UPLIZNA 100 mg Concentrate for Solution for Infusion

2. What you need to know before you are given 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 have 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), a rare but serious brain infection caused by a virus.
• if you have been told you have serious immune system problems.
• if you have cancer.

Warnings and precautions

Tell your doctor, pharmacist, or nurse before you are given Uplizna if:

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

Infusion-related reactions

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

Children and adolescents

This medicine must 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, breastfeeding, and fertility

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

Pregnancy

Uplizna must not be used during pregnancy because the medicine may pass through the placenta and affect the baby. If you can become pregnant, you must use a contraceptive method (contraception) continuously once you start receiving Uplizna. If your doctor recommends stopping treatment, continue using your contraceptive method until 6 months after the last infusion.

Breastfeeding

It is not known whether Uplizna passes into breast milk. If you are breastfeeding, talk to your healthcare professional 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 major component of table salt/cooking salt) in each infusion. This is equivalent to 2% of the maximum recommended daily intake of sodium for an adult.

3. How Uplizna is given

Uplizna is given by infusion (drip) into a vein under the supervision of a doctor with experience in treating patients with NMOSD.

The recommended dose is 300 mg.

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

You will be given other medicines between half an hour and one hour before the infusion to reduce the risk of you getting side effects. A doctor or nurse will monitor you during the infusion and for one hour after.

If you are unsure, consult your doctor again.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Your doctor will discuss with you the possible side effects and explain the risks and benefits of Uplizna before treatment.

Serious side effects

The most seriousside effectsare infusion-related reactions and infections (see section 2). These side effects can occur at any time during treatment or even after your treatment has finished. You may experience more than one side effect at the same time. If you get 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)

• bladder infection
• infection in the nose, throat, sinuses, and/or lungs
• common cold
• flu
• joint pain
• back pain
• low immunoglobulin levels

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
• sinusitis, usually caused by an infection
• pneumonia (lung infection)
• cellulitis, a potentially serious bacterial skin infection
• shingles (herpes zoster, a painful rash with blisters on one part of the body)
• reaction to Uplizna infusion (see Infusion-related reactions, above)

Uncommon(may affect up to 1 in 100 people)

• blood infection (sepsis), an extremely 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 airways

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 is the last day of the month stated.

Store in a refrigerator (2°C - 8°C).

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

Do not use this medicine if you notice particles or a change in color.

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, sodium chloride, trehalose dihydrate, and water for injections.

Appearance and package contents

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

Marketing authorisation holder

Amgen Europe B.V.

Minervum 7061

4817 ZK Breda

Netherlands

Manufacturer

Horizon Therapeutics Ireland DAC

Pottery Road

Dun Laoghaire

Co. Dublin

A96 F2A8

Ireland

Manufacturer

Amgen NV

Telecomlaan 5-7

1831 Diegem

Belgium

You can request more information about this medicine from the local representative of the marketing authorisation holder:

Date of last revision of this leaflet:

Other sources of information

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