ADAKVEO 10 mg /Ml Концентрат Для Инфузионного Раствора

Содержание инструкции

1. Adakveo 10 mg/ml concentrate for solution for infusion
   1. What is Adakveo and what is it used for
   2. What you need to know before you are given Adakveo
   3. How Adakveo is administered
   4. Possible side effects
   5. How to store Adakveo
   6. Package Contents and Other Information

Adakveo 10 mg/ml concentrate for solution for infusion

crizanlizumab

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

Read this leaflet carefully before this medicine is administered to you because
it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or nurse.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of this leaflet

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

1. What is Adakveo and what is it used for

What is Adakveo
Adakveo contains the active substance crizanlizumab, which belongs to a group of medicines called
monoclonal antibodies (mAbs).

What is Adakveo used for
Adakveo is used to prevent recurrent painful crises that occur in patients with sickle cell disease aged 16 years and older. Adakveo may be given in combination with
hydroxyurea/hydroxycarbamide, but it can also be used alone.
Sickle cell disease is an inherited blood disorder, which causes the affected red blood cells
to become sickle-shaped and have difficulty passing through small blood vessels. In addition,
in sickle cell disease, blood vessels are damaged and sticky due to chronic inflammation. As a
result, red blood cells adhere to blood vessels, causing acute episodes of pain and organ damage.

How does Adakveo work
Patients with sickle cell disease have higher levels of a protein called P-selectin.
Adakveo binds to P-selectin and this should prevent red blood cells from sticking to the walls of
blood vessels and help prevent painful crises.
If you have any questions about how Adakveo works or why you have been prescribed this medicine, please
talk to your doctor or nurse.

2. What you need to know before you are given Adakveo

You must not be given Adakveo:

• if you are allergic to crizanlizumab or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Infusion-related reactions
Medicines like this one (called monoclonal antibodies) are given into a vein (intravenously) through an infusion. These medicines can cause unwanted side effects (adverse reactions) when they are infused into the body. These reactions can occur during the infusion or within 24 hours of the infusion being given.

Tell your doctor or nurse immediatelyif you experience any of the following symptoms during the infusion or within 24 hours of the infusion, as these may be signs of an infusion-related reaction:

• Pain in various locations, headache, fever, chills or shaking, nausea, vomiting, diarrhoea, fatigue, dizziness, itching, hives, sweating, shortness of breath or wheezing. See also section 4, “Possible side effects”. Your doctor or nurse may monitor you for signs and symptoms of infusion-related reactions.

If you develop an infusion-related reaction, it may be necessary to stop or slow down the Adakveo infusion. You may receive additional medicines to treat the symptoms of the infusion-related reaction. Future Adakveo infusions may be given more slowly and/or with medicines to reduce the risk of an infusion-related reaction.

Blood tests during treatment with Adakveo
If you need to have blood tests, tell your doctor or nurse that you are being treated with Adakveo. This is important because this treatment may interfere with a laboratory test used to measure the number of platelets in your blood.

Children and adolescents
Adakveo must not be used in children or adolescents under 16 years of age.

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

Pregnancy and breastfeeding
Adakveo has not been studied in pregnant women, therefore information on its safety in pregnant women is limited.
If you are pregnant or might become pregnant and are not using contraception, the use of Adakveo is not recommended.
It is not known whether Adakveo or its individual components pass into breast milk.
If you are pregnant, suspect you are pregnant, are planning to become pregnant or are breastfeeding, ask your doctor for advice before you are given this medicine. The doctor will discuss with you the potential risks of Adakveo during pregnancy and breastfeeding.

Driving and using machines
Adakveo may slightly impair the ability to drive and use machines. If you feel tired, sleepy or dizzy, do not drive or use machines until you feel better.

Adakveo contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per vial, i.e. essentially ‘sodium-free’.

3. How Adakveo is administered

Adakveo will be administered to you by a doctor or nurse.
If you have any doubts about how Adakveo is administered, ask the doctor or nurse who is
administering the infusion.
The doctor will tell you when to receive the infusions and your next appointments.

How much Adakveo will be administered to you
The recommended dose is 5 mg per kilogram of body weight. The first infusion will be
administered at Week 0 and the second infusion after two weeks (Week 2).
Subsequently, you will receive an infusion every 4 weeks.

How the infusion is administered
Adakveo is administered intravenously (by intravenous route) as an infusion lasting 30 minutes.
Adakveo can be administered alone or with hydroxyurea/hydroxycarbamide.

How long the treatment with Adakveo lasts
You will discuss the duration of treatment with your doctor. The doctor will regularly check your
condition to verify that the treatment has the desired effect.

If you miss an Adakveo infusion
It is very important that you receive all the infusions. If you miss an appointment for an infusion,
contact your doctor as soon as possible to reschedule it.

If you stop treatment with Adakveo
Do not stop treatment with Adakveo unless your doctor has told you that you can
do so.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
manifest.

Some side effects can be serious
Tell your doctor or nurse immediately who is administering the infusionif you develop any
of the following symptoms during the infusion or within 24 hours of the infusion:

• pain in various locations, headache, fever, chills or tremors, nausea, vomiting, diarrhea, fatigue, dizziness, itching, hives, sweating, shortness of breath or wheezing. These symptoms may be signs of an infusion-related reaction, which is a common side effect (this means it can affect up to 1 in 10 people).

Other possible side effects
Other possible side effects include those listed below. If these side effects
become severe, tell your doctor or nurse.

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

• joint pain (arthralgia)
• nausea
• back pain
• fever
• upper and lower abdominal pain, abdominal tenderness and discomfort

Common (may affect up to 1 in 10 people)

• diarrhea
• itching (including vulvovaginal itching)
• vomiting
• muscle pain (myalgia)
• pain in the muscles or bones of the chest (musculoskeletal chest pain)
• sore throat (oropharyngeal pain)
• redness or swelling and pain at the infusion site

Not known (frequency cannot be estimated from available data)

• pain of any intensity (mild, moderate or severe) that occurs in various locations during the infusion or within 24 hours of the infusion, which may be a sign of an infusion-related reaction

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects directly
through the national reporting system detailed in Annex V. By reporting side effects you can
help to provide more information on the safety of this medicine.

5. How to store Adakveo

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 label after
Expiry/EXP. The expiry date refers to the last day of that month.
Keep the vial in the outer packaging to protect the medicine from light. Store in
refrigerator (2  C – 8  C). Do not freeze.
Infusion solutions must be used immediately after dilution.

6. Package Contents and Other Information

What Adakveo contains

• The active ingredient is crizanlizumab. Each 10 ml vial contains 100 mg of crizanlizumab.
• The other ingredients are sucrose, sodium citrate (E331), citric acid (E330), polysorbate 80 (E433) and water for injections.

Description of Adakveo and package contents
Adakveo concentrate for solution for infusion is a liquid from colourless to slightly yellow-
brownish.
Adakveo is available in packs containing 1 vial.

Marketing Authorisation Holder
Novartis Europharm Limited
Vista Building
Elm Park, Merrion Road
Dublin 4
Ireland

Manufacturer
Novartis Pharma GmbH
Roonstrasse 25
90429 Nuremberg
Germany
For further information on this medicine, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
Novartis Pharma N.V.
Tél/Tel: +32 2 246 16 11

Lietuva
SIA Novartis Baltics Lietuvos filialas
Tel: +370 5 269 16 50

България
Novartis Bulgaria EOOD
Тел: +359 2 489 98 28

Luxembourg/Luxemburg
Novartis Pharma N.V.
Tél/Tel: +32 2 246 16 11

Česká republika
Novartis s.r.o.
Tel: +420 225 775 111

Magyarország
Novartis Hungária Kft.
Tel.: +36 1 457 65 00

Danmark
Novartis Healthcare A/S
Tlf: +45 39 16 84 00

Malta
Novartis Pharma Services Inc.
Tel: +356 2122 2872

Deutschland
Novartis Pharma GmbH
Tel: +49 911 273 0

Nederland
Novartis Pharma B.V.
Tel: +31 88 04 52 555

Eesti
SIA Novartis Baltics Eesti filiaal
Tel: +372 66 30 810

Norge
Novartis Norge AS
Tlf: +47 23 05 20 00

Ελλάδα
Novartis (Hellas) A.E.B.E.
Τηλ: +30 210 281 17 12

Österreich
Novartis Pharma GmbH
Tel: +43 1 86 6570

España
Novartis Farmacéutica, S.A.
Tel: +34 93 306 42 00

Polska
Novartis Poland Sp. z o.o.
Tel.: +48 22 375 4888

France
Novartis Pharma S.A.S.
Tél: +33 1 55 47 66 00

Portugal
Novartis Farma - Produtos Farmacêuticos, S.A.
Tel: +351 21 000 8600

Hrvatska
Novartis Hrvatska d.o.o.
Tel. +385 1 6274 220

România
Novartis Pharma Services Romania SRL
Tel: +40 21 31299 01

Ireland
Novartis Ireland Limited
Tel: +353 1 260 12 55

Slovenija
Novartis Pharma Services Inc.
Tel: +386 1 300 75 50

Ísland
Vistor hf.
Sími: +354 535 7000

Slovenská republika
Novartis Slovakia s.r.o.
Tel: +421 2 5542 5439

Italia
Novartis Farma S.p.A.
Tel: +39 02 96 54 1

Suomi/Finland
Novartis Finland Oy
Puh/Tel: +358 (0)10 6133 200

Κύπρος
Novartis Pharma Services Inc.
Τηλ: +357 22 690 690

Sverige
Novartis Sverige AB
Tel: +46 8 732 32 00

Latvija
SIA Novartis Baltics
Tel: +371 67 887 070

United Kingdom (Northern Ireland)
Novartis Ireland Limited
Tel: +44 1276 698370
An authorisation “subject to conditions” has been granted for this medicinal product. This means that
further data on this medicinal product must be provided.
The European Medicines Agency will review the new information at least annually on this

Other sources of information
Detailed information on this medicine is available on the website of the European Medicines
Agency, http://www.ema.europa.eu/

The following information is intended exclusively for healthcare professionals:
The vials of Adakveo are for single use only.
Preparation of the infusion
The diluted solution for infusion must be prepared by a healthcare professional using aseptic
techniques.
The total dose and the required volume of Adakveo depend on the patient's weight; 5 mg of
crizanlizumab per kg of body weight are administered.
The volume to be used for preparing the infusion is calculated according to the following equation:
Volume (ml) =
Patient weight (kg) x prescribed dose [5 mg/kg]
Adakveo concentration [10 mg/ml]

• 1. Obtain the number of vials needed to administer the prescribed dose and bring them to room
  temperature (for a maximum of 4 hours). One vial is needed for every 10 ml of Adakveo (see the table below).

Weight
(kg)
Dose (mg)Volume (ml)Vials (n)
40 200 20 2
60 300 30 3
80 400 40 4
100 500 50 5
120 600 60 6

• 2. Visually inspect the vials.
• The solution in the vials must be clear to opalescent. Do not use the solution if particles are present.
• The solution must be colourless or may have a slight yellow-brownish tinge.
• 3. Withdraw a volume equal to the required volume of Adakveo from a 100 ml infusion bag containing
  sodium chloride 9 mg/ml (0.9%) or 5% dextrose solution and discard it.
• No incompatibilities have been observed between the diluted Adakveo solution and infusion bags made
  of polyvinyl chloride (PVC), polyethylene (PE) and polypropylene (PP).
• 4. Withdraw the required volume of Adakveo from the vials and slowly inject it into the previously
  prepared infusion bag.
• The solution must not be mixed or administered with other medicines through the same intravenous line.
• Keep the volume of Adakveo added to the infusion bag in the range of 10 ml to 96 ml to obtain a final
  concentration in the infusion bag between 1 mg/ml and 9.6 mg/ml.
• 5. Mix the diluted solution by gently inverting the infusion bag. DO NOT SHAKE.

Storage of the diluted solution
Chemical and physical stability during use, from the start of preparation of the diluted solution for
infusion to the end of the infusion, has been demonstrated for up to 8 hours at room temperature (up to
25°C) and at a temperature between 2°C and 8°C for up to 24 hours in total.
From a microbiological point of view, the diluted solution for infusion must be used
immediately. If it is not used immediately, the storage times and conditions before use are the
responsibility of the user and should normally not exceed 24 hours at a temperature between 2°C and
8°C, including the 4.5 hours at room temperature (up to 25°C) from the start of preparation to the
completion of the infusion, unless the dilution has taken place in controlled and validated aseptic
conditions.
Administration
The diluted Adakveo solution must be administered via an in-line, sterile, non-pyrogenic, 0.2 micron
filter, by intravenous infusion over 30 minutes. No incompatibilities have been observed between
Adakveo and infusion sets made of PVC, PE-coated PVC, polyurethane and in-line filter membranes
made of polyethersulfone (PES), polyamide (PA) or polysulfone (PSU).
After administration of Adakveo, flush the line with at least 25 ml of sodium chloride 9 mg/ml (0.9%) or
5% dextrose solution.
Disposal
Unused medicine and waste derived from this medicine must be disposed of in accordance with local
regulations.