Uplizna

Package leaflet: Information for the user

Uplizna 100 mg concentrate for solution for infusion

inebilizumab
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please 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 you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.
• Your doctor will provide you with a patient card containing important safety information that you should be aware of before and during treatment with Uplizna.

Contents of this leaflet

1. What Uplizna is and what it is used for
2. What you need to know before receiving 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 Uplizna is and what it is used for

Uplizna contains the active substance inebilizumab and belongs to a class of medicines called monoclonal antibodies. It is a protein that targets antibody-producing cells in the immune system (the body's natural defences), known as B-cells.
Uplizna is used to treat adults with:

• Neuromyelitis optica spectrum disorder (NMOSD), a rare condition affecting the optic nerves and spinal cord. This condition is believed to be caused by the immune system mistakenly attacking the body's own 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.
• Immunoglobulin G4-related disease (IgG4-RD), a rare condition affecting multiple organs in the body. The disease arises because the immune system damages the body's own tissues. Patients with IgG4-RD may have elevated levels of a specific type of antibody called IgG4. IgG4-producing B-cells accumulate in affected tissues and contribute to organ damage.
• Generalized myasthenia gravis (gMG), a rare condition in which the immune system attacks and damages muscle cells, causing muscle weakness throughout the body. Patients with gMG produce IgG autoantibodies directed against specific proteins, thereby disrupting or blocking nerve-to-muscle communication.

2. What you need to know before receiving Uplizna

Do not use Uplizna

• If you are allergic to inebilizumab or to any of the other ingredients of this medicine (listed in section 6).
• If you have an active severe infection such as hepatitis B.
• If you have untreated active or latent tuberculosis.
• If you have a history of progressive multifocal leukoencephalopathy (PML), a rare 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 receiving Uplizna if:

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

Infusion-related reactions
Inebilizumab may cause infusion-related reactions, which may include headache, nausea,
drowsiness, shortness of breath, fever, muscle pain, rash, palpitations, or other symptoms.
If symptoms occur, treatment may be paused 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, think you may be pregnant, or are planning to become pregnant, consult your doctor
before receiving this medicine.

Pregnancy
Uplizna must not be used during pregnancy, as the medicine may cross the placenta and
harm the unborn baby. If you are a woman of childbearing potential, you must always use a method of birth control (contraception) once you start receiving Uplizna. If your doctor advises you to stop treatment, continue using contraception for at least 6 months after your 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 feed your baby if you start treatment with Uplizna.

Driving and using machines
Uplizna is not expected to affect your ability to drive or use machines.

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

Uplizna contains polysorbate
This medicine contains 1 mg of polysorbate 80 per vial, equivalent to 0.1 mg/mL.
Polysorbates may cause allergic reactions. Inform your doctor if you have known allergies.

3. How Uplizna is administered

Uplizna is administered by intravenous infusion (drip) under the supervision of a doctor experienced in treating patients with the same disease.
The recommended dose is 300 mg.
The first dose is followed by a second dose 2 weeks later, and then by a dose every 6 months.
You will be given other medicines 30 minutes to 1 hour before the infusion to reduce the risk of unwanted effects. A doctor or nurse will monitor you during the infusion and for 1 hour after the infusion.
If you have any doubts about using this medicine, consult your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Before starting treatment, your doctor will explain to you the possible side effects, risks and benefits of Uplizna.
Serious side effects
Most serious side effects are infusion-related reactions and infections (see section 2). These side effects can occur at any time during treatment or even after treatment has ended. You may experience more than one side effect at the same time. If you experience an infusion-related reaction or an infection, call your doctor or seek immediate medical attention.
Other side effects
Very common (may affect more than 1 in 10 people)

• Bladder infection
• Infection of nose, throat, sinuses and/or lungs
• Common cold (nasopharyngitis)
• Influenza
• Joint pain
• Back pain
• Reduced immunoglobulins
• Lower than normal number of lymphocytes (a type of white blood cells) in the blood (lymphopenia)
• Reaction to Uplizna infusion (see above “Infusion-related reactions”)
• Headache

Common (may affect up to 1 in 10 people)

• Lower than normal number of neutrophils (a type of white blood cells) in the blood, which sometimes occurs 4 weeks or more after the last dose of Uplizna (neutropenia; delayed-onset neutropenia)
• Swollen sinuses, usually caused by an infection
• Pneumonia (lung infection)
• Cellulitis, a potentially serious bacterial skin infection
• Herpes zoster (a painful blistering rash on one part of the body)
• Muscle pain (myalgia)
• Fever (pyrexia)
• Cough

Uncommon (may affect up to 1 in 100 people)

• Blood infection (sepsis), an unusually severe response to an infection
• Progressive multifocal leukoencephalopathy (PML), a rare but serious brain infection caused by a virus
• Abscess (an infection under the skin usually caused by bacteria)
• Bronchiolitis, a viral infection of the respiratory tract

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via 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 stated on the carton after "Exp.". The expiry date refers to the last day of that month.
Store in a refrigerator (2 °C – 8 °C).
Keep in the original packaging to protect the medicine from light.
Do not freeze.
Do not use this medicine if you notice particles or changes in colour.

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, monohydrochloride monohydrate of histidine, polysorbate 80, sodium chloride, trehalose dihydrate, and water for injections.

Description of the appearance of Uplizna and contents of the pack
Uplizna 100 mg concentrate for solution for infusion is a solution ranging from clear to slightly opalescent, colourless to yellowish, supplied in a carton containing 3 vials.

Marketing Authorisation Holder
Amgen Europe B.V.
Minervum 7061
4817 ZK Breda
The Netherlands

Manufacturer
Horizon Therapeutics Ireland DAC
Pottery Road
Dun Laoghaire
Co. Dublin
A96 F2A8
Ireland

Manufacturer
Amgen NV
Telecomlaan 5-7
1831 Diegem
Belgium

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien