Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - uplizna

Document Subject

Generated Narrative: MedicinalProductDefinition mp664d393693f4983d6c9e5af3f5904561

identifier: http://ema.europa.eu/identifier/EU/1/21/1602/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Uplizna 100 mg concentrate for solution for infusion

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

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type: Strength part

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type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-664d393693f4983d6c9e5af3f5904561

identifier: http://ema.europa.eu/identifier/EU/1/21/1602/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - uplizna

Attesters

What is in this leaflet

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

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 reduce the risk of attacks in adults with a rare condition called neuromyelitis optic spectrum disorder (NMOSD), 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.

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 NMOSD. These medicines could increase your risk of getting an infection.

• have ever had hepatitis B or are a calirrier of the hepatitis B 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, 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 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 is given by a drip (infusion) into a vein under the supervision of a doctor experienced in treating patients with NMOSD.

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.

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
• flu
• joint pain
• back pain
• immunoglobulins decreased

Common (may affect up to 1 in 10 people)

• lower-than-normal number white blood cells in the blood, sometimes occurring 4 weeks or more after the latest dose of Uplizna
• 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)
• reaction to the Uplizna infusion (see Infusion-related reactions, above)

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 via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

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 discoloration.

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.

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 and Manufacturer

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

This leaflet was last revised in

Other sources of information

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