Prospect: information for the user

Uplizna 100 mg concentrate for solution for infusion

inebilizumab

This medicine is subject to additional monitoring, which will expedite the detection of new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section 4 includes information on how to report these adverse effects.

Read this prospect carefully before you are administered this medicine, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist or nurse.
• If you experience adverse effects, consult your doctor, pharmacist or nurse, even if they are not listed in this prospect. See section 4.

Uplizna contains the active ingredient inebilizumab and belongs to a class of medications called monoclonal antibodies. It is a protein that targets antibody-producing cells in the immune system (the body's natural defenses) called B lymphocytes. 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 spinal cord. It is believed that the disorder occurs when the immune system mistakenly attacks the body's nerves. Uplizna is administered to patients with NMOSD whose B lymphocytes produce antibodies against aquaporin-4, a protein that plays an important role in nerve function.

Do not use Uplizna

-if you are allergic to inebilizumab or any of the other components of this medication (listed in section 6).

-if you have an active severe infection such as hepatitis B.

-if you have active or latent untreated 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 that you have severe immune system problems.

-if you have cancer.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before receiving Uplizna if:

• you have or think you have an infection.
• you have ever taken, are taking, or plan to take medications that affect the immune system or other treatments for multiple sclerosis. These medications may increase your risk of infection.
• you have ever had hepatitis B or are a carrier of the hepatitis B virus.
• you have recently received a vaccine or are scheduled to receive one. You should receive any required vaccines at least 2 weeks before starting Uplizna treatment.

Infusion-related reactions

Uplizna may cause infusion-related reactions that can include headache, feeling sick (nausea), drowsiness, shortness of breath, fever, muscle pain, rash, or other symptoms. If symptoms occur, treatment may be interrupted or discontinued.

Children and adolescents

This medication should not be administered to children and adolescents because it has not been studied in this population.

Other medications and Uplizna

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

Pregnancy, breastfeeding, and fertility

If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor before receiving this medication.

Pregnancy

Uplizna should not be used during pregnancy as the medication may cross the placenta and affect the baby. If you can become pregnant, you should use continuous contraception once you start receiving Uplizna. If your doctor recommends discontinuing treatment, continue using contraception until 6 months after the last infusion.

Breastfeeding

The passage of Uplizna into breast milk is unknown. If you are breastfeeding, discuss the best way to feed your baby with your healthcare professional if you start Uplizna treatment.

Driving and operating machinery

Uplizna is not expected to affect your ability to drive or operate machinery.

Uplizna contains sodium

This medication contains 48 mg of sodium (main component of table salt/for cooking) in each infusion. This is equivalent to 2% of the maximum daily sodium intake recommended for an adult.

Uplizna is administered through infusion (perfusion) in a vein under the supervision of an experienced doctor in the treatment of patients with TENMO.

The recommended dose is 300 mg.

The first dose is followed 2 weeks later by a second dose, and then a dose every 6 months.

You will be given other medications between 30 minutes and 1 hour before the infusion to reduce the risk of adverse effects. A doctor or nurse will monitor you during the infusion and for 1 hour afterwards.

If in doubt, consult your doctor again.

Like all medicines, this medicine may cause side effects, although not everyone will experience them. Your doctor will review with you the possible side effects and explain the risks and benefits of Uplizna before treatment.

Severe side effects

Themost severeside effects are related to infusion and infections (see section 2). These side effects can occur at 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 experience an infusion-related reaction or an infection, call or consult your doctor immediately.

Other side effects

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

-Urinary tract infection

-Nasal, throat, paranasal sinus, and/or lung infection

-Common cold

-Influenza

-Joint pain

-Back pain

-Decreased immunoglobulins

Common (may affect up to 1 in 10 people)

-Low white blood cell count, which sometimes occurs 4 weeks or more after the last dose of Uplizna

-Paranasal sinus inflammation, usually caused by an infection

-Pneumonia (lung infection)

-Celulitis, a potentially severe bacterial skin infection

-Herpes zoster, a painful rash with blisters on a part of the body

-Uplizna infusion reaction (see Infusion-related reactions, above)

Uncommon(may affect up to 1 in 100 people)

-Blood infection (sepsis), an exceptionally severe response to an infection

-Progressive multifocal leukoencephalopathy (PML), a rare but severe brain infection caused by a virus

-Abscess, a skin infection usually caused by bacteria

-Bronchiolitis, a respiratory tract infection caused by a virus

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.esBy reporting side effects, you can contribute to providing more information about the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box after CAD.

The expiration date is the last day of the month indicated.

Store in refrigerator between 2 °C and 8 °C.

Store in the original box to protect it from light. Do not freeze.

Do not use this medication if you observe particles or a change in color.

Composition of Uplizna

• The active ingredient 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 injection preparations.

Appearance of the product and content of thecontainer

Uplizna 100 mg concentrate for solution for infusion is a transparent to slightly opalescent, colorless to slightly yellow solution that is supplied in a box containing 3 vials.

Holder of the marketing authorization and Responsible for manufacturing

Horizon Therapeutics Ireland DAC

70 St. Stephen’s Green

Dublin 2

D02 E2X4

Ireland

Date of the last review of this leaflet:

Other sources of information

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