UPLIZNA 100 mg Concentrate For Infusion Solution

Зміст інструкції

1. Uplizna 100 mg concentrate for solution for infusion
   1. What is Uplizna and what is it used for
   2. What you need to know before you receive Uplizna
   3. How Uplizna is administered
   4. Possible side effects
   5. How to store Uplizna
   6. Package contents and other information

Uplizna 100 mg concentrate for solution for infusion

inebilizumab

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

1. What is Uplizna and what is it used for

Uplizna contains the active substance inebilizumab and belongs to a class of medicines called
monoclonal antibodies. It is a protein that targets the cells that produce antibodies in the
immune system (the body's natural defenses) called B cells.
Uplizna is used to reduce the risk of attacks in adults with a rare condition called
neuromyelitis optica spectrum disorder (NMOSD), which affects the nerves of the eye and the
spinal cord. This condition is believed to be due to the immune system mistakenly
attacking the body's nerves. Uplizna is given to patients with NMOSD whose B cells
produce antibodies against aquaporin-4, a protein that plays an important role in
nerve function.

2. What you need to know before you receive Uplizna

Do not use Uplizna

• If you are allergic to inebilizumabor to any of the other ingredients of this medicine (listed in section 6).
• If you suffer from a serious active infection such as hepatitis B.
• If you have active or latent tuberculosis that is not being treated.
• If you have a history of progressive multifocal leukoencephalopathy (PML), an uncommon but serious brain infection caused by a virus.
• If you have been told you have serious problems with your immune system.
• If you have cancer.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before you receive Uplizna if:

• you have or think you may have an infection;
• you have ever taken or plan to take medicines that affect the immune system or other treatments for NMOSD. These medicines may increase the risk of contracting an infection;
• you have ever had hepatitis Bor are a carrier of the hepatitis B virus;
• you have been vaccinated recently or are planning to receive a vaccination. You should receive all necessary vaccinations at least 4 weeks before starting treatment with Uplizna.

Infusion-related reactions
Inebilizumab can cause infusion-related reactions, which may include headache, nausea,
drowsiness, shortness of breath, fever, muscle pain, rash or other symptoms. If you
experience symptoms, treatment may be suspended or stopped.

Children and adolescents
This medicine should not be given to children and adolescents as it has not been studied
in this population.

Other medicines and Uplizna
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 or are planning to become pregnant, ask your doctor
for advice before receiving this medicine.
Pregnancy
Uplizna should not be used during pregnancy as the medicine can cross the placenta and
harm the baby. If you are a woman of childbearing potential, you should always use a method of contraception
once you have started receiving Uplizna. If your doctor recommends that you
stop treatment, continue to use a method of contraception for up to 6 months after the last
infusion.
Breastfeeding
It is not known whether Uplizna passes into breast milk. If you are breastfeeding, talk to your doctor
about the best way to breastfeed your baby if you start treatment with Uplizna.

Driving and operating machinery
Uplizna is not expected to affect your ability to drive and operate machinery.

Uplizna contains sodium
This medicine contains 48 mg of sodium (the main component of table salt) in each
infusion, equivalent to 2% of the maximum daily intake recommended by the WHO which
corresponds to 2 g of sodium for an adult.

3. How Uplizna is administered

Uplizna is administered via intravenous infusion into a vein under the supervision of a doctor experienced in the treatment of patients affected by NMOSD.
The recommended dose is 300 mg.
The first dose is followed 2 weeks later by a second dose and, after this, by a dose every
6 months.
You will be given other medications half an hour to an hour before the infusion, to reduce the
risk of side effects. A doctor or nurse will monitor you during the infusion and for
one hour after the infusion.
If you have any doubts about the use of this medicine, please consult 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 explain the possible side effects, risks and benefits of Uplizna.

Serious side effects
Most serious side effectsare infusion-related reactions and infections
(see section 2). These side effects can occur at any time during treatment or even after it has finished. You may have more than one side effect
at the same time. If you experience an infusion-related reaction or an infection, call or see your doctor immediately.

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

• Bladder infection
• Infection of the nose, throat, sinuses and/or lungs
• Common cold
• Flu
• Joint pain
• Back pain
• Reduced immunoglobulins

Common(may affect up to 1 in 10 people)

• Lower than normal number of white blood cells, which sometimes occurs 4 weeks or more after the last dose of Uplizna
• Swollen sinuses, usually caused by an infection
• Pneumonia (lung infection)
• Cellulitis, a bacterial skin infection that can be serious
• Herpes zoster (a painful rash with blisters on one part of the body)
• Reaction to Uplizna infusion (see above “Infusion-related reactions”)

Uncommon(may affect up to 1 in 100 people)

• Blood infection (sepsis), an unusually serious response to an infection
• Progressive multifocal leukoencephalopathy (PML), an uncommon but serious brain infection caused by a virus
• Abscess (an infection under the skin usually caused by a bacterium)
• Bronchiolitis, a respiratory infection caused by a virus

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 listed in Annex V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Uplizna

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 pack after “Exp.”. The expiry
date refers to the last day of that month.
Store in a refrigerator (2 °C – 8 °C).
Store in the original package to protect the medicine from light.
Do not freeze.
Do not use this medicine if you notice particles and changes in color.

6. Package contents and other information

What Uplizna contains

• The active substance is inebilizumab.
• Each vial contains 100 mg of inebilizumab.
• The other components are histidine, histidine hydrochloride monohydrate, polysorbate 80, sodium chloride, trehalose dihydrate and water for injections.

Description of Uplizna and package contents
Uplizna 100 mg concentrate for solution for infusion is a solution from clear to slightly
opalescent, from colorless to yellowish provided in a carton containing 3 vials.

Marketing authorisation holder
Amgen Europe B.V.
Minervum 7061
4817 ZK Breda
Netherlands

Manufacturer
Horizon Therapeutics Ireland DAC
70 St. Stephen’s Green
Dublin 2
D02 E2X4
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 4220606

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

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 .