Patient leaflet - Uplizna 100 mg concentrate for solution for infusion
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) called B-cells.
Uplizna is used to treat adults with:
Neuromyelitis optic spectrum disorder (NMOSD), a rare condition
which affects the nerves of the eye and spinal cord. The condition is thought to be due to the immune system mistakenly attacking the nerves in the body. 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
which affects multiple organs in the body. The condition is due to the immune system damaging the body’s own tissues. Patients with IgG4-RD may have high levels of a specific type of antibody called IgG4. B cells producing IgG4 build up in affected tissues and contribute to organ damage.
Generalized myasthenia gravis (gMG), is a rare condition where
the immune system attacks and damages muscle cells causing muscle weakness throughout the body. Patients with gMG produce IgG autoantibodies against specific proteins, which disrupt or block communication between nerves and muscles.
2. What you need to know before you use Uplizna
Do not use Uplizna
if you are allergic to inebilizumab or any of the other ingredients
of this medicine (listed in section 6).
- if you are suffering from a severe active infection such as hepatitis B.
- if you have active or untreated latent tuberculosis.
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 that you have severe problems with your
immune system.
- if you have cancer.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before you are given Uplizna if you:
- have or think you have an infection.
have ever taken, take, or plan to take medicines that affect your
immune system, or other treatments for your condition. These medicines could increase your risk of getting an infection.
- have ever had hepatitis B or are a carrier of the hepatitis B virus
- have ever had hepatitis C or are a carrier of the hepatitis C virus.
have had a recent vaccination or are scheduled to receive any
vaccinations. You should receive any required vaccines at least 4 weeks before you start treatment with Uplizna.
Infusion-related reactions
Uplizna can cause infusion-related reactions, which can include headache, feeling sick (nausea), sleepiness, shortness of breath, fever, muscle pain, rash, palpitations or other symptoms. Treatment may be interrupted or stopped if symptoms occur.
Children and adolescents
This medicine should not be given to children and adolescents because 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, breast-feeding and fertility
If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before you are given this medicine.
Pregnancy
Uplizna should not be used during pregnancy as the medicine may pass across the placenta and affect the baby. If you are able to get pregnant you should use birth control (contraception) continuously once you start receiving Uplizna. If your doctor recommends stopping treatment, continue your contraception until 6 months after your last infusion.
Breast-feeding
It is not known if Uplizna passes into breast milk. If you are breast-feeding, talk to your healthcare provider about the best way to feed your baby if you start treatment with Uplizna.
Driving and using machines
Uplizna is not expected to impact your ability to drive or use machines.
Uplizna contains sodium
This medicine contains 48 mg sodium (main component of cooking/table salt) in each infusion. This is equivalent to 2% of the recommended maximum daily dietary intake of sodium for an adult.
Uplizna contains polysorbate
This medicine contains 1 mg of polysorbate 80 per vial which is equivalent to 0.1 mg/mL.
Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies.
3. How Uplizna is given
Uplizna is given by a drip (infusion) into a vein under the supervision of a doctor experienced in treating patients with your condition.
The recommended dose is 300 mg.
The first dose is followed 2 weeks later by a second dose, and after that a dose every 6 months.
You will be given other medicines 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 an hour afterward.
If you have any further questions on the use of this medicine, ask your doctor.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Your doctor will discuss the possible side effects with you and explain the risks and benefits of Uplizna prior to treatment.
Serious side effects
The most serious side effects are infusion-related reactions and infections (see section 2). These side effects may happen any time during treatment or even after your treatment has ended. You may experience more than one side effect at the same time. If you have an infusion-related reaction or infection, call or see your doctor right away.
Other side effects
Very common (may affect more than 1 in 10 people)
- bladder infection
- infection in the nose, throat, sinuses, and/or lungs
- common cold (nasopharyngitis)
- flu
- joint pain
- back pain
- immunoglobulins decreased
lower-than-normal number lymphocyte (a form of white blood cells)
in the blood (lymphopenia)
- reaction to the Uplizna infusion (see Infusion-related reactions, above)
- headache
Common (may affect up to 1 in 10 people)
lower-than-normal number of neutrophils (a form of white blood cells)
in the blood, sometimes occurring 4 weeks or more after the latest dose of Uplizna (neutropenia; late-onset neutropenia)
- swollen sinuses usually caused by an infection
- pneumonia (lung infection)
- cellulitis, a potentially serious bacterial skin infection
shingles (herpes zoster, a painful, blistering rash in one part of
the body)
- muscle pain (myalgia)
- fever (pyrexia)
cough
Uncommon (may affect up to 1 in 100 people)
- infection in the blood (sepsis), an unusually severe 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 bacteria)
- bronchiolitis, an infection of the airways caused by a virus
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly by using the Yellow Card scheme (see details below). By reporting side effects, you can help provide more information on the safety of this medicine.
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or
Apple App Store
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 carton after “EXP”. The expiry date refers to the last day of that month. Store in a refrigerator at 2°C to 8°C.
Store in the original carton to protect from light.
Do not freeze.
Do not use this medicine if you notice particulate matter and discolouration.
6. Contents of the pack and other information
What Uplizna contains
- The active substance is inebilizumab.
- Each vial contains 100 mg of inebilizumab.
- The other ingredients are histidine, histidine hydrochloride monohydrate, polysorbate 80 [E433], sodium chloride, trehalose dihydrate, and water for injections.
What Uplizna looks like and contents of the pack
Uplizna 100 mg concentrate for solution for infusion is a clear to slightly opalescent, colourless to slightly yellow solution supplied as one carton containing 3 vials.
Marketing Authorisation Holder
Amgen Limited
216 Cambridge Science Park
Milton Road
Cambridge
CB4 0WA
United Kingdom
Manufacturer
Horizon Therapeutics Ireland DAC
Pottery Road
Dun Laoghaire
Co. Dublin
A96 F2A8
Ireland
For any information about this medicine, please contact the Marketing Authorisation Holder:
Amgen Limited
Tel: +44 (0)1223 420305
This leaflet was last revised in March 2026
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Instructions for use for healthcare professionals handling Uplizna.
The following information is intended for healthcare professionals only.
Preparation of infusion solution
Prior to the start of the intravenous infusion, the prepared infusion solution should be at room temperature between 20°C and 25°C.
The concentrate should be visually inspected for particulate matter and discolouration. The vial should be discarded if the solution is cloudy, discoloured, or it contains discrete foreign particulate matter.
- The vial should not be shaken.
- The vial should be stored upright.
Obtain an intravenous bag containing 250 mL of sodium chloride
9 mg/ml (0.9%) solution for injection. Do not use other diluents to dilute inebilizumab as their use has not been tested.
- Withdraw 10 mL of Uplizna from each of the 3 vials contained in the carton and transfer a total of 30 mL into the 250 mL intravenous bag. Mix diluted solution by gentle inversion. Do not shake the solution.
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Uplizna®
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