted with a sodium chloride 9 mg/mL (0.9%) injectable solution, this medicine
contains 0.88 g of sodium (the main component of table salt) per 240 mL at the maximum dose.
This is equivalent to 44% of the recommended maximum daily intake with the diet of an adult.
You should take this into account if you are on a low-sodium diet.
When diluted with a sodium chloride 4.5 mg/mL (0.45%) injectable solution, this
medicine contains 0.67 g of sodium (the main component of table salt) per 240 mL at the
maximum dose. This is equivalent to 33.5% of the recommended maximum daily intake with the diet of
an adult. You should take this into account if you are on a low-sodium diet.

3. How to use Soliris

At least two weeks before starting treatment with Soliris, your doctor will administer a
meningococcal infection vaccine to you, if the vaccine has not already been administered in
the past 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 Soliris, your doctor
will prescribe antibiotics to reduce the risk of infection for up to two weeks after vaccination.
Your 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
Therapy will be administered by the doctor or another healthcare professional through the infusion of a
diluted solution of a vial of Soliris through an intravenous line directly into a vein. It is recommended
that the start of therapy, the so-called "initial phase", continues for 4 weeks and is followed by a
maintenance phase:
If you are using this medicine for the treatment of PNH:
For adults:

• Initial phase Every week for the first four weeks, the doctor will administer an intravenous infusion of a diluted solution of Soliris. Each infusion will consist of a dose of 600 mg (two 30 mL vials) and will last 25-45 minutes (35 minutes ± 10 minutes).
• Maintenance phase
• In the fifth week, the doctor will administer an intravenous infusion of a diluted solution of Soliris at a dose of 900 mg (three 30 mL vials) over a period of 25-45 minutes (35 minutes ± 10 minutes).
• After the fifth week, the doctor will administer 900 mg of diluted Soliris solution every two weeks as long-term therapy.

If you are using this medicine for the treatment of aHUS, refractory MG or NMOSD:
For adults:

• Initial phase Every week for the first four weeks, the doctor will administer an intravenous infusion of a diluted solution of Soliris. Each infusion will consist of a dose of 900 mg (3 30 mL vials) and will last 25-45 minutes (35 minutes ± 10 minutes).
• Maintenance phase
• In the fifth week, the doctor will administer an intravenous infusion of a diluted solution of Soliris with a dose of 1200 mg (4 30 mL vials) over a period of 25-45 minutes (35 minutes ± 10 minutes).
• After the fifth week, the doctor will administer 1200 mg of diluted Soliris solution every two weeks as long-term therapy.

Children and adolescents with PNH, aHUS or refractory MG with a body weight equal to and
greater than 40 kg receive the same dosage as adults.
Children and adolescents with PNH, aHUS or refractory MG with a body weight less than 40 kg
require a lower dose based on their weight. Your doctor will calculate it.
For children and adolescents with PNH and aHUS under the age of 18:
Patients undergoing plasma exchange may receive a supplemental dose of
Soliris.
You will remain under observation for about an hour after each infusion. The doctor's instructions must
be carefully followed.

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

If you forget to go to an appointment for Soliris administration
If you should forget an appointment, contact your doctor immediately and refer to the
following paragraph "If you stop treatment with Soliris".

If you stop treatment with Soliris for PNH
Discontinuation or suspension of therapy may cause the symptoms of
PNH to recur quickly in a more severe form. The doctor will discuss with you the possible side effects and explain the
risks. The doctor will monitor you closely for at least 8 weeks.
The risks of stopping Soliris 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 Soliris for aHUS
Discontinuation or suspension of therapy with Soliris may cause the symptoms of
aHUS to recur. The doctor will discuss with you the possible side effects and explain the risks. The doctor will monitor you
closely.
The risks of stopping Soliris 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.

If you stop treatment with Soliris for refractory MG
Suspension or interruption of treatment with Soliris may cause a recurrence of the symptoms
of MG. Consult your doctor before stopping treatment with Soliris. The doctor will explain to you
possible side effects and risks. The doctor will also monitor you closely.
If you have any doubts about the use of this medicine, ask your doctor, pharmacist or
nurse.

If you stop treatment with Soliris for NMOSD
Discontinuation or suspension of treatment with Soliris may cause a worsening of
NMOSD and the occurrence of relapse. Consult your doctor before stopping treatment with Soliris.
The doctor will explain the possible side effects and risks. The doctor will also monitor you closely.
If you have any doubts about 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 everyone will experience them.
Before treatment, your doctor will discuss possible side effects with you and explain the risks and
benefits of Soliris.
The most serious side effect has been meningococcal sepsis.
If you experience any symptoms of meningococcal infection (see section 2 Warning about meningococcal
infection and other infections caused by Neisseria), you should inform your doctor immediately.
If you are not sure about the side effects listed below, ask your doctor for clarification.

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 (pharyngodynia), bronchitis, cold sores (herpes simplex)
• diarrhoea, 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 part of the body (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, 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 (Aspergillus infection), 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 clotting
• hyperactivity of the thyroid gland (Graves’ 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 muscles of the mouth, swelling of the 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, even those not listed in this leaflet, tell your doctor, pharmacist or
nurse. You can also report side effects directly through the national reporting system listed in
Appendix V. By reporting side effects you can help provide more information on the safety of this
medicine.

5. How to store Soliris

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 box 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 Soliris in the original packaging can be removed from the refrigerator only once for a maximum of 3 days. At the end of this period the product can be returned to the
refrigerator.
Store in the original packaging 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 Soliris contains

• The active substance is eculizumab (300 mg/30 mL in a vial of 10 mg/mL).
• The other ingredients are:
• monobasic sodium phosphate
• dibasic sodium phosphate
• sodium chloride
• polysorbate 80 (of vegetable origin). Solvent: water for injections.

Description of Soliris and contents of the pack
Soliris is presented as a concentrate for solution for infusion (30 mL in a vial – pack of
1 vial).
Soliris is a clear and colourless solution.

Marketing Authorisation Holder
Alexion Europe SAS
103-105 rue Anatole France
92300 Levallois-Perret
France

Manufacturer
Almac Pharma Services
22 Seagoe Industrial Estate
Craigavon BT63 5QD
United Kingdom
Alexion Pharma International Operations Limited
College Business and Technology Park
Blanchardstown Road North,
Dublin 15
D15 R925
Ireland
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
Alexion Pharma Belgium
Tél/Tel: +32 0 800 200 31

Lietuva
UAB AstraZeneca Lietuva
Tel: +370 5 2660550

България
АстраЗенека България ЕООД
Teл.: +359 24455000

Luxembourg/Luxemburg
Alexion Pharma Belgium
Tél/Tel: +32 0 800 200 31

Česká republika
AstraZeneca Czech Republic s.r.o.
Tel: +420 222 807 111

Magyarország
AstraZeneca Kft.
Tel.: +36 1 883 6500

Danmark
Alexion Pharma Nordics AB
Tlf: +46 0 8 557 727 50

Malta
Alexion Europe SAS
Tel: +353 1 800 882 840

Deutschland
Alexion Pharma Germany GmbH
Tel: +49 (0) 89 45 70 91 300

Nederland
Alexion Pharma Netherlands B.V.
Tel: +32 (0)2 548 36 67

Eesti
AstraZeneca
Tel: +372 6549 600

Norge
Alexion Pharma Nordics AB
Tlf: +46 (0)8 557 727 50

Ελλάδα
AstraZeneca A.E.
Τηλ: +30 210 6871500

Österreich
Alexion Pharma Austria GmbH
Tel: +41 44 457 40 00

España
Alexion Pharma Spain, S.L.
Tel: +34 93 272 30 05

Polska
AstraZeneca Pharma Poland Sp. z o.o.
Tel.: +48 22 245 73 00

France
Alexion Pharma France SAS
Tél: +33 1 47 32 36 21

Portugal
Alexion Pharma Spain, S.L. - Sucursal em
Portugal
Tel: +34 93 272 30 05

Hrvatska
AstraZeneca d.o.o.
Tel: +385 1 4628 000

România
AstraZeneca Pharma SRL
Tel: +40 21 317 60 41

Ireland
Alexion Europe SAS
Tel: +353 1 800 882 840

Slovenija
AstraZeneca UK Limited
Tel: +386 1 51 35 600

Ísland
Alexion Pharma Nordics AB
Sími: +46 0 8 557 727 50

Slovenská republika
AstraZeneca AB, o.z.
Tel: +421 2 5737 7777

Italia
Alexion Pharma Italy srl
Tel: +39 02 7767 9211

Suomi/Finland
Alexion Pharma Nordics AB
Puh/Tel: +46 0 8 557 727 50

Κύπρος
Alexion Europe SAS
Τηλ: +357 22490305

Sverige
Alexion Pharma Nordics AB
Tel: +46 0 8 557 727 50

Latvija
SIA AstraZeneca Latvija
Tel: +371 67377100

United Kingdom (Northern Ireland)
Alexion Europe SAS
Tel: +44 (0) 800 028 4394

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/. Also, links to other websites on rare diseases and related therapeutic
treatments are provided.
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Instructions for use for healthcare professionals
Handling of Soliris
The following information is intended for healthcare professionals only:

• 1- How is Soliris supplied?Each vial of Soliris contains 300 mg of active substance in 30 mL of solution.
• 2- Before administrationReconstitution and dilution must be performed in accordance with good preparation practices, in particular with respect to aseptic technique. Soliris must be prepared for administration by a qualified healthcare professional using aseptic technique.
• Visually inspect the Soliris solution to ensure the absence of particles or discoloration.
• Withdraw the required amount of Soliris from the vial(s) using a sterile syringe.
• Transfer the recommended dose into an infusion bag.
• Dilute Soliris 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 Soliris (10 mg/mL) and add 30 mL of diluent. For 600 mg doses use 60 mL of Soliris and add 60 mL of diluent. For 900 mg doses use 90 mL of Soliris and add 90 mL of diluent. For 1200 mg doses use 120 mL of Soliris and add 120 mL of diluent. The final volume of the diluted Soliris solution at 5 mg/mL is 60 mL for 300 mg doses, 120 mL for 600 mg doses, 180 mL for 900 mg doses or 240 mL for 1200 mg doses. Diluents are sodium chloride 9 mg/mL (0.9%) solution for injection, sodium chloride 4.5 mg/mL (0.45%) solution for injection or dextrose in water (5%).
• Gently swirl the infusion bag containing the diluted Soliris solution to allow thorough mixing of the medicinal product and diluent.
• The diluted solution must be allowed to warm to room temperature (18°C-25°C) before administration by exposing it to ambient air.
• The diluted solution must not be heated in a microwave or by any other heat source other than room temperature.
• Discard any unused portion remaining in the vial.
• Diluted solutions of Soliris can be stored at a temperature of 2°C - 8°C for up to 24 hours before administration.
• 3- Administration
• Do not administer Soliris by rapid intravenous injection or bolus.
• Soliris must be administered only by intravenous infusion.
• The diluted solution of Soliris should be administered by intravenous infusion over 25-45 minutes (35 minutes ± 10 minutes) in adult patients and over 1-4 hours in paediatric patients under 18 years of age via a gravity drip, syringe pump or infusion pump. During administration, the diluted solution of Soliris does not need to be protected from light. The patient should be monitored for one hour after the infusion. If an adverse event occurs during the administration of Soliris, the infusion may be slowed or stopped 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 paediatric patients under 18 years of age.

• 4- Special precautions for handling and storageStore in a refrigerator (2°C – 8°C). Do not freeze. Store in the original packaging to protect the medicinal product from light. Vials of Soliris in the original packaging may be removed from the refrigerator once only for a maximum of 3 days. At the end of this period the product can be returned to the refrigerator. Do not use this medicinal product after the expiry date which is stated on the packaging and on the vial label after the words “Scad.”. The expiry date refers to the last day of that month.